Three sources confirmed to Reuters that China is currently in negotiations with Pfizer Inc for a license that will allow Chinese drugmakers to produce and distribute a generic version of the antiviral drug COVID-19 in China.
One source with knowledge said that China’s regulator for medical products, the National Medical Products Administration (NMPA), has been leading talks with Pfizer since late December.
According to a source, Beijing wants to conclude licensing deals before the Lunar New Year begins on January 22.
China’s hospitals are feeling severe pressure since the government abandoned its “zero COVID” policy last month. This has caused the infection to skyrocket. International alarm has been raised by the rising number of infections in China. It has led to overcrowded hospitals and emptied pharmacies.
Paxlovid was found to reduce hospitalizations in high-risk patients by approximately 90% in a clinical study. Many Chinese are trying to obtain the drug overseas and ship it to China. Beijing is resistant to western treatments and vaccines. Paxlovid, an oral treatment that is foreign, has been approved by Beijing.
China approved Paxlovid in February 2013. This was to make it more widely available to high-risk patients across several provinces. Last month, Pfizer reached an agreement with China to export Paxlovid via a local business in order to make the medicine more accessible.
Reuters reached out to the NMPA and State Council Information Office for media inquiries for the government but they did not respond.
A spokesperson for Pfizer stated that the company was actively working with Chinese authorities and other stakeholders to ensure adequate supplies of Paxlovid in China.
None of the sources could be identified because they were not authorized to speak to the media.
Two sources claimed that the NMPA met with Chinese drugmakers late in December to discuss the preparations required to produce a generic Paxlovid in order to be able to obtain the licence.
Zhejiang Huahai Pharmaceutical who signed a contract with Pfizer to produce Paxlovid exclusively for use on the mainland in August, and CSPC Pharmaceutical Group who is a developer of a potential mRNA-based COVID vaccine, were among the people that attended the meeting.
According to the second source, the NMPA also advised firms that they should prepare to register with regulators to make the generic Paxlovid.
Several potential candidates, including Huahai as well as CSPC, have been performing “bioequivalence testing” in recent weeks. These tests are required by Chinese regulators prior to generic drugs being launched. According to two sources and another source with knowledge of the matter,
These tests are necessary to ensure that generic drugs work in the same way as branded medicines.
Both Huahai, CSPC and CSPC will submit the test results to the NMPA in the latter part of this month. One added.
Huahai, CSPC and CSPC didn’t respond to a request for comment.
35 generic drug companies from around the globe, including five Chinese ones, agreed in March to produce cheap Paxlovid versions for 95 countries that are less fortunate through a licensing agreement with the U.N.-backed Medicines Patent Pool. The companies cannot sell generic Paxlovid to China under the licence.
Pfizer is exempt from royalty under the MPP licensing agreement, and COVID-19 continues to be classified by the World Health Organization as a Public Health Emergency of International Concern.
Sales to low-income nations will continue to be royalty-free after the pandemic, but lower-middle-income countries and higher-income countries may have to pay a 5% or 10% royalty for sales of goods to the public sector.
Many have turned to underground channels to obtain Paxlovid or other drugs due to the severe shortage of antivirals. Paxlovid boxes can be purchased for as high as 50,000 Yuan ($7,260), more than 20 times the original price of 2,300 Yuan.
China also asked Pfizer to lower Paxlovid’s price, as the government wants to include it in its national medical insurance plan. This could help cover a portion of the cost.
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