27 1 月, 2023

Eisai: Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease Accepted by European Medicines Agency

TOKYO and CAMBRIDGE, Mass., Jan 27, 2023 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for lecanemab, an investigational anti-amyloid beta (Abeta) protofibril* antibody, for the treatment of early Alzheimer's disease (mild cognitive impairment due to Alzheimer's disease (AD) and mild AD dementia) with confirmed amyloid pathology, for review following a standard timeline. In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023. On the same day, Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway based on the results from the Phase III Clarity AD confirmatory study. In Japan, Eisai submitted a marketing authorization application to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023. In China, Eisai has initiated submission of data for a BLA to the National Medical Products Administration (NMPA) of China in December 2022. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. *Protofibrils are large Aβ aggregated soluble species of 75-500 Kd.(1),(2)(1) "Lecanemab Sweeps up Toxic AΒ Protofibrils, Catches Eyes of Trialists." ALZFORUM, ALZFORUM, 21 Nov. 2021, bit.ly/3HzXXyE.(2) Sehlin D, Englund H, Simu B, Karlsson M, Ingelsson M, Nikolajeff F, Lannfelt L, Pettersson FE. Large aggregates are the major soluble Aβ species in AD brain fractionated with density gradient ultracentrifugation. PLoS One. 2012;7(2): e32014. doi: 10.1371/journal.pone.0032014. Epub 2012 Feb 15. PMID: 22355408; PMCID: PMC3280222.For more information, visit www.eisai.com/news/2023/news202311.html. Copyright 2023 JCN Newswire. All rights reserved. (via SEAPRWire)

16 1 月, 2023

Eisai Files Marketing Authorization Application for Anti-Amyloid-Beta Protofibril Antibody Lecanemab for Early Alzheimer’s Disease in Japan

TOKYO and CAMBRIDGE, Mass., Jan 16, 2023 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has submitted a marketing authorization application for lecanemab (Brand Name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril(1) antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia (collectively known as early AD) with confirmed presence of amyloid pathology in the brain to the Pharmaceuticals and Medical Devices Agency (PMDA).This application is based on the results of the Phase III Clarity AD study and Phase IIb clinical study (Study 201), which demonstrated the lecanemab treatment showed a reduction of clinical decline in early AD. Prior to submitting this application, Eisai utilized the prior assessment consultation system of PMDA, with the aim of shortening the review period for lecanemab. In the Clarity AD study, lecanemab treatment resulted in highly statistically significant results, reducing clinical decline on the global cognitive and functional scale as the primary endpoint (CDR-SB(2): Clinical Dementia Rating-Sum of Boxes) as early as six months, and over time across all time points. All key secondary endpoints also showed highly statistically significant results. Especially, treatment with lecanemab showed a statistically significant reduction in amyloid plaque burden at all timepoints starting at 3 months in the amyloid PET study and statistically significantly slowed decline of activities of daily living on ADCS MCI-ADL(3). The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.In November 2022, the results of Clarity AD study were presented at the 15th Clinical Trials on Alzheimer's Disease (CTAD) conference and simultaneously published in the peer-reviewed medical journal the New England Journal of Medicine(New Window).In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023. On the same day, Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway. In Europe, Eisai submitted marketing authorization application (MAA) to the European Medicines Agency (EMA) on January 9, 2023. In China, Eisai initiated submission of data for BLA to the National Medical Products Administration (NMPA) of China in December 2022.Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully gain health authority approval.For more information, visit www.eisai.com/news/2023/news202307.html.MEDIA CONTACT:Eisai Co., Ltd.Public Relations DepartmentTEL: +81-(0)3-3817-5120Eisai Inc. (U.S.)Libby Holman+ 1-201-753-1945Libby_Holman@eisai.com INVESTOR CONTACT:Eisai Co., Ltd.Investor Relations DepartmentTEL: +81-(0)03-3817-5122 Copyright 2023 JCN Newswire. All rights reserved. (via SEAPRWire)

