For the first time foreign medicine for coronavirus Paxlovid approved in China
February 11, the State Food and Drug Administration announced that, in
accordance with the relevant provisions of the "Drug Management Law", in
accordance with special drug approval procedures, emergency review and approval,
Pfizer's new oral drug has become the first foreign drug from COVID-19 approved
in China. But as more and more second-generation antivirals on the global market
enter clinical trials, patients will also have more options in the future.
On Saturday, China's National Medical Products Administration said it had granted conditional marketing authorization for Pfizer's new oral coronavirus drug Paxlovid less than two months after the drug was approved in the US.
Paxlovid is approved for the treatment of adults with mild to moderate Covid-19 who are at high risk of developing severe disease, although the NMPA said further research and data reporting on the drug is needed.
Pfizer executives said the company is in active discussions with more than 100 countries to buy Paxlovid. Last week, Pfizer released a financial report that said the company has the ability to deliver 120 million courses of new oral drugs this year and predicts sales of new oral drugs will grow to $22 billion in 2022, with revenues expected to from the new corona vaccines will decrease.
The new oral drug belongs to small molecule drugs, therefore, due to the different mechanisms of action, the mutation of the virus has little effect on the effectiveness of oral drugs. The main mechanism of antiviral drugs is to reduce the ability of the virus to replicate by blocking or mutagenesis. For example, Pfizer's new coronavirus antiviral blocks the 3CL protease required for the new coronavirus to replicate, while Merck's antiviral directly kills the new coronavirus gene.
In December, Pfizer said final clinical trial results showed that Covid-19 patients who received Paxlovid within three to five days of symptom onset had an almost 90% lower risk of hospitalization or death.
As for the approval of Pfizer's oral medicines in China, Meng Lilian, chief expert at the Sichuan Tianfu Health Industry Research Institute, believes it could be more symbolic. On the one hand, the number of people infected with the new corona in China is small, and the combination therapy of traditional Chinese and Western medicine has proven to be reliable and effective, and the market demand for Pfizer oral medicines may be limited. On the other hand, the approval of Pfizer's new oral drug for sale in China shows that China attaches great importance to international cooperation to fight the epidemic. The approval of Pfizer's new oral drug can not only enrich China's anti-epidemic measures, but also show China's open attitude and be the first step to the recognition of foreign vaccines
Создано: 13 февраля 2022