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Fuel Cell Bus Trials on the BRT Hikoboshi Line

TOKYO, Feb 8, 2023 - (JCN Newswire via SEAPRWire.com) - Fukuoka Prefecture, Commercial Japan Partnership Technologies Corporation (CJPT), and Kyushu Railway Company (JR Kyushu) have entered an agreement to conduct trials of a small fuel cell electric bus (FC bus) that runs on hydrogen, an environmentally-friendly next-generation energy source, on the BRT Hikoboshi Line (officially "Hitahikosan Line BRT"), a bus rapid transit system planned for launch around the summer of 2023.This initiative will be the first implementation of the partnership agreement between Fukuoka Prefecture and CJPT, entered into on December 26 last year, to expand commercial FC mobility and create a sustainable hydrogen society with the aim of achieving carbon neutrality. Fukuoka Prefecture and CJPT will work with JR Kyushu to hold the trials with a view to bringing FC mobility to local transportation.With the cooperation of communities along the line, JR Kyushu is working toward the launch of the BRT Hikoboshi Line, which is under development based on the concept of being "kind to people, communities, and the future." Expectations are that the trials of a next-generation small FC bus will further advance efforts toward regional development as an environmentally friendly transportation option.Going forward, Fukuoka Prefecture, CJPT, and JR Kyushu will collaborate in preparing to launch the trial runs as follows.1. Overview of the initiativeTrial runs for the practical application of next-generation small FC buses that run on hydrogen energySignificance and aims of the trials- The trials aim to deepen awareness of hydrogen as a future energy source by using it to operate a local transportation system familiar to residents while achieving region-wide sustainable growth.- By verifying the feasibility of adopting FC mobility, the trials will increase the options for local transportation and help create a green transportation system.- While bringing the use of hydrogen to local transportation, the trials will lead to the development of areas along the Hitahikosan Line BRT.Roles of each partyFukuoka Prefecture: Overall coordination and support for improving the environment of the trial runs CJPT: Development planning for the next-generation hydrogen bus and coordination of the trial vehicle JR Kyushu: Operation of the trial vehicle on the BRT Hikoboshi Line2. Trial vehicleVehicle stylingDrawing on the image of hydrogen as an environmentally friendly energy, the trial vehicle is styled to reflect the blue skies prevalent along the route of the BRT Hikoboshi Line. The use of a pattern that depicts the flowing robes of Orihime―a name for star Vega and lover of Hikoboshi (the star Altair) from Japanese legend―creates a unified and original styling for all vehicles to operate on the BRT Hikoboshi Line.Vehicle overviewSmall FC bus 1 vehicle FC bus based on the Toyota Coaster, 20-seater(1) with actual seating for 14 (planned)Length x Width x Height 6,990 mm x 2,100 mm x 2,630 mm Second-generation FC system from Mirai FCEV, with outstanding environmental performance of zero CO2 emissions during operation(2)Trial periodApproximately fall 2023 to spring 2025 (planned)Additional informationDetailed information, including the start date and timetables of the trial to be conducted prior to the trial runs and the actual trial runs, will be announced at a later date.(1) Includes driver's seat(2) FC mobility options are environmentally friendly vehicles that use a chemical reaction between hydrogen and oxygen to generate electricity, which does not generate CO2 emissions during use.For more information, visit https://global.toyota/en/newsroom/corporate/38698094.html. Copyright 2023 JCN Newswire. All rights reserved. (via SEAPRWire)

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DOCOMO Conducts World’s First Trial of Transmissive Metasurface on Window to Deliver Indoor Radio Waves to Outdoor Foot of Building

TOKYO, Jan 30, 2023 - (JCN Newswire via SEAPRWire.com) - NTT DOCOMO, INC. announced today that it has succeeded in what it believes to be the world's first trial of redirecting millimeter-band (28 GHz) radio waves coming from inside a building to the foot of the building outdoors by bending the radio waves with a film-shaped transmissive metasurface(1) attached to a window surface. The trial was conducted from October to November 2022 at the DOCOMO R&D Center in Yokosuka, Japan, aiming at realization of advanced fifth-generation (5G Evolution) and sixth-generation (6G) mobile communication systems.High-frequency radio waves, which are expected to be used in 5G Evolution and 6G, have difficulty coming around behind obstacles and are easily attenuated as propagation distances increase. DOCOMO has also been studying the use of metasurface technology to enhance radio signal reception indoors using outdoor base station(2), and to improve indoor with many obstructions as a user moves(3).Radio waves in the high-frequency band have difficulty reaching places that are not in the line of sight of the transmitting base station installed on the rooftop of buildings, making it difficult to create reception areas at the foot of buildings. One of the solutions is to install antennas on a neighboring structural object, but there are cases where such installation is not possible due to landscape and other issues. This trial was conducted in order to expand the area coverage around the foot of a building.The transmissive metasurface for the 28 GHz band used in the trial is a metasurface designed and processed to bend millimeter wave bands passing through a glass window in a specific direction, in this trial, towards the bottom of a building's exterior(4). The film-shaped material was attached to the window glass on the interior side, making it easier to install, and its transparency did not spoil the landscape and existing design. In addition, the transmissive metasurface is designed not to affect other frequency bands such as LTE and Sub-6 bands.Millimeter waves from a base station installed indoor passed through transmissive metasurfaces on the window glass and throughput performance in the foot area of the building was measured. We confirmed that the throughput performance in the foot area was greatly improved by bending the millimeter waves with the transmissive metasurfaces.DOCOMO is also researching and developing various technologies to improve indoor and outdoor coverage in the high frequency bands. For example, it may be possible to direct signals from Multi-Sector Antenna Indoor Base Station, as announced by DOCOMO on January 30(5), to the transmissive metasurface attached to a glass window to improve both indoor and outdoor area coverage. Also, in the future, when constructing a massive multiple-input multiple-output (MIMO) system that uses much larger number of antennas, it may be possible to achieve an equivalently large-scale configuration with a relatively small number of antennas at a low cost by applying metasurface technology(6).Going forward, DOCOMO will continue to research and develop efficient and flexible construction of reception areas and radio configurations for 5G Evolution and 6G.The transmissive metasurface used in the trial will be exhibited at "docomo Open House '23," which will be held online from Thursday, February 2.(1) Metasurfaces are a type of artificial medium (metamaterial) that achieve arbitrary permittivity and permeability by periodically arranging structures that are small in relation to wavelength, and are artificial surfaces in which the periodic arrangement of structures is two-dimensional.(2) "DOCOMO and AGC Use Metasurface Lens to Enhance Radio Signal Reception Indoors" (January 26, 2021)www.docomo.ne.jp/english/info/media_center/pr/2021/0126_00.html(3) "NTT and NTT DOCOMO Trial First Use of User-tracking Metasurface Reflector for Extreme Mobile Coverage in Current 5G and Coming 6G Era" (November 12, 2021)www.docomo.ne.jp/english/info/media_center/pr/2021/1112_00.html(4) The transmissive metasurfaces were designed and provided based on the cooperation of AGC Inc.(5) "Small, Efficient 5G Multisector Antenna Indoor Base Station Achieves World's First Demonstration using 28GHz" (January 30, 2023)www.docomo.ne.jp/english/info/media_center/pr/2023/0130_01.html(6) "5G Evolution and 6G (5.0 version)," NTT DOCOMO (November 2022)bit.ly/3HDP8E6 (Japanese only)About NTT DOCOMONTT DOCOMO, Japan's leading mobile operator with over 85 million subscriptions, is one of the world's foremost contributors to 3G, 4G and 5G mobile network technologies. Beyond core communications services, DOCOMO is challenging new frontiers in collaboration with a growing number of entities ("+d" partners), creating exciting and convenient value-added services that change the way people live and work. Under a medium-term plan toward 2020 and beyond, DOCOMO is pioneering a leading-edge 5G network to facilitate innovative services that will amaze and inspire customers beyond their expectations.https://www.docomo.ne.jp/english/. Copyright 2023 JCN Newswire. All rights reserved. (via SEAPRWire)

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APAC Attracts 50% of Global Clinical Trials According to New GlobalData Report

SYDNEY, Sep 2, 2022 - (ACN Newswire via SEAPRWire.com) - Novotech, the leading Asia Pacific biotech specialist CRO has released new market data in a report now available titled "Evolution of Clinical Trials in the Asia Pacific Region". The report was prepared by GlobalData and confirms that "the Asia-Pacific (APAC) region was the largest contributor to the global clinical trial landscape from 2017 to 2021, accounting for more than 50% of conducted trials during the analysis period."Download report here https://novotech-cro.com/whitepapers/evolution-clinical-trials-asia-pacific-region-compared-us-and-eu5In addition, the GlobalData research found that all phases of clinical trials in the region registered higher growth than both the US and the EU5.The region registered significantly higher growth than the US and the EU5 across all analysed therapeutic areas, including CNS diseases, cardiovascular diseases, gastrointestinal diseases, and infectious diseases, the latter of which witnessed the highest growth. There was also 100% growth in oncology trials during the same period.GlobalData analysis of this strong growth has been linked to a range of factors, including:- site availability, particularly for oncology trials, when compared to the US and Europe- lower operating costs- the pharmacogenomic profile of Asian populations as a key factor that requires Phase I data in local populations. "Add to the mix the ease of regulatory compliance as well as the high standards required, and overseas drugmakers have never been keener to access this burgeoning market," according to GlobalData. "Recent streamlining of drug approval by the government, guided by the National Health Commission (NHC) and National Medical Products Administration (NMPA), has also resulted in a more efficient and clear-cut drug approval system based on global standards."According to Yooni Kim, Vice President, Global Clinical Services Novotech: "Asia-Pacific offers a compelling solution for expedited clinical trials with its vast patient populations, less competitive clinical trial landscape, and world-class KOLs, in addition, regulatory reforms have accelerated approval processes. Novotech's service delivery model is tailored to the needs of biotech clients. Our local teams have exceptional site and investigator access, our project management approach emphasizes problem-solving, ownership and flexibility, and our investments in data and technology ensure clients have real-time access to trial performance. In addition, experienced CRO operations across APAC and the US offer a unique and unparalleled suite of services for early to late phase biotech clinical research."Novotech has recently been benchmarked as a top 10 CRO among the world's leading CROs, and has signed 45 Leading Site Partnership agreements over the last 3 years. About Novotech Novotech is the leading Asia-Pacific biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 4,000 clinical trials across a broad range of therapeutic areas. Novotech is well-positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/contactMedia ContactDavid JamesE: communications@novotech-cro.comAU: +61 2 8218 2144 USA: +1 415 951 3228Asia: +65 3159 3427 Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Zhaoke Ophthalmology Announces 2022 Interim Results

