Exclusive: China in talks with Pfizer for generic COVID drug

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 the US firm’s COVID-19 antiviral drug Paxlovid 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 sources with knowledge of the matter said.

Beijing wants to finalize the terms of the license agreement before the Lunar New Year that begins on January 22, the source said.

Chinese hospitals are under intense pressure after the government abruptly abandoned its “zero-COVID” policy last month, causing infections to skyrocket. The mounting wave of infections across the country has overwhelmed hospitals, emptied drug pharmacies and caused international alarm.

Paxlovid, which was found to reduce hospitalizations in high-risk patients by around 90% in a clinical trial, is in high demand with many Chinese trying to source the drug abroad and ship it to China. Beijing has been largely resistant to Western vaccines and treatments. The oral treatment Paxlovid is one of the few foreigners that has been approved.

In February of last year, China approved Paxlovid, which was supposed to be largely available through hospitals, to treat high-risk patients in several provinces. Last month, Pfizer struck a deal 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 working with the Chinese authorities and all interested parties to ensure an adequate supply of Paxlovid in China.

All the sources declined to be identified as they are 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 make a generic version of Paxlovid in the hope that it could be licensed in the near future, two of the sources said.

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

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

GENERIC PHARMACEUTICALS

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

For a generic drug to be considered equivalent to a brand name drug, such tests are required to make sure they work the same way in the body.

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

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

In March, 35 generic drug makers from 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). That license does not allow companies to sell generic Paxlovid in China. read more

The MPP license agreement is royalty-free for Pfizer, while COVID-19 continues to be 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-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 private sector, the MPP said then.

With severe shortages of antivirals, as 1.4 billion Chinese battle infections, many have turned to underground channels to obtain Paxlovid and other drugs, according to national media. Resellers charge as much as 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 lower the price of Paxlovid as the government aims to include the drug in the national health insurance plan that 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; Edited by Sumeet Chatterjee and Jacqueline Wong

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