On
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