China’s Fosun Pharma Receives Acceptance Notice of Application for Clinical Trial of BioNTech’s mRNA COVID-19 Vaccine

Fosun Pharma (Shanghai, China) has received acceptance notice of its clinical trial application for the licensed COVID-19 vaccine product candidate BNT162b1 being co-developed with Biopharmaceutical New Technologies (BioNTech Mainz, Germany).

In March 2020, Fosun had obtained the license granted by BioNTech to exclusively develop and commercialize its vaccine products based on BioNTech's proprietary mRNA technology platform targeting COVID-19 in China. The vaccine candidate is a prophylactic biological product, aimed at preventing COVID-19 among people aged 18 years and above. The mRNA vaccine introduces genetic information into the human body, so that the cells in the body produce the corresponding antigen, which induces the body to produce neutralizing antibodies and stimulates the response of T cells, fighting against the virus through the dual mechanisms of humoral and cellular immunity. In the face of a outbreak, compared with traditional vaccines, mRNA vaccine possesses advantages such as more convenient synthetic and manufacturing process, strong immunogenicity with no need for additional adjuvant as needed by the traditional vaccine, and with a good safety.

BioNTech has announced the interim analysis data from an ongoing phase 1/2 study of mRNA-based vaccine candidate against SARS-CoV-2. Additionally, BioNTech’s two most advanced mRNA-based SARS-COV-2 vaccine candidates BNT162b1 and BNT162b2 have recently received Fast Track Designation from the US Food and Drug Administration (FDA). Subject to approval by the regulatory authorities, BioNTech expects to begin a Phase 2b/3 trial as early as in later this month and enroll up to 30,000 subjects in the trial. Fosun had submitted a clinical trial application for the vaccine to the National Medical Products Administration (NMPA) which has now accepted the application.

"We are greatly excited about this news. 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," said Dr. Aimin Hui, Senior Vice President, President of Global R&D, and Chief Medical Officer of Fosun Pharma.

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