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The Evolving Global Landscape in Vaccine Development: Novotech and Endpoints News Webinar

SYDNEY, AU, Feb 15, 2023 - (ACN Newswire via SEAPRWire.com) - Novotech, the leading Asia Pacific centred biotech CRO with extensive experience in vaccine trials, is convening an expert panel webinar covering the evolving landscape in vaccine development.Register here https://webinars.endpts.com/keeping-pace-with-the-evolving-global-landscape-in-vaccine-development/ Between 2017 and 2021, there were close to 1,400 industry-sponsored single country vaccine based clinical trials globally, with the Asia Pacific involved in over 45% of the trials. Download our latest data report here: Vaccines - Asia Pacific Clinical Trial Landscape. https://novotech-cro.com/whitepapers/vaccines-asia-pacific-clinical-trial-landscapeThe webinar, Keeping pace with the evolving global landscape in vaccine development, will hear from a panel of life science experts on the latest advancements and innovative modalities paving the way in the global vaccine development space including:- The COVID-19 impact on drug development and the regulatory landscape. - Key factors contributing to Asia Pacific being recognised as the hub for vaccine development and opportunities for biotech's to leverage. - Key considerations for pre-clinical and clinical planning to accelerate vaccine development, supporting a robust global strategy.Date/Time: March 09 11:00 am - 12:00 pm ESTRegister here https://webinars.endpts.com/keeping-pace-with-the-evolving-global-landscape-in-vaccine-development/Panelists:SUSHANT SAHASTRABUDDHEASSOCIATE DIRECTOR GENERAL, INTERNATIONAL VACCINE INSTITUTE (IVI)Dr. Sushant Sahastrabuddhe, Associate Director General at the International Vaccine Institute (IVI), joined in July 2010, leading the clinical trials of IVI's typhoid vaccine and process to achieve its licensure, the global clinical development of and licensure of SK bioscience's COVID-19 vaccines and Phase 1 and 2 trials of Bharat Biotech's Chikungunya vaccine. As a vaccine enthusiast with more than 17 years of experience in multiple countries across diverse projects, he continues to lead collaborative efforts with companies and partners in Korea, India and globally to get these vaccines through early- to late-stages of their clinical development. Dr. Sahastrabuddhe is also the Associate Editor for Vaccines for tropical diseases and associated with Yonsei University as Research Professor and with Universite Claude Bernanrd, Lyon France as Research Fellow. In 2021, Dr. Sahastrabuddhe was named an 'Honorary Citizen of Seoul' for his contributions to the joint efforts with Korean companies and international partners to develop vaccines against COVID-19 and other diseases.PAUL GRIFFINASSOCIATE PROFESSOR, INFECTIOUS DISEASES PHYSICIAN, MICROBIOLOGIST, UNIVERSITY OF QUEENSLANDAn Infectious Diseases Physician and Microbiologist, Dr. Paul Griffin was appointed as the Director of Infectious Diseases at Mater Health Services in 2013 and continues an appointment as an Associate Professor of Medicine at the University of Queensland Medical School. Additionally, Dr. Griffin chairs the Advanced Training Committee in Infectious Diseases with the Royal Australasian College of Physicians, the committee that oversees the training of Infectious Diseases specialists in Australia.Previously, Dr. Griffin was the Principal Investigator (PI) and Medical Director at Nucleus Network, a contract research organization specializing in infectious diseases trials, which included a PI role on in excess of 125 clinical trials predominantly in Infectious Diseases including novel vaccines and COVID-19 vaccines. With fellowships in Infectious Diseases from the Royal Australasian College of Physicians, in Clinical Microbiology from the Royal College of Pathologists of Australasia and from the Australasian College of Tropical Medicine, Dr. Griffin has an active interest in vaccine education and advocacy and has become a trusted media authority and spokesperson across the nation during the COVID-19 pandemic.BABAJI YADAVSENIOR CONSULTANT, NOVOTECH DRUG DEVELOPMENT CONSULTINGBabaji Yadav is a Senior Consultant with over eight years of academic experience in pre-clinical oncology drug development and eight years of industry experience in drug development. Babaji has a strong background in pharmaceutical sciences with a Ph.D. in Pharmacology and Toxicology from the University of Otago, New Zealand. Previously he has worked as a Research Project Manager to oversee IND-enabling toxicology studies for lead oncology drugs and, prior to joining Novotech, was a Clinical Project Manager for early-phase oncology trials. Babaji is a UK Registered Toxicologist and at Novotech he is focused on providing technical toxicology advice and product development strategies to facilitate the entry of client's compounds into clinical trials. Babaji has experience in small molecules, combination products, and biologicals including vaccines, proteins, monoclonal antibodies, and advanced cell and gene therapies.JENNIFER ARELLANODIRECTOR OF CLINICAL SERVICES (PHILIPPINES), NOVOTECHJennifer Arellano is the Director of Clinical Services in the Philippines with over 25 years of technical and leadership experience in managing clinical trial operations for sponsors and CROs. With a Bachelor of Industrial Pharmacy from the University of the Philippines and a Pharmacist license, Jennifer's research operations experience includes monitoring, auditing, project leadership, feasibility, study start-up, driving inspection readiness and hosting regulatory inspection, client engagement and business development, learning & development and organization SOP development/review. Jennifer has contributed to the transformation of the Philippine clinical research industry - bringing improvement to the local clinical research regulations and practices and is the founding President of a non-profit organization, the Philippine Clinical Research Professionals Inc, with more than 400 members from pharmaceutical and CROs, and has more recently, volunteered pro-bono services during the Covid-19 pandemic to provide trial management consultancy to the Philippine DOH-funded trials such as WHO Solidarity COVID-19 Treatment and Vaccine trials, Avigan COVID-19 treatment trial, and Philippine Heart Association funded cardiovascular outcome study.Novotech has recently acquired EastHORN, a European CRO with clinical, medical and regulatory expertise in multiple strategically important locations across the continent. The acquisition is part of Novotech's global expansion program in Europe and the US.Novotech has recently been benchmarked as a top 10 CRO among the world's leading CROs, is the recipient of the Asia Pacific Cell & Gene Therapy Clinical Trials Excellence award and the Asia-Pacific Contract Research Organization Company of the Year Award, and has signed 45 Leading Site Partnership agreements over the last 3 years.Novotech offers biotechs a unique and unparalleled suite of early to late-phase CRO services across Europe and the US, with a specialist focus on Asia Pacific where the company has built a reputation for delivering high-quality expedited clinical trials. About Novotech (Novotech-CRO.com)Novotech is internationally recognized as the leading Asia Pacific centred biotech Contract Research Organization (CRO) with global execution capabilities. Novotech is a clinical CRO with labs, phase I facilities, drug development consulting services and FDA regulatory expertise and has experience in over 3,700 pre-clinical and clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biotech clients conducting clinical trials in Asia Pacific, the US and Europe. Novotech has over 2,700 staff working across offices in 20 geographies. 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 2023 ACN Newswire. All rights reserved. (via SEAPRWire)

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InaVac gets emergency approval from BPOM

Surabaya, East Java, Indonesia, Nov 14, 2022 - (ACN Newswire via SEAPRWire.com) - The Food and Drug Supervisory Agency (BPOM) has issued emergency use authorization (EUA) for InaVac, a COVID-19 vaccine developed by researchers from Airlangga University (Unair).InaVac, COVID-19 vaccine, is developed by the University of Airlangga in Surabaya, East Java Province. (ANTARA/HO-BPBRIN Unair)"InaVac has obtained emergency use authorization from BPOM and will be mass-produced," the rector of Unair, Prof. Moh. Nasih, said on the sidelines of the campus' dies natalis (anniversary) on Wednesday.The vaccine, which can be used to prevent a COVID-19 infection, has been made using an inactivated virus, which means, a virus that cannot reproduce and cause disease.InaVac has been approved for use as a primary vaccine for people aged 18 and above for boosting immunity levels.According to Nasih, the vaccine was developed as part of an effort by the university to significantly contribute to and impact the health sector.Following the provision of EUA from BPOM, he expressed his gratitude to various stakeholders that have supported the development of the vaccine."Thank you to the Ministry of Health for providing support in the form of large amounts of funding; the provincial government has also provided extraordinary support," he remarked."Dr. Soetomo Hospital has also been very supportive. Equally important has been the role of Unair researchers who worked hard for this," he added.Former state-owned enterprises minister Dahlan Iskan also expressed his pleasure over the completion of the domestically-made COVID-19 vaccine."I am happy because Unair has processed this vaccine to completion. How this vaccine was successfully launched, how to find people who want to undergo the vaccine. Finding people who are willing to be clinically tested is extremely difficult but Unair managed to finish it," he said.It is hoped that after InaVac, more vaccines will be produced through continued research and development so that they can answer future challenges and problems.Unair is currently developing a booster vaccine and a COVID-19 vaccine for children."The news about vaccines has been very encouraging; hopefully, later booster vaccines and children can be produced," he said.For further information, please visit: https://www.unair.ac.id/Written by: Abdul Hakim, Yashinta Difa, Editor: Fardah Assegaf (c) ANTARA 2022 Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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AIM Vaccine Announces Global Offering Results, Offer Price of HK$16.16 per H Share

HONG KONG, Oct 5, 2022 - (ACN Newswire via SEAPRWire.com) - AIM Vaccine Co., Ltd. ("AIM Vaccine" or the "Company", together with its subsidiaries, the "Group", stock code: 06660.HK), the second largest vaccine company in China in terms of 2021 approved lot release volume (excluding COVID-19 vaccines), today announced the allotment results of its Global Offering. The Offer Price is HK$16.16 per H share. Dealings in the H shares of the Company on the Main Board of The Stock Exchange of Hong Kong Limited (the "Hong Kong Stock Exchange") are expected to commence on 6 October 2022 (Thursday) in board lot of 200 H shares each.The H shares initially offered under the International Offering were over-subscribed. The net proceeds from the Global Offering are intended for advancing R&D of vaccine candidates and continuing to enrich vaccine pipeline, funding the capital expenditure on the construction of new production facilities for new vaccine products, and investing in sales and marketing activities. The Company said, through one decade of organic growth and external resource integration, AIM Vaccine has become a major player in the Chinese vaccine industry. The official listing on the Hong Kong Stock Exchange marks an important milestone in the history of the development of AIM Vaccine, opening a new chapter for the Company's development. The successful listing shows the trust and support of global investors for the Company's business development, and lays a firm ground for the Company's long-term growth. Looking forward, AIM Vaccine will carry on accelerating the R&D and commercialization process of the pipeline of vaccine candidates, and become a world-class vaccine company, thereby continuing to create greater value for shareholders. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Bio Farma secures multi-year Purchase Contract from UNICEF for its novel Oral Polio Vaccine type 2 (nOPV2)

