As BioNTech makes inroads with its COVID-19 vaccine in Western countries under a partnership with Pfizer, the German biotech is bringing its work in China to the next level as the shot nears a local approval.
BioNTech and Fosun Pharma is setting up a 50-50 joint venture to make and sell the COVID mRNA shot in China, with manufacturing capacity to produce up to 1 billion doses a year, Fosun said in a filing (PDF) to the Hong Kong Exchange on Sunday.
The news came as the pair expects a Chinese approval for the vaccine, known as BNT162b2 or Comirnaty, by July the latest, according to BioNTech CEO Ugur Sahin’s comment a few days ago, and as reported by Reuters.
It also came on the heels of the World Health Organization greenlighting an inactivated vaccine by China’s state-owned Sinopharm for emergency use on Friday. The Wall Street Journal first reported mid-April that Chinese officials were expected to greenlight the BioNTech vaccine by July. But some people familiar with the internal discussions told the newspaper that the final decision depends in part on approvals for Chinese vaccines abroad.
BioNTech first joined hands with Fosun last March with an exclusive licensing agreement for the Chinese market. Since then, BioNTech’s been providing the vaccine for local clinical trials and for ongoing commercial rollout in Hong Kong and Macau.
Through an update in December, BioNTech agreed to supply Fosun an initial 100 million doses for Chinese mainland this year. It also agreed to let Fosun onshore manufacturing, and the JV’s meant to execute that deal to localize COVID-19 vaccine production.
For the new company, Fosun will contribute up to $100 million of assets in cash and a manufacturing facility, while BioNTech will pour in another $100 million but in the form of proprietary manufacturing technology and know-how, Fosun said in its filing.
As of early last week, BioNTech’s ex-China partner Pfizer had shipped around 430 million Comirnaty doses to different parts of the world. The team will be able to produce nearly 3 billion doses this year, Sahin said last week.
Compared with its quick advancement in the U.S. and EU, the BioNTech shot has been moving relatively slowly in China; the vaccine’s still in a phase 2 bridging study, which the companies launched in August. Data from the trial will be combined with existing efficacy data from the shot’s global phase 3 for a local application.
China is currently dominated by domestically developed vaccines by Sinopharm, Nasdaq-listed Sinovac Biotech and Tianjin’s CanSino Biologics. But compared with the country’s huge population, the pace of the vaccines’ rollout hasn’t been ideal. As of Sunday, about 324.3 million doses of COVID shots have been administered in Chinese mainland, the country’s health department said.
If approved, Comirnaty will be the first foreign-made COVID vaccine available in China.
The BioNTech-Fosun JV carries a 15-year term, during which the two parties may potentially expand the collaboration beyond the coronavirus vaccine product into other mRNA programs.