HONG KONG, Aug 24, 2022 - (ACN Newswire via SEAPRWire.com) - Zhaoke Ophthalmology Limited ("Zhaoke Ophthalmology" or the "Company", SEHK: 6622), a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacturing and commercialization of therapies that address significant unmet medical needs, today announced its interim results for the six months ended 30 June 2022 ("Reporting Period").Zhaoke Ophthalmology is strategically focused on treatments that cover a wide range of ophthalmic diseases, with one of the largest and most comprehensive drug portfolios of innovative and generic treatments covering the six major eye diseases across both the front-and back-of-the-eye, including dry eye disease ("DED"), myopia, presbyopia, wet age-related macular degeneration ("wAMD"), diabetic macular edema ("DME") and glaucoma. The Company's portfolio includes several potential blockbuster innovative drug candidates.Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, said, "Innovation and commercialization are Zhaoke Ophthalmology's dual focuses for 2022. We are proud to say that in the first half of 2022, we accomplished multiple milestone achievements in both areas, despite the challenging environment in China and globally."The first highlight has been the completion of patient recruitment for concurrent Phase III clinical trials for one of the Company's core innovative drug candidates, NVK002, significantly ahead of schedule. In July 2022, NVK002, a treatment for myopia progression in children and adolescents, completed the recruitment for its concurrent two-year Phase III clinical trial ("China CHAMP") and one-year Phase III bridging trial ("Mini-CHAMP"). The China CHAMP trial involves 19 centers and 770 patients, and the Mini-CHAMP involves 18 centers and 526 patients. The former completed enrolment on 21 July 2022, two months ahead of schedule, while the latter completed enrolment on 28 July 2022, three months ahead of schedule. Dr. Li continued, "Completing patient recruitment for these clinical trials so far ahead of schedule reflects both the strong capabilities and expertise of Zhaoke Ophthalmology's clinical operations team, as well as the immense demand for a safe and efficacious treatment for myopia progression in China."The second highlight is the launch of Zhaoke Ophthalmology's first commercialized product, "Baodeshi" the Heat Compress Eyepatch, a category 2 medical device for reducing symptoms of mild cases of dry eye. The Eyepatch launch, will accelerate the Company's efforts to establish an omnichannel commercial strategy Dr. Li added, "We are excited about the recent launch of the "Baodeshi" Heat Compress Eyepatch with an official flagship store on Tmall. The launch of the eyepatch exemplifies our core belief that a combination of drug regimen therapy and medical device will ultimately deliver the best treatment options for many patients. Moreover, the eyepatch also helps to increase the general public's awareness and knowledge of eye diseases and treatment solutions in China."During the Reporting period, Zhaoke Ophthalmology achieved several milestones across its comprehensive drug pipeline. The Company's self-developed innovative drug, CsA Ophthalmic Gel for DED, submitted a New Drug Application (NDA) to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. The submission was accepted in June 2022 and is now under review by the CDE. In May 2022, Zhaoke Ophthalmology announced a new partnership with Visus, a US pharmaceutical company, to license BRIMOCHOL(TM) PF and Carbachol PF, innovative drugs for presbyopia. The introduction of the two innovative assets enabled Zhaoke Ophthalmology to become the first ophthalmic pharmaceutical company in China with innovative drugs in advanced clinical development covering the three major front-of-the-eye diseases - dry eye, myopia, and presbyopia. Also, TAB014, the company's first drug for the treatment of back-of-the-eye diseases, initiated a Phase III clinical trial and the first patient was enrolled for wAMD in June 2022. Zhaoke Ophthalmology continues to focus on enhancing the Company's innovative omni-channel strategy through expanding its partnership network and strengthening digital engagement The strategy was kick-started with the launch of the Zhaoke Boshi WeChat platform in September 2021, in response to the demand from the ophthalmologist community for high quality content focusing on cutting-edge ophthalmology research in China and globally. This platform not only showcases outstanding content, but also allows leading KOLs to share their knowledge and best practices and facilitates discussions in the Chinese ophthalmologist community. Less than a year after its launch, the Zhaoke Boshi platform has attracted close to 10,000 followers. At the same time, over 60 leading KOLs in various fields of ophthalmology have contributed content or participated in livestream discussions on the platform.Following the momentum established by Zhaoke Boshi, the launch of "Baodeshi" Heat compress eyepatch on Tmall with its own flagship store, marks the next milestone in our omni-channel commercialization strategy by establishing a direct channel of interaction with dry eye patients and eye-health-conscious consumers alike. In February 2022, the Company established a corporate gift agreement with John Hopkins University, one of the world's leading private research institutes, to support translational research and academic exchange. In March 2022, Zhaoke Ophthalmology signed strategic partnership agreements with three of China's leading pharmaceutical supply chain service companies, Sinopharm Group Distribution Co., Ltd, Shanghai Pharmaceuticals Co., Ltd., and China Resources Pharmaceutical Commercial Group Limited to collaborate in areas including procurement models, logistics management, market developments, joint projects and information communication.Turning to financial performance, Zhaoke Ophthalmology recorded a total loss of approximately RMB161.0 million for the six months ended 30 June 2022, compared to an approximately RMB1,987.7 million for the same period in 2021. During the period, the Company's R&D expenses reached approximately RMB100.9 million, compared to approximately RMB123.4 million for the six months ended 30 June 2021. Whilst the decrease in R&D expenses is mostly a result of the timing of various clinical programs, the Company is strictly focused on exercising discipline towards capital expenditure in light of overall financial market conditions.As at the end of the Reporting Period, Zhaoke Ophthalmology recorded cash, cash equivalents and time deposits of approximately RMB1,860.3 million.Dr. Li continued, "Looking forward, we anticipate the second half of 2022 will be an exciting period for Zhaoke Ophthalmology. Several milestones are expected to be completed in the coming months, including our partner Vyluma Inc. announcing the clinical results of their global three-year Phase III trial for NVK002. This will be an important step towards making this drug potentially the first US FDA-approved low-dose atropine for the treatment of myopia progression in children and adolescents."He added, "Meanwhile, we will continue to adhere to our strategy ando combine our strong R&D capabilities, comprehensive asset portfolio and innovative commercialization approach to capture the huge unmet medical need not only in China, but also globally. With the dedication and unwavering passion of our employees, we are well positioned to capture the tremendous market opportunity." Zhaoke Ophthalmology highlighted several pipeline updates as a part of the results announcement:CsA Ophthalmic Gel for DED (self-developed)OverviewCsA Ophthalmic Gel is an innovative drug being developed by us for the treatment of moderate to severe DED. It is a single, daily dose hydrogel which eliminates daytime administration and the associated discomfort and inconvenience and aims to dramatically improve patients' treatment compliance and quality of life. It is a proprietary hydrogel with patent approval in China and internationally. This novel formulation enhances the pharmacokinetic profiles of CsA on the ocular surface allowing efficacy similar to that of Cyclosporine A products currently available for DED. However, unlike the current treatment, CsA Ophthalmic Gel's unique formulation stays on the eye for longer, requiring only once-a-day dosing (compared with traditional twice-a-day dosing). In the Phase III clinical trial for CsA Ophthalmic Gel, the treatment also showed a faster onset of action by demonstrating efficacy at around a two-week period, while other CsA drugs normally take around seven to eight weeks.Updates during the Reporting PeriodOn June 8, 2022, the NDA for CsA Ophthalmic Gel was accepted for review by the CDE.Our Company continues to target the commercialization of CsA Ophthalmic Gel in China as early as 2023. Due to the treatment's potential to benefit millions of people globally, we are also exploring opportunities outside of China.NVK002 (Atropine) for Myopia (partnered with Vyluma)OverviewTo date, low concentration atropine is the only medication that is consistently effective in myopia progression control among children and adolescents. Our innovative treatment, NVK002, is currently positioned as the first clinically-proven pharmaceutical product approved for treating the progression of myopia globally. This treatment has a proprietary formulation that successfully addresses the instability of low-concentration atropine and is preservative-free with an expected shelf life of more than 24 months. The clinical development of NVK002 involves two different concentrations of preservative-free atropine (0.01% and 0.02%) to determine the efficacy, safety and tolerability in children and adolescents with myopia, offering a distinct choice for doctors and patients.Our Company's licensing partner for NVK002 is Vyluma, a wholly owned subsidiary of US-based Nevakar. Vyluma is currently conducting the Phase III clinical trial for NVK002 in the US and Europe. The results of the three-year trial are expected to be available by the end of 2022 and will be followed by an NDA submission to the FDA in 2023.In September 2021, we received approval from the CDE to initiate two concurrent Phase III clinical trials, including China CHAMP and Mini-CHAMP. Combined with global data from Vyluma's Phase III clinical trial in the US and Europe, the overall trial for NVK002 will be one of the most comprehensive and robust Phase III clinical trials for low dose atropine use in the world.Updates during the Reporting PeriodThe main objective of China CHAMP and Mini-CHAMP is to evaluate the efficacy and safety of NVK002 in the treatment of myopia progression in children and adolescents from 3 to 17 years old.Led by Professor Wang Ningli from Beijing Tongren Hospital as the principal investigator, the China CHAMP trial involves 19 centers and has completed the enrollment of 777 patients. Co-led by Professor Qu Xiaomei from the Eye and ENT Hospital of Fudan University and Professor Yang Xiao from the Zhongshan Ophthalmic Center of Sun Yat-Sen University as the principal investigators, the Mini-CHAMP trial involves 18 centers and has completed the enrollment of 526 patients.Both the China CHAMP and Mini-CHAMP have completed patient recruitment in July 2022, representing two and three months significantly ahead of schedule respectively. The early completion of patient recruitment across both trials gives our Company a strong head start in moving towards the goal of leading the market in launching a myopia progression treatment.The drug could be available in the PRC market as early as 2024, potentially making Zhaoke Ophthalmology one of the first companies to commercialize a myopia drug in the PRC market.BRIMOCHOL(TM) PF and Carbachol PF (partnered with Visus)OverviewBRIMOCHOL(TM) PF and Carbachol PF are pupil-modulating eye drops designed to be once-daily, preservative-free therapeutics to correct the loss of near vision associated with presbyopia. BRIMOCHOL(TM) PF is a fixed-dose combination of carbachol (a cholinergic agent) and brimonidine tartrate (an alpha-2 agonist). Carbachol PF is a proprietary, preservative-free formulation of carbachol monotherapy. Both investigational therapies reduce the size of the pupil resulting in a "pinhole effect" so that only centrally focused light rays are able to enter the eye, thereby sharpening both near and intermediate images.In the VIVID Phase II study conducted by Visus in the US, both formulations met primary and secondary endpoints, demonstrating a three-line improvement in near visual acuity with no loss of distance vision out to nine hours. Both BRIMOCHOL(TM) PF and Carbachol PF were well tolerated with no serious adverse events. Phase III pivotal trials commenced in March 2022, with interim topline data expected in the fourth quarter of 2022.Corresponding to the ongoing Phase III clinical study of BRIMOCHOL(TM)PF and Carbachol PF in the US, we plan to launch a clinical study in China for presbyopia in the near future.TAB014 (Bevacizumab) for wAMD (partnered with TOT BIOPHARM)OverviewTAB014 is the first clinical-stage bevacizumab-based antibody indicated for wAMD in China. Bevacizumab is a clinically validated anti-VEGF drug. Globally, bevacizumab is approved for oncology treatment through intravenous infusion. However, there has been increasing off label use of bevacizumab via intravitrealinjection for the treatment of wAMD.Updates during the Reporting PeriodIn March 2022, Zhaoke Guangzhou, a wholly-owned subsidiary of our Company, and TOT BIOPHARM Co., Ltd. Suzhou, a wholly owned subsidiary of TOT BIOPHARM, entered into a supplemental agreement - pursuant to which Zhaoke Guangzhou will have full control in the execution of clinical trials and the ultimate decision-making power in the development and commercialization of TAB014 in China, Hong Kong and Macau. Zhaoke Guangzhou has also been given the right to develop TAB014 for other ophthalmic indications besides wAMD or novel formulations for ophthalmic indications.On June 28, 2022, we completed the recruitment of the first patient for the Phase III clinical trial of TAB014.The Phase III clinical trial of TAB014 is a randomized, double-blind and noninferiority study. The main objective of the study is to evaluate the change from baseline in best corrected visual acuity (BCVA) at week 52 in TAB014-treated subjects group compared with Lucentis(R)-treated subjects group. The study will involve up to approximately 60 centers and enroll a total of 488 patients, led by Professor Chen Youxin from Peking Union Medical College Hospital as the principal investigator.ZKY001 (self-developed)OverviewZKY001 is a seven-amino acid peptide derived from the functional fragment of Thymosin beta4 that binds actin, a type of protein that plays a central role in cell structure and movement. We are exploring multiple indications as we believe this asset can potentially be applied to multiple disease indications.ZKY001 has broad applications in the healing of corneal wounds and can potentially be used in multiple indications. We are currently exploring four indications for ZKY001, including CED, corneal epithelial defect, TPRK, a surgical treatment for myopia, pterygium, a growth in the cornea or the conjunctiva, and NK, a rare degenerative corneal disease.Updates during the Reporting PeriodWe completed treatment for the last patient in the Phase II clinical trial of ZKY001 for CED in February 2022. On March 16, 2022, the first patient was enrolled for Phase II clinical trial for pterygium disease. On August 5, 2022, the first patient was enrolled for the Phase II clinical trial for TPRK. We will refine our clinical development strategy for this asset once we have the trial results across multiple indications.NTC010OverviewNTC010 is a fixed dose combination of antibiotics and steroids to prevent infection and inflammation for patients undergoing cataract surgery. The drug belongs to a new generation of antibiotics, which increase efficiency and cover a wider range of bacteria. The drug also shortens the duration of the treatment by half - from 14 to seven days - making it beneficial to patients' overall health and helping to prevent antibiotic overuse. The drug has already been approved in seven European countries. We plan to submit an NDA to the NMPA in the near future.PAN-90806 (VEGFR2 inhibitor) for wAMD and DME (partnered with PanOptica)OverviewPAN-90806 is an innovative drug indicated in the treatment of wAMD, as well as DME, the leading cause of blindness in diabetic patients worldwide. PAN-90806 is a novel eye drop formulation, which decreases the number of injections required. If approved as a maintenance therapy, PAN-90806 will bring significant convenience and a less invasive treatment alternative for patients. This will reduce the frequency of intravitreal injections and other treatment issues associated with mainstream anti-VEGF therapies while at the same time maintaining visual stability. PAN-90806 is expected to significantly reduce treatment discontinuation, and therefore slow underlying disease progression through improved patient comfort, acceptance, convenience and compliance.We are currently focused on optimizing the formulation of PAN-90806. Subject to regulatory approvals, our Company plans to commence human trials after completion of requisite animal studies.Generic DrugsWe follow a balanced approach in designing our drug pipeline. In addition to innovative drug candidates, our Company has several key generic drugs in the pipeline. Generic drugs address a substantial portion of ophthalmic medical needs in China. From a market demand perspective, our generic pipeline complements our innovative pipeline and better positions us to become an efficient one-stop comprehensive solution provider. From a supply perspective, our generic programs also offer several strategic benefits.During the Reporting Period, we continue to focus on commercializing Bimatoprost Timolol, a generic drug for glaucoma, as our first commercialized drug asset. The launch of this treatment will position us in the under-served glaucoma market and prepare us for the future commercial launch of our innovative drugs.About Zhaoke OphthalmologyFounded in 2017, Zhaoke Ophthalmology (SEHK: 6622) is a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacturing and commercialization of therapies that address significant unmet medical needs in the world. The company was listed on the Main Board of the Hong Kong Stock Exchange on 29 April 2021. Zhaoke Ophthalmology has a comprehensive drug portfolio of innovative and generic treatments covering six major eye diseases across both the front and back of the eye. Many of the drugs are being produced in its state-of-the-art and fully functional development and production facility in Nansha, Guangzhou.Zhaoke Ophthalmology is focusing on advancing towards the goal of product commercialisation, and achieving the objective of improving visual health in China through scientific research as soon as possible.Through its ambitious growth strategy, including partnering with domestic and international pharmaceutical companies, Zhaoke Ophthalmology's goal is to become a leader in ophthalmology in the world. For more information, please visit: www.zkoph.com Media Contact:Artemis Associates Diana Footitt, CEOM: +852 9183 0667E: diana.footitt@artemisassociates.comBowen Chui, DirectorM: +852 9783 0643E: bowen.chui@artemisassociates.comIris Pei, DirectorM: +86 15000 465 016E: iris.pei@artemisassociates.com Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Legend Capital Portfolio: China-leading CRO Enterprise R&G Pharmastudies Listed on the ChiNext Market Successfully

