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Exclusive: China in talks with Pfizer for generic COVID drug

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HONG KONG/BEIJING, Jan 6 (Reuters) – China is in talks with Pfizer Inc (PFE.N) to obtain a license that will allow domestic drugmakers to manufacture and distribute a generic version of Paxlovid’s COVID-19 antiviral drug Paxlovid US company in 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 people with knowledge of the matter said.

Beijing wants to finalize the terms of the licensing agreement before the Lunar New Year, which starts Jan. 22, the source said.

Chinese hospitals are under intense pressure after the government abruptly abandoned its “zero-COVID” policy last month, driving up infections. The rising wave of infections across the country has overwhelmed hospitals, depleted pharmacies of drugs and caused international alarm.

Paxlovid, which reduced hospitalizations in high-risk patients by about 90% in a clinical trial, is in high demand with many Chinese looking to take the drug overseas and ship it to China. Beijing has been largely resistant to Western vaccines and treatments. The Paxlovid oral treatment is one of the few foreign approved treatments.

In February last year, China approved Paxlovid, which was supposed to be widely available in hospitals, to treat high-risk patients in several provinces. Pfizer reached an agreement last month to export Paxlovid to China through a local company to make the drug more widely available.

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

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

All sources declined to be identified as they are not authorized to speak to the media.

The NMPA held a meeting with several Chinese drug makers in late December to discuss preparations needed to make a generic version of Paxlovid, hoping it could secure a license in the near future, two of the sources said.

Zhejiang Huahai Pharmaceutical (600521.SS), which signed a deal with Pfizer in August to produce Paxlovid for mainland use only, and CSPC Pharmaceutical Group (1093.HK), developer of a potential mRNA COVID vaccine, are among those who attended the meeting, said the first source.

The second source said the NMPA also advised companies to prepare to register with the regulatory body to produce the generic version of Paxlovid.

GENERIC DRUGS

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

For a generic drug to be considered equivalent to a brand name drug, these tests are needed to ensure that they work the same way in the body.

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

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

In March, 35 generic drug makers around the world, including five Chinese companies, agreed to make cheap versions of Paxlovid for 95 poorer countries through a licensing deal with the UN-backed Medicines Patent Pool (MPP). . This license does not allow companies to sell generic Paxlovid in China. see more information

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

After the pandemic period, sales to low-income countries will remain royalty-free, lower-middle- and upper-middle-income countries will be subject to a 5% royalty for public sector sales and a 10% royalty for industry sales private, MPP said at the time.

Due to the severe shortage of antivirals as 1.4 billion Chinese people battle infections, many have turned to clandestine channels to obtain Paxlovid and other drugs, according to domestic media. Scalpers charge up to 50,000 yuan ($7,260) for a box of Paxlovid, more than 20 times its original price of 2,300 yuan.

China has also put pressure on Pfizer to reduce the price of Paxlovid as the government plans to include the drug in the national medical insurance scheme, which could cover part of the cost, the 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; Editing by Sumeet Chatterjee and Jacqueline Wong

Our Standards: Thomson Reuters Trust Principles.

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