11 1 月, 2023

Eisai Submits Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease in Europe

TOKYO, Jan 11, 2023 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that Eisai has submitted a marketing authorization application (MAA) for lecanemab (Brand Name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril antibody, for the treatment of early Alzheimer's disease (mild cognitive impairment due to Alzheimer's disease (AD) and mild AD dementia) to the European Medicines Agency (EMA). This application is based on the results of the Phase III Clarity AD study and the Phase IIb clinical study (Study 201), which demonstrated that lecanemab treatment showed a reduction of clinical decline in early AD, and is subject to a validation to determine whether the EMA accepts the application for review.The Clarity AD study met its primary endpoint (CDR-SB(1): Clinical Dementia Rating-Sum of Boxes) and all key secondary endpoints with highly statistically significant results. The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference, and simultaneously published in the New England Journal of Medicine, peer-reviewed medical journals.In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023. Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway on the same day. In China, Eisai has initiated submission of data for BLA to the National Medical Products Administration (NMPA) of China in December 2022. In Japan, Eisai plans to submit a marketing authorization application by the end of Eisai's fiscal year 2022, which ends March 31, 2023.Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.(1) CDR-SB is a numeric scale used to quantify the various severity of symptoms of dementia. Based on interviews of people living with AD and family/caregivers, qualified healthcare professionals assess cognitive and functional performance in six areas: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The total score of the six areas is the score of CDR-SB, and CDR-SB is also used as an appropriate item for evaluating the effectiveness of therapeutic drugs targeting the early stages of AD.Media Contacts:Eisai Co., Ltd.Public Relations DepartmentTEL: +81 (0)3-3817-5120Eisai Europe, Ltd.(Europe, Australia, New Zealand and Russia)EMEA Communications Department+44 (0) 786 601 1272EMEA-comms@eisai.netBiogen Inc.Natacha Gassenbach+ 1-857-777-6573public.affairs@biogen.comInvestor Contacts: Eisai Co., Ltd. Investor Relations DepartmentTEL: +81 (0) 3-3817-5122Biogen Inc.Mike Hencke+ 1-781-464-2442IR@biogen.com Copyright 2023 JCN Newswire. All rights reserved. (via SEAPRWire)

6 10 月, 2022

Audiolox Announces Early-Stage Fundraising Pledge by Investors Surpassed Its Seed Round Target by 20%

NEW YORK, NY,October 06, 2022- (SEAPRWire) – Audiolox, a blockchain-powered and secure music platform, announced that the early-stage pledges from investors were 20% higher than its seed round target. The Dubai-based company was launched on October 5, 2022, and is already attracting investors’ confidence. The event, held at the Dubai SLS hotel’s convention hall, was anchored by CLS. The idea for the creation of Audiolox was first conceptuliazed in 2019, as a blockchain streaming application. However, after seeing the challenges artists face with contracts from record labales and notable streaming giants, incesant breach of users’ data, etc. the team decided to combine blockchain technology and artificial intelligence. This innovative approach gave birth to the Audiolox Secure Music Platform. According to the founding team, the mission of the project is to be the first platform that allows writers, singers, producers, etc to share music with a large audience in a fast, secure, and environmentally safe manner. One of the major highlights of the project launch was the presentation of the Audiolox technology to the guests by Dr. Mark Lane, the brain behind the creation of Audiolox music application. After the presentation, there was an exclusive private rooftop after-party where VIPs could interact with crypto leaders and experts. In his statement, Dr. Mark revealed that “Audiolox is the first fully decentralized Web3 Secure Music Application based on the new Loxsync Technologies Artificial Intelligence structure.” Dr. Mark Lane is the founder and Chief Technical Officer (CTO) of Audiolox technologies. He is also the Project contractor for a number of well-known companies. The Project Roadmap Below are the development plans for the Audiolox project: Q3 2022: Assembling computational and forecasting evaluation structures.Q4 2022: commencing ICO filing, launching the Alpha version, and auditing the community development’s platformQ1 2023: Make improvements to the platform’s users’ feedback. Establish R&D Department. Platform expansion. DEX % CEX Listings.Q2 2023: commencing the app’s Beta version, attaining the 1 million users’ milestone, and presenting the platform’s development analysis report.Q3 2023: advancing associated AI platforms like Healthlox, Sportslox, Cinemalox, Crimelox, Casinolox, and other banking apps. About Audiolox Audiolox is a Web3 decentralized music application. Motivated by the difficulties encountered with web2 music applications, such as the use of third-party databases for storing files which makes it vulnerable for hackers to infiltrate, and the low-income base for the various music platforms, the founding team created Audiolox to reposition the music industry towards the future by utilizing web3 features and blockchain structures. Audiolox is an innovative and revolutionary new Artificial Intelligence music app technology, mainly developed to serve the music industry. The infrastructures of Audiolox were developed from the mix of blockchain and Loxsync’s AI features, the first of its kind. Driven by the desire to craft a difference in the music industry, the Audiolox team came up with the first-ever blockchain and web3-inspired music application specifically designed to serve the needs of songwriters, producers, users, and artists. Audiolox is gradually adopting full decentralization status within the music industry. This is possible given the presence of blockchain infrastructures and the new AI. Moreover, Audiolox offers a competitive payout package to its users. Users earn One Penny Per Play (OPPP), the highest for any existing music application. ALOX is a dual-purpose token that will be used within the Audiolox application. First, the token will help the team to raise the last round of funding required to complete the full development of the Audiolox application. The second use case of the ALOX token is that it will serve as a utility token for in-app transactions like individual subscriptions and online merchandise. Social Media Twitter: https://twitter.com/aloxtoken Telegram: https://t.me/aloxtoken Facebook: https://www.facebook.com/aloxtoken Instagram: https://www.instagram.com/aloxtoken.official/ LinkedIn: https://www.linkedin.com/in/alox-utility-token-4097a3246/ Reddit: https://www.reddit.com/r/Aloxtoken/ Tiktok: https://www.tiktok.com/@aloxtoken?is_from_webapp=1&sender_device=pc Media Contact Company Name: Audiolox Secure Music Application Contact Person: Dr. Mark Lane Contact Person Title: CTO Company Website: www.aloxtoken.com Company Email: info@aloxtoken.com Source:Audiolox Secure Music Application The article is provided by a third-party content provider. SEAPRWire ( https://www.seaprwire.com/ ) makes no warranties or representations in connection therewith. Any questions, please contact cs/at/SEAPRWire.com Sectors: Top Story, Daily News SEA PRWire: PR distribution in Southeast Asia (Hong Kong: AsiaExcite, EastMud; AsiaEase; Singapore: SEAChronicle, VOASG; NetDace; Thailand: SEAsiabiz, AccessTH; Indonesia: SEATribune, DailyBerita; Philippines: SEATickers, PHNotes; Malaysia: SEANewswire, KULPR; Vietnam: SEANewsDesk, PostVN)

