BEIJING: China's medical products regulator said on Saturday (Feb 12) 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.
Paxlovid has so far been authorised in several countries including the United States and Israel, while the European Union has permitted member states to use it ahead of formal approval as an emergency measure against the Omicron variant.
Unlike COVID-19 vaccines, the drug does not target the ever-evolving spike protein that the coronavirus uses to invade cells.
It is not immediately clear if China is already in talks with Pfizer to procure the pill.
"This is an important milestone in our fight against COVID-19," a Pfizer representative said in a statement, without providing information about procurement.
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 hospitalisation or death by 89 per cent in COVID-19 patients at risk of severe illness given the treatment within three days of the onset of symptoms, and by 88 per cent when given within five days of onset.
The United States is paying around US$530 for each course of Paxlovid and US$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 authorised several domestically developed shots.