HONG KONG, Aug 15, 2022 - (ACN Newswire via SEAPRWire.com) - On August 2, 2022, R&G Pharmastudies Co., Ltd. (stock code: 301333.SZ), a China-leading CRO enterprise invested by Legend Capital, was successfully listed on the ChiNext of Shenzhen Stock Exchange. R&G Pharmastudies publicly issued 15,000,000 shares at a price of RMB78.88 per share, and the total amount of funds raised is expected to be RMB1.18 billion.R&G PharmaStudies is a large-scale professional clinical trial outsourcing service supplier in China. It has established a complete set of pharmaceutical R&D outsourcing service systems covering the whole chain of clinical trials. R&G PharmaStudies provides integrated services throughout the entire process of clinical trials with its comprehensive drug R&D service system; the main services offered by the company cover clinical trial operation services, clinical trial site management services, biological sample testing services, data management, and statistical analysis services, clinical trial consulting services, clinical pharmacology services, etc. R&G PharmaStudies is committed to providing high-quality and efficient clinical research services in line with international standards. With a broad and high-quality customer base, it has provided professional services for about 750 Chinese and foreign pharmaceutical companies.Legend Capital invested in the Series A round of R&G PharmaStudies in the second half of 2017 and has kept on supporting the development of R&G PharmaStudies. Jafar Wang, the Co-Chief Investment Officer of Legend Capital, said, "Congratulations on the successful listing of R&G PharmaStudies! R&G PharmaStudies is a veteran of China's pharmaceutical clinical CRO industry and has long provided full-chain clinical CRO services for Chinese and foreign innovative pharmaceutical enterprises. The successful listing will be the starting point of the new long run of R&G PharmaStudies; with its global vision, well-known expert team, and high-quality service system, we are optimistic about the long-term development potential of R&G PharmaStudies, and look forward to the continuous growth of the company." Legend Capital has a systematic layout in CRO/CDMO. In addition to R&G PharmaStudies, Legend Capital has invested in plenty of other new-drug R&D CRO/CDMO companies, such as WuXi Apptec, WuXi Biologics, Pharmaron, Bellen, ClinChoice, SAFE Pharmaceutical, dMed Biopharmaceutical, XiHua Scientific, BirdoTech, Intellective Biologics, Biortus, and Simoon Record.About Legend CapitalFounded in 2001, Legend Capital is a leading VC&PE investor focusing on the early-stage and growth-stage opportunities in China, with offices across Beijing, Shanghai, Shenzhen, Hong Kong, and Seoul, Korea. It currently manages USD and RMB funds of over US$10 billion in commitments and has invested in around 600 companies, covering technology, healthcare, consumer, enterprise service and intelligent manufacturing sectors. Rooted in China, Legend Capital participated in the rise of many world-leading companies through solid investment coverage and systematic post-investment value-add. Over the years, Legend Capital has also become a widely recognized name in bridging key resources in China and overseas through cross-border activities, and a valuable partner to Chinese and overseas investors. Legend Capital values long-term sustainable investment and incorporates ESG into its long-term development strategy. As a UNPRI signatory since November 2019, Legend Capital is among the first group of top VC/PE firms in China to join the initiative. For more information, please visit www.legendcapital.com.cn/index_en.aspx and follow us on LinkedIn @Legend Capital (https://www.linkedin.com/company/legend-capital). Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Virios Therapeutics: The ‘Virus Hypothesis’ That Stands to Change the Lives of 10M Americans

NEW YORK, NY, Aug 9, 2022 - (ACN Newswire via SEAPRWire.com) - PCG Digital -- Life may change for the better for the 10 million Americans suffering from fibromyalgia. The development-stage biotech Virios Therapeutics, Inc. (Nasdaq:VIRI) is anticipating the reporting of phase 2b treatment results for its lead fibromyalgia treatment candidate this September and continues to add value through its research and development of compelling clinical assets for multiple categories of viruses.Virios Therapeutics, Inc.Humans and viral pathogens have co-existed for millennia. Some human viruses are gone as quickly as they came, while others - such as the herpes virus - are able to co-exist with a human's immune system, leaving genetic material permanently in the host's cells.Nearly four billion people around the world are infected with herpes viruses. Most of us don't even know if we are infected and the virus may remain dormant in the body for months or years before reactivating in response to stress.Dr. William Pridgen, the founder of Virios Therapeutics, Inc. has observed the effects of virus reactivation firsthand. In 2002, he noted recurring functional gastrointestinal disorder symptoms ("FGIDs") in his surgical patients that waxed and waned, worsening in times of stress. He observed that his treatment protocol for these patients - a combination of antiviral drugs - not only improved his patient's FGIDs, but also alleviated symptoms including pain, fatigue, depression and fibromyalgia (FM).We spoke with Dr. Pridgen to learn more about the virus hypothesis and why he thinks Virios Therapeutics' lead candidate could potentially be life-changing for the 10 million Americans living with FM.Q: Can you tell us about FM and how IMC-1, Virios Therapeutics' lead product candidate, could potentially be an effective treatment?FM is a chronic pain disorder characterized by severe fatigue, gastrointestinal and sleep disturbances and increased levels of depression and anxiety. It can be difficult to diagnose - on average, patients wait five years for a diagnosis, due to the lack of widely-accepted medical testing - and the disorder can be even harder to treat. There are currently three FDA approved drugs available to FM patients, each of which treat the symptoms of FM, rather than targeting a potential underlying cause of the disease. All three approved medications work to control pain, but often induce side-effects which can limit their utility when used chronically, as is required to manage FM. As a result, patients are largely dissatisfied with available treatments.In a recent phase 2a double-blind randomized controlled trial, FM patients who took IMC-1 reported statistically significant improvements in pain, fatigue, anxiety and depression compared with patients treated with placebo. Notably, IMC-1 was better tolerated than placebo in this proof-of-concept trial. A follow-on phase 2b trial of IMC-1, called FORTRESS (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1), is fully recruited, with results expected to be reported in September 2022.Q: How does IMC-1 work?It is my belief that viral outbreaks of herpes resident in the central nervous system, where the brain amplifies the aberrant pain processes that the research community believes is causing FM. Our lead development candidate, oral IMC-1, offers the exciting potential to treat a potential root cause of fibromyalgia - not just management of select symptoms - but by suppressing viral activity and improving FM patients symptoms and functioning.IMC-1 is a fixed-dose combination of two medications, famciclovir and celecoxib, that work together to inhibit replication of activated herpes viruses and convert activated herpes back into a dormant state. Famciclovir inhibits viral DNA polymerase, a key enzyme that the virus uses to make DNA and replicate. Meanwhile, celecoxib inhibits a different enzyme, cyclooxygenase-2, which is upregulated during herpes virus replication. By targeting two enzymes important for viral replication, this combination treatment has to-date proven to effectively treat FM, and because of the novelty of the approach, has garnered the first-ever FDA "fast track" review designation.Q: Based on your real-world experience, can you tell us more about how IMC-1 has the potential to change lives?Living with FM can be debilitating and isolating. Affected patients carry a three times greater risk for committing suicide. Patients fight for a diagnosis for years, and when they get their diagnosis, they are often unsatisfied with their prescribed treatment. In my practice, and in research carried out with my colleague, virologist Dr. Carol Duffy, we have seen marked increase in the presence of actively replicating herpes simplex virus type 1 in gastric mucosal tissue from patient groups with functional gastrointestinal disorders and with FM, as compared to control patients.In my experience, IMC-1 treats the potential root cause of several somatic syndrome disorders, and we've demonstrated that the two antivirals together do something that individually the components failed to achieve, notably, reducing the symptoms associated with a FM diagnosis. By targeting the potential viral trigger of FM, we hope to not only treat acute FM symptom "flare-ups", but also delay future FM "flare-ups" by keeping the herpes virus in a dormant state through chronic administration of IMC-1.Q: Virios has been working through rigorous clinical trials to establish the safety and efficacy of IMC-1. What can we expect to see next from the company?A: Virios announced in April that it had completed enrollment in its 425 patient Phase 2b FORTRESS clinical trial, which is a testament to the interest and motivation that clinicians, investigators and patients have shown about being involved in the study. The study will build on the statistically significant results from Virios' previous clinical study, which evaluated 143 FM patients, and demonstrated that IMC-1 improved FM patient pain, fatigue, anxiety and depression, as well as improved their overall functioning. Importantly in the context of current patient dissatisfaction with FDA approved medications, IMC-1 was statistically better tolerated than placebo. If IMC-1 proves to be as effective and well tolerated in the ongoing Phase 2b trial as it was in the completed Phase 2a trial, we think we have a potential game changing therapy for FM patients worldwide. Virios expects to report top line results for its phase 2b FORTRESS clinical trial in September 2022. At the same time, the company is completing chronic toxicology studies in preparation for future FM Phase 3 program discussions with FDA. It is an exciting time for Virios and its shareholders but more than that, it has the potential to completely change the lives of FM patients.Forward-Looking StatementsStatements in this press release contain "forward-looking statements," within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "suggest," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Virios Therapeutics' current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the success, cost and timing of Virios Therapeutics' preclinical studies and clinical trials; its ability to obtain regulatory approval for IMC-1, IMC-2 and any future product candidates; the company's need for additional funding; and Virios Therapeutics' ability to develop and, if approved, commercialize its product candidates. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" in the Annual Report on Form 10-K for the year ended December 31, 2021, filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. (VIRI) undertakes no duty to update such information except as required under applicable law.DisclaimerThis communication was produced by PCG Digital Holdings, LLC, an affiliate of PCG Advisory Inc., (together "PCG"). PCG is not a registered or licensed broker-dealer nor investment adviser. No information contained in this communication constitutes an offer to sell, a solicitation of an offer to buy, or a recommendation of any security. PCG may be compensated by respective clients for publicizing information relating to its client's securities. See www.pcgadvisory.com/disclosures.PCG Digitalinfo@pcgadvisory.com646-863-6341 Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Oculis Announces First Patient Enrolled in Phase 3 OPTIMIZE Trial of OCS-01 in the Treatment of Inflammation and Pain Following Cataract Surgery

