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 a generic version of the U.S. company’s COVID-19 antiviral drug Paxlovid and distributed 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, said one of the sources with knowledge of the matter.
Beijing wants to finalize the terms of the licensing agreement before the Lunar New Year that begins on January 22, the source said.
China’s hospitals are under severe pressure after the government abruptly abandoned its “zero-COVID” policy last month, sending infections soaring. A surge of infections across the country has overwhelmed hospitals, emptied pharmacies of medicines and caused international panic.
Paxlovid, which was found to reduce hospitalization in high-risk patients by about 90% in a clinical trial, is in high demand, with many Chinese trying to get the drug overseas and ship it to China. Beijing has largely opposed western vaccines and treatments. Oral treatment Paxlovid is one of the few foreign ones he has approved.
In February last year, China approved Paxlovid, which was supposed to be available mostly through hospitals, to treat high-risk patients in some provinces. Pfizer reached an agreement last month to export Paxlovid to China through a local company to make the medicine 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 cooperating with the Chinese authorities and all interested parties to ensure an adequate supply of Paxlovid in China.
All the sources declined to be identified because they are not authorized to speak to the media.
The NMPA held a meeting with several Chinese drug manufacturers in late December to discuss the preparations needed to make a generic version of Paxlovid in the hope that it would be able to obtain the license in the near future, two of them said. the sources.
Among those in present at the meeting, the first source said.
The second source said the NMPA also advised firms to prepare to register with the regulator to produce the generic version of Paxlovid.
In recent weeks potential candidates including Huahai and CSPC have been undergoing “bioequivalence tests”, which are required by Chinese regulators before generic drugs can be shipped, the two sources and another with direct knowledge of the matter said.
For a generic drug to be considered equivalent to a branded medicine, such tests are needed to ensure that they work in the same way in the body.
Both Huahai and CSPC hope to submit the results of the tests to the NMPA later this month, one of which was added.
Neither Huahai nor CSPC responded to a request for comment.
In March, 35 generic drug makers around the world including five Chinese firms agreed to make cheap versions of Paxlovid for 95 poorer countries through a licensing arrangement with the UN-backed Medicines Patent Office (MPP). That license does not allow the companies to sell generic Paxlovid in China. Read more
The MPP licensing arrangement is royalty-free for Pfizer, and 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-income countries and upper-middle-income countries will be subject to a 5% royalty for sales to the public sector and a 10% royalty for sales. for the private sector, MPP said at the time.
Due to a severe shortage of antivirals as China battles 1.4 billion infections, many have turned to underground channels to secure 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 the original price of 2,300 yuan.
China has also pressured Pfizer to lower the price of Paxlovid as the government aims 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: The Thomson Reuters Trust Principles.