BioNTech’s BNT162 platform (actually 4 versions of an mRNA-based vaccine) represents one of the most promising COVID-19 vaccine candidates undergoing clinical trials. Part of “Project Lightspeed,” the German company partnered with Pfizer for the development and commercialization of this potential vaccine. In China, the company has partnered with Shanghai Fosun Pharmaceutical Group, Co. Ltd. (Fosun Pharma) to study the vaccine in that country. The pair recently released a press release announcing that the first 72 participants of a Chinese clinical trial testing BNT162b1 have been dosed.
The duo submitted an IND, which was approved by the Chinese regulatory authority known as the National Medical Products Administration (NMPA). BioNTech and Fosun Pharma are jointly developing the COVID-19 vaccine candidate in China. The trial is part of the BioNTech’s global development program aimed at supporting a global supply upon regulatory approval.
The recent press release shares that the randomized, placebo-controlled, observer-blinded Phase 1 clinical trial in China will enroll 144 healthy subjects to evaluate the safety and immunogenicity of the vaccine as well as to confirm dose selection. The first group of subjects immunized in Stage 1 of the study will be healthy adults aged 18 to 55 years, followed by elderly healthy participants (>55 years). As part of the two-dose cohort design, subjects will receive two injections (prime-boost), 21 days apart, of 10µg or 30µg of the vaccine candidate or placebo. The dose range selection was determined based on early data from clinical trials conducted in Germany and the United States. The participants will be dosed in Taizhou Clinical Phase1 Center, Jiangsu province.
This study is designed to support the regulatory approval process for the Chinese market and intends to confirm the safety and immunogenicity profile observed in participants from the German and U.S. trials is comparable to that of Chinese participants.
BNT162b1 Evaluated in China
Following on from the ongoing Phase 1/2 studies in Germany and the United States, the Chinese study will initially evaluate nucleoside-modified messenger RNA (modRNA) candidate BNT162b1, one of two vaccine candidates based on BioNTech’s proprietary mRNA technology to have received FDA Fast Track designation in the United States. Meanwhile, BNT162b2, the other vaccine candidate is currently being evaluated in a global Phase 2b/3 trial conducted by BioNTech and Pfizer which commenced on July 27th. The companies also intend to explore the possibility of initiating clinical development of other vaccine candidates based on BioNTech’s proprietary mRNA technology in China.
Investigational Product Made in Europe: China if Approved
During the clinical development stage, BioNTech will provide the clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe. If the vaccine receives marketing authorization in China, Fosun Pharma will exclusively commercialize the vaccine in Mainland China, Hong Kong and Macau Special Administration Regions and in Taiwan.
Biopharmaceutical New Technologies or BioNTech 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, Genevant, Fosun Pharma, and Pfizer.
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.