9 6 月, 20229 6 月, 2022

SinoMab Announces IND APPLICATION FOR SN1011 ACCEPTED BY NMPA CDE

Continuously expanding the scope of potential indications for SN1011 HONG KONG, June 9, 2022 - (ACN Newswire) - 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, is pleased to announce that, on 6 June 2022, an Investigational New Drug application ("IND", for neuromyelitis optica spectrum disorder ("NMOSD")) for SN1011 has been filed with and accepted by the Center for Drug Evaluation (the "CDE") of the National Medical Products Administration of China (the "NMPA"). The Company plans to initiate the Phase II clinical study in China upon approval of the present IND. The present IND submission, once granted, will enable the Company to conduct clinical program in China for treatment of NMOSD. SN1011 is the Company's third generation, covalent reversible BTK inhibitor with improved safety, higher selectivity and superior efficacy and for the long-term treatment of systemic lupus erythematous, pemphigus vulgaris, multiple sclerosis, rheumatoid arthritis, and other immunological diseases. SN1011 differentiates from existing BTK inhibitors currently available in the market in terms of mechanism of action, affinity, selectivity and safety. The Phase I clinical study (first-in-human clinical trial) of SN1011 was conducted in Australia and China in 2019 and completed in July 2021, which has demonstrated improved safety and good pharmacokinetics profile. Currently, the IND application for SN1011 in the treatment of systemic lupus erythematosus (SLE), pemphigus vulgaris (PV) and multiple sclerosis (MS) have been approved by NMPA, the Company plans to launch the Phase II clinical study of SN1011 for pemphigus in the third quarter of 2022. The Company is also planning an IND submission for multiple sclerosis (MS) in the U.S. in the second quarter of 2022, thereby accelerating the initiation of a global phase II trial in the third quarter of 2022. NMOSD is an autoimmune-mediated inflammatory demyelinating disease of the central nervous system with predominant involvement of the optic nerve and spinal cord. The pathogenesis of NMOSD is mainly associated with aquaporin-4 (AQP4) antibodies and is a separate disease entity from multiple sclerosis, with severe optic neuritis and longitudinal extensive transverse myelitis as the main clinical features. However, the cause of NMOSD is unknown, with a combination of environmental factors such as smoking, low vitamin D levels, EBV infection and genetic susceptibility contributing to the development of the disease. In 2020, according to inpatient registration data published in China, the incidence of NMOSD is about 0.278 (100,000 people/year), with children at 0.075 (100,000 people/year) and adults at 0.347 (100,000 people/year). NMOSD is seen at all ages, with young adults being the most common, with the average age of onset being 40 years. NMOSD is a highly recurrent and disabling disease, with 40-60% of patients experiencing a recurrence within one year and 90% within three years, and 50% of patients with a natural course of the disease having severe visual or motor impairment within 5-10 years. Currently, there are only three drugs officially approved by the US FDA or the European Union for the treatment of NMOSD, including complement inhibitors, IL-6 receptor blockers and B-lymphocyte-depleting agents. On 30 April 2021, the NMPA officially approved satralizumab for treatment of AQP4-IgG positive patients over the age of 12 years, making it the first drug approved for NMOSD treatment indications in mainland China. An IND application for NMOSD for SN1011 of SinoMab has been accepted by the CDE of the NMPA, and once approved, will facilitate the clinical research and development of new drugs for NMOSD in China. Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: "NOMSD is the fourth indication of SN1011 in China following the approvals of IND application for systemic lupus erythematosus (SLE), pemphigus vulgaris (PV) and multiple sclerosis (MS), and is also the third IND application submitted by the Company to the regulatory authority this year, which fully reflects the team's ability to simultaneously advance the research and development of multiple drug candidates and to effectively execute and communicate. The potential indications for SN1011 continue to expand, BTK inhibitor has a wide range of applications in the field of treatment of autoimmune diseases and huge future market potential. We believe that if the SN1011 product is successfully approved and commercialized in the future, it is expected to bring positive benefits to the Company, provide new options for the treatment of various autoimmune diseases and bring hope to the majority of patients." About SinoMab BioScience Limited SinoMab 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.

