Supply agreement reflects both companies’ shared commitment and efforts to achieve vaccine accessibility and affordability in China
A local Phase 2 clinical trial of mRNA COVID-19 vaccine candidate BNT162b2 is on-going in Jiangsu, China
MAINZ, GERMANY, and SHANGHAI, CHINA, 16 December
— BioNTech SE
(Nasdaq: BNTX, “BioNTech” or “the Company”) and Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma” or “Group”; Stock Code: 600196.SH, 02196.HK) today announced an agreement to supply Mainland China with 100 million doses initially of their BNT162 mRNA-based vaccine candidate against COVID-19 in 2021, subject to regulatory approval. Initial supply will be delivered from BioNTech’s production facilities in Germany.
“We would like to thank the Chinese government and National Medical Products Administration for their commitment and trust in our vaccine development efforts to help address this global pandemic threat,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.
“This joint development effort with Fosun Pharma is a testament to the importance of global cooperation and reflects our strategy to supply our vaccine globally. This agreement is an important step toward our shared goal of bringing a safe and efficacious vaccine to people worldwide.”
"Since the outbreak of the COVID-19 epidemic, we have been working closely with BioNTech. With the support of the Joint Prevention and Control Mechanism of The State Council, especially the National Medical Products Administration, the National Health Commission, the Ministry of Science and Technology and other relevant authorities, the R&D and clinical trial of our COVID-19 mRNA vaccine in China has been promoted rapidly. On the premise of ensuring the safety and effectiveness of the vaccine, we actively promote the marketing of the vaccine in China. The BNT162b2 mRNA vaccine is a successful model of international R&D collaboration," Wu Yifang, Chairman and CEO of Fosun Pharma
said. “We are pleased to reach the supply agreement with BioNTech, which is an important step in Fosun Pharma and BioNTech's efforts to achieve vaccine accessibility and affordability in China.”
In March 2020, BioNTech and Fosun Pharma announced their strategic collaboration to work jointly on the development and commercialization of a potential COVID-19 vaccine based on BioNTech’s mRNA technology platform.
On November 24, 2020, the companies initiated a Phase 2 clinical trial of vaccine candidate BNT162b2 in Jiangsu Province, China. The trial commenced with the recruitment of 960 healthy participants, between 18 to 85 years old, to assess the safety and immunogenicity of the vaccine candidate and to support future Biologic License Application (BLA) in China.
Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de
About Fosun Pharma
Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; stock code: 600196.SH, 02196.HK) is a leading healthcare group in China. Fosun Pharma has built a strong root in China and developed a global operation strategy, with pharmaceutical manufacturing and R&D being the largest and core business segment, together with strong presences in medical devices and diagnostics, healthcare services, pharmaceutical distribution and retail.
With R&D innovation as core driving factor, Fosun Pharma continues to optimize its pharmaceutical operations across both innovative and generic drugs. The company has established international R&D centers for excellence in areas such as innovative small molecule drugs, high-value generic drugs, biologics, and cell-therapy.
Under guidance of our 4IN strategy (Innovation, Internationalization, Integration and Intelligentization), Fosun Pharma follows the brand concept of Innovation for Good Health and strives to be a leading enterprise in the global pharmaceutical and healthcare markets.
For more information, please visit: www.fosunpharma.com
Forward-looking Statements of BioNTech
This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech’s efforts to combat COVID-19; the collaboration between BioNTech and Fosun Pharma to develop a potential COVID-19 vaccine; our expectations regarding the potential characteristics of BNT162b2 in our Phase 2/3 trial and/or in commercial use based on data observations to date; the expected time point for additional readouts on efficacy data of BNT162b2 in our Phase 2/3 trial; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for, or receipt of, any marketing approval or Emergency Use Authorization; our contemplated shipping and storage plan, including our estimated product shelf-life at various temperatures; and the ability of BioNTech to supply the quantities of BNT162 to support clinical development and, if approved, market demand, including our production estimates for 2020 and 2021. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our productions capabilities; and other potential difficulties.
For a discussion of these and other risks and uncertainties, see BioNTech’s Quarterly Report for the Three and Nine Months Ended September 30, 2020, filed as Exhibit 99.2 to its Current Report on Form 6-K filed with the SEC on November 10, which is available on the SEC’s website at www.sec.gov
. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.