LAUSANNE, Switzerland, Jun 29, 2022 - (ACN Newswire via SEAPRWire.com) - Oculis S.A., (Oculis) a global ophthalmology company developing life-changing treatments to save sight and improve eye care with breakthrough innovations, today announced that the first patient has been enrolled in its Phase 3 OPTIMIZE (Once-daily Post ocular surgery Treatment for InflaMmation and paIn to minimiZE drops) trial evaluating the efficacy and safety of once-daily OCS-01, a novel, high concentration, preservative-free, topical OPTIREACH formulation of dexamethasone for the treatment of inflammation and pain following cataract surgery.In the completed Phase 2 SKYGGN study, once-daily OCS-01 successfully met its primary endpoint demonstrating superior efficacy and safety vs vehicle (placebo) in the treatment of inflammation and pain following cataract surgery. Positive data from that trial was presented at the American Society of Cataract and Refractive Surgery (ASCRS) 2020 Annual Meeting. Oculis subsequently held a positive end-of-Phase 2 meeting with U.S. FDA which enabled the start of the Phase 3 OPTIMIZE trial. OPTIMIZE is a randomized, double-blind, placebo-controlled Phase 3 trial in 25 participating sites across the US and is scheduled to enroll approximately 240 patients. Efficacy measures of the trial include the absence of anterior chamber cells at Day 15 and absence of pain at Day 4. Treatment of inflammation and pain following ocular surgery is another indication being pursued for OCS-01, following the commencement in November 2021 of the Phase 3 DIAMOND trial investigating OCS-01 in patients with DME.Eric Donnenfeld, M.D. clinical professor of ophthalmology at New York University and Trustee of Dartmouth Medical School, said: "Following cataract surgery, patients often need to self-administer eye drops several times a day to manage inflammation and pain. An efficacious, preservative-free alternative, administered just once a day could provide significant advantages over current options." Riad Sherif, M.D., CEO of Oculis, said: "This is another important development milestone for OCS-01, following the start of our Phase 3 trial in DME last year, which further signals the potential for this novel product candidate to address the limitations of currently available treatments for both retinal and front-of-the-eye indications. Clinical data generated so far have been very encouraging and we look forward to generating further data in this trial to support regulatory submissions."OCS-01 has been developed using Oculis's OPTIREACH solubilizing nanoparticle technology, a proprietary platform that enables the formulation of drugs as non-invasive topical eyedrop treatments, a longer residence time on the eye surface and enhances their bioavailability in the relevant eye tissues, particularly the retina.About OculisOculis is a global biopharmaceutical company purposefully driven to save sight, improve eye care and address significant unmet medical needs with breakthrough innovations. Oculis's highly differentiated pipeline includes candidates for topical retinal treatments, topical biologics and disease modifying treatments. With a presence in key international markets, Oculis is poised to deliver life-changing treatments to patients worldwide. Headquartered in Lausanne, Switzerland and with operations in Europe, the U.S. and China, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors. For more information, please visit: www.oculis.com Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Novotech Receives “Best Biologics CRO Award 2022” at Korea Bioprocessing Excellence Awards 2022

SEOUL, S.KOREA, Jun 29, 2022 - (ACN Newswire via SEAPRWire.com) - Novotech, the leading Asia Pacific biotech specialist CRO which has recently expanded its services to the US, was today awarded the Best Biologics CRO Award at a ceremony as part of 11th Biologics Manufacturing Korea, the 6th Cell & Gene Therapy World East Asia, and the 3rd BioLogistics World Korea conferences (29th - 30th June 2022) which attract more than 300 representatives from Korea's top biopharmas, vaccine manufacturers, and biologics companies.Novotech Country Managing Director Sanghee Kim said the Korea team was extremely pleased to receive this award in recognition of the clinical excellence provided to clients in the biologics sector.Novotech Vice President Global Head Clinical Services Yooni Kim also said: "Novotech's Asia-Pacific and US teams support cost-effective expedited clinical research with world-class data and the most advanced technology including solutions that enable acceleration of clinical trials across the regions."Novotech now has a workforce of ~2,500 clinical trial professionals across Australia, New Zealand, South Korea, Greater China, Southeast Asia, India, South Africa and the US.Novotech CEO Dr. John Moller said: "The focus on Asia-Pacific for biotech clinical research over the past five years makes the region the fastest-growing clinical trial destination with China being the leading location for new trials followed by the US. Asia-Pacific offers a compelling solution for expedited clinical trials especially in oncology with its vast patient populations, less competitive clinical trial landscape, and world-class KOLs, in addition regulatory reforms have accelerated approval processes. The expansion into the US provides US-based expertise and infrastructure for our US clients wanting trials in APAC and the US, and for our APAC clients wanting US clinical programs. Clients will receive a seamless service, with a unified approach to systems and SOPs," Moller said. About Novotech Health HoldingsNovotech Health Holdings Pte. Ltd. ("Novotech") is the leading Asia-Pacific and US biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 4,000 clinical trials across a broad range of therapeutic areas. Novotech is well-positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/contactMedia ContactDavid JamesE: communications@novotech-cro.comAU: +61 2 8218 2144 USA: +1 415 951 3228Asia: +65 3159 3427 Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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SinoMab Dosed First Healthy Subject in Phase I Clinical Trial of SM17 in the U.S.

HONG KONG, Jun 15, 2022 - (ACN Newswire via SEAPRWire.com) - SinoMab BioScience Limited ("SinoMab" or the "Company", together with its subsidiaries, the "Group", stock code: 3681.HK), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases, today announced that, the first healthy subject has been dosed in the Phase I clinical trial of SM17 in the U.S. SM17 is a First-in-Class (FIC) humanized anti-IL-17RB monoclonal antibody. The subject is currently in a normal condition.SM17 is the world's first humanized IgG4-k monoclonal antibody targeting IL-17RB. SM17 is currently under development by SinoMab, and was engineered by LifeArc (a leading medical research charity based in the United Kingdom). SM17 was originally developed by Dr. Andrew McKenzie, FRS, who also serves as a member of the Company's Scientific Advisory Board, at the MRC Laboratory of Molecular Biology (LMB).SM17 could suppress Th2 immune responses by binding to IL-17RB on Type 2 Innate Lymphoid cells (ILC2s), blocking a cascade of responses induced by interleukin-25 (IL-25). IL-25 is a critical cytokine classified as "alarmin", which has shown to be implicated in the pathogenesis of airway viral responses and allergic diseases, such as uncontrolled severe asthma. Uncontrolled severe asthma is associated with increased mortality/ morbidity, diminished quality of life and increased health expenditures. These patients are at a risk of recurrent asthma exacerbations and hospitalizations. The Company expected that targeting upstream mediators of the Th2 inflammatory cascade, such as IL-17RB on ILC2s, will have a broad effect on airway inflammation. The Company believes the huge potential of SM17 could satisfy unmet medical needs in asthma treatment. The Phase I study is a Single Ascending Dose (SAD) and Multiple Ascending Doses (MAD) to investigate the safety, tolerability and pharmacokinetics of SM17 in healthy subjects.SM17 received Investigational New Drug (IND) approval from U.S. Food and Drug Administration (FDA) on 11 March 2022. Despite the pandemic, SinoMab have soon initiated the first-in-human dose in the Phase I clinical trial. This marks a significant milestone on the collaboration between SinoMab and LifeArc, and demonstrates the efficient implementation of SinoMab's new drug R&D programs.Melanie Lee, Chief Executive Officer of LifeArc, said: "We applied our antibody capabilities when working with Dr. Andrew McKenzie at the LMB, to firstly generate and select a clinical candidate antibody targeting IL-17RB, and then humanise it. After evaluating and choosing the lead candidate, it was licensed to SinoMab to take forward into clinical development and towards patients. It's so rewarding to know that this antibody is going into trials and could eventually make a difference to people with severe asthma."Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: "SM17's successful first-in-human dosing in Phase I clinical trial marked another milestone in our pipeline development. Following our flagship product, SM03 and key product, SN1011, we now have another key asset entering the clinical trial stage. This further assures our potential commercialization prospects and proves our capability for progressing multiple assets of R&D concurrently. We are confident of the enormous prospects for SM17's clinical development as well as our commercialization opportunities in general. Moving forward, we will accelerate implementation of our projects, adhere to our vision of independent innovation to bring benefits to patients and create value for shareholders."About LifeArcLifeArc is a self-financing and leading UK medical research charity. It partners and works with academics, industry, charities and patient groups to unlock the potential of early stage science. It has an office in London and scientific research facilities in Stevenage and Edinburgh. It also has a specialist science team working at the Francis Crick Institute in London.About SinoMab BioScience LimitedSinoMab BioScience Limited (stock code: 3681.HK) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The Company's flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis (RA) and is currently in Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), pemphigus vulgaris (PV), non-Hodgkin's lymphoma (NHL), asthma, and other diseases with major unmet clinical needs. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Novotech’s APAC and USA Leadership Teams at BIO 2022

SAN DIEGO, CA, Jun 14, 2022 - (ACN Newswire via SEAPRWire.com) - Novotech, the leading Asia Pacific biotech specialist CRO which has recently expanded its services to the US, will have key executives from APAC and the US attend BIO 2022 for meetings with biotechs considering the Asia-Pacific region to expedite their clinical trials. #4907Book a meeting with one of the Novotech experts at BIO here. https://novotech-cro.com/contactNovotech, which has a reputation for delivering full-service, high-quality expedited clinical trials in Asia-Pacific, can now offer its biotech clients clinical services in the US to support later phase global studies. Novotech now has a workforce of ~2,500 clinical trial professionals across Australia, South Korea, Greater China, Southeast Asia, India, South Africa and the US.Novotech CEO Dr. John Moller said Novotech's Asia-Pacific and US teams support cost effective expedited clinical research with world-class data, and the most advanced technology including solutions that enable acceleration of clinical trials across the regions. "The focus on Asia-Pacific for biotech clinical research over the past five years makes the region the fastest growing clinical trial destination with China being the leading location for new trials followed by the US. Asia-Pacific offers a compelling solution for expedited clinical trials especially in oncology with its vast patient populations, less competitive clinical trial landscape, and world-class KOLs, in addition regulatory reforms, such as those in China, have accelerated approval processes. The expansion into the US was a strategic move to provide US-based expertise and infrastructure for our US clients wanting trials in APAC and the US, and for our APAC clients wanting US clinical programs." Clients will receive a seamless service, with a unified approach to systems and SOPs," Moller said. According to Global Data whitepaper: EVOLUTION OF CLINICAL TRIALS IN THE ASIA PACIFIC REGION COMPARED TO THE US AND THE EU5*, Over the last five years more than 70,000 new clinical trials were registered in the APAC region, the US, and the EU5. The APAC region was the largest contributor, with more than 50% of the trials followed by the US (29%) and the EU5 (17%). The APAC region has become the preferred destination for conducting clinical trials due to its large patient population, ease of regulatory compliance, lower cost of conducting studies, high-quality standards and the presence of top clinical sites.* https://novotech-cro.com/whitepapers/evolution-clinical-trials-asia-pacific-region-compared-us-and-eu5About Novotech Health Holdings Novotech Health Holdings Pte. Ltd. ("Novotech") is the leading Asia-Pacific and US biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 3,700 clinical trials across a broad range of therapeutic areas. Novotech is well positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/contactMedia ContactDavid JamesE: communications@novotech-cro.comAU: +61 2 8218 2144USA: +1 415 951 3228ASIA: +65 3159 3427 Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Eisai Initiates Preparation for New Drug Application, Based on the Results of an Investigator-Initiated Clinical Trial of Ultrahigh-Dose Mecobalamin for Amyotrophic Lateral Sclerosis in Japan