10 5 月, 2022

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)

20 4 月, 2022

SinoMab Announces IND APPLICATION FOR SN1011 APPROVED BY NMPA

HONG KONG, Apr 20, 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, is pleased to announce that, on 19 April 2022 (after trading hours), an Investigational New Drug application ("IND", for multiple sclerosis) for SN1011 was approved by the National Medical Products Administration of China (the "NMPA"). The IND approval would enable the Company to initiate the Phase II clinical study to evaluate the efficacy and safety of SN1011 in patients with multiple sclerosis in China. The planned first patient enrollment is in the fourth quarter of 2022.SN1011 is the Company's third generation, covalent reversible BTK inhibitor designed for higher selectivity, superior efficacy and improved safety for the long-term treatment of systemic lupus erythematous, pemphigus vulgaris, multiple sclerosis, rheumatoid arthritis, and other immunological diseases. SN1011 differentiates from existing BTK inhibitors currently available in the market, such as Ibrutinib, in terms of mechanism of action, affinity, selectivity and safety.The Phase I study (first-in-human clinical trial) of SN1011 was conducted in Australia and China in 2019 and completed in July 2021, which has demonstrated good safety and pharmacokinetics profile. Currently, the IND application for SN1011 in the treatment of systemic lupus erythematosus (SLE), pemphigus vulgaris (PV) and multiple sclerosis (MS) have been approved by NMPA, the Company plans to launch the Phase II clinical study for pemphigus in the third quarter of 2022. In addition to the approval of this IND, the Company is planning an IND submission for multiple sclerosis (MS) in the U.S. in the second quarter of 2022, thereby accelerating the initiation of a global phase II trial in the third quarter of 2022.MS is a demyelinating disease, which potentially damages the patient's brain and spinal cord. MS may cause a wide range of symptoms, including but not limited to vision problems and movement disorders. Global MS prevalence reached 2.7 million people in 2018 and is expected to increase to 3.1 million people in 2023 at a CAGR of 2.8% from 2018, and 3.7 million people in 2030 at a CAGR of 2.7% from 2023. Global MS market expanded to US$23.0 billion in 2018, and is expected to reach US$30.8 billion in 2023 at a CAGR of 6.0% from 2018, and US$48.9 billion in 2030 at a CAGR of 6.8% from 2023.Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: "The IND application for MS for SN1011 was accepted by the NMPA at the beginning of the year, and was approved only three months later, which fully reflects the NMPA's recognition of the Company's candidate products, and also confirms the efficient execution of the Company's new drug R&D program. The approval of this IND application is the third indication of SN1011 in China following the approval of IND application for SLE and pemphigus, fully demonstrating the great potential of our innovative BTK inhibitor in the field of the treatment of autoimmune diseases. We are absolutely confident in the enormous prospects of SN1011's clinical development, we will also accelerate clinical trials and continuously expand the scope of potential indications. In the future, we will accelerate our R&D projects implementation, devote to the vision of independent innovation, further expand the product portfolio and potential indications, dedicate to exploring safe and effective treatments for patients suffering from autoimmune diseases worldwide."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)

30 7 月, 2021

SecIron Presents Their Latest Version of IronWALL Mobile Apps Security for Huawei’s HarmonyOS Applications