BANDUNG, INDONESIA, Oct 2, 2022 - (ACN Newswire via SEAPRWire.com) - PT Bio Farma (Persero), the holding company for pharmaceutical state-owned enterprises (SOEs), will export its novel Oral Polio Vaccine type 2 (nOPV2) having secured a purchase contract with the United Nations Children's Fund (UNICEF) for 2022 & 23. Under the contract, Bio Farma will export its oral polio vaccines based on purchase requests from UNICEF via multilateral contract agreement for the years 2022 & 23.Indonesian State-Owned Enterprises (SOEs) Minister Erick Thohir has said, "In line with the theme of the Indonesian G20 Presidency, "Recover Together, Recover Stronger", it is important for Indonesia's state-owned enterprises to lead with concrete actions realized through strategic initiatives and large-scale transformations to create global impacts." Honesti Basyir, President Director of Bio Farma, said, "UNICEF procures nOPV2 under a multilateral supply agreement as part of a global effort to prevent spread of the polio disease. Bio Farma will provide its annual production to the global nOPV2 stockpile, which is a contribution to the global health industry, as we are able to manufacture stockpiles that fulfill world needs. In turn, we will fulfill individual deliveries to target countries or regions following UNICEF request."The nOPV2 vaccine received an Emergency Use of Listing (EUL) from the World Health Organization (WHO) in November 2020, the first ever vaccine certified for emergency use, adding to Bio Farma's portfolio of products that were already available globally. It was initially used to combat outbreaks of circulating vaccine-derived polio viruses (cVDPVs) in a number of African and East Mediterranean countries.Bio Farma's nOPV2 vaccine is now distributed internationally, ex-Indonesia, as Indonesia has been polio-free since 2014. Target countries in Africa for the vaccine have included Algeria, Cameroon, Kongo, Ethiopia, Gambia, Ghana, Nigeria, Senegal, and Uganda. In Europe, it is administered in Israel and Ukraine, and in the Middle East, in Egypt, Iran, Somalia and Yemen.According to Honesti, nOpV2 vaccine is a result of collaboration between Bio Farma and several international research institutes, including Bill and Melinda Gates Foundation (BMGF), PATH, and the WHO. Bio Farma has since become the main supplier of polio vaccines in the world, and currently contributes 67% of the global stockpile, while Bio Farma's laboratories have become the reference for sampling polio vaccines in the world.In manufacturing the nOPV2 vaccine, Bio Farma collaborated with world-class institutions like the Bill and Melinda Gates Foundation (BMGF), the PATH, and the WHO. Bio Farma has since become the main supplier of polio OPV vaccines in the world, and currently contributes 67% of the global OPV stockpile. Bio Farma's Laboratories have also been widely acknowledged as reference labs for poliovirus testing, while Bio Farma's success in producing and exporting the nOPV2 vaccines shows the Indonesian company fully contributing to the world health sector, apart from providing the necessary vaccines at home in Indonesia.In Line with G20Honesti said Bio Farma's provision of vaccines is in line with a main pillar of the Indonesian G20 Presidency (2021-22), Global Health Architecture. Through its G20 Presidency, Indonesia has showcased its success in controlling the Covid-19 pandemic and maintaining public health and steady economic growth through vaccination. Bio Farma has been a front liner in the government-initiated vaccination program.Bio Farma has been ready to mass-produce its IndoVac brand Covid-19 vaccine.* On September 24, an Emergency Use of Authorization (EUA) was granted by the Indonesian Food and Drug Authority (BPOM), following the halal certification from the Indonesian Ulema Council (LPPOM MUI), and the Halal Certification Agency (BPJPH).With this EUA and certification, mass production of IndoVac is beginning immediately, as preparation work for the first batch was already in place at the company's facility in Bandung. Bio Farma plans to increase its production capacity to 40 million doses next year, and to 100 million doses by 2024, given demand in the global markets. Bio Farma hopes that its IndoVac vacciness can contribute to reducing the spread of Covid-19 in the world, much as its nOPV2 vaccine has contributed to reducing the polio spread.About Bio FarmaPT Bio Farma (Persero), the holding company for pharmaceutical state-owned enterprises (SOEs), offers end-to-end services across the healthcare spectrum - from pharmaceutical research and development, manufacturing and distribution to the operation of retail pharmacies, health clinics and clinical laboratories. Bio Farma's head office and production facilities are in Bandung, West Jawa, with a representative office in Jakarta, Indonesia's capital city.Bio Farma is a leading human vaccine producer with production capacity of 3.2 billion doses per year, and has exported its vaccines to more than 150 countries. Bio Farma recently became the parent through merger of listed state-owned pharmaceutical companies PT Kimia Farma Tbk (IDX: KAEF), PT Indofarma Tbk (IDX: INAF) and PT Phapros Tbk (IDX: PEHA). For further information, please visit www.biofarma.co.idMedia contact:R. Rifa HerdianPT Bio Farma (Persero)Corporate Secretary & Investor RelationsTel: +62-81-2542-8844Email: rifaherdian@biofarma.co.id* 9/11/22: "Bio Farma ready to mass produce IndoVac brand Covid-19 vaccine"https://www.acnnewswire.com/press-release/english/77878/indonesia's-bio-farma-ready-to-produce Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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AIM Vaccine Announces Proposed Listing on the Main Board of SEHK

