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China’s National Medical Products Administration (NMPA) has accepted an application submitted by Shanghai Fosun Pharmaceutical unit Fosun Pharmaceutical Industrial seeking approval to trial Covid-19 vaccine candidate, BNT162b1.
Fosun Pharma obtained licence for the vaccine candidate from German company BioNTech to exclusively develop and commercialise the product in China.
Based on BioNTech’s mRNA technology platform, the vaccine candidate is a prophylactic biological product intended to protect individuals aged 18 and above from Covid-19.
Fosun Pharma chief medical officer Dr Aimin Hui said: “Fosun Pharma’s Global R&D Center has been striving for a patient-centered and clinical-driven approach to the pandemic, and actively promoting the international collaboration with BioNTech to co-develop an mRNA vaccine against the Covid-19.
“We hope that the clinical trial will be initiated in China as soon as possible, and the global pandemic will be defeated eventually with the launch of a safe and effective vaccine.”
BNT162b1 is already undergoing Covid-19 clinical trials in Germany and the US.
According to preliminary data from 24 participants, the vaccine candidate could be given at a dose that was well tolerated and produced dose dependent immunogenicity.
Subject to regulatory approval, BioNTech also intends to launch a Phase IIb/III trial later this month in up to 30,000 participants.
Fosun Pharma president and CEO Wu Yifang said: “We have been collaborating with Biotech and endeavor to promote clinical trials of mRNA vaccines in China.
“We will continue to work closely with the NMPA and other relevant agencies to evaluate the safety and efficacy of these vaccine candidates, and strive to obtain clinical trial approval, and launch Covid-19 vaccine products synchronised with the international pace.”
BioNTech’s two most advanced Covid-19 vaccine candidates, BNT162b1 and BNT162b2, have already received fast track designation from the US Food and Drug Administration (FDA).