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 secure a license that will allow domestic drugmakers to manufacture and distribute a generic version of US-based company Paxlovid’s COVID-19 antiviral drug in China, three sources told Reuters.

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

Beijing is keen to finalize the terms of the license agreement before the Lunar New Year which begins on January 1. 22, the source said.

Chinese hospitals are under intense pressure after the government abruptly abandoned its “zero-COVID” policy last month, sending infections are skyrocketing. The growing wave of infections across the country has overwhelmed hospitals, emptied drugstores 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 trying to get the drug abroad and have it shipped to China. Beijing has been largely resistant to Western vaccines and treatments. Paxlovid oral treatment is one of the few foreigners he has endorsed.

In February last year, China Paxlovid approved, which was supposed to be widely available through hospitals, to treat high-risk patients in several provinces. Pfizer struck a deal 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 working with Chinese authorities and all stakeholders 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 drugmakers in late December to discuss the preparations needed to manufacture a generic version of Paxlovid with the hope of getting the license 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 only for mainland use, and CSPC Pharmaceutical Group (1093.HK)a developer of a potential mRNA COVID vaccine, are among those who attended the meeting, the first source said.

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

MANUFACTURERS OF GENERIC MEDICINES

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

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

Huahai and CSPC plan 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 manufacture cheap versions of Paxlovid for 95 poorest countries through a licensing agreement with the Medicines Patent Pool (MPP) backed by the ‘UN. This 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 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 duty free, lower middle income countries and upper middle income countries will be subject to a 5% royalty for sales to the public sector and a 10 % for sales to the private sector, MPP said at the time.

Due to severe shortages of antivirals as 1.4 billion Chinese battle infections, many have turned to underground channels to secure Paxlovid and other drugs, according to national 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 urged Pfizer to lower the price of Paxlovid as the government aims to include the drug in the national medical insurance scheme which could cover some of the costs, 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: The Thomson Reuters Trust Principles.