China's anti epidemic "weapon" adds another one.
On February 12, according to the State Food and drug administration, Pfizer's covid-19 oral drug paxlovid was conditionally approved by the State Food and Drug Administration for listing and can be used to treat adults with mild to moderate covid-19 pneumonia (covid-19) with severe high-risk factors.
According to data previously disclosed by the company, the drug can reduce the risk of hospitalization or death of non hospitalized high-risk adults with covid-19 by 89% compared with placebo.
This is China's first covid-19 oral drug, which enriches China's "weapons" of epidemic prevention. Hu Shanlian, a professor at the school of public health of Fudan University, told the daily economic news: "this is good news.".
Covid-19 oral drug related raw materials and intermediates enterprises may usher in a new era
Image Source: screenshot of the website of the State Food and Drug Administration
It can reduce the risk of severe illness or death by 89%
In February 12th, the State Administration of Drug Administration approved the import registration of Pfizer Inc COVID-19 virus therapeutic drug naermatway tablets / Ritonavir Tablets package (Paxlovid) for the treatment of mild to moderate COVID-19 pneumonia in adults with severe risk factors, such as advanced age, chronic kidney disease, diabetes, cardiovascular disease, and so on. Patients with severe high-risk factors such as chronic lung disease.
On December 22 last year, paxlovid's emergency use authorization application was approved by the FDA. Today, it takes only 50 days for China to approve the import registration, which Hu Shanlian believes is very fast.
The reporter noted that paxlovid obtained conditional approval for import registration this time, which means that 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 November 5, 2021, Pfizer published the interim analysis results of paxlovid's phase II / III study on its official website. Paxlovid reduced the risk of hospitalization or death by 89%, which means that it can prevent about nine of the ten hospitalizations caused by covid-19. This result is better than molnupiravir, an oral drug of mosadon covid-19, which has greatly boosted the covid-19 treatment market by reducing the risk of hospitalization or death (30%).
Hu Shanlian said in an interview with the reporter of the daily economic news that Pfizer's paxlovid is a covid-19 oral drug with good therapeutic effect. The conditional approval of its import registration by the State Food and drug administration is good news, and it will be one more means for China's epidemic prevention and control.
"From a global perspective, this year will be an important turning point in epidemic prevention and control. Paxlovid's treatment effect is relatively good, which may create a new situation of prevention and control. Maybe more antiviral drugs will appear in the future, which will also initiate the research and development of new drugs in our country. With the introduction of covid-19 oral drugs, there are more weapons for epidemic prevention and control." Hu Shanlian analysis.
It is expected to provide 120 million courses of treatment worldwide in 2022
On February 12, the reporter asked Pfizer insiders for information on drug purchase channels and pricing. He was told that there was no more information at present. All information was subject to the information published on the official website of the State Food and drug administration.
According to the reporter, since November 2021, Pfizer's paxlovid has been approved to be listed in the United States, the United Kingdom, Israel, South Korea, Canada, Singapore, Japan and other countries. According to the company's previous disclosure, it will continue to increase investment in the production and distribution of paxlovid, and is expected to provide 120 million courses of drugs by the end of 2022.
The contribution of covid-19 oral drug paxlovid to Pfizer's performance has also attracted investors' attention. From the company's recently released annual financial performance report for 2021, Pfizer's annual revenue in 2021 was US $81.3 billion, a year-on-year increase of 95%. Excluding the revenue contributed by covid-19 vaccine comirnaty and covid-19 oral drug paxlovid, the revenue is about US $44.4 billion, a year-on-year increase of 6%.
For the performance in 2022, Pfizer expects the annual revenue to be US $98 billion to US $102 billion, and raised the revenue forecast from covid-19 vaccine comirnaty to about US $32 billion. It is preliminarily estimated that the revenue of covid-19 oral drug paxlovid is about US $22 billion.
Southwest Securities Co.Ltd(600369) it is predicted that the global oral covid-19 drug market will be billions to tens of billions of dollars. Covid-19 oral medicine has become another super outlet, and Chinese manufacturers of raw materials and intermediates related to covid-19 oral medicine have also become the object of market attention.
The reporter noted that on the day before the State Food and Drug Administration announced the conditional approval of paxlovid import registration, Porton Pharma Solutions Ltd(300363) announced that it had recently received a new batch of purchase orders from Pfizer, and the company would provide contract customized R & D and production (cdmo) services. The total amount of newly obtained orders was 681 million US dollars (about 4.3 billion yuan), more than 50% of the company's audited operating revenue in the latest fiscal year. At present, the order is effective and the delivery date is 2022.
However, the announcement does not indicate that this order is related to axlovid.
