On November 16, 2021, local time, Freiburg, Germany, filmed the process of making anti-new coronavirus drugs in local laboratories. (People's Vision/Photo)
On February 11, 2022, the State Drug Administration (NMPA) approved the import registration of Pfizer's new coronavirus treatment drug Paxlovid. This is the first oral drug approved by the State Food and Drug Administration to treat new crown pneumonia.
According to the news released on the official website of the State Food and Drug Administration on February 12, the approved Paxlovid Chinese name is nematvir tablets / ritonavir tablets combination packaging. The product is an oral small molecule new coronavirus treatment drug for the treatment of adults with mild to moderate coronavirus pneumonia (COVID-19) with high-risk factors for progression to severe disease, such as patients with advanced age, chronic kidney disease, diabetes, cardiovascular disease, chronic lung disease and other high-risk factors for severe disease.
The State Food and Drug Administration also mentioned in the above-mentioned news that it requires the marketing authorization holder to continue to carry out relevant research work, complete the conditional requirements within a time limit, and submit follow-up research results in a timely manner.
According to the provisions of the Drug Administration Law, for the treatment of serious life-threatening diseases and drugs urgently needed in public health, clinical trials of drugs that have data showing efficacy and can predict their clinical value may be conditionally approved and the relevant matters shall be specified in the drug registration certificate. If a conditionally approved drug fails to complete the research in accordance with the requirements within the time limit or cannot prove that its benefits outweigh the risks, the drug supervision and administration department under the State Council shall handle it in accordance with law until the drug registration certificate is cancelled.
The main ingredient of Paxlovid developed by Pfizer is a 3CL protease inhibitor, which can block the activity of the new coronavirus master protease to inhibit the replication of the virus. Clinical data released by Pfizer in December 2021 showed that after 3 days of treatment, the proportion of hospitalizations to deaths due to COVID-19 in the Paxlovid dosing group decreased by 89% compared with the placebo group. In January 2022, Pfizer announced that research data showed paxlovid's maintenance effect on the Aumechjong strain.
(Screenshot/photo of the official website of the State Food and Drug Administration)
Neutralizing antibodies and small molecule drugs are the two main forms of NEWCC drugs. Li Ning, CEO of Junshi Biology, previously stressed to the Southern Weekend reporter the importance of dealing with future viral mutations in the research and development stage, at least from four aspects: choosing the appropriate development path, whether it is neutralizing antibody drugs or oral antiviral new drugs are based on the already clear mechanism of action; through screening to improve the anti-mutation ability of drugs, such as in the selection of antibodies, pay attention to site conservatism, affinity and other characteristics; consider combination therapy, so that a variety of drugs with different paths complement each other; accelerate the speed and efficiency of research and development.
According to Pfizer's official website, Paxlovid has been approved or authorized for emergency use in more than a dozen countries and regions. In December 2021, Paxlovid was approved for emergency use by the U.S. FDA for COVID-19 patients over the age of 12 who develop symptoms and are at higher risk of developing severe illness. On February 3, Singapore announced approval for Paxlovid listing.
Pfizer said on Feb. 8 that it expects Paxlovid's sales to reach $22 billion in 2022. According to Reuters, the company's president, Albert Bourla, said it was in talks with more than 100 countries to supply Paxlovid, with up to 120 million treatments available this year.
Southern Weekend reporter Haiyang