HONG KONG, Sep 23, 2022 - (ACN Newswire via SEAPRWire.com) - AIM Vaccine Co., Ltd. ("AIM Vaccine" or the "Company", together with its subsidiaries, the "Group", stock code: 06660.HK), the second largest vaccine company in China in terms of 2021 approved lot release volume (excluding COVID-19 vaccines), announced the proposed listing of its H shares on the Main Board of The Stock Exchange of Hong Kong Limited ("SEHK") today.AIM Vaccine plans to offer an aggregate of 9,714,000 H shares (the "Offer Shares") under the Global Offering (subject to the Over-allotment Option), comprising an international offering (the "International Offering") of 8,742,400 H shares (subject to adjustment and the Over-allotment Option) and Hong Kong public offering (the "Hong Kong Public Offering") of 971,600 H shares (subject to adjustment), at an offer price of HK$16.16 per H share.The Hong Kong Public Offering will commence at 9:00 a.m. on 23 September 2022 (Friday) and close at 12:00 noon on 28 September 2022 (Wednesday) in Hong Kong. Dealings in H shares of the Company on SEHK are expected to commence at 9:00 a.m. on 6 October 2022 (Thursday), with the stock code 06660.HK in board lots of 200 H shares each.Goldman Sachs (Asia) L.L.C., China International Capital Corporation Hong Kong Securities Limited, China Securities (International) Corporate Finance Company Limited and Macquarie Capital Limited are the Joint Sponsors, Joint Global Coordinators, Joint Bookrunners and Joint Lead Managers. BOCI Asia Limited, ICBC International Securities Limited, CMB International Capital Limited, Futu Securities International (Hong Kong) Limited, and Tiger Brokers (HK) Global Limited are the Joint Bookrunners and Joint Lead Managers. Livermore Holdings Limited is the Joint Lead Manager.Empowered by a full spectrum of proven human vaccine platform technologies, covering the full value chainAIM Vaccine is a major player in the Chinese vaccine industry. According to CIC, the National Medical Products Administration of the PRC ("NMPA") approved lot releases of 623.8 million doses of 46 vaccines against 26 diseases (exclusive of COVID-19 vaccines) in 2021, of which AIM Vaccine contributed 7.4%, or approximately 46 million doses, making AIM Vaccine the second largest vaccine manufacturer group and the largest among all privately-owned vaccine companies in the PRC in terms of approved lot release volume (excluding COVID-19 vaccines). AIM Vaccine covers the full value chain from research and development to manufacturing and to commercialization. According to CIC, AIM Vaccine is the only China-based vaccine player that has all five proven human vaccine platform technologies worldwide, namely bacterial vaccine technologies, viral vaccine technologies, genetically engineered vaccine technologies, combination vaccine technologies and mRNA vaccine technologies, with at least one approved product or one vaccine candidate at CTA or clinical stages under each platform. AIM Vaccine is one of the first two human vaccine companies in the PRC that has been granted permission under the Fourteenth Five Year Plan of the PRC to build a P3 Lab. In response to the current pandemic, AIM Vaccine has taken full advantages of the Group's full-spectrum platform technologies and is developing COVID-19 vaccine candidates spanning multiple technology routes validated by approved vaccines. AIM Vaccine currently commercializes eight vaccine products against six disease areas, of which the HBV vaccines and human rabies vaccine are its market-leading key commercialized vaccine products. According to CIC, in 2021, AIM Vaccine was the largest supplier of HBV vaccines in the globe and in the PRC, possessing a 45.4% market share in China in terms of approved lot release volume. In 2021, AIM Vaccine was the second largest supplier of human rabies vaccines in the globe and in the PRC, possessing 18.1% and 16.2% market shares of China market, respectively, in terms of approved lot release volume and sales revenue. AIM Vaccine also has 22 vaccine candidates in the Group's pipeline against 13 disease areas, of which five candidates are at clinical stages. AIM Vaccine's comprehensive vaccine product portfolio is empowered by high-quality, commercial-scale manufacturing capabilities of the Group's four individual licensed manufacturing facilities, enabling AIM Vaccine to achieve scalable and quality supply of multiple vaccines. As of 16 September 2022, a total of 45 production permits were granted by the NMPA to 33 vaccine manufacturers or manufacturer groups, and only seven had approved lot releases for four or more products in 2021, including the Group. By obtaining four production permits, the Group is the largest holder of production permits in the PRC among all privately-owned companies, and the second largest holder overall.Strive to access the best industry resources and innovative technologies to accelerate product development and commercializationIn order to accelerate building up a vaccine portfolio with true market potential, AIM Vaccine is profoundly committed to striving to access the best industry resources. AIM Vaccine currently has four individual licensed manufacturing facilities with differentiated product foci. AIM Vaccine acquired Rong'an Bio, AIM Honesty, AIM Kanghuai and AIM Weixin between 2015 and 2017, together with their vaccine products against human rabies, HBV, HAV, mumps and HFRS. After these acquisitions, AIM Vaccine upgraded the manufacturing infrastructure in each subsidiary to meet the latest GMP standards, improved manufacturing processes and techniques in pursuit of higher product quality and stronger supply capabilities, formulated and executed production plans which closely follow group marketing strategies and consolidated supply chains.In addition, AIM Vaccine turns science to high-quality vaccine products through a truly interactive R&D and manufacturing process with high efficiency. AIM Vaccine has established dedicated R&D departments in each of the four operating subsidiaries, with a specific focus on developing new vaccine varieties based on their respective leading products and manufacturing specialties. In addition, AIM Explorer, one of the Group's three research institutions, focuses on offering technological support to the four operating subsidiaries with research on early-stage and cutting-edge technologies as its priority. A cross-functional, cross-entity collaboration, which enables AIM Vaccine to consider both biological attributes and sound engineering and manufacturing principles from program inception onwards, could significantly improve R&D success rates and vaccine delivery efficiency. AIM Vaccine realizes a promotive synergy across vaccine R&D and manufacturing. On one hand, AIM Vaccine has ready-for-use commercial-scale manufacturing facilities to harness development of various vaccine candidates. On the other hand, the intensive pilot and scale-up productions of diverse candidates also rapidly refine and improve the Group's process know-how, production facilities, and productivity and skillset of production teams. Such a collaborative development path and culture enable AIM Vaccine to generate 22 vaccine candidates across different development stages.Leading mRNA COVID-19 vaccine in R&D progress is expected to capture massive market opportunitiesThe ongoing COVID-19 pandemic has created a massive and sustainable vaccine market in the globe and PRC. To capture such massive and underserved vaccine market opportunities, AIM Vaccine is currently developing vaccines for COVID-19 based on mRNA technology platform and has initiated a global Phase III clinical trial. According to CIC, as of 16 September 2022, there was no approved mRNA COVID-19 vaccine in the PRC. Six PRC vaccine developers were undertaking clinical trials for their respective mRNA COVID-19 vaccine candidates in the PRC or overseas, two of which (including AIM Vaccine) reached Phase III clinical trials. Therefore, AIM Vaccine's mRNA COVID-19 vaccine candidate is expected to be one of the first few to be approved in the PRC. Moreover, AIM Vaccine's mRNA vaccine pilot scale production facility is also among the first one to reach GMP standards in the PRC. In addition, for candidates against variant strains, AIM Vaccine has successfully constructed and produced trial vaccines against different variant strains in preclinical studies, including the Omicron variant strain. AIM Vaccine plans to first obtain NDA approval for and/or launch the Group's mRNA vaccine against the Original Strain in the second quarter of 2023 to address the urgent and near-term market demand. For the longer future, AIM Vaccine plans to launch the broad-spectrum recombinant adenoviral vector vaccine, which is not only effective against COVID-19 variants, but also risks of other coronavirus. Strong pipeline consisting of market-leading vaccine products and vaccine candidates with large market sizeAs of 16 September 2022, AIM Vaccine had eight vaccine products against six vaccine-preventable infectious diseases, and 22 vaccine candidates against 13 major vaccine-preventable infectious diseases. According to CIC, the Group's portfolio of vaccine products and vaccine candidates covers all top 10 vaccine products worldwide by 2021 global sales (totaling US$101.9 billion).Among its vaccine products, HBV vaccines and human rabies vaccines are the Group's key commercialized products, which is the main source of revenue for the Company, and each has a leading position in the corresponding Chinese vaccine market. In addition to these two types of market-leading key commercialized vaccines, AIM Vaccine has other vaccine products against HAV, meningococcal diseases, mumps and HFRS, which diversify the Group's product portfolio and revenue sources.Among 22 vaccine candidates in the Group's pipeline against 13 disease areas, AIM Vaccine has five candidates at clinical stages, and plans to file over 10 CTAs by the end of 2023 to advance multiple CTA-enabling and preclinical candidates to clinical trial stages. Out of this robust pipeline, AIM Vaccine expects to obtain NDA approvals for and/or launch new vaccine products every year from 2023 to 2025 and 12 other new products in and after 2026, to bring sustainable new growth drivers to the Group's business with a continuously diversifying product portfolio.Strong R&D capabilities fueled up by the full-spectrum proven human vaccine platform technologies, and mass-scale manufacturing capabilities with proven quality managementAIM Vaccine is the only China-based vaccine company that possesses all five proven human vaccine platform technologies worldwide, namely bacterial vaccine technologies, viral vaccine technologies, genetically engineered vaccine technologies, combination vaccine technologies and mRNA vaccine technologies. As of 16 September 2022, AIM Vaccine operates four individual licensed manufacturing facilities (Rong'an Bio, AIM Honesty, AIM Kanghuai and AIM Weixin), with a designed annual production capacity of 25.0 million doses, 45.0 million doses, 5.3 million doses and 16.0 million doses, respectively, or 91.3 million doses in aggregate. Each licensed manufacturing facility is responsible for producing one or more specific types of vaccines with different production processes and techniques. According to CIC, vaccine quality and safety attributes are highly dependent on the production processes and techniques, which take time to accumulate and are very hard to copy or switch. In addition, vaccine companies in China are generally prohibited from outsourcing manufacturing to CMOs. As a result, these four individual licensed manufacturing facilities create a highly competitive edge for the Group. By equipping AIM Vaccine with extensive hands-on experiences, process know-how and ready-for-use large-scale production capacity for multiple vaccine products, they enable AIM Vaccine to promptly respond to increasing commercial demand and shorten vaccine development cycle.AIM Vaccine has established a comprehensive quality management from vaccine research, development and manufacturing, with high and consistent quality as the Group's top priority. All the Group's four licensed manufacturing facilities have maintained 100% pass rate in vaccine lot release quality audits by the National Institutes for Food and Drug Control ("NIFDC") under the Group's operation, higher than the industry average level, according to CIC. AIM Vaccine is the only human rabies vaccine manufacturer with 100% pass rate in lot release quality audits by NIFDC over the past five years, and the Group's 10ug HBsAg/0.5ml recombinant HBV vaccine (Hansenula Polymorpha) has maintained 100% pass rate in lot release quality audits for 15 years since commercial launch.Extensive sales network and highly experienced and efficient commercialization teamThe Group's sales and marketing function is centralized, and is specialized and market-oriented. AIM Vaccine's in-house sales and marketing team, consisting of over 100 members with an average of more than 10 years' experience in sales of pharmaceuticals or vaccines. AIM Vaccine's core commercial leadership team has an average of 12 years of experiences in vaccine commercialization in leading multinational pharmaceutical companies, and has excellent track records in marketing international blockbuster vaccines, including global first HPV, IPV and DTaP-IPV-Hib. AIM Vaccine consolidates and integrates quality resources at the Group level instead of dispersing into four operating subsidiaries, which enables AIM Vaccine to achieve a high cost-efficiency, especially in team building and management. Through the sales and marketing centralization, AIM Vaccine has built effective sales channels for and strong CDC recognition of the Group's products, enabling AIM Vaccine to cross-sell existing vaccine products and rapidly ramp up sales of vaccine products. As of 16 September 2022, AIM Vaccine sold vaccine products to all 31 provinces, direct-controlled municipalities and autonomous regions in the PRC, covering all provincial CDCs and over 2,000 county-level CDCs.Visionary founder with strong support from experienced execution team and industry-leading scientistsAIM Vaccine's core management team comprises a group of seasoned vaccine industry professionals with a strong track record and proven execution capabilities. The industry experience, management expertise, professional knowledge and contributions of key members of the senior management are crucial to the Group's success. AIM Vaccine has leading scientists joining or collaborating with AIM Vaccine to support the Group's vaccine development and manufacturing. Within the group, AIM Vaccine has also established a Group-level vaccine expert panel. In addition, outside the group, AIM Vaccine has established a scientific advisory board that comprises prominent scientists in China's vaccine industry to offer advice and recommendations on the direction of the Group's R&D efforts. These scientists, in together, have and would continue to cultivate their scientific insights, deep industry knowledge and rich experience in the Group's vaccine development and production processes, and have helped to shape a dedicated, quality-forward and market-oriented culture in the Group.Vaccines have been one of the most important innovations in the science of public health, China has increasing demand from all age groups for high-quality vaccines. Including the COVID-19 vaccine market, the overall PRC vaccine market is expected to increase from RMB303.6 billion in 2021 to RMB431.4 billion in 2030. Leveraging its strong R&D capabilities and mass-scale manufacturing capabilities, to capture opportunities arising from the massive and underserved vaccine market in the PRC, the Group plans to advance R&D of the Group's vaccine candidates and to continue to enrich the Group's vaccine pipeline, construct new production facilities to expand production capacity for new vaccine products, as well as further invest in sales and marketing. Looking forward, AIM Vaccine will continue to realize its mission to "develop and manufacture top quality vaccines to safeguard the health of the world" through a diversified product portfolio, and strive to become a leader in the global vaccine industry. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Indonesia’s Bio Farma ready to produce ‘IndoVac’ Covid-19 vaccines

