China may approve first Covid-19 drug within weeks

Name: Joy as US borders reopen to fully vaccinated visitors after 20 months of Covid-19 restrictions
Uploaded: 2021-11-15T15:00:20.000Z
Duration: 1 min 10 s
Description: Joy as US borders reopen to fully vaccinated visitors after 20 months of Covid-19 restrictions

Monoclonal antibody treatment developed by Chinese and US researchers might get conditional approval by year-end, science and technology ministry daily says

Sinopharm subsidiary meanwhile is readying clinical trials for both human and lab-made antibody treatments

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An electron microscope image of the Covid-19 virus. Photo: Handout via AP

Josephine Ma

Published: 11:00pm, 15 Nov 2021Updated: 1:30pm, 17 Nov 2021

Corrected [1:28pm, 17 Nov, 2021]

[1:28pm, 17 Nov, 2021]
An earlier version of this story incorrectly reported that Brii Bio was seeking conditional approval for its drug in China. The story has been amended to reflect that a company spokeswoman did not specify what kind of approval was sought.

China is on track to approve its first drug for Covid-19, possibly within weeks.

This comes as Chinese scientists race to find an effective treatment for the disease, crucial for the country with a zero-tolerance strategy before it can consider reopening its borders, even as vaccination remains a priority.

Conditional approval may be given to a neutralising monoclonal antibody treatment co-developed by Chinese and US researchers by the end of the year, according to an official publication of the Ministry of Science and Technology.

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Joy as US borders reopen to fully vaccinated visitors after 20 months of Covid-19 restrictions

Brii Biosciences, a multinational pharmaceutical firm based in the US and China, developed the therapy with scientists at Tsinghua University and the Third People’s Hospital of Shenzhen, Science and Technology Daily reported on Monday.

Monoclonal antibodies are laboratory-made protein molecules that can act like human antibodies. The Brii Bio treatment combines two neutralising monoclonal antibodies, BRII-196 and BRII-198, created by cloning and combining antibodies found in recovered patients in China. The combination therapy has to be administered by infusion.

Brii Bio applied to the Chinese drug regulator last month after phase 3 trials delivered promising interim data. The company was also seeking emergency use clearance in the US, a spokeswoman said.

“We hope the Chinese regulator will approve it by the end of this year,” she said.

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