Kuala Lumpur, Malaysia / SEAPRWire / July 30, 2021 / - Mobile devices like phones and tablets are no longer just communication devices for the users; they contain the very life of the users in a sense. Most users have all their information, bank statements, and other important details about themselves on their mobile devices. That is why it is necessary to keep the apps protected. Asia's leading mobile apps security solution provider, SecIron is offering innovative mobile application security solutions for the world's top OS that is HarmonyOS of HuaWei. The company is one of the first to have the capability in providing mobile security solutions for HuaWei's very own operating system HarmonyOS. The mobile app security firm has developed a brilliant application hardening platform solution named IronWALL. The latest version of it is 100% compatible for use with HarmonyOS. Their application hardening platform offers exemplary defence to the apps reducing their vulnerability in every aspect. That way it helps the applications running on the HarmonyOS to become more user-friendly and secure. SecIron provides innovative support in the building of secure mobile applications on HarmonyOS. The users of the latest HarmonyOS will definitely feel and experience the difference and improvement in the security features with the latest version of IronWALL. The latest version of SecIron's IronWALL mobile application security hardening is armed with improved cryptographic encryption technology and Runtime Application Self-Protection (RASP). The newest version already supports HuaWei's HarmonyOS. The integration of IronWALL onto HarmonyOS applications will ultimately result in a safer runtime environment for users from cybersecurity threats. It will lower the attack surfaces of applications from static and dynamic attacks by providing a secured defensive perimeter and a fortified wall. IronWALL will be able to prevent technology piracy and counterfeiting, repackaging, and such. SecIron is optimistic in that it will be part of creating an entire ecosystem with maximum security against any type of cybersecurity threats. The advanced version of IronWALL works with great efficiency providing effective results against all kinds of cybersecurity threats. It prevents cyber-attacks in mobile apps and prevents any kind of mishap from happening. It also detects attacks on mobile apps from suspicious behaviour including but not limited to debugging, tempering, reverse engingeering on the mobile applications. It provides an immediate response to the attacks on the mobile apps through responsive security protocols which also assists to avoid future damages on the mobile application. SecIron is a mobile application security solutions company with its headquarter based in Tokyo, Japan. They have adapted the open web application security project or OWASP to build next-generation security architecture called IronWALL to protect the mobile applications. Now it supports the newest operating system by HuaWei, HarmonyOS. They have a countless number of satisfied clients all over Asia safeguarding tens of thousands of mobile applications in various industries. To know about their services in detail, visit them at www.seciron.com. Social Links https://www.facebook.com/SecIron https://www.linkedin.com/company/seciron https://twitter.com/SecIron1 Media Contact Company: SecIron Contact: Azlan Yeng, Marketing Manager Telephone: +60193259662 E-mail: business@seciron.com Website: https://www.seciron.com/ SOURCE: SecIron The article is provided by a third-party content provider. SEAPRWire ( www.seaprwire.com ) makes no warranties or representations in connection therewith. Any questions, please contact cs/at/SEAPRWire.com Sectors: Top Story, Daily News SEA PRWire: PR distribution in Southeast Asia (Indonesia, Thailand, Vietnam, Singapore, Malaysia, Philippines & Hong Kong )

12 3 月, 2021

CropLife Asia’s ‘Drone for Pesticide Application’ Online Forum draws Asian Policymakers and Global Experts