TOKYO, May 10, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. today announced that it has initiated preparation on a New Drug Application for ultrahigh-dose mecobalamin (development code: E0302) for amyotrophic lateral sclerosis (ALS) in Japan, based on a favorable clinical results of the JETALS (The Japan Early-Stage Trial of Ultrahigh-Dose Methylcobalamin for ALS: JETALS), an investigator-initiated Phase III trial to evaluate efficacy and safety of ultrahigh-dose methylcobalamin (mecobalamin) in early onset ALS patients, published by a research team led by Extraordinary Professor Ryuji Kaji (Principal Investigator), Tokushima University and Professor Yuishin Izumi (Coordinating Investigator), the Department of Neurology, Tokushima University Graduate School of Biomedical Sciences. Eisai submitted an application for an orphan drug designation of this agent to the Ministry of Health, Labour and Welfare (MHLW) in March 2022, and plans to submit a new drug application in fiscal year 2023. For ultrahigh-dose mecobalamin, Eisai submitted a new drug application as treatment for ALS in May 2015 based on the results of a Phase II/III clinical trial (Study 761) for ALS, but withdrew the application in March 2016 after receiving the opinion about the application package not being sufficient from the Pharmaceuticals and Medical Devices Agency (PMDA). However, an additional analysis of Study 761 suggested that ultrahigh-dose mecobalamin prolonged survival period and suppressed progression in ALS patients who commenced treatment within 12 months of ALS onset. In order to re-examine its efficacy and safety in ALS patients within 1 year of onset, JETALS was conducted as an investigator-initiated clinical trial by the research team led by the Tokushima University with the support of the Japan Agency for Medical Research and Development (AMED). The results of the study showed the efficacy, safety, and tolerability of ultrahigh-dose mecobalamin, which have now been published in the peer-reviewed journal JAMA Neurology(New Window). Based on the results of JETALS, in consultation with the Tokushima University, Eisai has decided to newly submit the application for approval of ultrahigh-dose mecobalamin for ALS in Japan. Eisai considers neurology a therapeutic area of focus and is committed to new drug development in this field in order to fulfill unmet medical needs and further contribute to increasing the benefit for patients and their families. About Amyotrophic Lateral Sclerosis (ALS)ALS is an intractable, progressive, neurodegenerative disease that results in severe muscle atrophy and weakness in the muscles due to motor neuron dysfunction. As the main cause of death is respiratory failure due to paralysis of the respiratory muscles, without the use of an artificial respirator, death occurs within approximately 3 to 6 years from the onset of the disease. According to the number of patients issued a Certificate of the Recipient of Specified Disease Treatment, there were 10,514 patients with ALS in Japan in 2020. Currently, there is no curative treatment established for ALS, and since there are only limited number of medicines approved in Japan and abroad, this is a disease with significant unmet medical needs.About MecobalaminMecobalamin (development code: E0302) is approved and marketed as Methycobal, a 500 microgram injection of mecobalamin indicated for the treatment of peripheral neuropathies and megaloblastic anemia caused by vitamin B12 deficiency. Methycobal is also approved as a tablet formulation as well as a fine granule formulation indicated for the treatment of peripheral neuropathies. While the mechanism of action of mecobalamin in ALS is not known, it has been suggested in non-clinical research that mecobalamin may have efficacy through a neuroprotective effect and regeneration of nerve axons. Since the 1990s, clinical research has been carried out on ultrahigh-dose mecobalamin in ALS by a study group on neurodegenerative disease, funded through the Ministry of Health, Labour and Welfare's Specified Disease Treatment Research Program. Short- and long-term trials of intramuscular injection of mecobalamin at 25 mg and 50 mg per day, which is respectively 50 and 100 times the approved dosage of Methycobal, suggested that ultrahigh-dose mecobalamin could have a clinical effect in ALS.Therefore, Eisai had conducted the Phase II/III clinical trial (Study 761) since 2006 and submitted a new drug application for ultrahigh-dose mecobalamin as treatment for ALS in May 2015 but withdrew the application in March 2016 after the Pharmaceuticals and Medical Devices Agency (PMDA) indicated that additional clinical trials were necessary.Media Inquiries:Public Relations Department,Eisai Co., Ltd.+81-(0)3-3817-5120 Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

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Essex Bio-Technology Announces 2021 Financial Results

HONG KONG, Mar 22, 2022 - (ACN Newswire via SEAPRWire.com) - Essex Bio-Technology Ltd ("Essex" or the "Group", Stock Code: 1061.HK) today announced the annual results for the year ended 31 December 2021.Highlights-- The group's turnover surged 67.4% to HK$1,637.7 million, Profit-After-Tax lifted 58% to HK$346.0 million;-- Sales coverage increased to around 10,500 hospitals and 2,110 pharmaceutical stores in the PRC;-- Obtained an approval for the registration and commercialisation of the preservative-free unit-dose Moxifloxacin Hydrochloride Eye Drops in the PRC;-- Significant progress in R&D program, 15 R&D programs in the pre-clinical to clinical stage, out of which 3 ophthalmology programs are in clinical stage as the below:SkQ1 eye drops, second phase 3 clinical trial (US FDA) (VISTA-2) topline data released on 24 February 2021;Azithromycin eye drops, ongoing review by external key opinion leaders (National Medical Products Administration ("NMPA") in the PRC);Bevacizumab intravitreal injection for wet-AMD, phase 3 clinical trial (US FDA, European Medicines Agency, Therapeutic Goods Administration and NMPA in the PRC);-- Holds a total of 44 patent certificates or authorisation letters: 35 invention patents, 4 utility model patents and 5 design patents;-- Completed the acquisition of IP rights relating to R&D, production and MAH of Shilishun Iodized Lecithin Capsules.Significant progression in Financial PerformancesEssex achieved significant progression and encouraging performances amid the COVID-19 pandemic and macro uncertainties. For the year ended 31 December 2021, the Group recorded a turnover growth of 67.4% to approximately HK$1,637.7 million as compared to approximately HK$978.1 million in 2020, indicating a strong recovery to the pre-COVID-19 operating level. In tandem with the increase of turnover, the Group achieved an increase of 58% in after-tax profit to approximately HK$346.0 million as compared to approximately HK$218.9 million in 2020. Turnover of Ophthalmology and Surgical Segments Surged 60.6% and 72.6% respectivelyThe Group's turnover is primarily made up from the segments of Ophthalmology and Surgical (wound care and healing). The core products that are of current growth driver under each segment are: 1. Ophthalmology - Beifushu series (Beifushu eye drops, Beifushu eye gel and Beifushu unit-dose eye drops), Tobramycin Eye Drops, Levofloxacin Eye Drops, Sodium Hyaluronate Eye Drops, Moxifloxacin Hydrochloride Eye Drops and Shilishun(Iodized Lecithin Capsules); and 2. Surgical (Wound care and healing) - Beifuji series (Beifuji spray, Beifuji lyophilised powder and Beifuxin gel), Carisolv dental caries removal gel, Dr. YaDian mouth wash and Yi Xue An Granules. The sectoral turnover of Ophthalmology and Surgical is approximately 41.1% and 58.9% of the Group's turnover, respectively. The combined turnover of the Group's flagship biologics, Beifushu series and Beifuji series, the basic fibroblast growth factor (bFGF) based biologic drugs, represented about 84.3% of the Group's total turnover, of which Beifushu series and Beifuji series accounted for 26.1% and 58.2% of the Group's turnover, respectively. The remaining 15.7% of the Group's turnover is mainly contributed from sales of Tobramycin Eye Drops, Levofloxacin Eye Drops, Sodium Hyaluronate Eye Drops, Moxifloxacin Hydrochloride Eye Drops, Shilishun Iodized Lecithin Capsules, Carisolv dental caries removal gel, Dr. YaDian mouth wash and Yi Xue An Granules, collectively. Ophthalmology segment contributed approximately HK$673.3 million to the Group's turnover for the year ended 31 December 2021, representing an increase of 60.6% as compared to approximately HK$419.2 million in 2020. Surgical segment recorded a total turnover of approximately HK$964.4 million for the year ended 31 December 2021, representing an increase of 72.6% as compared to approximately HK$558.9 million in 2020. The increase was attributable to the resumption of clinical operations in hospitals to normalcy in the PRC and the expansion of sales.The selling of Xalatan Eye Drops and Xalacom Eye Drops would be discontinued in 2022 that contributed approximately 2% to the Group's gross profit for the year ended 31 December 2021.The Board proposed a final dividend of HK$0.055 (2020: HK$0.05) per ordinary share to be approved at the upcoming annual general meeting of the Company.Mr. Patrick Ngiam, Chairman of Essex, said, "2021 has been a year full of diverse challenges. Our part of the world has been affected by extended lockdowns and border closures under COVID zero regime, even as other regions begun to reopen. Despite yet another difficult year inflicted by the pandemic of COVID-19 on us all, the tenacity, drive and leadership in our DNA was able to deliver greater stakeholder value. The Group has achieved significantly improved financial performances in the financial year ended 31 December 2021. This is a testament that the Group's business is resilient and was able to recover swiftly to the pre-COVID-19 level after the normalcy of the clinical operations of hospitals resumed in the PRC since September 2020."Significant Business Development ActivitiesThe Group is committed to pragmatically investing in new products and technologies to strengthen the Group's product and R&D pipeline as near to mid-term growth driver in ophthalmology and long-term plan for new therapeutics in oncology. During the year under review, major investments in ophthalmic products are outlined as follows:Investment in OphthalmologySignificant progress for SkQ1's second phase 3 clinical trialIn 2018, the Group entered into a co-development agreement with Mitotech S.A. ("Mitotech") and Mitotech LLC for the United States Food and Drug Administration (the "US FDA") phase 3 clinical trial of an ophthalmic solution containing SkQ1 for dry eye disease. As disclosed in the announcement of the Company dated 24 February 2021, positive outcome was achieved during second phase 3 clinical trial (VISTA-2). The clinical trial study repeated statistically significant positive results on key predefined secondary end-point (Central Corneal Fluorescein Staining). The Board is enthusiastic about the read-out of clearing of central staining of the cornea (defined as zero staining in central cornea), which reveals the potential of SkQ1 in addressing oxidative stress in dry eye diseases. Following the positive trial outcome of VISTA-2, Mitotech has planned a pivotal trial (VISTA-3), which will commence once Mitotech's management team has fully assessed there is no potential disruption to trial centres and patient recruitment during the ongoing COVID-19 pandemic. However, recent developments in Ukraine have led to governments and industries reacting to business relationships with Russia in a way that could potentially induce delays in Mitotech's VISTA clinical trial program.HLX04-O approved for phase 3 clinical trialIn 2020, the Group entered into a co-development and exclusive license agreement with Shanghai Henlius Biotech, Inc. to co-develop a pharmaceutical product that contains an anti-vascular endothelial growth factor ("anti-VEGF") as a drug substance, which is intended for the treatment of exudative (wet) age-related macular degeneration ("wet-AMD"). As at the date of 22 March 2022, the recombinant anti-VEGF humanised monoclonal antibody injection HLX04-O ("HLX04-O") for the treatment of wet-AMD has been approved to commence the phase 3 clinical trial in Australia, the United States, Singapore, Russia, Serbia and European Union countries such as Hungary, Spain, Latvia, the Czech Republic and Poland. Also, the first patient has been dosed in a phase 3 clinical study for HLX04-O for the treatment of wet-AMD in the PRC.Ophthalmology business is expected to be further strengthened by the acquisition of Shilishun Iodized Lecithin CapsulesThe successful acquisition of IP rights relating to R&D, production and MAH of Shilishun Iodized Lecithin Capsules will enable the Group to strengthen its ophthalmology business.Market DevelopmentRobust Market Access CapabilityOver the years, the Group has been relentlessly investing in establishing and strengthening its market access capability. As at 31 December 2021, the Group maintains a network of 43 regional sales offices in the PRC and a total number of about 1,265 sales and marketing representatives, out of which 64% are full-time employees and 36% are on contract basis or from appointed agents. More Extensive Healthcare Network for Product PrescriptionDuring the year under review, the Group's therapeutic products are being prescribed in more than 10,500 hospitals and medical providers, coupled with approximately 2,110 pharmaceutical stores, which are mainly located in the major cities, provinces and county cities in the PRC. Further Investments to Strengthen Competitiveness and Customer BaseFor achieving a sustainable traction on growth for currently marketed products as well as for near-term to mid-term new products being commercialised, the Group initiated investments to improve its competitiveness and widen its customer base under the following plans:-- Investing in clinical observation programs for affirming additional clinical indications of its commercialised products;-- Reaching out to market in lower-tier cities;-- Cultivating pharmaceutical stores, where possible, as complementary sales channel; and-- Building on-line platform for medical consultation and e-prescription for patients with chronic diseases under its healthtech initiative.The Group has initiated its market access expansion to Southeast Asian countries by setting up a base and expanded its presence in Singapore since 2020.Research and DevelopmentThe Group renewed its R&D's vision, emphasising the dedication to science and innovation, with a mission to develop therapeutics that would meet unmet clinical and/or commercial needs. The Group concurrently kick-started a 5-year (2021 to 2025) R&D's development plan to further strengthen its R&D capability and its position in Ophthalmology.As at 31 December 2021, there are 15 R&D programs in the pre-clinical to clinical stage, out of which 3 ophthalmology programs are in clinical stage. The 3 ophthalmology programs listed below are targeted as mid-term growth driver.1. EB11-18136P: SkQ1 eye drops, second phase 3 clinical trial (US FDA) (VISTA-2) topline data released on 24 February 20212. EB11-15120P: Azithromycin eye drops, ongoing review by external key opinion leaders (National Medical Products Administration ("NMPA") in the PRC)3. EB12-20145P: Bevacizumab intravitreal injection for wet-AMD, phase 3 clinical trial (US FDA, European Medicines Agency, Therapeutic Goods Administration and NMPA in the PRC) As at the date of this announcement, the Group has obtained a total of 44 patent certificates or authorisation letters: 35 invention patents, 4 utility model patents and 5 design patents.The Group currently has diversified its R&D resources to multiple research sites in Zhuhai (PRC), Boston (United States), London (United Kingdom) and Singapore which supports not only our pursuit for new therapeutics but also our acquisition of global talent.ProspectsLooking ahead, the Group will continue to monitor the circumstances under the uncertainty of COVID-19 in 2022. Its strong team spirit and dynamic leadership have provided it with the capacity to navigate these turbulent times, and capture any opportunities in the ever changing world. The Group remains highly dynamic in delivering positive results in the coming year."COVID-19 remains a major concern in 2022 globally. We continue to monitor the situation and will take appropriate actions to overcome any unforeseen challenges. Barring the unforeseen circumstance, the Group remains focus on executing its plans and delivering progressive results. I would like to take this opportunity to express my sincere gratitude to all stakeholders, business associates and valued customers for the trust, support and cooperation accorded to us, and each and every member of the Group for their relentless efforts rendered in shaping the Group into being a progressive and promising pharmaceutical player.", said Mr. Patrick Ngiam.Full version of Essex's FY2021 Annual Results Announcement can be downloaded at: https://www1.hkexnews.hk/listedco/listconews/sehk/2022/0322/2022032200780.pdf About Essex Bio-Technology Limited (Stock Code: 1061.HK)Essex Bio-Technology Limited is a bio-pharmaceutical company that develops, manufactures and commercialises genetically engineered therapeutic rb-bFGF (FGF-2), having six commercialised biologics marketed in China since 1998. Additionally, it has a portfolio of commercialised products of preservative-free unit-dose eye drops and Shilishun Iodized Lecithin Capsules etc.. The products of the Company are principally prescribed for the treatment of wounds healing and diseases in Ophthalmology and Dermatology, which are marketed and sold through approximately 10,500 hospitals and managed directly by its 43 regional sales offices in China. Leveraging on its in-house R&D platform in growth factor and antibody, the Company maintains a pipeline of projects in various clinical stages, covering a wide range of fields and indications.Media Enquiry:Strategic Financial Relations Limited (Website: http://www.sprg.com.hk)Shelly Cheng +852 2864 4857 shelly.cheng@sprg.com.hk Yan Li +852 2114 4320 yan.li@sprg.com.hkJill Cheung +852 2114 4870 jill.cheung@sprg.com.hk Media: media@essex.com.cn Investor Enquiry:Investor Relations: investors@essex.com.cn Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Fujitsu Leverages World’s Fastest Supercomputer and AI Tech in Joint Field Trial for Safe and Efficient Tsunami Evacuations in Kawasaki City

