(14 July 2020, Shanghai) Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma", stock code: 600196.SH; 02196.HK) announces that its subsidiary Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. ("Fosun Pharmaceutical Industrial") has received the acceptance notice of clinical trial application for the licensed COVID-19 vaccine product candidate BNT162b1 (the “Vaccine”). The clinical trial application of the Vaccine was accepted by the National Medical Products Administration (the “NMPA”).
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-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”
In March 2020, Fosun Pharma has obtained the license granted by German company BioNTech SE (“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, aiming at the precaution of COVID-19 for people who aged 18 or above. According to public information, BioNTech has announced interim analysis data from an ongoing phase 1/2 study of mRNA-based vaccine candidate against SARS-CoV-2, and its two most advanced mRNA-based SARS-COV-2 vaccine candidates BNT162b1 and BNT162b2 have recently received the Fast Track Designation from the U.S. Food and Drug Administration (FDA). Subject to approval by regulatory authorities, BioNTech expects to begin a Phase 2b/3 trial as early as in later this month and expects up to 30,000 subjects to be enrolled in the trial.
Wu Yifang, President and CEO of Fosun Pharma said, “With the COVID-19 still spreading around the world, vaccine research and development is of the greatest urgency. 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 synchronized with the international pace.”
mRNA is a nucleic acid molecule that carries genetic information. The mRNA vaccine introduces the 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.