BANDUNG, INDONESIA, Sep 12, 2022 - (ACN Newswire via SEAPRWire.com) - PT Bio Farma, the holding company for state-owned pharmaceutical companies in Indonesia, announced a new milestone in manufacturing IndoVac, its Covid-19 vaccines brand, including primary series vaccines, booster vaccines and vaccines for children, in development since November 2021.IndoVac Covid-19 vaccine in production at PT Bio Farma's facilities near Bandung, Indonesia (Image: PT Bio Farma)Honesti Baasyir, President Director of Bio Farma, said the company collaborated with Baylor College of Medicine, a private, independent health sciences centre in Houston, Texas to develop IndoVac, a recombinant protein subunit vaccine produced from yeast.According to Honesti, "IndoVac uses vaccine technology platforms which are compatible with our equipment and facilities. The technology platforms for protein recombinant vaccines also offer other benefits; they can be adapted to new strains of Covid-19."Results from primary series Phase 1 and Phase 2 clinical trials show that IndoVac vaccines offer quality safety and efficacy, no less competitive than other Covid-19 vaccines. Now we are completing documentation to wrap up Phase 3."Honesti said Bio Farma has had intense communication with the Indonesian Food and Drug Administration (BPOM) since July to provide necessary Phase 3 primary series data, so the BPOM can release an Emergency Use Authorization (EUA) permit for the vaccine. The EUA is the permit for medical supplies, including vaccines and medications, used during a public health emergency.In Indonesia, BPOM plays the key role as a regulatory gatekeeper of medicines and vaccines used in the country. BPOM's head Penny K. Lukito, during a hearing at the Indonesian House of Representatives, said that the regulator expects to release the EUA for IndoVac's primary series vaccines in mid-September.Shariah ComplianceBio Farma has also processed the Halal (or Shariah compliant) certification for IndoVac's primary series vaccine. The vaccine has passed an audit by The Indonesian Ulema Council Food and Drug Analysis Agency (LPPOM MUI), which reviews the halal aspect of a product. The certificate from the Halal Certification Agency (BPJPH) of the Religious Affairs Ministry is expected to be released soon after the BPOM EUA for IndoVac.After securing all the necessary permits, Bio Farma will be ready to move on to the next stage, mass production of the vaccine. Bio Farma plans to produce an initial 20 million doses of primary series vaccine this year, which will be further increased to 40 million doses in 2023, as the company expands its production facilities. In 2024, production may further increase to 100 million doses per year, depending on demand and the market.Booster Vaccine and Vaccine for ChildrenBio Farma also started clinical trials for its booster vaccine on September 1. Bio Farma conducted the trials for its booster vaccine at Hasan Sadikin General Hospital in Bandung (Faculty of Medicine, Padjajaran University) and Dr I.G.N.G Ngoerah General Hospital in Bali (Children's Health Sciences Dept, Udayana University). Trials involved 900 subjects aged 8 and above to test the booster vaccines. Next, the company plans to conduct clinical trials for children, following registration with the BPOM.All Covid-19 vaccines made by Bio Farma, including the primary series vaccines, booster vaccines and vaccines for children, will be labelled IndoVac. Bio Farma started the process of registering IndoVac as a brand name for Covid-19 vaccines at the Directorate General of Intellectual Property (DGIP) of the Ministry of Law and Human Rights on July 29.President Joko Widodo gave the IndoVac name to the vaccine. "We are in the process of securing it. Should no-one object at this level, we will proceed to the next stage until we secure an IndoVac trade licence and patent from the ministry, as a product of Bio Farma," Honesti said.Made-in-Indonesia VaccinesHonesti said IndoVac is special, as one of the few made-in-Indonesia vaccine products, developed and manufactured for the nation's children. Bio Farma handles the manufacturing process from upstream to downstream. The locally sourced content in the IndoVac vaccines, according to Bio Farma, will be around 80%."This is a step closer to achieving independence in the health sector. With such a high proportion of local content, we expect to help reduce the nation's dependency on imported vaccines," Honesti said.Bio Farma hopes to capture the export market with its IndoVac vaccines. "We will not only produce them to meet domestic needs, but for the supply of global markets," said Honesti. "We registered for EUL with the World Health Organization (WHO), so the vaccine can be used in other countries through Covax Facility multilateral procurement. (The EUL assesses and lists vaccines during emergencies in non-vaccine-producing countries.)"With our Covid-19 vaccines, we hope to contribute to the health industry, not just in Indonesia, but in the world," said Honesti.For Bio Farma, it is not the first experience with clinical trials, having conducted more than 30 clinical trials (including Covid-19) in Indonesia. Bio Farma also has experience in conducting clinical trials overseas for Pentabio and Novel Oral Polio Vaccine type 2 (nOPV2).Bio Farma's Success in Polio VaccineHonesti said apart from the Covid-19 primary series vaccines, Bio Farma previously secured EUA from BPOM and EUL from WHO for its novel Oral Polio Vaccine type 2 (nOPV2). As Indonesia hasn't had any polio outbreaks since 2014, it never used nOPV2. However, the Bio Farma-manufactured vaccine was used by countries in Africa, Europe and the Middle East.Among the countries in Africa that have used Bio Farma's nOPV2's vaccine are Algeria, Cameroon, the Democratic Republic of Congo, Djibouti, Ethiopia, Gambia, Ghana, Nigeria, Senegal, and Uganda. In Europe, the vaccine was used in Ukraine and in the Middle East, it was used in Israel, Egypt, Somalia and Yemen.In manufacturing the nOPV2 vaccine, Bio Farma collaborated with world-class institutions like Bill and Melinda Gates Foundation (BMGF), PATH and the WHO. Bio Farma has since become the main supplier of polio vaccines in the world, and currently contributes 67 percent to the global supply of polio vaccines. It distributes the vaccines via bilateral or multilateral means (through UNICEF).Bio Farma's Laboratories have been internationally acknowledged as reference labs to check samples of polio viruses, while Bio Farma's success in producing and exporting nOPV2 vaccines shows the Indonesian state-owned company contributing to the world's health sector, apart from providing the necessary polio vaccine for domestic use at home in Indonesia.Media Contact:R. Rifa HerdianPT Bio Farma (Persero)Corporate Secretary & Investor RelationsTel: +62-81-2542-8844Email: rifaherdian@biofarma.co.id Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Indonesian pharmaceutical Bio Farma ready to produce IndoVac Covid-19 vaccines

Bandung, W Java, Indonesia, Sep 9, 2022 - (ACN Newswire via SEAPRWire.com) - PT Bio Farma, the holding company for state-owned pharmaceutical companies in Indonesia, announced a new milestone in the manufacturing of IndoVac, a Covid-19 vaccine brand it has developed since November 2021.IndoVac Covid-19 vaccine in production at PT Bio Farma's facilities near Bandung, Indonesia (Image: PT Bio Farma)Honesti Baasyir, the President Director of PT Bio Farma, said the company collaborated with Baylor College of Medicine, a private, independent health sciences centre in Houston, Texas to develop IndoVac, a recombinant protein subunit vaccine produced from yeast. PT Bio Farma has completed Phase 1 and Phase 2 clinical trials and is currently in the Phase 3 stage to produce the primary series vaccines or two vaccine doses for everyone aged 18 years and older. "IndoVac uses vaccine technology platforms which are compatible with the equipment and facilities within our factories. The technology platforms for protein recombinant vaccines also offer other benefits: they can be adapted to the new strains of Covid-19. Results from Phase 1 and Phase 2 clinical trials showed that IndoVac offers quality safety and efficacy, not less competitive than other Covid-19 vaccines. Now we are completing a report to wrap up Phase 3."Honesti said, Bio Farma has had intense communication with the Indonesian Food and Drug Administration (BPOM) since July 2022 to provide the necessary data, so that BPOM can release the Emergency Use Authorization (EUA) permit for IndoVac's primary series vaccines in the near term. The EUA, released by a country's regulatory agency, is a permit for medical supplies (including vaccines) and medications during a public health emergency. In Indonesia, BPOM plays the key role as a regulatory gatekeeper of medicines and vaccines used in the country.BPOM's head Penny K. Lukito, during a hearing with Commission IX at the Indonesian House of Representatives, has said that the regulator expects to release the EUA for IndoVac's primary series vaccines in mid-September 2022. Shariah ComplianceBio Farma also has processed the Halal (or Shariah compliant) certification for IndoVac's primary series vaccines to provide comfort to Indonesian Muslim consumers. The vaccines have passed an audit from The Indonesian Ulema Council Food and Drug Analysis Agency (LPPOM MUI), which reviews the halal aspect of a product. The certificate from the Halal Certification Agency (BPJPH) under the Religious Affairs Ministry is expected to be released in the near term after BPOM release the EUA for IndoVac. After securing all the necessary permits, Bio Farma is ready to move on to the next stage, which is producing IndoVac's primary series vaccines massively. At the first stage, Bio Farma plans to produce a maximum of 20 million doses of primary series vaccines, before this can be further increased to 40 million doses in 2023, as the company expands its production facilities. In 2024, the company may further increase the volume to 100 million doses per year, depending on the demands and needs in the markets. Honesti said after the company has secured all the necessary permits, then IndoVac's primary series vaccines "can be massively used by people aged 18 and above." Booster Vaccine and Vaccine for ChildrenAt the same time, Bio Farma also started clinical trials for its booster vaccine on September 1, 2022. "We have secured approval for a clinical trial (PPUK) from BPOM for IndoVac booster vaccine," Honesti said. Next, Bio Farma plans to conduct clinical trials for children after it secures PPUK from BPOM. Bio Farma conducted clinical trials for its booster vaccine at Hasan Sadikin General Hospital (Faculty of Medicine of Padjajaran University, Bandung) and Dr. I.G.N.G Ngoerah General Hospital in Bali (Children's Health Sciences Department, Udayana University). Trials involved 900 subjects aged 8 and above to test IndoVac's booster vaccines. BPOM requires vaccine manufacturers to conduct clinical trials to decide if a vaccine is safe and can boost immunity against Covid-19, and to determine whether the vaccine offers good efficacy to help protect the subjects from heavy symptoms and risks of fatalities due to Covid-19 infection.All Covid-19 vaccines made by Bio Farma, including the primary series, booster vaccines and vaccines for children, will be labelled IndoVac. Bio Farma started the process of registering IndoVac as a brand name for Covid-19 vaccines at the Directorate General of Intellectual Property (DGIP) of the Ministry of Law and Human Rights on July 29.President Joko Widodo gave the IndoVac name to the vaccine. "We are in the process of securing it. Should no-one object at this level, we will proceed to the next stage until we secure an IndoVac trade licence and patent from the ministry, as a product of Bio Farma," Honesti said. For Bio Farma, it is not the first time embarking on clinical trials. The company has conducted more than 30 clinical trials in Indonesia. This includes the Phase 3 clinical trials for the Covid-19 vaccine. Bio Farma also has experience in conducting clinical trials overseas for Pentabio and Novel Oral Polio Vaccine type 2 (nOPV2).Made-in-Indonesia VaccinesHonesti Basyir said IndoVac is special as one of the few made-in-Indonesia vaccine products. The vaccines (which include the primary series vaccines, the booster vaccines and vaccines for children) are developed and manufactured for nation's children. Bio Farma handles the manufacturing process from upstream to downstream.The local contents of IndoVac's primary series vaccines, according to Bio Farma, will be around 80%. "This is a step closer to achieving independence in the health sector. With such a high proportion of local content, we expect to help reduce the nation's dependency on imported vaccines. This will also impact foreign exchange reserves," Honesti said. In the long term, Bio Farma hopes to capture the export market with IndoVac vaccines. "We will not only produce them (the three types of vaccines) to meet domestic needs but also target the supply of global markets," he said. "We registered for Emergency Use Listing (EUL) with the World Health Organization (for primary series), so this vaccine can be used in other countries through the Covax Facility (multilateral procurement). Through its Covid-19 vaccines, Bio Farma expects to contribute to the health industry, not just in Indonesia, but also to the world."Bio Farma's Success in Polio VaccineHonesti said apart from manufacturing Covid-19 primary series vaccines, which is currently waiting for the results of Phase 3 clinical trials and the EUA, Bio Farma has previously proven that it can secure the EUA from BPOM and the EUL from the WHO for its novel Oral Polio Vaccine type 2 (nOPV2).The EUL, which is released by the WHO, is a procedure for assessing and listing vaccines during public health emergencies by non-vaccine-producing countries. As Indonesia hasn't had any polio outbreaks since 2014, it never used nOPV2. The Bio Farma-manufactured vaccine was used by countries in Africa, Europe and the Middle East. Among the countries that have used Bio Farma's nOPV2's vaccine are Algeria, Cameroon, the Democratic Republic of Congo, Djibouti, Ethiopia, Gambia, Ghana, Nigeria, Senegal, and Uganda. In Europe, the vaccine was used in Ukraine and in the Middle East, it was used in Israel, Egypt, Somalia and Yemen. In the manufacturing of nOPV2 vaccine, Bio Farma collaborated with world-class research institutions like Bill and Melinda Gates Foundation (BMGF), PATH and the WHO. Bio Farma has become the main supplier for the polio vaccine in the world. The company currently contributes 67 percent to the global supply of polio vaccines. It distributes the vaccines via bilateral or multilateral means (through UNICEF). Apart from producing polio vaccines, Bio Farma's Laboratories have secured international acknowledgement as the reference labs to check samples of polioviruses. The world was previously waiting for two countries, Afghanistan and Pakistan, to combat polio diseases, before a 'world-free polio' can be declared. However, during the wait, polio outbreaks occurred in Africa and the Middle East. The nOPV2 vaccine became an important product to prevent further spread of the polio disease. Bio Farma's success in producing and exporting nOPV2 vaccine means that the Indonesian state-owned company has contributed to the world's health sector, apart from providing the necessary polio vaccine for domestic use at home in Indonesia. Media Contact:R. Rifa HerdianPT Bio Farma (Persero)Corporate Secretary & Investor RelationsTel: +62-81-2542-8844Email: rifaherdian@biofarma.co.id Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Therapeutic Goods Administration Grants Provisional Approval for Moderna’s COVID-19 Vaccine in Children Aged Six Months to Five Years