SINGAPORE, Mar 12, 2021 - (ACN Newswire via SEAPRWire.com) - A first-of-its-kind virtual conference on drone use for pesticide application in Asia concluded this week after three days of dialogue and discussion among stakeholders from across the food supply chain. The event focused on perspectives ranging from those of regional governments, manufacturers as well as commercial adopters, and experts in the field forecasting future innovations."Our industry takes seriously its commitment to ensure responsible use of plant science technologies and sustainable agricultural practices. Drones are a new tool that can support and strengthen that effort - and have the potential to play a transformative role in Asian agriculture," said Mr. Gustavo Palerosi-Carnerio, CropLife Asia President."As with any innovation, the most critical components are the best practices that reflect responsible use and the policies that underpin them. Through this week's conference, we've heard vital insights from agricultural drone use experts in these areas and what the future may hold. We look forward to continuing these constructive conversations, and working with regulators and other key stakeholders across the food supply chain to help deliver drone use for pesticide application in Asia that is conducted responsibly."Drones or unmanned aerial vehicles (UAVs) are increasingly being used by large and small-scale farmers globally. This includes use for mapping, crop surveillance and scouting, pesticide application, and monitoring both irrigation as well as grazing livestock. According to a recent Industry ARC report, "Agricultural Drones Market - Forecast (2021-2026)", the market for agricultural drones is projected to reach more than $5.8 billion by 2026.In Asia, the use of drones for pesticide application is rapidly growing in popularity due to the advantages it provides, namely: efficiency with use of inputs; enhanced spray precision; reduced water consumption; and less dependence on labor, resulting in lower associated costs. "As food and agricultural stakeholders, we all have a duty to ensure our region's farmers are enabled and empowered to grow the nutritious crops on which we depend - and help deliver a food supply for Asia that is safe, secure and sustainable," commented Dr. Siang Hee Tan, CropLife Asia Executive Director."When used responsibly, drone technology can be a game-changer for Asia's smallholder farmers. However, it's critical that the growth in agricultural drone use in our region is matched by an expansion of sound and science-based regulations to support their responsible use. By bringing together a broad array of government and private sector stakeholders, this week's forum was a substantial step forward on that front."Asia is home to the smallest-sized farms and the largest number of smallholder farmers in the world. It's estimated that 85% of the world's 525 million smallholder farmers live and work within our continent. These growers face unique challenges in comparison with larger commercial farmers - landholder rights, access to finance, labor shortages, and availability of technology among them. With COVID-19 having an exacerbating effect on many of these and other obstacles Asia's smallholders face, drone use with pesticide application has the potential to benefit these growers by helping drive production and sustainability at the same time.CropLife Asia's Drone for Pesticide Application Online Forum was conducted 8-10 March and brought together virtually technology experts and sector stakeholders from across Asia and around the globe. The three-day conference was structured to convey and grow: common understanding of drone benefits to sustainability as well as farmers' safety and productivity; strong cross-sector partnership between government and industry; and an open exchange of knowledge and best practices to manage risks and concerns.A total of seven sessions were conducted during the forum to guide the discussion on a range of topics. From the "government" perspective, this included sessions on: Digital transformation and its impact on government agricultural policies; Regulatory frameworks for pesticide application by drone around Asia Pacific; and Safety Standard Operating Procedure (SOP) for pesticide application by drone. Sessions focusing on the "field" perspective included: R&D - Technology enablers for pesticide application by drone; and Commercial adoption of drone for pesticide application in APAC. Lastly, capturing the "future" perspective were sessions on: Emerging technological advancements in drone for pesticide application; and Roundtable - Future collaborations to drive best practices in the region. For additional details regarding the Forum, including a full roster of moderators and panelists who participated, please consult the Events section of the CropLife Asia website, www.croplifeasia.org.About CropLife AsiaCropLife Asia is a non-profit society and the regional organization of CropLife International, the voice of the global plant science industry. We advocate a safe, secure food supply, and our vision is food security enabled by innovative agriculture. CropLife Asia supports the work of 15 member associations across the continent and is led by six member companies at the forefront of crop protection, seeds and/or biotechnology research and development. For more information, visit us at www.croplifeasia.org.For more information please contact:Duke HippDirector, Public Affairs & Strategic PartnershipsCropLife Asiaduke.hipp@croplifeasia.org Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

11 3 月, 2021