TOKYO, Mar 3, 2022 - (JCN Newswire via SEAPRWire.com) - The International Research Institute of Disaster Science (IRIDeS) at Tohoku University, the Earthquake Research Institute at the University of Tokyo, Fujitsu, and the City of Kawasaki(1) today announced plans to conduct a field trial of AI that is constructed on the world's fastest supercomputer, Japan's Fugaku(2), and provide high-resolution, real time tsunami flooding forecast for supporting safe and efficient tsunami evacuations during disaster prevention drills in Kawasaki, Japan on Saturday, March 12, 2022.Figure 1: Image of the dedicated app (Japanese and English language version in development)Figure 2: Image of community-based evacuation processDuring this field trial, participants from the surrounding community will be notified about the arrival time and the flooding height of a predicted tsunami through a special smartphone application developed by Fujitsu. The exercise aims to identify the most effective ways to use the technology to support local communities in sharing information amongst residents and avoid cases of people being left behind during evacuations.This project represents the latest milestone in an ongoing initiative between the parties. As part of a framework agreement signed between Kawasaki City and Fujitsu in 2014 to promote the creation of sustainable communities(3), the four parties have been engaging in R&D activities as part of the "Joint Project Aiming for Tsunami Disaster Risk Reduction Using ICT in the Kawasaki Coastal Area" since 2017. Verifying the effectiveness of information sharing amongst field trial participants via the app, the parties aim to further promote the practical use of disaster risk mitigation methodologies that leverage the capabilities of AI, high performance computing (HPC), and communications technologies for tsunami flooding forecasts, ultimately contributing to the realization of a safer society.BackgroundRecent years have witnessed the development of several different technologies for real time tsunami flooding forecasts that make use of the capabilities of high-speed supercomputers and AI. Barriers to the practical deployment of such technologies remain, however, including how to share relevant information in an inclusive yet effective manner to the public, taking into account individual differences of users and varying levels of digital literacy.The four parties aim to address some of these challenges by conducting a field trial to test the technology with actual residents of the community in circumstances that replicate the uncertainty of an actual disaster, including the possibility that the AI forecast information itself isn't 100% certain.Outline of the field trialDate: March 12, 2022 (Saturday) 8: 15 to 11: 15 JST (held at the same time as the comprehensive disaster prevention drills in Kawasaki Ward)Place: Kawasaki Municipal Kawanakajima Junior High School and surrounding area (Kawasaki Ward, Kawasaki City)Participants: local residents and project membersOverview: Field trial to verify the effectiveness of evacuation using AI tsunami flooding forecast data(4)-this data will be delivered to a dedicated app developed by Fujitsu, which residents and organizers will refer to in real time during a simulated evacuation. The field trial will be conducted under the supervision and guidance of Prof. Fumihiko Imamura, Director of the International Research Institute of Disaster Science at Tohoku University and Prof. Takashi Furumura at the Earthquake Research Institute at the University of Tokyo.Several participants briefed in advance of the field trial (including the possibility that AI forecast information isn't 100% certain) will act as disaster information leaders and receive detailed information including the predicted arrival time and flooding height of the tsunami. Other participants will receive a text message on the app indicating that AI has forecast flooding for their location.When evacuating, disaster information leaders can check the current location of participants in the same community and alert those who are behind in evacuating by using the app's messaging function.The field trial will be followed by an online disaster prevention course, in which evacuation actions of the participants will be reviewed.About the appThe app has two display modes. The first one is a detailed mode, in which AI-generated tsunami flooding forecast data is displayed on a map in different colors corresponding to the arrival time and the flooding height of the incoming tsunami. The second mode is a simple display that only shows a text message warning users in a certain area about the predicted tsunami flooding. The app also includes a messaging function that allows users to check the location of other community members on a map and help one another to communicate and gather safely during the evacuation. Users can further post and share information on points along evacuation routes that are assumed to be damaged and difficult to pass (a function which has been validated in prior field trials(5)) and also share real-time information about the number of people who have successfully evacuated and gathered at evacuation centers.Future PlansBased on the feedback from the participants of the field trial, the four parties will further investigate methods to transmit and use AI disaster forecasting to realize safer and more efficient community-based evacuation and promote the use and practical application of AI to support disaster mitigation measures and contribute to the realization of safer local communities.(1) Kawasaki City :city located in Kanagawa Prefecture, Japan; Mayor: Norihiko Fukuda(2) AI that is constructed on the world's fastest supercomputer, Japan's Fugaku :This AI was built using computational resources of supercomputer Fugaku provided by the RIKEN Center for Computational Science through the HPCI System Research Project (Project ID: hp210220).(3) a framework agreement signed between Kawasaki City and Fujitsu in 2014 to promote the creation of sustainable communities :Kawasaki City and Fujitsu in June 2021 further strengthened their collaboration to promote various initiatives utilizing cutting-edge digital technology, focusing on the four priority themes of "health," "safety and security," "environment," and "work and living" that will further increase the value of communities by making them more livable. "Fujitsu, City of Kawasaki Strengthen Cooperation to Realize a Sustainable "Future City""(4) AI tsunami flooding forecast data :Authorization from the Japan Meteorological Agency (JMA) based on the Meteorological Service Act is required when actual tsunami forecast is issued by an organization other than JMA.(5) prior field trials :From 2018 to 2020, the four parties conducted experiments to realize tsunami evacuation using smartphone applications. "Fujitsu Leverages AI Tech in Joint Project to Contribute to Safe Tsunami Evacuation in Kawasaki""Fujitsu Optimizes Evacuation Center Management to Mitigate COVID-19 Risk with AI in Joint Field Trial in City of Kawasaki"About FujitsuFujitsu is the leading Japanese information and communication technology (ICT) company offering a full range of technology products, solutions and services. Approximately 126,000 Fujitsu people support customers in more than 100 countries. We use our experience and the power of ICT to shape the future of society with our customers. Fujitsu Limited (TSE:6702) reported consolidated revenues of 3.6 trillion yen (US$34 billion) for the fiscal year ended March 31, 2021. For more information, please see www.fujitsu.com.Press Contacts:Tsunami Engineering Lab International Research Institute of Disaster Science (IRIDeS) Tohoku University Dr. Daisuke SugawaraE-mail:sugawara@irides.tohoku.ac.jp Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

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Novotech Recognized as Top 10 CRO in CenterWatch Site Relationship Benchmarking Report

SYDNEY, Feb 9, 2022 - (ACN Newswire via SEAPRWire.com) - Novotech, the leading Asia Pacific biotech specialist CRO, has been recognized as a top 10 CRO in the 2021 CenterWatch Global Site Relationship Benchmark Survey. Report available here. https://novotech-cro.com/news/novotech-recognized-top-10-cro-centerwatch-site-relationship-benchmarking-reportCenterWatch, established in 1994, is a global benchmarking authority for the clinical trials sector.The benchmarking report results reflect how more than 3,700 representatives from clinical trial sites around the world rate their clinical research organisation (CRO) relationships and their responses to the COVID-19 pandemic.The criteria for benchmarking CROs included:- Professionalism- Organizational processes- Preparedness- CommunicationsSite respondents were asked to rank the overall reputation of 29 CROs and rate the relative importance of performance-related attributes."Strong site, sponsor, and CRO relationships form the essential foundation on which efficient and effective clinical trials are built. We conduct the CenterWatch Global Site Relationship Benchmark Survey as a service to the industry, highlighting behaviors and approaches that are strengthening partnerships and revealing areas that merit improvement. As COVID-19 has put additional strain on relationships of all types, we also requested feedback on partners' pandemic response in this latest survey," said Cynthia Carter, President, Market Intelligence and Insights at WCG.Novotech CEO Dr. John Moller said we are very pleased to be benchmarked as a top 10 CRO among the world's leading CROs. Sites are key to our client's success so being ranked highly by sites for our professionalism, communications, and processes is a major achievement for our global team."Novotech serves biotechs globally and we pride ourselves on the depth of relationships that we have built with hundreds of Asia-Pacific sites over the last 25 years. In addition, Novotech has signed 45 Leading Site Partnership agreements over the last 3 years. As part of these agreements, Novotech works very closely with the leading sites in the region to promote their research strengths internationally, while enjoying preferential access to their clinical trial infrastructure."With more than 2,000 highly experienced professionals, our clients appreciate our strong site and KOL relationships, our deep regulatory expertise, and our ability to accelerate clinical trials across the Asia Pacific and in particular China.""Industry-leading technology is at the core of our business and ensures rapid and efficient processes, insightful analytics and reporting, and high quality data and compliance."Novotech recently announced a partnership and investment in tech firm Prospection to support accelerated clinical trials with healthcare data analytics using real-world data.Novotech has also partnered with virtual research organisation ObvioHealth to expedite trials leveraging remote technologies. This patient-centric approach improves subject retention and allows sponsors to reach populations outside major cities for clinical trial participation.About Novotech Health Holdings Novotech Health Holdings Pte. Ltd. ("Novotech") is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech Holdings is a CRO with integrated labs and phase I facilities providing drug development consulting and clinical development services. It has been instrumental in the success of approximately 3,700 clinical trials across all trial phases and broad range of therapeutic areas. Novotech Holdings is well positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally. For more information visit https://novotech-cro.com/contactMedia ContactDavid Jamescommunications@novotech-cro.comAU: +61 2 8218 2144 USA: +1 415 951 3228Asia: +65 3159 3427 Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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B-cell lymphoma clinical trials now open on the TrialWire Platform