Cambridge, MA, Jul 19, 2022 - (ACN Newswire via SEAPRWire.com) - Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Therapeutic Goods Administration (TGA) in Australia has granted provisional registration for the use of Moderna's mRNA COVID-19 vaccine, Spikevax, in a two-dose series of 25 ug per dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6 months to 5 years. Until now, children under six were the only age group not eligible for vaccination against COVID-19 in Australia."We are pleased that our vaccine for children under six years of age has received provisional approval by the TGA," said Michael Azrak, General Manager of Moderna for Australia and New Zealand. "The continued evolution of COVID-19 represents an emergent threat to global public health, including young children. Since the onset of the pandemic, we have worked with a deep sense of responsibility to deliver on the promise of mRNA science to all Australians. The approval from TGA helps extend an opportunity to all parents and caregivers in Australia to protect their young children against SARS-COV-2."Positive interim results from the Phase 2/3 KidCOVE study, announced on March 23, 2022, showed a robust neutralizing antibody response in the 6-month to 5 years of age group after a two-dose primary series of mRNA-1273, along with a favorable safety profile. The antibody titers in the pre-specified 6 month to 23 month and 2 years to 5 years of age sub-groups met the statistical criteria for similarity to the adults in the COVE study, which satisfied the primary objective of the study. Preliminary efficacy analysis on PCR-confirmed cases collected during the Omicron wave showed similar efficacy estimates against Omicron in the 6-month to 5 years of age group to those in adults after two doses of mRNA-1273.The KidCOVE study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. The ClinicalTrials.gov identifier is NCT04796896.Moderna is committed to supporting the Australian Government on the COVID-19 program implementation in children aged 6 months to five years upon receiving a recommendation from the Australian Technical Advisory Group on Immunisation (ATAGI).The TGA previously approved the use of Moderna's mRNA COVID-19 vaccine, Spikevax (elasomeran mRNA vaccine), for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged six years or over.Authorized UseTherapeutic Goods Administration has provisionally approved the use of Moderna's mRNA COVID-19 vaccine, Spikevax (elasomeran mRNA vaccine), for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older.About ModernaIn 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both ground-breaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most-effective vaccines against the COVID-19 pandemic.Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.Forward Looking StatementsThis post contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the development of the Company's COVID-19 Vaccine (mRNA-1273, or Spikevax); the approval of the vaccine in children ages 6 months to 5 years by the Therapeutic Goods Administration; and the safety, efficacy, and tolerability of the vaccine in children ages 6 months to 5 years of age. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this post in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.Moderna ContactsMedia:Luke Mircea-WillatsDirector, Media Relations & CommunicationsLuke.mirceawillats@modernatx.comInvestors:Lavina TalukdarSenior Vice President & Head of Investor Relations617-209-5834Lavina.Talukdar@modernatx.comSOURCE: Moderna, Inc. Copyright 2022 ACN Newswire. All rights reserved. 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Novotech Client SK bioscience Achieves SKYCovione(TM) COVID-19 Vaccine Approval in Korea

SEOUL, S.KOREA, Jul 13, 2022 - (ACN Newswire via SEAPRWire.com) - Novotech, the leading Asia Pacific biotech specialist CRO which has recently expanded its services to the US, congratulates its client SK bioscience on the recent COVID-19 vaccine licence approval.SK bioscience and GSK recently announced the successful authorization:SK bioscience announced that 'SKYCovione(TM),' South Korea's first COVID-19 vaccine candidate adjuvanted with GSK's pandemic adjuvant has been authorized by the Korean Ministry of Food and Drug Safety (KMFDS). South Korea has become one of the few countries in the world to have both a domestically developed COVID-19 vaccine and a treatment.SKYCovione(TM) is a self-assembled nanoparticle vaccine targeting the receptor binding domain of the SARS-CoV-2 Spike protein for the parental SARS-Cov-2, jointly developed with the Institute for Protein Design (IPD) at the University of Washington School of Medicine with combination of GSK's pandemic adjuvant. The development of SKYCovione(TM) has been supported by funding from the Bill & Melinda Gates Foundation and Coalition for Epidemic Preparedness Innovations (CEPI). The results of the Phase III clinical trial, collected in 4,037 adults over 18-year-old, showed that SKYCovione(TM) induced neutralizing antibody responses, against the SARS-CoV-2 parental strain. The neutralizing antibody titres increased about 33 times compared to before the injection and were 3 times that of AstraZeneca's Vaxzevria(TM), the control vaccine used in the study, 2 weeks after the second dose.The clinical trial was conducted in cooperation with 16 institutions, including Korea University Guro Hospital and IVI (International Vaccine Institute), a non-profit international organization.SK bioscience will apply for authorizations at other selected regulatory agencies for distribution of SKYCovione(TM), including through the COVAX Facility and for emergency use listing (EUL) to the World Health Organization (WHO).SKYCovione(TM) is based on recombinant protein vaccine technology which has been used for development of current vaccines including influenza, hepatitis B, and HPV. SKYCovione(TM) can be stored in normal refrigeration conditions from 2 to 8 degrees Celsius, so it is particularly suitable for use in low-income settings without the need for ultra-cold chain facilities.The market expects that SKYCovione(TM) will accelerate securing of Korea's vaccine sovereignty and reducing dependence on vaccine imports.Jaeyong Ahn, CEO of SK bioscience said, "The development of Korea's first COVID-19 vaccine was achieved based on the efforts of the government and members who have been working hard all day and night. We will continue to work with various global organizations based on our own research and manufacturing technologies to preemptively respond to new pandemics."See full press release here https://www.skbioscience.co.kr/en/news/news_01_01?mode=view&id=132&Dr. John Moller, CEO Novotech said, "As the lead CRO managing the Phase lll study in six APAC countries, the entire team at Novotech congratulates SK bioscience for such an outstanding clinical success and subsequent licence approval. Licence approval is the ultimate goal in clinical research and drug development and we are honoured to be part of the process of bringing new life-saving therapies to market. We look forward to working with SK bioscience on further vaccine developments in the near future."About NovotechNovotech 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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Legend Capital’s Portfolio Company Recbio Lists on HKEX Successfully

HONG KONG, Apr 7, 2022 - (ACN Newswire via SEAPRWire.com) - On 31 March 2022, Legend Capital's portfolio company Jiangsu Recbio Technology Co., Ltd. ("Recbio", stock code: 2179.HK), a leading novel vaccines company, went public on the Hong Kong Stock Exchange. The listing makes Recbio "the first HPV vaccine stock in Hong Kong" and "the first novel adjuvant vaccine stock in Hong Kong". Recbio is expected to inject new vitality into the capital market in Hong Kong.Recbio is a novel vaccine company driven by independent novel adjuvant technology. It has built a comprehensive and high-valued vaccine portfolio consisting of 12 candidates, covering cervical cancer, COVID-19, adult tuberculosis, shingles, HFMD, influenza, etc. Recbio is primarily focused on the R&D of HPV vaccine candidates. Its core product REC603, a recombinant HPV 9-valent vaccine, is currently under phase III clinical trial, and is expected to become the first approved domestic HPV 9-valent vaccine in China. In addition, Recbio has also begun to deploy in the mRNA vaccine field and is currently developing the COVID-19 mRNA vaccine.Recbio has constructed the three core technology platforms consisting of independent novel adjuvants, protein engineering and immunological evaluation. It is one of the few companies capable of independent development of novel adjuvants and the novel adjuvants it developed have been successfully applied in various innovative vaccines such as COVID-19 vaccines, HPV vaccines and shingles vaccines.Legend Capital led Recbio's Series B financing in 2020, through a coordinated investment of the comprehensive growth fund and the healthcare fund and re-upped on its Series C financing in 2021, marking Recbio another successful case towards Legend Capital's multi-fund coordinated investment. As the major institutional investor to Recbio, Legend Capital provides Recbio with multi-faceted support involving corporate governance, business strategy, technical route, R&D resources, management improvement and financial support. Dr. Liu Yong, the Founder, Chairman of the Board, and General Manager of Recbi, said, "We are much appreciated Legend Capital's long-term and firm support to Recbio. As the institutional investor with the largest shareholding in the company, Legend Capital's investment philosophy of 'Business First, People Crucial' is highly compatible with our corporate culture. Legend Capital has always supported our management team in major decision-making and continued to assist in the development, becoming one of the most trusted and respected investors of Recbio. The listing is just a new chapter of Recbio, and the management team hopes to work closely with all the investors represented by Legend Capital to write a new legend!"Hank Zhou, the Co-Chief Investment Officer of Legend Capital, said: "Congratulations to Recbio and its team led by founder Dr. Liu Yong. Liu has been engaged in vaccine research and development for over two decades, with high academic status and extensive experience in the industry. Liu's team has been deeply involved in the field of vaccine research and development for many years. Its vaccine portfolio strategically aimed at major disease and the team is actively deploying large-scale production. We admire Liu's great enthusiasm for the vaccine industry and his strong sense of responsibility and commitment. Recbio is now the leading vaccine company in China. After the successful listing, we believe that Recbio will continue to make breakthroughs in its core field of new adjuvant and vaccines to benefit more patients."Frank Hong, the Managing Director of Legend Capital, said: "After the outbreak of the pandemic, the vaccine industry has stepped into a high-speed development stage after years of accumulation on technology and talent pool. Recbio is one of the few vaccine companies with high-quality technology platforms, which can continuously produce high-quality vaccine products to meet unmet clinical needs. We are optimistic about Recbio's future of its core pipelines, including the HPV vaccine, recombinant shingles vaccine REC610 and COVID-19 vaccine. Advanced with its disruptive technology in the field of recombinant protein vaccines, Recbio is expected to be a company with strong competitiveness in the global market."Legend Capital has long paid close attention to investments in the field of life sciences. In addition to Recbio, there are other portfolio companies listed on A shares or H shares, including Pharmaron Inc. (300759.SZ; 03759.HK), KingMed Diagnostics (603882.SH), WuXi AppTec(603259.SH; 02359.HK), WuXi Biologics (02269.HK), Innovent Biologics (01801.HK), Berry Genomics (000710.SZ), Harbour BioMed (02142.HK), New Horizon Health (06606.HK), Chemclin Diagnostics (688468.SH), etc. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Official Listing of Recbio on HKEX, Vaccine Innovation and Iteration Accelerated by Novel Adjuvant Technology

