The collaboration between BioNTech and Pfizer on a COVID-19 vaccine candidate based on mRNA technology continues apace, with hopes for an emergency approval in late-2019. In China, home to 1.4 billion people, BioNTech is leveraging the expertise of domestic firm Fosun Pharma for trials and commercialisation of another vaccine candidate, with similarly ambitious approval expectations.
Founded in 1994, Shanghai Fosun Pharmaceutical Group (Fosun Pharma for short), is one of China’s most well-established pharma firms, active in both innovative and generic drugs. Fosun boasts a global footprint, manufacturing and R&D facilities, and a strong presence in medical devices and diagnostics, healthcare services, and pharmaceutical distribution and retail.
The Fosun-BioNTech collaboration forms part of BioNTech’s global development program, with the ultimate aim of securing global supply of a vaccine immediately upon regulatory approval. During the currently ongoing clinical development stage, BioNTech provides the clinical supply of the vaccine, while Fosun draws on its sizeable experience in the domestic Chinese market to take charge of clinical trial design and execution, regulatory approval and commercializing the vaccine in China. If the vaccine receives marketing authorization in China, Fosun Pharma will exclusively commercialize it in Mainland China, Hong Kong and Macau Special Administration Region and Taiwan Region.
Dosing the first Chinese subject with BNT162b1 marks a milestone of the global co-development program in China
Ai-Min Hui, Fosun Pharma
With global Phase IIb/III trials involving over 25,000 participants conducted by Pfizer and BioNTech underway for the BNT162b2 vaccine candidate, Focsun and BioNTech have announced that trials in China will focus on the BNT162b1 candidate, which also utilises mRNA technology. The Phase I China trials will build on the ongoing Phase I/II studies in Germany and the USA.
“Dosing the first Chinese subject with BNT162b1 marks a milestone of the global co-development program in China,” said Ai-Min Hui, president of Global R&D and CMO of Fosun Pharma. “We are closely working with BioNTech and regulatory authorities to evaluate the safety and efficacy of BNT162b1 and other mRNA vaccine candidates, in order to synchronize the development process in China with other countries, and to bring the vaccine to public as soon as possible, if the vaccine succeeds.”
BioNTech CEO and co-founder Ugur Sahin added, “We are proud to be among the first international biopharmaceutical companies to initiate a clinical trial of a COVID-19 vaccine candidate in China as part of our effort to make our vaccine available globally, if approved. This is an important step toward our goal to reach marketing authorization and ensure vaccine supply in China to help prevent new COVID-19 outbreaks in the most populous country in world.”
Should a vaccine candidate gain regulatory approval in China, BioNTech and Fosun are optimistic in terms of their ability to supply the Chinese market and have already inked a deal for ten million doses of BNT162 in Hong Kong and Macau.
“We are looking forward to a safe and effective COVID-19 vaccine product as soon as possible, so as to turn the tide of COVID-19 pandemic effectively. Fosun Pharma will take advantage of our available resources and marketing network to ensure the accessibility and affordability of vaccine products in China,” said Li Shengli, VP of Fosun Pharma, who is responsible for the commercialization in China market.
Sean Marett, chief business and chief commercial officer at BioNTech added, “This announcement is the first one to potentially supply the Chinese market with a BioNTech vaccine together with our partner Fosun Pharma. It further demonstrates our commitment to provide our vaccine candidate as broadly as possible globally to help end the SARS-CoV-2 pandemic.”