China Pharma News: Paxlovid Approval; Anti-Monopoly Push; FDA Concern for China Developed Drugs


A selection of recent top stories from the Chinese pharma industry, including China’s conditional approval of Pfizer’s COVID treatment pill Paxlovid; a new push to combat monopoly practices and unfair competition in the domestic industry; and US FDA concerns about the applicability of Chinese clinical trial results for the US population.


China conditionally approves Pfizer’s Covid treatment pill Paxlovid (The Guardian)

The National Medical Products Administration in China has conditionally approved Pfizer’s Covid-19 drug Paxlovid to treat adults at risk of developing severe conditions from the disease.

This is the first oral pill approved to treat the disease in the country and is a boost for Pfizer that expects $22bn in sales from the drug this year alone.

The country’s medical products regulator has stated that it will require further study on the drug to be submitted and it is not clear whether the country is in discussions with the company to procure the pill.


China to strengthen anti-monopoly efforts in pharma industry (Reuters)

Law enforcement is expected to toughen in the country to combat monopoly practices and unfair competition in the sale of pharmaceuticals.

The action to improve the business environment in the pharmaceutical industry follows the guidelines issued in November aimed at cracking down on monopolies in the active pharmaceutical ingredients (API) market.


National medical bulk-buy program to be expanded (China Daily)

China is preparing for a seventh round of its centralized procurement program for drugs and medical apparatus which has created estimated savings of $41 bn.


China biotech has moving U.S. target on the back (Reuters)

Pharmaceutical company WuXi Biologics plunged 23% on Tuesday after Washington added it and 32 other Chinese groups to a list that would make U.S. imports of components like bioreactors much more painful. The $34 billion contract drugmaker rushed to explain read more that the list is not the much-feared entity black list, and hinted things will improve once China’s Covid-19 restrictions ease and field inspections can be completed. But it’s the second time in merely two months that the company was hammered read more out of fears over its heavy U.S. exposure as bilateral ties sour.


China likely needs mRNA vaccines to reopen. Omicron boosters are a better bet (Fortune)

Sinovac Biotech, the world’s largest COVID-19 vaccine maker, has battled concerns that its inactivated COVID jab has waned in efficacy against the highly transmissible variant Omicron. But the private, Beijing-based vaccine maker says that its Omicron-specific booster may be ready for widespread distribution by May, a potentially critical step in ensuring the world’s largest country is protected from the new strain.


FDA may halt approval on cancer drugs developed in China (Independent)

The FDA may halt approval on some cancer drugs and other medications being developed in China after concerns were raised over the whether the results of drug studies carried out in the country could be applied to the US population.


Chinese firms approved to make Merck’s Covid-19 pills for poor countries (SCMP)

UN-backed agency says manufacturing agreements for molnupiravir critical to ensuring global access to treatment for the coronavirus

Five Chinese companies get the go-ahead to make generic versions of the drug or ingredients but they will not be sold in China.

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