HONG KONG, Apr 1, 2022 - (ACN Newswire via SEAPRWire.com) - On March 31, the China-based novel vaccines company - Jiangsu Recbio Technology Co., Ltd. ("Recbio" or the "Company", Stock Code: 2179.HK) went public and was officially listed on the Hong Kong Stock Exchange. Assuming the Over-allotment option is not exercised, 30,854,500 H shares were issued under the Global Offering, with a price of HK$24.80 per share and proceeds up to approximately HK$765 million. The Hong Kong public Offering received an enthusiastic response from investors and was over-subscribed by more than 9.65 times. As the cornerstone investors of the Company, the cornerstone subscription ratios of Yangtze River Pharmaceutical, Harvest Global and Sequoia China exceed 50%. Previously, the Company has won the favor of many well-known investment institutions, including Legend Capital, LYFE Capital, Oriental Fortune Capital, Fer-Capital, Sequoia China, CMB International, Lake Bleu and Temasek. Having successfully listed in Hong Kong, becoming "the first HPV vaccine stock in Hong Kong" and "the first novel adjuvant vaccine stock in Hong Kong", Recbio is expected to inject new vitality into the capital market in Hong Kong.Chart: Innovative vaccine portfolio of RecbioDomestic vaccine innovation and iteration accelerated by novel adjuvant technologyVaccines are praised as the "golden track" in the medical health field. According to the Frost & Sullivan report, from 2016 to 2020, the size of the global vaccine market has increased from US$27.5 million to US$39.9 billion at a CAGR of 9.7%, while the CAGR of global pharmaceutical market was only 3.02%. China has become the second largest vaccine market globally, with the market volume increased from RMB27.1 billion in 2016 to RMB75.3 billion in 2020 at a CAGR of 29.1%.Regarding the insufficient domestic supply of and the unmet urgent demand for novel vaccines, it has become an important part of the Development Planning of the Pharmaceutical Industry in the "14th Five-Year Plan" in China (referred as the "Plan") to promote enterprises to speed up the development of related products and to achieve product availability as soon as possible. Regarding the development of the vaccine industry, the "Plan" also states that research and development of novel vaccines (such as novel adjuvants for vaccines and mRNA vaccines) and building of industrialization capability shall be accelerated. It also emphasizes on the development of novel COVID-19 vaccines, herpes vaccines, polyvalent human papillomavirus (HPV) vaccines and other products. As an innovative novel vaccine company, Recbio has constructed the three core technology platforms consisting of novel adjuvants, protein engineering and immunological evaluation, forming synergy in antigen design and optimization, adjuvant development and production, identification of the best combination of antigen and adjuvants. The Company has built a comprehensive and high-valued vaccine portfolio consisting of 12 candidates, covering cervical cancer, COVID-19, adult tuberculosis, shingles, HFMD, influenza etc. It covers five of the ten diseases with the greatest burden under the 2019 Global Burden of Diseases issued by the World Health Organization and disease areas of the three of the top five globally bestselling vaccine products in 2020. Novel adjuvant for vaccines is the "bottleneck" technology of innovative vaccines. Through years of technical research, Recbio has successfully achieved independent control of all FDA-approved novel adjuvants, and is one of the few companies in the world capable of independent development of novel adjuvants. It has also successfully applied in various innovative vaccines such as COVID-19 vaccines, HPV vaccines and shingles vaccines.A moat constructed with a rich product portfolioHPV vaccines are one of the most commercially valuable vaccines in the world. It is expected that there will be 234 million females in China aged 9-45 unvaccinated for HPV in 2025 assuming 3 doses per person, requiring additional 702 million doses. Currently, Recbio has formed a full coverage of bivalent, quadrivalent and 9-valent vaccines and novel adjuvant upgrades in the field of HPV vaccines. The core product REC603, a recombinant HPV 9-valent vaccine is currently under phase III clinical trial, expected to become the first approved domestic HPV 9-valent vaccine. Regarding the global immunization program market, REC601, a bivalent vaccine has the potential to become one of the most popular vaccine options. At the same time, the Company is also in the process of developing second-generation HPV vaccines, namely REC604a (a quadrivalent vaccine) and REC604b (a 9-valent vaccine). Both vaccines have adopted our self-developed novel adjuvants and are expected to achieve two-shot regimens in the future. The construction of the first phase of the HPV manufacturing facility of Recbio is expected to be completed by the end of this year. By then, it will realize the designed capacity of five million doses of HPV 9-valent vaccines or 30 million doses of HPV bivalent vaccines per year. As the first cancer preventive vaccine in the world, HPV vaccines have been in shortage for a long time. With the gradual release of domestic HPV vaccines in the future and the gradual release of production capacity, domestic substitution will be accelerated. Protein engineering, novel adjuvant and other technology are comprehensively used in ReCOV, the COVID-19 vaccine of Recbio, to thoroughly optimize the vaccine, allowing ReCOV to possess a series of comprehensive advantages, including excellent safety, strong immunogenicity, strong cross-protection effectiveness with Omicron and Delta mutant strains, easy-to-scale-up production, low production cost, high preparation stability, storage and transportation in room temperature etc. The international phase II/III clinical trials of such vaccine are currently in progress. EUA/BLA applications are estimated to be submitted in 2022. On the side of production supply, the Company has completed the construction of our GMP-standard manufacturing facility for ReCOV and obtained the drug production license in November 2021. The manufacturing facility has a total GFA of approximately 17,000 sq.m., has the potential to support an annual manufacturing capacity of 300 million doses of ReCOV and can be used to manufacture recombinant shingles vaccines.In the field of shingles vaccines, shingles virus is dormant in almost all adults over 50 of age in China, affecting approximately 2.5 million adults in China every year. However, Shingrix is currently the only shingles vaccine approved in China. The novel adjuvant which benchmarking AS01 is adopted in REC610 of the Company, significantly improving vaccine immunogenicity, hoping to achieve domestic substitution quickly. Recogen, our subsidiary has first achieved technology breakthrough in lyophilized mRNA vaccines. It has applied the self-developed freeze-drying technology to achieve preparation stability at 4 degrees Celsius and 25 degrees Celsius, allowing storage and transportation under general cold-chain conditions, effectively solving the current defect in availability of mRNA vaccines."We are glad that the Hong Kong stock IPO has been highly recognized by the capital market. The successful listing of Recbio is expected to bring more confidence to the Hong Kong 18A stock market. Thanks to all the investors for their strong support, we were able to successfully go public as originally planned in such extremely depressed environment of the Hong Kong capital market!" Regarding the listing of Recbio in Hong Kong, Dr. Liu Yong, the Founder, Chairman of the Board, and General Manager of Recbio stated that, "Against the backdrop of a huge global demand for innovative vaccines in this era, through continuous innovation and international cooperation, we will accelerate the commercialization of products in the global market, promote innovation in the entire value chain of the vaccine industry from R&D to commercialization, and create greater value for shareholders and investors. Today is the beginning of a brand-new journey for Recbio. I hope that all investors will continue to support our Company. Let's hope we will continue to move forward hand in hand, through the sweltering summer and winter, and create new glory together!"About RecbioFounded in 2012, Recbio is an innovative vaccine company with independent research and development technology as its core driving force. It is committed to building a full value chain of innovative vaccines, covering research and development, production and commercialization. The Company has always adhered to the mission of "creating first-class vaccines and protecting human health". With a strong research and development engine comprising of novel adjuvants, protein engineering, immunological evaluation and other core technology platforms, strategically focusing on disease areas with significant burden such as cervical cancers COVID-19, shingles, adult TB, HFMD and flu etc., the Company has established a high-value product pipeline consisting of 12 vaccine candidates with independent intellectual property rights, in order to meet the under-fulfilled public health needs. For more information, please visit https://www.recbio.cn/. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Recbio Announces Proposed Listing on the Main Board of the Hong Kong Stock Exchange

