Chinese vaccine maker Sinopharm seeks government regulatory approval for public use of COVID shots

By Lokmat English Desk | Published: November 26, 2020 11:00 AM2020-11-26T11:00:00+5:302020-11-26T11:00:00+5:30

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A leading Chinese vaccine developer has applied for authorization to bring its Covid-19 shot to the market, seeking to get a jump on Western rivals as the race for a working inoculation against the virus enters the final stretch.

China National Biotec Group Co. has submitted an application to Chinese regulators, reported state media Xinhua Finance on Wednesday, citing parent company Sinopharm’s vice general manager Shi Shengyi.

The application likely includes interim data from the company’s Phase III human testing conducted in the Middle East and South America.

Stocks related to Sinopharm Group, including its Hong Kong unit, surged on Wednesday after the news.

A CNBG spokeswoman said she had no further information when contacted by Bloomberg. Calls to Sinopharm Group went unanswered.

With the application, CNBG will likely become the first developer outside of Russia to see its shots made available for general public use, underscoring China’s determination to be a major player in supplying inoculations to countries around the world.

Aadar Poonawala, chief executive officer (CEO) of the Serum Institute of India, said the potential vaccine on Covid 19 was highly effective, according to drugmaker AstraZeneca. The vaccine may soon be available to the public.

Western drugmakers like Pfizer Inc. and AstraZeneca Plc are only at the stage of seeking authorization for emergency use of their shots, a status China granted to its developers months ago. But unlike western frontrunners, CNBG has yet to release any public data on the efficacy of its shots in Phase III trials, making it difficult to compare its vaccines to others, or estimate how quickly it is likely to receive approval.

The regulator will now review data from CNBG’s Phase I and II trials, plus interim data from its Phase III trials, which Chairman Yang Xiaoming said last week the company has just started un-blinding. China’s drug regulator, the National Medical Products Administration, did not immediately respond to requests for comment.

The regulator will now review data from CNBG’s Phase I and II trials, plus interim data from its Phase III trials, which Chairman Yang Xiaoming said last week the company has just started un-blinding. China’s drug regulator, the National Medical Products Administration, did not immediately respond to requests for comment.

The vaccine race has taken on vital importance as countries look to more definitively re-open their economies and stem a pandemic that has sickened more than 59 million. Inoculations are seen as the best hope as a fresh wave of infections is forcing nations to reintroduce lockdowns and other restrictions.