BioNTech and Fosun Pharma receive approval to commence COVID-19 Vaccine Candidate BNT162b2 trial in China

▴ BioNTech and Fosun Pharma receive approval to commence COVID-19 Vaccine Candidate BNT162b2 trial in China
BNT162b2 is currently in Phase 3 clinical trials in the United States, Germany, Argentina, Brazil, South Africa, Turkey and other countries

BioNTech SE and Shanghai Fosun Pharmaceutical announced that the China National Medical Products Administration has approved the clinical trial in Mainland China for their mRNA vaccine candidate, BNT162b2.

Wu Yifang, Chairman and CEO of Fosun Pharma, said: “As the ultimate weapon against the COVID-19 pandemic, vaccines will play a vital role in the economic development and social stability of the entire world. I would like to thank the National Medical Products Administration for their great support and for their approval of the clinical trial and we will continue our close collaboration with BioNTech. We are working together and moving forward with the clinical trials and commercialization of mRNA vaccines, to be able to also supply China.”

“This start of the b2 trial in China, in conjunction with the recent interim analysis of the global Phase 3 trial that indicates that our lead candidate may be effective in protecting against COVID-19, is another important step forward,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “Time is of the essence in this effort and we greatly appreciate the support by Chinese regulators and the collaboration with our Chinese partner Fosun Pharma. We will continue to collaborate closely to advance clinical development in China toward market approval.”

BioNTech through its partner Fosun Pharma will now commence a Phase 2 clinical trial in Mainland China. On March 13, 2020, BioNTech and Fosun Pharma announced their strategic collaboration to work jointly on the development and commercialization of potential COVID-19 vaccine products based on BioNTech’s mRNA technology platform in Mainland China, Hong Kong and Macau Special Administration Region, and the Taiwan Region.

BNT162b2 is currently in Phase 3 clinical trials in the United States, Germany, Argentina, Brazil, South Africa, Turkey, and other countries, and received Fast Track designation from the U.S. FDA. In addition, a rolling submission to the European Medicines Agency (EMA) for BNT162b2 has been initiated.

Tags : #BioNTechSE #LatestNewsonBioNTechSE20thNov #FosunPharma #LatestNewsonFosunPharma20thNov #LatestPharmaNews20thNov #LatestNewsonCOVIDVaccine20thNov #LatestPharmaCollaboration20thNov #USFDA #EuropeanMedicinesAgency #MainlandChina

About the Author


Team Medicircle

Related Stories

Loading Please wait...
-Advertisements-


Trending Now

1,031 new cases of COVID-19 confirmed in Himachal PradeshNovember 25, 2020
Cooking with wood may cause lung damageNovember 25, 2020
More than 56 lakh sample tests for COVID-19 conducted in OdishaNovember 25, 2020
COVID-19 recovery rate in Bihar improves to 97.30 pctNovember 25, 2020
Green Mediterranean (‘green Med’) diet may be even better for healthNovember 25, 2020
Chhattisgarh: Intensive Covid screening of all passengers to be done mandatorily at airportsNovember 25, 2020
New guidance issued on policies to protect populations in vulnerable situations in context of COVID-19November 25, 2020
Life Extension® Launches Bloat Relief Formula.November 25, 2020
Todos Medical Completes Installation of Lab Automation Equipment at Wisconsin Lab Client to Support COVID-19 PCR TestingNovember 25, 2020
Bristol Myers Squibb Receives European Commission Approval for OpdivoNovember 25, 2020
QualTex Laboratories adds Ortho Diagnostics VITROS® Anti-SARS-CoV-2 IgG assayNovember 25, 2020
China resorts to rigorous measures after multiple locally transmitted coronavirus cases detected in three citiesNovember 25, 2020
National COVID-19 recovery rate reaches 93.72 pctNovember 25, 2020
Nearly 11,60,000 COVID samples tested in country in last 24 hoursNovember 25, 2020
Lokelma label update approved in China for patients with hyperkalaemia on chronic haemodialysisNovember 25, 2020
Taking the Pill may cut risk of severe asthma bouts in women of reproductive ageNovember 25, 2020
Multilateral cooperation is key to overcoming global challenges such as COVID-19: Dr Harsh VardhanNovember 25, 2020
Polaryx Therapeutics receives both rare pediatric disease and orphan drug designations from US FDANovember 25, 2020
Panaxia and Neuraxpharm expand strategic collaboration to France with medical cannabisNovember 25, 2020
6,224 new cases of COVID-19 detected in DelhiNovember 25, 2020