BEIJING — China’s medical products regulator said on Saturday it has given conditional approval for Pfizer’s COVID-19 treatment Paxlovid, making it the first oral anti-coronavirus pill approved in the country to treat the disease.
The National Medical Products Administration said Paxlovid has obtained conditional approval to treat adults who have mild to moderate COVID-19 and high risk of progressing to a severe condition. Further study on the drug needed to be conducted and submitted to the authority, it said.
It is not immediately clear if China is already in talks with Pfizer to procure the pill. Pfizer did not reply to a Reuters request for comment.
The approval is a boost to Pfizer which expects US$22 billion in 2022 sales of the treatment.
Pfizer executives said the company is in active discussions with over 100 countries about Paxlovid, and has the capacity to provide 120 million courses if needed.
While a number of vaccines are available worldwide to help prevent infection and serious illness, including one made by Pfizer, there are limited treatment options for people infected with COVID-19.
Pfizer in December said final trial results showed its treatment reduced the chance of hospitalization or death by 89% in COVID-19 patients at risk of severe illness given the treatment within three days of the onset of symptoms, and by 88% when given within five days of onset.
The United States is paying around US$530 for each course of Paxlovid and $700 for each course of rival COVID-19 pill molnupiravir developed by Merck & Co.
China has yet to approve any COVID-19 vaccines developed by foreign drugmakers but authorized several domestically developed shots.
(Reporting by Roxanne Liu and John Horwitz; Editing by Miyoung Kim and Lincoln Feast.)
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