HONG KONG, Mar 21, 2022 - (ACN Newswire via SEAPRWire.com) - The China-based novel vaccines company - Jiangsu Recbio Technology Co., Ltd. ("Recbio" or the "Company", stock code: 2179.HK, today announced the proposed listing of its H Shares on the Main Board of The Stock Exchange of Hong Kong Limited (the "Hong Kong Stock Exchange"). Recbio plans to offer 30,854,500 H Shares (subject to the Over-allotment Option), of which 27,769,000 H Shares will be International Placing Shares (subject to reallocation and the Over-allotment Option), representing approximately 90% of the initial Offer Shares; the remaining 3,085,500 H Shares will be Hong Kong Offer Shares (subject to reallocation), representing approximately 10% of the initial Offer Shares. Recbio will open for Hong Kong Public Offering in Hong Kong at 9:00 a.m., 21 March 2022 (Monday), and close at 12:00 noon, 24 March 2022 (Thursday). Dealings in H Shares of Recbio on the Main Board of the Hong Kong Stock Exchange is expected to commence on 31 March 2022 (Thursday). The H Shares will be traded in board lot of 500 H Shares each. The Company's stock code is 2179.HK.-- Morgan Stanley Asia Limited, CMB International Capital Limited and CLSA Capital Markets Limited are the Joint Sponsors; and Morgan Stanley Asia Limited, CMB International Capital Limited and CLSA Limited are the Joint Global Coordinators, Joint Bookrunners and Joint Lead Managers.-- China Industrial Securities International Capital Limited, Haitong International Securities Company Limited, GF Securities (Hong Kong) Brokerage Limited, Essence International Securities (Hong Kong) Limited and Valuable Capital Limited (in relation to the Hong Kong Public Offering only) are the Joint Bookrunners and Joint Lead Managers.-- Livermore Holdings Limited is the Joint Lead Manager.A Vaccine Pipeline Driven by Novel Adjuvant TechnologyRecbio is the vaccine company with a high-value vaccine portfolio driven by in-house developed technologies. The Company is primarily focus on the R&D of HPV vaccine candidates. Its vaccine portfolio consists of 12 vaccines, including the Core Product, REC603, a recombinant HPV 9-valent vaccine under phase III clinical trial, and the Company is one of the few domestic vaccine companies to have phase III stage HPV 9-valent vaccine candidate.In recent years, vaccinology field has entered into a new era. Advanced technologies and breakthroughs in immunology have largely reshaped the vaccinology by creating opportunities for safer and more effective vaccine solutions. According to Frost & Sullivan, subunit vaccines accounted for approximately 55.4% of China's vaccine market in 2020, which is expected to further grow to 86.6% in 2030. Driven by the growing number of subunit vaccines and technology breakthroughs, China's vaccine market is expected to grow from RMB75.3 billion in terms of production value in 2020 to RMB333.3 billion in 2030 at a CAGR of 16.0%. With its strong R&D capabilities in developing subunit vaccines, the Company believe it is well-positioned to further benefit from the overall growth of China's vaccine market.With years of dedication in developing vaccines and leveraging its in-house developed technology platforms, the Company has been built a comprehensive vaccine portfolio consisting of 12 candidates, covering a broad disease spectrum including cervical cancer, COVID-19, adult tuberculosis, shingles, HFMD and influenza. Its vaccine portfolio extends to five of the ten diseases with the greatest burden under the 2019 Global Burden of Diseases assessed by DALYs issued by the WHO and covers disease areas of the three of the top five globally bestselling vaccine products in 2020. The Core Product, REC603, is a recombinant HPV 9-valent vaccine candidate, which is currently under phase III clinical trial in China. The Company plan to submit the BLA application in 2025 for REC603 and commence commercialization once the BLA application is approved. In addition, its COVID-19 vaccine, ReCOV, has commenced a phase I clinical trial in New Zealand in June 2021 and obtained the initial partially unblinded data in October 2021. Based on the major safety and immunogenicity data and the partially unblinded efficacy data from the phase I trial, the Company subsequently obtained the clinical trial approval from the Philippines FDA to conduct the global phase II/III trial for ReCOV in January 2022. To date, the Company has initiated subject enrollment for the global phase II/III trial for ReCOV in the Philippines. In January 2022, the Company also obtained the unblinded clinical data for the remaining three cohorts and has been finalizing data analysis and clinical trial report. It plans to file the EUA/BLA application in 2022.A Pipeline of Vaccine Candidates Covering Diseases With Significant Unmet NeedsThe Company has adopted a vaccine development strategy aimed to firmly position itself at the vanguard of the vaccine industry. In light of overarching vaccine industry trends, it has strategically developed a pipeline that extends from preventative to post-exposure prophylaxis. In addition to HPV and COVID-19, its comprehensive pipeline also includes a recombinant shingles vaccine, two TB vaccines for adults, an influenza quadrivalent vaccine, and an HFMD quadrivalent vaccine.HPV vaccines are one of the most commercially valuable vaccines in the world, with a global market size of US$4.2 billion in 2020, accounting for approximately 11.5% of the global vaccine market in terms of production volume. Therefore, the Company has strategically developed a comprehensive HPV pipeline to address the unmet urgent need for HPV vaccines. To date, the Company is advancing clinical trials of three key vaccine candidates namely a recombinant HPV 9-valent vaccine, REC603, and two recombinant bivalent vaccines, REC601 and REC602, targeting different countries and populations. At present, the Company is also developing REC604a and REC604b with a potentially fewer dose regimen, employing a self-developed novel adjuvant benchmarking AS04, and plans to submit INDs filing in 2022 and 2023, respectively.What is noteworthy is that, its recombinant HPV 9-valent vaccine, REC603, is expected to be the one of the first of domestic vaccines of its kind to be approved and commercialized in China. The Company is currently conducting a phase III clinical trial and has completed 12,500 subjects enrollment for the potency tests in October 2021. The first subject was enrolled on June 26, 2021 and the Company is actively working with industry leading PIs and highly-qualified CROs to accelerate its trial progress. The Company expects to complete three-shot dosing by the first half of 2022 and plans to reach primary endpoints for its phase III clinical trial and submit BLA to the NMPA in 2025.Self-Developed Advanced Technology Platforms that Support and Drive the Development of Next Generation Vaccine CandidatesThrough years of dedication and focus on vaccinology field, the Company has developed a comprehensive vaccine innovation engine consisting of a novel adjuvant platform, protein engineering platform and immunological evaluation platform. The Company is the one of the few companies that are capable of developing novel adjuvants, benchmarking all of the FDA-approved novel adjuvants to date. The technology platforms form a solid trifecta, creating synergies among the design and optimization of antigens, the development and production of adjuvants and the identification of the optimal combinations of antigens and adjuvants. Supported by these platforms, the Company is constantly upgrading its technology to further enrich its R&D toolbox so that to drive its vaccine development going forward.In addition to the technology platforms, its IPD System lays a solid foundation for the R&D activities. The IPD system governs the entire life cycle of vaccine candidates. Empowered by the IPD System, the Company is able to advance multiple vaccine development projects simultaneously.Continuously Expand Production Capacity, Strengthen Competitive AdvantageThe company has started to build up its manufacturing capabilities at an early stage to ensure the vaccine candidates can be smoothly transferred into successful commercial vaccine products. The manufacturing and quality control system is built in compliance with the industry leading GMP standard. It also has recruited many talents in charge of production and quality, who has gained abundant industry insights and profound understanding from their commercialization experience in vaccine companies.Currently, the Company is constructing its HPV vaccine manufacturing facility in Taizhou, Jiangsu province, the first phase of which has a designed capacity of five million doses of HPV 9-valent vaccines or 30 million doses of HPV bivalent vaccines per year. The construction of the first phase of its HPV manufacturing facility is expected to be completed by the end of 2022. In addition, the Company has obtained a drug production license from ReCOV and completed the construction of the GMP-standard manufacturing facility for ReCOV in November 2021. The manufacturing facility, which can also be used for the manufacturing of recombinant shingles vaccines, has a total GFA of approximately 17,000 sq.m. and has the potential to support an annual manufacturing capacity of 300 million doses of ReCOV.High Performance Management and Scientific R&D Team, Supported by Leading Investors in the Healthcare IndustryR&D is crucial to the continuous success. The vaccine industry has been rapidly evolving with various scientific advancement and innovative technologies to constantly reshape the vaccinology field. The Company is led by an experienced management and elite scientific team consisting of industry-leading scientists with extensive experiences in academic studies of immunology and development of vaccine products and industry-leading experts who are familiar with bringing vaccine candidates from concept to market.The Company has also received strong support from its shareholders, including leading investors in healthcare industry as well as major institutional investor such as Lake Bleu Capital, Temasek, Legend Capital and Sequoia Capital, representing recognition from its shareholders on the market position and growth potential. The Company believe its diversified shareholder base will fuel the future growth with financial support and industry insights.The Chairman of the Board, Executive Director and General Manager of Jiangsu Recbio Technology Co., Ltd., Dr. LIU Yong said, "As the vaccinology field enters a new era driven by novel vaccine technologies and significant expansion in disease and population coverage, we expect that China's vaccine market will grow significantly. With our strong R&D capabilities, we expect to further benefit from the overall growth in China's vaccine market. Looking ahead, we plan to continuously accelerate R&D, clinical trial and commercialization of our vaccine candidates, including rapidly advancing the development of our HPV vaccines, COVID-19 vaccines as well as the development and commercialization of our other vaccine candidates. We also intend to boost our market penetration and profitability by encouraging continuous innovation, streamlining our organization structure, company culture, and talent recruiting system, commercializing our technologies and products in the global market, and expanding vaccine candidates and technologies internationally through collaboration. At the same time, we will continue to explore opportunities to acquire advanced technologies and recruit international talent to supplement our in-house R&D capabilities. We are also evaluating establishing an overseas R&D center to closely collaborate with academic institutes and scientists abroad and to advance our R&D activities. Finally, driven by our strong R&D capabilities, we are focusing on complete value chain innovation from R&D to commercialization in the vaccine industry, to maximize value for our shareholders and investors."Use of Proceeds:The Company estimates that it will receive net proceeds of approximately HK$672.4 million from the Global Offering, after deducting the underwriting commissions and other estimated offering expenses payable by the Company, assuming the Over-allotment Option is not exercised and assuming the Offer Price is fixed at HK$24.80 per H Share. The Company intends to use the net proceeds for the following purposes:-- Approximately 47.3%, or HK$317.9 million, will be allocated to continue to optimize, develop and commercialize HPV vaccine pipeline, including the Core Product, the recombinant HPV 9-valent vaccine REC603-- Approximately 17.7%, or HK$119.3 million, will be used for the preclinical and clinical studies, registration of the COVID-19 vaccine, namely ReCOV-- Approximately 21.1%, or HK$142.0 million, will be used for the preclinical and clinical studies, registration of other vaccine candidates, including recombinant shingles vaccine, REC610; TB vaccines, REC606; and REC607, recombinant quadrivalent influenza vaccine, REC617; and recombinant HFMD quadrivalent vaccine, REC605-- Approximately 6.7%, or HK$44.7 million, will be used to further enhance the R&D capabilities and enhance its operating efficiencies-- Approximately 7.2%, or HK$48.5 million, will be used for working capital and general corporate purposes Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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V-01 as a Sequential Booster Can Produce Good Protection against Omicron —- Latest Phase III Data of COVID-19 Vaccine by Livzon Pharma

