COVID-19 vaccine candidate gets green light for trial in China
The COVID-19 vaccine candidate, BNT162b1, has been approved for clinical trial registration by China’s National Medical Products Administration (NMPA).
Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. announced that the Chinese National Medical Products Administration (NMPA) has accepted its clinical trial application for the licensed COVID-19 vaccine candidate, BNT162b1.
According to the enterprise, it obtained the licence to exclusively develop and commercialise BioNTech’s BNT162b1 vaccine in mainland China, Hong Kong, Macao and Taiwan back in March 2020. The vaccine is intended to protect people aged 18 and over from COVID-19.
An interim analysis of BioNTech’s ongoing Phase I/II trial evaluating BNT162b1 and a second candidate based on the same mRNA technology (BNT162b2) recently approved Fast Track designation from the US Food and Drug Administration (FDA). Subject to regulatory approval, the enterprise expects to begin a Phase IIb/III trial later this month.
Dr Aimin Hui, Senior Vice President, President of Global R&D and Chief Medical Officer of Fosun Pharma said: “We are greatly excited about this news. Fosun Pharma’s Global R&D Center has been striving for a patient-centred 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”