China’s regulatory authority accepts Fosun Pharma clinical trial application of mRNA vaccine candidate
Mareeg.com-The clinical trial application of the MRNA vaccine BNT162b2 for COVID-19, developed by a subsidiary of Chinese pharmaceutical company Fosun Pharma, was received by China’s regulatory authority on Wednesday.
Shanghai Fosun Pharmaceutical Industrial Development Co, a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co, has received the “Acceptance Notice”, and the clinical trial application for the licensed mRNA vaccine product BNT162b2 for COVID-19 was accepted by the National Medical Products Administration, Fosun Pharma said in a statement sent to the Global Times on Thursday.
BNT162b2, the second vaccine candidate introduced by Fosun Pharmaceutical Industrial, is a preventive biological product intended to be used on people aged between 18 and 85 for preventing COVID-19.
As of Thursday, BNT162b2 is in phase III clinical trial in the US, Germany, Argentina, Brazil, South Africa and Turkey, respectively, and BNT162b2 has been granted Fast Track Designation by the US Food and Drug Administration, Fosun Pharma’s statement said.
The application acceptance came after Fosun Chairman Guo Guangchang said he had received news from the two partners – Pfizer and BioNTech – that their jointly developed mRNA vaccine BNT162b2 was up to 90 percent effective based on early data from a phase three clinical trial, far higher than previous estimates.
This compares to the average flu shot’s 70 percent effectiveness and a minimum of 50 percent required for approval by the US Food and Drug Administration, Guo’s post on social media WeChat read.
The Shanghai-based conglomerate will maintain close communication with regulatory and licensing authorities, and hopes ongoing research and testing will show the vaccine complies with Chinese laws and will be available as quickly as possible, wrote Guo.
In March, Fosun Pharmaceutical Industrial was granted a license by German company BioNTech to exclusively develop and commercialize its vaccine products developed based on BioNTech’s proprietary mRNA technology platform targeting COVID-19 in China.
The stock of Fosun Pharma opened more than 3 percent higher on Thursday on Hong Kong stock market.
Source: Global Times