Exclusive: China in talks with Pfizer for generic COVID drug

HONG KONG/PEIJING, Jan 6 (Reuters) – China is in talks with Pfizer Inc ( PFE.N ) for a license that would allow domestic drugmakers to manufacture and distribute a generic version of the U.S. firm’s COVID-19 antiviral drug Paxlovid. China, three sources told Reuters.

China’s medical products regulator, the National Medical Products Administration (NMPA), has been leading talks with Pfizer since late last month, one of the sources with knowledge of the matter said.

The source said Beijing is interested in finalizing the terms of the license agreement by the Lunar New Year, which begins on January 22.

China’s hospitals are under intense pressure after the government abruptly abandoned its “zero-COVID” policy last month, leading to a surge in infections. A growing wave of infections across the country has overwhelmed hospitals, overwhelmed pharmacies and sparked international alarm.

Paxlovide, which was found in a clinical trial to reduce hospitalizations in high-risk patients by about 90%, is in high demand, with many Chinese trying to buy the drug overseas and ship it to China. Beijing is largely resistant to western vaccines and treatments. Oral treatment Paxlovid is one of the few approved external drugs.

In February last year, China approved Pakhlovid, which must be obtained mainly through hospitals, to treat high-risk patients in several provinces. Pfizer agreed last month to export Paxlovid to China through a local company to make the drug more widely available.

The State Council Information Office, which handles media inquiries for the NMPA and the government, did not respond to Reuters requests for comment.

A Pfizer spokesperson said the company is actively working with Chinese authorities and all stakeholders to ensure an adequate supply of Paxlovid in China.

All the sources declined to be identified because they were not authorized to speak to the media.

The NMPA held a meeting with several Chinese drugmakers in late December to discuss the preparations needed to develop a generic version of Paxlovid and hoped to secure a license in the near future, two of the sources said.

They include Zhejiang Huahai Pharmaceutical ( 600521.SS ), which signed a deal with Pfizer in August to make Paxlovid for mainland use only, and CSPC Pharmaceutical Group ( 1093.HK ), the developer of a potential mRNA COVID vaccine. The first source said that he participated in the meeting.

A second source said the NMPA recommended that firms register with the regulator to manufacture a generic version of Paxlovid.


Potential candidates, including Huahai and CSPC, have in recent weeks undergone “bioequivalence tests” required by Chinese regulators before launching generic drugs, two of the sources and another person with direct knowledge of the matter said.

For a generic drug to be equivalent to a brand-name drug, these types of tests are required to make sure it works the same way in the body.

Both Huahai and CSPC expect to submit test results to the NMPA later this month, one of them added.

Huahai and CSPC did not respond to a request for comment.

In March, 35 generic drugmakers around the world, including five Chinese firms, agreed to develop cheaper versions of Paxlovid for 95 poor countries through a licensing agreement with the UN-backed Medicines Patent Pool (MPP). This license does not allow companies to sell generic Paxlovid in China. read more

The MPP licensing arrangement is royalty-free for Pfizer, while COVID-19 is classified as a “Public Health Emergency of International Concern” by the World Health Organization (WHO).

Post-pandemic sales to low-income countries will remain royalty-free, while low-middle-income countries and upper-middle-income countries will be subject to a 5% royalty on sales to the public sector and a 10% royalty on sales to the public sector. MPP told the private sector at the time.

Due to a severe shortage of antivirals, as 1.4 billion Chinese battle infections, many have turned to underground channels to secure Paxlovid and other drugs, according to local media. Scalpers are charging 50,000 yuan ($7,260) for a box of Paklovid, more than 20 times its original price of 2,300 yuan.

China has also pressured Pfizer to lower the price of Paxlovide as the government aims to include the drug in the national health insurance scheme, three sources said.

($1 = 6.8875 Chinese yuan)

Reporting by Julie Zhu in Hong Kong and Kevin Huang in Beijing; Additional reporting by Michael Erman in New York; Edited by Sumeet Chatterjee and Jacqueline Wong

Our standards: Thomson Reuters Trust Principles.

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