Inaugural Forum on Pesticide Application Drone use in Asia brings together Regional Policymakers and Global Experts

SINGAPORE, Mar 11, 2021 - (ACN Newswire via SEAPRWire.com) - A first-of-its-kind virtual conference on drone use for pesticide application in Asia concluded this week after three days of dialogue and discussion among stakeholders from across the food supply chain. The event focused on perspectives ranging from those of regional governments, manufacturers as well as commercial adopters, and experts in the field forecasting future innovations."Our industry takes seriously its commitment to ensure responsible use of plant science technologies and sustainable agricultural practices. Drones are a new tool that can support and strengthen that effort - and have the potential to play a transformative role in Asian agriculture," said Mr. Gustavo Palerosi-Carnerio, CropLife Asia President."As with any innovation, the most critical components are the best practices that reflect responsible use and the policies that underpin them. Through this week's conference, we've heard vital insights from agricultural drone use experts in these areas and what the future may hold. We look forward to continuing these constructive conversations, and working with regulators and other key stakeholders across the food supply chain to help deliver drone use for pesticide application in Asia that is conducted responsibly."Drones or unmanned aerial vehicles (UAVs) are increasingly being used by large and small-scale farmers globally. This includes use for mapping, crop surveillance and scouting, pesticide application, and monitoring both irrigation as well as grazing livestock. According to a recent Industry ARC report, "Agricultural Drones Market - Forecast (2021-2026)", the market for agricultural drones is projected to reach more than $5.8 billion by 2026.In Asia, the use of drones for pesticide application is rapidly growing in popularity due to the advantages it provides, namely: efficiency with use of inputs; enhanced spray precision; reduced water consumption; and less dependence on labor, resulting in lower associated costs. "As food and agricultural stakeholders, we all have a duty to ensure our region's farmers are enabled and empowered to grow the nutritious crops on which we depend - and help deliver a food supply for Asia that is safe, secure and sustainable," commented Dr. Siang Hee Tan, CropLife Asia Executive Director."When used responsibly, drone technology can be a game-changer for Asia's smallholder farmers. However, it's critical that the growth in agricultural drone use in our region is matched by an expansion of sound and science-based regulations to support their responsible use. By bringing together a broad array of government and private sector stakeholders, this week's forum was a substantial step forward on that front."Asia is home to the smallest-sized farms and the largest number of smallholder farmers in the world. It's estimated that 85% of the world's 525 million smallholder farmers live and work within our continent. These growers face unique challenges in comparison with larger commercial farmers - landholder rights, access to finance, labor shortages, and availability of technology among them. With COVID-19 having an exacerbating effect on many of these and other obstacles Asia's smallholders face, drone use with pesticide application has the potential to benefit these growers by helping drive production and sustainability at the same time.CropLife Asia's Drone for Pesticide Application Online Forum was conducted 8-10 March and brought together virtually technology experts and sector stakeholders from across Asia and around the globe. The three-day conference was structured to convey and grow: common understanding of drone benefits to sustainability as well as farmers' safety and productivity; strong cross-sector partnership between government and industry; and an open exchange of knowledge and best practices to manage risks and concerns.A total of seven sessions were conducted during the forum to guide the discussion on a range of topics. From the "government" perspective, this included sessions on: Digital transformation and its impact on government agricultural policies; Regulatory frameworks for pesticide application by drone around Asia Pacific; and Safety Standard Operating Procedure (SOP) for pesticide application by drone. Sessions focusing on the "field" perspective included: R&D - Technology enablers for pesticide application by drone; and Commercial adoption of drone for pesticide application in APAC. Lastly, capturing the "future" perspective were sessions on: Emerging technological advancements in drone for pesticide application; and Roundtable - Future collaborations to drive best practices in the region. For additional details regarding the Forum, including a full roster of moderators and panelists who participated, please consult the Events section of the CropLife Asia website, www.croplifeasia.org.About CropLife AsiaCropLife Asia is a non-profit society and the regional organization of CropLife International, the voice of the global plant science industry. We advocate a safe, secure food supply, and our vision is food security enabled by innovative agriculture. CropLife Asia supports the work of 15 member associations across the continent and is led by six member companies at the forefront of crop protection, seeds and/or biotechnology research and development. For more information, visit us at www.croplifeasia.org.For more information please contact:Duke HippDirector, Public Affairs & Strategic PartnershipsCropLife Asiaduke.hipp@croplifeasia.org Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

