On February 11, the State Food and Drug Administration conducted emergency review and approval in accordance with the relevant provisions of the drug administration law and the special drug approval procedures, and conditionally approved the import registration of the combined packaging of nevitavir tablets / ritonavir tablets (i.e. paxlovid) of Pfizer covid-19 virus treatment drug.
According to the information released by the State Administration of drug control, Paxlovid is an oral small molecule COVID-19 virus therapeutic agent for the treatment of mild to moderate New Coronavirus pneumonia (COVID-19) in adults with severe risk factors, such as elderly, chronic kidney disease, diabetes, cardiovascular disease, and chronic lung disease. Patients should use drugs in strict accordance with the instructions under the guidance of doctors, and pay close attention to the interaction information with other drugs listed in the instructions.
The State Food and drug administration requires the listing permit holder to continue to carry out relevant research work, complete the conditional requirements within a time limit, and submit the follow-up research results in time.
On December 8, 2021, the State Food and Drug Administration approved the registration application of covid-19 virus neutralizing antibody combination therapy drug of Tengsheng Huachuang company, which is the first covid-19 virus neutralizing antibody combination therapy drug approved with independent intellectual property rights in China.
The conditional approval of Pfizer covid-19 oral drug paxlovid has also become the first overseas covid-19 drug approved in China. Previously, paxlovid had obtained the emergency use authorization from the FDA in December 2021.
For the listing schedule and price of covid-19 oral drug after approval, Pfizer said in response to Nanfang + reporters that there was no further public information for the time being.
According to public information, paxlovid is priced in the United States as a five-day course, and the U.S. government needs to pay about 530 US dollars (about 3367 yuan).
Pfizer’s 2021 annual financial report first announced the 2022 annual financial forecast of covid-19 oral therapeutic drug paxlovid. According to the annual report, paxlovid’s revenue in 2022 is expected to be about $22 billion, reflecting the treatment dose expected to be mainly provided according to the supply contracts signed or committed by the end of January.
The approval of the first overseas covid-19 oral drug has also stirred many enterprises in China’s relevant industrial chain. At the opening of trading on February 14, a number of covid-19 drug concept stocks, including Porton Pharma Solutions Ltd(300363) and Chengda pharmaceutical, rose by the limit.
On the evening of February 11, Chinese pharmaceutical enterprise Porton Pharma Solutions Ltd(300363) announced that it had recently received a new batch of purchase orders from Pfizer Ireland pharmaceuticals, a multinational pharmaceutical company, and the company would provide contract customized R & D and production (cdmo) services. As of the disclosure date of this announcement, the total amount of newly obtained orders was USD 681 million, exceeding 50% of the audited operating revenue of the company in the latest fiscal year.
According to the announcement, Porton Pharma Solutions Ltd(300363) has a long-term cooperative relationship with Pfizer. In terms of the company’s sales to Pfizer in the last three years, the revenue in 2019 was 58.46 million yuan, accounting for 3.77% of the operating revenue of the year; In 2020, the revenue will be 103 million yuan, accounting for 4.99% of the operating revenue of the current year; From January to September 2021, the revenue was 151 million yuan, accounting for 7.46% of the current operating revenue. However, whether the order cooperation involves covid-19 oral drugs is not mentioned in the announcement.