HONG KONG, Feb 18, 2022 - (ACN Newswire via SEAPRWire.com) - Global pandemic control is still facing enormous challenges after more than two years since the outbreak of the COVID-19. Following the Delta and Beta variants, Omicron variant emerged at the end of 2021, and its enhanced infectivity has cast a shadow over the global COVID-19 control. Recently, Omicron quickly spread in Japan and South Korea, and the number of newly confirmed cases in South Korea has exceeded 90,000 for two consecutive days. Although COVID-19 vaccine booster shots have been administered across the globe since 3Q2021, vaccine efficacy is shown to vary among vaccine products, and it is crucial to find and apply a vaccine with stronger protection against Omicron. Livzon Pharmaceutical Group Inc. ("Livzon"), a long-established pharmaceutical company dedicated to research and development of innovative product, has developed a recombinant protein COVID-19 vaccine (the "V-01 vaccine") leveraging their recombinant protein technology platform since 2021.It is reported that the V-01 vaccine is a COVID-19 recombinant protein vaccine jointly developed by Livzon MabPharm Inc. ("Livzon MAB") and the Institute of Biophysics, Chinese Academy of Sciences (the "Institute"). To date, Livzon MAB has conducted two global Phase III clinical trials in multiple countries, including (1) two doses of V-01 as basic immunization scheme, and (2) V-01 as a sequential booster for people who have received two doses of inactivated vaccine 3 to 6 months earlier. This is the only global Phase III clinical trial of sequential boosting immunization of the COVID-19 vaccine that have been approved by the regulatory authorities of multiple countries. On February 16, Livzon has completed the interim analysis of the Phase III clinical trial for the sequential booster protocol, and released key data from this trial. According to the results disclosed, the person-year incidence rates of the V-01 sequential booster (after two doses of inactivated vaccine) group vs. the group who have only received two doses of inactivated vaccine were 6.73% and 12.80%, respectively, which showed a significant statistical difference (P=0.0012); and the absolute vaccine efficacy of the V-01 sequential booster was 61.35%, which is also shown to be significantly superior. The absolute vaccine efficacy after V-01 sequential booster has met World Health Organization's (WHO) standards. Sixty valid genotype sequencing samples in this trial were confirmed to be Omicron using first-generation genotype sequencing of SARS-CoV-2 virus (the rest of samples are in the process of second-generation sequencing), indicating that V-01 sequential booster can produce good protection against Omicron infection. This is the first COVID-19 vaccine in the world of which the Phase III trial interim results have been disclosed since the Omicron outbreak.Additionally, the Phase II trial results showed that V-01 had excellent immunogenicity and safety; and the overall incidence of adverse events was lower in the elder group than that of the younger adult group in comparison. According to the company, the manufacturing of V-01 is well established in China with stable raw material supply and adequate reserves, ready to provide for global market once launched. The production line of Livzon MAB has been approved by the Guangdong Food and Drug Administration, and the vaccine production license has been granted. It is also disclosed that a workshop with an annual bulk product capacity of 3.5 billion doses is up and running at Livzon MAB, and the annual production capacity of formulated product has reached 1.5 billion doses.With 71.32 million confirmed infected cases and 5.85 million cumulative deaths worldwide, the development and application of a safe and effective COVID-19 vaccine is urgent as the virus is spreading and mutating rapidly. Livzon, as a member of the Chinese Vaccine Research and Development Team, is in the process of obtaining EUA (Emergency Use Authorization) and conditional marketing approval for V-01 vaccine domestically and abroad, so as to provide a more robust and clinical-proven option for continuous immunization boosting for general public and to contribute to the global pandemic control efforts. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Therapeutic Goods Administration of Australia Authorizes Moderna’s Covid-19 Vaccine in Children (6-11 Years)

Cambridge, MA, Feb 17, 2022 - (ACN Newswire via SEAPRWire.com) - Moderna, Inc., (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Therapeutic Goods Administration (TGA) in Australia has granted provisional registration for the use of Moderna's mRNA COVID-19 vaccine, Spikevax, in a 50 ug dose, two-dose series, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6-11 years."The TGA authorization for the use of our COVID-19 vaccine in children 6-11 years old in Australia is an important milestone for Moderna as it is the first regulatory authorization for the use of our vaccine in this age group. We are grateful to the TGA for their diligence and the Government of Australia for its continued confidence in our mRNA platform," said Stephane Bancel, Chief Executive Officer of Moderna. "We are grateful for the opportunity to provide protection against COVID-19 to this important age group, keeping children safe and able to continue life as normally as possible."Professor Robert Booy from the Immunisation Coalition commented, "I welcome this decision by the TGA and look forward to the uptake of vaccination in children increasing even more to provide protection of children and maximize school attendance."Moderna's vaccine was investigated in the ongoing Phase 2 "KidCOVE" study, a randomized, observer-blind, placebo-controlled expansion study to evaluate the safety, tolerability, reactogenicity, and effectiveness of two 50 ug doses of Spikevax (mRNA-1273) given to healthy children 28 days apart. The study population was divided into three age groups (6 to under 12 years, 2 to under 6 years, and six months to under 2 years).Data submitted to the TGA demonstrated that vaccination of children 6 to under 12 years of age with a 50 ug mRNA-1273 primary series is associated with non-inferior anti-SARS-CoV-2 neutralizing antibody responses when compared to that in individuals 18-25 years old from the Phase 3 Cove study. The geometric mean ratio (GMR) comparing the response in children to the response in young adults from the Phase 3 COVE study was 1.5 (95% CI: 1.3, 1.8), with a seroresponse rate of 99.3%. Two 50 ug doses of mRNA-1273 were generally well tolerated.The study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS). The ClinicalTrials.gov identifier is NCT04796896.Moderna's vaccine has already received regulatory approval for adults and adolescents in Australia. On 9 August 2021, the TGA granted provisional registration to the Moderna COVID-19 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older. On 3 September 2021, the provisional registration was extended to individuals 12 years of age and older.About ModernaIn 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most-effective vaccines against the COVID-19 pandemic.Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.AUTHORIZED USEThe Therapeutic Goods Administration (TGA) in Australia has granted provisional registration for the use of Moderna's mRNA COVID-19 vaccine, Spikevax for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals six years of age and older.Forward Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the Company's development of a vaccine against COVID-19 (mRNA-1273, or Spikevax); the ability of Spikevax to trigger a neutralizing antibody response in children similar to that in older populations and to protect against COVID-19; and the safety and tolerability profile for Spikevax. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent lings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.Moderna Contacts:Media:Luke Mircea WillatsDirector, Corporate CommunicationsLuke.Mirceawillats@modernatx.comInvestors:Lavina TalukdarSenior Vice President & Head of Investor Relations617-209-5834Lavina.Talukdar@modernatx.comSOURCE: Moderna, Inc. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Phase I Clinical Trial of AIM mRNA COVID-19 Vaccine (LVRNA009) Won the Praise of the Industry for High Safety and Well Tolerance

HANGZHOU, CHINA, Jan 12, 2022 - (ACN Newswire via SEAPRWire.com) - On January 8, AIM Vaccine held a meeting at Shulan (Hangzhou) Hospital to report on the analysis results of the phase I clinical trial data of its mRNA COVID-19 vaccine (LVRNA009). Safety data on the phase I clinical trial was released by Director Chen Guiling of Phase I Clinical Trial Laboratory of Shulan (Hangzhou) Hospital, and the results indicated high safety and well toleration. Also, Dr. Shan Chao from Wuhan Institute of Virology, CAS announced the virus neutralizing antibody test at the meeting, "the GMT on day 56 of the adult low-dose group, the adult medium-dose group and the adult high-dose group was 576.6, 1591.2 and 845.7 respectively." Compared to the phase I clinical trial results of similar products, it demonstrated excellent safety and immunogenicity. At present, the phase I clinical trials of all 3 China's mRNA vaccines are carried out at the Phase I Clinical Trial Laboratory of Shulan (Hangzhou) Hospital, among which the first mRNA vaccine is already under phase III clinical trial overseas. At the meeting, top-notch experts acclaimed the phase I results of the mRNA COVID-19 vaccine (LVRNA009) of AIM Vaccine. Based on the current situation of pandemic prevention and control, experts expressed that drugs will not bring an end to the pandemic; vaccine remains the most effective means of prevention and control, and will continue to be applied on a large scale; thus, the sequential immunization with COVID-19 vaccine in China is of great significance. Renowned public health expert and epidemiologist Zeng Guang believed that novel coronavirus may be continuously weakening but cannot be eliminated, and it may coexist with the mankind over the long term; therefore, China must implement sequential immunization to establish a solid and most effective barrier of colony immunity. Zeng Guang expressed the importance of vaccination in plain language: "With vaccine, there is nothing to be afraid of!" Professor Wang Yu - distinguished visiting professor from Vanke School of Public Health, Tsinghua University and former director of Chinese Center for Disease Control and Prevention - elaborated on his opinion with the examples of H7N9 and poliomyelitis. According to him, antivirus drug is not the ultimate solution to the spread and infection of virus, and COVID-19 vaccine will continue to be used on a large scale. Professor Wang explained how mRNA technology can be applied in vaccines, and pointed out that our understanding of the biological behaviors of novel coronavirus is far from enough due to the suddenness of its outbreak, which requires the efforts of R&D enterprises and scientists and endless researches on new vaccine technologies. Distinguished professor of Fudan University and researcher of Institutes of Biomedical Sciences Xu Jianqing set forth the challenges in COVID-19 prevention and control and the latest progress of vaccines. At present, the proportion of asymptomatic infection remains high, and it is an extremely challenging task to achieve colony immunity through infection or a single vaccine. Xu said mRNA vaccine has obvious advantages as a booster short in view of its antibody durability and response to variants. Prof. Peng Yucai, lead scientist of AIM vaccine, expounded on the features of its mRNA COVID-19 vaccine at the meeting, with a comprehensive introduction made to its advantages in terms of gene sequence design, mRNA delivery method, vaccine stability and product quality control. Prof. Peng said, the mRNA COVID-19 vaccine (LVRNA009) originated from the R&D base of LIVERNA, which has begun its R&D of mRNA vaccine since 2017 as the first in China. In addition to a strong team and its mRNA R&D technology, LIVERNA also has its own pilot-scale production workshop for producing phase I and phase I clinical samples, which guarantees the quality control of its mRNA products. He commented, "This is rare." In addition, the internationally most advanced and most widely applied LNP delivery technology is adopted for this mRNA COVID-19 vaccine, its advantages including higher mRNA encapsulation and delivery efficiency than all previous technologies, good and controllable particle homogeneity, relatively simple production process, and easily realizable scale-up. "Now, our confidence in its R&D is boosted by factors on every aspect."Prof. Qin Xiaofeng of Systems Research Center of Institute of Basic Medical Sciences (Chinese Academy of Medical Sciences & Peking Union Medical College) and Suzhou Institute of Systems Medicine felt heartened by the phase I clinical trial data of AIM mRNA vaccine. He expressed: "With few adverse reactions and high neutralizing antibody titer, this product has great prospects."Besides clinical research, the industrialization of mRNA COVID-19 vaccine is another hot topic at the meeting. Dr. Xiong Changyun, who is charge of mRNA industrialization at AIM Vaccine, introduced the future path of industrialization of its mRNA vaccines. With modular workshops for mRNA vaccine production under planning in Ningbo, Shanghai and/or Beijing, AIM Vaccine has confidence in satisfying the market demands with its production capacity. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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