ADELAIDE, AUS, Jan 5, 2022 - (ACN Newswire via SEAPRWire.com) - TrialWire(TM) is pleased to announce new B-cell lymphoma clinical studies are now available on the TrialWire Platform. More than 6 million people have used TrialWire over the past few years to find clinical trials that are right for them at clinics and specialist centers near them.The studies on TrialWire are available in Australia, New Zealand, and the U.S. They include new therapies in research for relapsed B-cell lymphoma run by leading lymphoma specialists.You can search for a study near you and find your local specialist team here. https://www.research-finder.com/b-cell-lymphoma-pr/ Then see if you are eligible and apply instantly.TrialWire is the most secure and accessible digital clinical trial search platform which is powered by HIPAA compliant Salesforce Health Cloud.People can search for a clinical trial, check their eligibility and apply instantly. The Platform connects people with Study Coordinators at clinics so they can discuss their condition and eligibility and potentially join a study that is right for them.Importantly, patient information is only shared with the clinic selected by the applicant. It is not shared, sold or reused to enroll patients in other studies.TrialWire uses advanced algorithms and AI-Match to find people online who are interested in specific medical conditions. These people have proven to be highly motivated for both enrollment and retention. The biggest challenge to finding cures for medical conditions is that people who might benefit, don't know there is a trial on near them that could be right for them.Most clinical trials either fail to enroll enough patients or need to extend enrollment timelines adding significant time and cost.TrialWire provides a rapid and secure enrolment solution that benefits patients and sponsors.TrialWire Platform sources clinical trial information from leading Government databases of approved clinical trials.Find B-cell lymphoma clinical trial near you today. Places for most clinical trials are limited. Clinical trials can offer advanced check-ups, advice and care as well as access to the latest therapies in research. https://www.research-finder.com/b-cell-lymphoma-pr/About TrialWire(TM) www.Trial-Wire.comTrialWire(TM) is the leading digital patient recruitment platform for Sponsors and CROs requiring a rapid study recruitment boost.Unlike all other recruitment tools, TrialWire uses advanced algorithms to find people when they are searching for health solutions online and, within 2 minutes, AI-Matches them with studies near them (or for DCTs) and connects them directly with the relevant site.TrialWire Study Dashboards for Sponsors, CROs and Study Coordinators are powered by Salesforce Health Cloud providing the most secure and informative insights across the entire recruitment process. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Autism clinical trials now open on the TrialWire Platform

ADELAIDE, AUS, Jan 5, 2022 - (ACN Newswire via SEAPRWire.com) - TrialWire(TM) is pleased to announce new Autism (ASD) clinical studies are now available on the TrialWire Platform.More than 6 million people have used TrialWire over the past few years to find clinical trials that are right for them at clinics and specialist centers near them.The ASD studies on TrialWire are available in Australia, New Zealand, and the U.S.They include studies for children, teenagers and adults around ASD possible causes, and managing symptoms that can impact people's lives.You can search for a study near you and find your local specialist team here. https://www.autism-localresearchfinder.com/asd-research-enrolling/ Then see if you are eligible and apply instantly.TrialWire is the most secure and accessible digital clinical trial search platform which is powered by HIPAA compliant Salesforce Health Cloud.People can search for a clinical trial, check their eligibility and apply instantly. The Platform connects people with Study Coordinators at clinics so they can discuss their condition and eligibility and potentially join a study that is right for them.Importantly, patient information is only shared with the clinic selected by the applicant. It is not shared, sold or reused to enroll patients in other studies.TrialWire uses advanced algorithms and AI-Match to find people online who are interested in specific medical conditions. These people have proven to be highly motivated for both enrollment and retention. The biggest challenge to finding cures for medical conditions is that people who might benefit, don't know there is a trial on near them that could be right for them.Most clinical trials either fail to enroll enough patients or need to extend enrollment timelines adding significant time and cost.TrialWire provides a rapid and secure enrolment solution that benefits patients and sponsors.TrialWire Platform sources clinical trial information from leading Government databases of approved clinical trials.Find an ASD clinical trial near you today. Places for most clinical trials are limited. Clinical trials can offer advanced check-ups, advice and care as well as access to the latest therapies in research. https://www.autism-localresearchfinder.com/asd-research-enrolling/About TrialWire(TM)TrialWire(TM) is the leading digital patient recruitment platform for Sponsors and CROs requiring a rapid study recruitment boost.Unlike all other recruitment tools, TrialWire uses advanced algorithms to find people when they are searching for health solutions online and, within 2 minutes, AI-Matches them with studies near them (or for DCTs) and connects them directly with the relevant site.TrialWire Study Dashboards for Sponsors, CROs and Study Coordinators are powered by Salesforce Health Cloud providing the most secure and informative insights across the entire recruitment process. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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SinoMab Announces the Completion of Enrollment in Phase III Clinical Trial in China for its Flagship Product, SM03

HONG KONG, Nov 30, 2021 - (ACN Newswire via SEAPRWire.com) - SinoMab BioScience Limited ("SinoMab", or the "Company", stock code: 3681.HK), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases, is pleased to announce that, on 30 November 2021, SM03 (Suciraslimab) Phase III clinical trial for rheumatoid arthritis (RA) has completed its targeted enrollment of 510 patients. The patients currently in screening will be randomized by end of December 2021, given eligibility criteria are met. SM03 (Suciraslimab), a potential global first-in-target anti-CD22 monoclonal antibody for the treatment of RA and potentially for the treatment of other immunological diseases, is currently in Phase III clinical trials in China. The Phase III clinical trial is a multi-center, randomized, double-blind, placebo-controlled, parallel group study to confirm the clinical efficacy and long-term safety in active RA patients receiving methotrexate (MTX).The efficacy and safety of Suciraslimab was previously evaluated in a phase II clinical study in moderate-to-severely active RA patients. The study results were published recently and shown that Suciraslimab at a dose of 600 mg with 4 and 6 infusions respectively, were both efficacious and well-tolerated throughout the 24 weeks of treatment when compared with the placebo group. Suciraslimab was effective in suppressing disease activity and alleviates symptoms of moderate-to-severely active RA patients receiving stable doses of background MTX.Dr. Shui On LEUNG, Executive Director, Chairman and Chief Executive Officer of the Company, said, "After the Company announced the results of the flagship product, SM03, which is efficacious and well-tolerated earlier, the completion of enrolment in phase III clinical trial is a major milestone in the research and development process; with the smooth progression of the clinical trial, SM03 will soon step into commercialization officially."About SinoMab BioScience LimitedSinoMab BioScience Limited (stock code: 3681.HK) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The Company's flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis and is currently in Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis, systemic lupus erythematosus, pemphigus vulgar, non-Hodgkin's lymphoma, asthma, and other diseases with major unmet clinical needs. Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

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Transgene and NEC Announce Positive Preliminary Data from Phase I Studies of TG4050, a Novel Individualized Neoantigen Cancer Vaccine