2 11 月, 2020

BioVaxys Files Patent Application for Novel COVID-19 Diagnostic for T-Cell Immunity

Vancouver, BC, Nov 2, 2020 - (ACN Newswire) - BioVaxys Technology Corp. (CSE: BIOV) ("BioVaxys" or "the Company"), a world leader in haptenized protein vaccine research and development, announced today that it has filed a Provisional Patent Application with the U.S. Patent and Trademark Office entitled METHOD AND KIT FOR DETECTION OF CELL MEDIATED IMMUNE RESPONSE related to the potential development of a diagnostic for evaluating the presence or absence of a T-cell immune response to SARS-CoV-2, the virus that causes COVID-19.The BioVaxys method is based on measuring an immune response in a human showing no signs or symptoms of an active SARS-CoV-2 infection by administering a skin test of a subunit of the SARS-CoV-2 S-protein. Using Delayed Type Hypersensitivity[1] ("DTH"), a method which is known to demonstrate prior exposure and T cell immunity to tuberculosis[2], the immune system causes an inflammatory response that develops 24 to 72 hours after exposure. This type of immune response involves mainly T-cells rather than antibodies, which are made by B-cells.If ultimately successful, the diagnostic is intended to provide a low-cost, easy-to-administer, and accurate way to test for the presence of T-cells against SARS-CoV-2. Currently, the available methods of measuring T-cell immunity require a blood draw from the test subject followed by the time-consuming and expensive analysis of the blood sample at specialized laboratories. BioVaxys' diagnostic includes a way to digitally measure T-cell presence via a smartphone (through the magnitude of the skin response which is a hallmark of DTH) so results can be sent immediately to healthcare providers. At this time, future studies and experiments are required to demonstrate that DTH from protein skin prick correlates to T-cell immunity in the blood against SARS-CoV-2. Now that the provisional patent application has been filed, BioVaxys intends to begin its studies, leveraging the planned work in Q1 2021 related to the manufacturing and clinical development of BVX-0320, BioVaxys's preclinical vaccine candidate for SARS-CoV-2, as it is anticipated that BioVaxys will initially investigate the use of the same GMP-compliant protein for the DTH diagnostic that is used in the manufacturing of BVX-0320.David Berd, M.D., Chief Medical Officer at BioVaxys, who initially studied the potential use of DTH as a surrogate marker of T cell immunity in the context of clinical investigation of therapeutic autologous haptenized cancer vaccines[3], stated, "The availability of a low-cost and simple diagnostic for T-cell immunity would represent a critical tool for public health authorities to identify safe and at-risk populations and may contribute to worldwide efforts to combat COVID-19. BioVaxys believes that its novel T-cell diagnostic also provides an effective and low-cost tool to evaluate the effectiveness of any SARS-CoV-2 vaccine candidate in stimulating T cell immunity."[3]Recent peer-reviewed studies, including one in Nature[4] and Cell[5], have highlighted the potential importance of T-cell, in addition to antibodies, when it comes to evaluating long-term immunity in patients who have recovered from COVID-19. While further evaluation is necessary, exploring this part of the immune system's response to prevent future infection will be necessary in the global fight against this disease.BioVaxys' CEO, James Passin stated, "We are thrilled to further develop and move our novel diagnostic for SARS-CoV-2 T-cell immunity towards commercialization. The mass availability of our low cost and easy-to-administer T-cell immunity diagnostic could help to complement antibody testing and various public health risk mitigation strategies."A provisional patent application offers a patent applicant an option of filing without including a formal patent claim. In BioVaxys's case, however, numerous patent claims have been included in the Provisional Application. The aim of a provisional patent application is to establish an early effective filing date, in addition to allowing the patent applicant to ascribe the phrase "patent pending" to any commercial products, methods, or services contemplated by the subject matter claimed. BioVaxys also plans to pursue an international Patent Cooperation Treaty (PCT) application, from which national stage patent applications can be submitted in both industrial jurisdictions and developing countries around the world.Additional Information:- BioVaxys' patent application is for a diagnostic tool to test for SARS-COV-2, and not for a therapeutic treatment of SARS-COV-2. In addition, BioVaxys intends to seek future clearance from the U.S. Food & Drug Administration after sufficient clinical tests can be evaluated.- BioVaxys makes no express or implied claims that it has developed a vaccine to treat COVID-19 (or SARS-2 Coronavirus) at this time.David Berd, M.D. the Chief Medical Officer of BioVaxys, has reviewed and approved the scientific disclosure contained in this press release. Dr. Berd is a medical oncologist with a lifelong record of clinical research in medical oncology and cancer immunotherapy. Dr. Berd received his BS from Pennsylvania State University and his MD from Jefferson Medical College of Thomas Jefferson University.About BioVaxys Technology Corp.Based in Vancouver, BioVaxys Technology Corp. is a British Columbia-registered, early stage biotechnology company that is developing viral and oncology vaccine platforms for SARS-CoV-2 and various cancers. The Company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its haptenized autologous cell therapy used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors that will initially be developed for ovarian cancer. BioVaxys has two issued US patents and two patent applications related to its cancer vaccine, and a patent application for its SARS-CoV-2 (Covid-19) technology. BioVaxys common shares trade on the CSE under the stock symbol "BIOV" and are listed on the Frankfurt Bourse (FSE: 5LB).ON BEHALF OF THE BOARDSigned "James PasJames Passin, CEO+1 646 452 7054jpassin@biovaxys.comMedia ContactsAndrea Vuturo+1 508 301 3774biovaxys@dittopr.coCautionary Statements Regarding Forward Looking InformationThis press release includes certain "forward-looking information" and "forward-looking statements" (collectively "forward-looking statements") within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as "expects", "anticipates", "believes", "intends", "estimates", "potential", "possible", and similar expressions, or statements that events, conditions, or results "will", "may", "could", or "should" occur or be achieved. Forward-looking statements in this news release relate to, among other things, the success and ultimate commercialization of its diagnostic test for T-cell immunity. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements.These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and commercializing its diagnostic test for T-cell immunity and the issuance of a patent for such technology, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that such diagnostic testing will not prove to be effective and/or will not receive the required regulatory approvals. With regards to BioVaxys' business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new diagnostic tests for marketing approval and, if so, whether the technology will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties.The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.[1] Immunology and Allergy Clinics of North America; Volume 21, Issue 2, 1 May 2001, Pages 383-397[2] M. tuberculosis-complex specific T-cell stimulation and DTH reactions induced with a peptide from the 38-kDa protein. H M Vordermeier 1, D P Harris, P K Mehrotra, E Roman, A Elsaghier, C Moreno, J Ivanyi. Scandavian Journal of Immunology 1992 Jun;35(6):711-8.[3] BERD D, Sato T, Maguire HC Jr, Kairys J, Mastrangelo MJ: Immunopharmacological analysis of an autologous, hapten-modified human melanoma vaccine. J. Clin. Oncol., 22:403-415, 2004.[4] Le Bert, N., Tan, A.T., Kunasegaran, K. et al. (2020). "SARS-CoV-2-specific T cell immunity in cases of COVID-19 and SARS, and uninfected controls." Nature 584:457-462, 2020[5] Sekine, T., et al. (2020). "Robust T cell immunity in convalescent individuals with asymptomatic or mild COVID-19." Cell 183: 158-163To view the source version of this press release, please visit https://www.newsfilecorp.com/release/67255 Copyright 2020 ACN Newswire. All rights reserved. www.acnnewswire.com