Strasbourg, France & Tokyo, Japan, Nov 23, 2021 - (JCN Newswire via SEAPRWire.com) - Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation (NEC; TSE: 6701), a leader in IT, network and AI technologies, today announce positive preliminary immunogenicity and clinical data on TG4050, their jointly developed individualized neoantigen cancer vaccine. TG4050 is the first candidate based on Transgene's myvac platform. Powered by NEC's cutting-edge AI capabilities, it is being evaluated in two ongoing multicenter Phase I trials in patients with ovarian cancer and head and neck cancer."We are extremely pleased to demonstrate the ability of TG4050 to effectively prime the immune system of the first patients who received this novel treatment and observe first signals of clinical activity. We believe this establishes the potential role of TG4050 as a new approach for individualized cancer vaccination. TG4050 appears to demonstrate a favorable safety profile thus far. We have also confirmed the feasibility of the "needle to needle" process with these two multicenter international Phase I trials, using our own internal manufacturing facility. Strikingly, when supported by NEC's powerful prediction tool, the myvac viral vector used in TG4050, which has been genetically optimized to improve immunogenicity and peptides presentation, induced robust and consistent response against class I and class II epitopes. We are working hard to complete the studies to further confirm these findings and generate additional immune and clinical data. We are very excited by the potential of TG4050 and hope to share additional data at a major oncology congress in 2022. Based on the additional data, we will identify the most appropriate path to take TG4050 forward," commented Hedi Ben Brahim, Chairman and CEO of Transgene."We are very excited to see early signs of clinical activity in the TG4050 clinical trials that uses our AI-driven neoantigen prediction system. NEC's proprietary machine learning algorithms are built upon decades of AI expertise, enabling us to prioritize and map the most immunogenic neoantigens on personalized vaccine blueprints. The safety profile and early immunogenicity data against multiple patient-specific tumor targets in the first patients is a testimony of TG4050's potential and of the complementary synergies between the two companies. This milestone illustrates the central role of expanding the AI approach for individualized cancer immunotheraphy. As we previously stated, NEC and Transgene share a common goal to harness the power of data and develop new targeted therapies in oncology. We continue to be hopeful that TG4050 will make a significant difference in the lives of patients throughout the world," commented Motoo Nishihara, Executive Vice President, CTO (Chief Technical Officer) and Member of the Board, NEC Corporation.Prof. Christian H. Ottensmeier, MD, PhD, Professor of Immuno-oncology, at University of Liverpool and Prof. Jean-Pierre Delord, MD, PhD, General Manager of IUCT Oncopole of Toulouse, will share their insights on these early results in two upcoming webcasts, respectively in English and in French (see details at the end of the release).TG4050 IS AN INDIVIDUALIZED NEOANTIGEN VACCINE TAILORED FOR EACH PATIENT.This individualized immunotherapy is based on Transgene's advanced virus engineering platform myvac and NEC's deep expertise in artificial intelligence (AI). TG4050 is based on an MVA viral vector which is designed to educate the immune system against each patient's most relevant tumor targets (up to 30 patient-specific neoantigens).These mutations are identified by next generation sequencing (NGS) and selected using NEC's proprietary AI-based immunogenicity prediction system. The main goal of the vaccine is to elicit a strong and long-lasting immune response against tumor antigens by targeting class I and class II epitopes. These two types of responses have been established as key factors in driving a sustained anti-tumor response.DATA WERE GENERATED FROM 6 PATIENTS THAT HAVE BEEN TREATED WITH TG4050 ACROSS THE TWO PHASE I CLINICAL TRIALS.The two studies are designed to assess biological and clinical activity of TG4050 given alone. In particular, the studies were designed to provide insights on the capacity of the selected target neoantigens to induce immune responses against these epitopes and, ultimately, to correlate clinical outcome with biological responses in two indications with significantly different genomic profiles.The two Phase I clinical trials are exploring the activity of repeated injections of TG4050 as monotherapy in patients with minimal residual disease:- In the ovarian cancer trial, patients receive the vaccine at first signs of asymptomatic relapse of their high grade, advanced-stage disease (after surgery and first-line chemotherapy). Asymptomatic relapse is defined as the detection of elevated CA-125 (tumor marker of ovarian cancer frequently associated with a relapse) or as low volume radiologic disease. The first patient was dosed in August 2020. Data have been generated from four patients treated in this trial.- Patients with HPV-negative, advanced-stage head and neck cancer are at high risk of relapse after surgery and adjuvant therapy. In the trial, they are randomized after completion of this primary treatment to receive vaccination (early treatment arm) or to receive TG4050 at relapse (delayed vaccination arm). In this trial, the first patient was dosed in January 2021. As of today, six patients were randomized in this trial, two in the early treatment arm and four in the delayed vaccination arm.Overall the data discussed today were obtained from the first six patients who received TG4050 across the two trials. The primary endpoints of these trials include safety and feasibility. Secondary endpoints include biological activity of the therapeutic vaccine TG4050.CELLULAR IMMUNE RESPONSE WAS EVALUABLE FOR 4 OF THE PATIENTS TREATED WITH TG4050.T-cell responses for each targeted mutation were assessed after 9 weeks of treatment with TG4050 and compared to baseline for the 4 patients for which evaluable samples were available. Neoepitope immunoreactive T-cells were quantified by ex vivo IFNgamma ELISPOT.- All 4 patients developed a robust T-cell response against multiple targeted mutations (neoantigens) with a median of 10 positive responses per patient, confirming the capability of the AI to accurately select immunogenic neoantigens across the two selected indications.- T-cell responses were observed for class I and class II epitopes. They consisted of de novo responses in 64% of observed responses (onset of response that were absent at baseline) and amplifications of preexisting responses for 36% of vaccine responses.- Additionally, the development of these adaptive responses was concomitant with maturation and activation of the patients' circulating immune cells, suggesting that the vaccine is able to effectively prime the immune system.Compared to previously reported neoantigen studies, these data reinforce the rationale for TG4050's prediction system and support the validation of the MVA vector as an efficient platform for anti-tumor vaccination.All immune assessments were conducted by the clinical immunology laboratory of Institut Curie (Paris).FIRST SIGNALS OF CLINICAL ACTIVITY ARE EXTREMELY PROMISING FOR TG4050In the ovarian cancer trial (n=4), one patient treated after an elevation of CA-125 experienced a normalization of CA-125 without clinical progression during 9 months until death from an unrelated chronic illness. Another patient with radiologic lesions is stable and is still under treatment with TG4050 9 months after the first injection.In the head and neck trial early treatment arm (n=2), the two patients have been treated with TG4050 for 10 and 5 months respectively and are stable. Their treatment is ongoing.To date, the vaccine has been well tolerated and no related Serious Adverse Events have been reported across the two studies. Adverse events are consistent with previous observations made with the MVA viral vector. They mainly consist of mild and transient symptoms, mostly injection site reactions.HIGHLY ENCOURAGING DATA POINT TO BE SHARED WITH THE COMMUNITY AND BE SUPPORTED BY ADDITIONAL DATA.Additional data will be generated in the coming months. Transgene expects to present them at a major oncology conference in 2022.In both clinical studies, enrollment and patient dosing are progressing in line with our expectations. Overall, Transgene plans to enroll 13 patients in the ovarian cancer trial and 30 patients in the head and neck trial.A conference call in English is scheduled on November 23, 2021, at 3:00 p.m. CET.A conference call in French is scheduled on November 23, 2021, at 8:30 a.m. CET.Replays will be available on the Transgene website (www.transgene.fr) following the live events.About the trialsTG4050 is being evaluated in two Phase I clinical trials for patients with ovarian cancers (NCT03839524) and HPV-negative head and neck cancers (NCT04183166).In a first Phase I trial, TG4050 is being administered to patients with HPV-negative head and neck cancer. A personalized treatment is created for each patient after they complete surgery and while they receive an adjuvant therapy. Half of the participants receive their vaccine immediately after they complete their adjuvant treatment. The other half is given TG4050 as an additional treatment at the time of recurrence of the disease. This randomized study is evaluating the treatment benefits of TG4050 in patients who have a high risk of relapse. Up to 30 patients will receive TG4050 in France, in the UK and in the USA. The principal investigator of the trial is Prof. Christian Ottensmeier, M.D., Ph.D., Consultant Medical Oncologist at the Clatterbridge Cancer Centre and Professor of Immuno-Oncology at the University of Liverpool. In France, the clinical trial is being conducted, at Institut Curie, Paris, by Prof. Christophe Le Tourneau, M.D., PhD, Head of the Department of Drug Development and Innovation (D3i) and at the IUCT-Oncopole, Toulouse, by Prof. Jean-Pierre Delord. In the USA, the trial is being led by Dr. Yujie Zhao, M.D., Ph.D., at the Mayo Clinic. Endpoints of the trial include safety, feasibility and biological activity of the therapeutic vaccine.In parallel, a Phase I clinical trial of TG4050 is enrolling patients with ovarian cancer. The first patient has been dosed in the USA. This second trial is including patients after surgery and first-line chemotherapy. Dr. Matthew Block, Consultant Medical Oncology, Consultant Immunology and Associate Professor of Oncology at the Mayo Clinic (USA) is the principal investigator of the trial; in France, the trial is being conducted by Prof. Le Tourneau at Institut Curie and by Dr. Alexandra Martinez, Associate Head of Surgical Department, at IUCT-Oncopole. Endpoints of the trial include safety, feasibility and biological activity of the therapeutic vaccine.About myvacmyvac is a viral vector (MVA - Modified Vaccinia Ankara) based, individualized immunotherapy platform that has been developed by Transgene to target solid tumors. myvac-derived products are designed to stimulate the patient's immune system, recognize and destroy tumors using the patient's own cancer specific genetic mutations. Transgene has set up an innovative network that combines bioengineering, digital transformation, established vectorization know-how and unique manufacturing capabilities. Transgene has been awarded "Investment for the Future funding from Bpifrance for the development of its platform myvac". TG4050 is the first myvac-derived product being evaluated in clinical trials.About TG4050TG4050 is an individualized immunotherapy being developed for solid tumors that is based on Transgene's myvac technology and powered by NEC's longstanding artificial intelligence (AI) expertise. This virus-based therapeutic vaccine encodes neoantigens (patient-specific mutations) identified and selected by NEC's Neoantigen Prediction System. The prediction system is based on more than two decades of expertise in AI and has been trained on proprietary data allowing it to accurately prioritize and select the most immunogenic sequences.TG4050 is designed to stimulate the immune system of patients in order to induce a T-cell response that is able to recognize and destroy tumor cells based on their own neoantigens. This individualized immunotherapy is developed and produced for each patient.About NEC's Neoantigen Prediction SystemNEC's neoantigen prediction system utilizes its proprietary AI, such as graph-based relational learning, trained on multiple sources of biological data to discover candidate neoantigen targets. These targets are carefully analyzed using proprietary machine learning algorithms that include in-house HLA binding and antigen presentation AI tools to evaluate the likelihood of eliciting a robust and clinically relevant T cell response. With NEC OncoImmunity now onboard, NEC continues to strengthen its top class neoantigen prediction pipelines with the aim of maximizing the therapeutic benefits of personalized cancer immunotherapy for patients worldwide. For more information, visit NEC at www.nec.com. For additional information, please also visit NEC OncoImmunity at https://www.oncoimmunity.com/About TransgeneTransgene (Euronext: TNG) is a biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. Transgene's programs utilize viral vector technology with the goal of indirectly or directly killing cancer cells.The Company's clinical-stage programs consist of two therapeutic vaccines (TG4001 for the treatment of HPV-positive cancers, and TG4050, the first individualized therapeutic vaccine based on the myvac platform) as well as two oncolytic viruses (TG6002 for the treatment of solid tumors, and BT-001, the first oncolytic virus based on the Invir.IO platform).With Transgene's myvac platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The myvac approach allows the generation of a virus-based immunotherapy that encodes patient-specific mutations identified and selected by Artificial Intelligence capabilities provided by its partner NEC.With its proprietary platform Invir.IO, Transgene is building on its viral vector engineering expertise to design a new generation of multifunctional oncolytic viruses. Transgene has an ongoing Invir.IO collaboration with AstraZeneca.Additional information about Transgene is available at: www.transgene.frFollow us on Twitter: @TransgeneSAAbout NEC CorporationNEC Corporation has established itself as a leader in the integration of IT and network technologies while promoting the brand statement of "Orchestrating a brighter world." NEC enables businesses and communities to adapt to rapid changes taking place in both society and the market as it provides for the social values of safety, security, fairness and efficiency to promote a more sustainable world where everyone has the chance to reach their full potential. For more information, visit NEC at https://www.nec.com.DisclaimerThis press release contains forward-looking statements, which are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. The occurrence of any of these risks could have a significant negative outcome for the Company's activities, perspectives, financial situation, results, regulatory authorities' agreement with development phases, and development. The Company's ability to commercialize its products depends on but is not limited to the following factors: positive pre-clinical data may not be predictive of human clinical results, the success of clinical studies, the ability to obtain financing and/or partnerships for product manufacturing, development and commercialization, and marketing approval by government regulatory authorities. For a discussion of risks and uncertainties which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the Universal Registration Document, available on the AMF website (http://www.amf-france.org) or on Transgene's website (www.transgene.fr). Forward-looking statements speak only as of the date on which they are made, and Transgene undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future. Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

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Apollomics Inc. Doses First Patient in Phase 3 Clinical Trial with APL-106 (Uproleselan Injection) in Chinese Patients with Relapsed/Refractory Acute Myeloid Leukemia

Foster City, CA, Shanghai and Hangzhou, China, Nov 22, 2021 - (ACN Newswire via SEAPRWire.com) - Apollomics Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, today announced that the first patient has been successfully dosed in a Phase 3 clinical trial of APL-106 (uproleselan injection) for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) in China. Apollomics licensed the Greater China rights for uproleselan from GlycoMimetics."As our first Phase 3 clinical trial, dosing of the first patient with APL-106 is a major inflection point for Apollomics as we now become a company in late-stage development," said Guo-Liang Yu, PhD, Co-Founder, Chairman and Chief Executive Officer. "AML is a highly aggressive hematological cancer, and the prognosis of patients with relapsed or refractory disease is extremely poor. APL-106 acts via an innovative mechanism that drives cancer cells out of the bone marrow, making them a prime target to be killed by chemotherapy. This combined treatment approach could have a meaningful impact on the lives of patients living with relapsed or refractory AML."The Phase 3 trial with APL-106 is part of the overall development program for Apollomics in China that also includes an ongoing Phase 1 pharmacokinetics (PK) and tolerability study. The Phase 3 clinical trial is a randomized, double-blind, placebo controlled, bridging study that will evaluate the efficacy of uproleselan in combination with chemotherapy, compared to chemotherapy alone, for treating relapsed/refractory AML, in Chinese patients. The trial will enroll approximately 140 adult patients with primary refractory AML or relapsed AML (first or second untreated relapse) and eligible to receive induction chemotherapy. The primary endpoint for the trial is overall survival. Secondary outcome measures include the rate and duration of remission, and whether uproleselan could reduce the rate of oral mucositis, a chemotherapy-related side effect. Apollomics expects to conduct this study at approximately 20 blood cancer clinical research centers across China. Additional information on the Phase 3 trial can be found on clinicaltrials.gov (NCT05054543) About APL-106 (uproleselan injection) APL-106 (uproleselan injection) is an innovative drug discovered and developed by GlycoMimetics. Uproleselan (yoo' pro le' sel an) is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells, thereby disrupting the mechanism of leukemic cell resistance within the bone marrow microenvironment. Apollomics licensed uproleselan from GlycoMimetics, and Apollomics has the rights to clinical development, production and commercial sales in the Greater China market (Mainland China, Hong Kong, Macau and Taiwan). The U.S. Food and Drug Administration granted Breakthrough Therapy Designation to uproleselan for the treatment of adults with relapsed or refractory acute myeloid leukemia. APL-106 has also been granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China.About Acute Myeloid Leukemia (AML)Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow. It is an aggressive disease that causes the bone marrow to produce immature cells that are unable to carry out their normal function and develop into leukemia cells. In the U.S., there are approximately 20,000 new cases of AML each year, and the 5-year survival rate is 28.7%1. The annual incidence of AML in China in 2019 is approximately 26,9002, and relapsed/refractory AML has an extremely poor prognosis.1National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) Program2CIC ReportAbout Apollomics Inc.Apollomics Inc. is an innovative biopharmaceutical company committed to the discovery and development of monotherapies and combination therapies of tumor-targeting and immuno-oncology agents. The Company's product pipeline has several programs at different stages of development, including novel, humanized monoclonal antibodies that restore the body's immune system to recognize and kill cancer cells, and targeted therapies against uncontrolled growth signaling pathways. Apollomics has operating entities in Foster City, California, USA, Hangzhou and Shanghai, China. For more information, please visit www.apollomicsinc.com.Contact Information:Investor Contact:Wilson W. CheungChief Financial Officer(650) 209-4436wcheung@apollomicsinc.comU.S. Media Contact:Remy BernardaCorporate Communications(415) 203-6386remy.bernarda@apollomicsinc.comChina Media Contact:Porda Havas International Finance Communications GroupKelly FungGeneral Manager(852) 3150 6763kelly.fung@pordahavas.com Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

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