Our reporter Zhang Min
On February 12, the State Food and Drug Administration issued an announcement stating that in accordance with the relevant provisions of the "Drug Administration Law", in accordance with the special drug approval procedures, emergency review and approval, and conditional approval of Pfizer's (hereinafter referred to as Pfizer) new coronavirus treatment drug Naima Tevir tablet/ritonavir tablet combination package (ie Paxlovid) is registered for import.
Regarding Paxlovid's future pricing and production and supply capabilities in China, a reporter from Securities Daily asked Pfizer, but relevant sources said that there is no further information yet.
It is worth mentioning that the new crown oral drug is the current market hotspot, and the approval of Pfizer's new crown oral drug has triggered the "early daily limit" of A-share related concept stocks.
In addition, there are domestic companies that have received large orders from Pfizer.
Pfizer's new crown oral drug approved
According to the information released by the State Food and Drug Administration, Paxlovid is an oral small-molecule novel coronavirus treatment drug for the treatment of adults with mild to moderate novel coronavirus pneumonia (COVID-19) patients with high risk factors for progression to severe disease, such as those with Patients with severe risk factors such as advanced age, chronic kidney disease, diabetes, cardiovascular disease, and chronic lung disease.
Patients should strictly follow the instructions for medication under the guidance of physicians, and should pay close attention to the interaction information with other drugs listed in the instructions during use.
The State Food and Drug Administration requires the marketing authorization 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 a timely manner.
At the moment when the global new crown epidemic is spreading, Pfizer has launched two blockbuster products including a new crown vaccine and a new crown oral drug.
On February 10, Pfizer’s official Weibo announced the 2021 transcript.
In 2021, the company will achieve operating income of 81.3 billion US dollars, a year-on-year increase of 92%.
Revenue excluding the new crown vaccine Comirnaty and the new crown oral drug Paxlovid was $44.4 billion, an increase of 6% year-on-year.
In addition, Pfizer provided record revenue guidance for full-year 2022, which is expected to be $98 billion to $102 billion.
Raise Comirnaty's revenue forecast to about $32 billion in 2022.
Paxlovid's 2022 revenue is expected to be about $22 billion.
Related concept stocks have reached the daily limit
New crown oral drug concept stocks have become a hot spot.
The research report released by Sinolink Securities believes that with the progress of oral new crown drugs (original research + imitation), the upstream CDMO of the pharmaceutical industry and its upstream fine chemical supply chain related products are expected to increase in volume.
The reporter noticed that on the investor interaction platform, investors have asked listed companies whether they have received orders related to new crown oral drugs.
On the evening of February 11, Proton announced that recently, the company has received a new batch of "Purchase Orders" from PfizerIreland Pharmaceuticals, a subsidiary of the multinational pharmaceutical company Pfizer Inc. (hereinafter referred to as "Pfizer"). CDMO) service.
As of the disclosure date of this announcement, the total amount of newly obtained orders was US$681 million, exceeding 50% of the company's audited operating income in the most recent fiscal year.
It is worth mentioning that the new crown concept stocks Essence Pharmaceuticals and Yaben Chemical once soared.
Since December 21, 2021, Essence Pharmaceuticals once rose from 6 yuan per share to 22.45 yuan per share on January 21, 2022, an increase of more than 200%.
Essence Pharma previously stated in the stock price change announcement that the company's holding subsidiary Senxuan Pharmaceutical has not signed a purchase and sale contract with Pfizer for ritonavir pharmaceutical intermediates; the ritonavir series of intermediates that Senxuan Pharmaceutical has sold are mainly Applied in the synthesis of anti-AIDS drug ritonavir.
Since December 20, 2021, Yaben Chemical has risen from 7.34 yuan per share to the highest price of 27.32 yuan per share on January 14, 2022, with a cumulative increase of over 270%.
Because of the continuous abnormal fluctuation of the stock price, Yaben Chemical received a letter of concern from the exchange.
However, Essence Pharma and Yaben Chemical have continued to adjust in recent days.
As of February 11, the closing price of Essence Pharmaceuticals was 11.33 yuan per share, and the closing price of Yaben Chemical was 15.3 yuan per share.
Domestic Oral Drugs Accelerate R&D
Pfizer's Paxlovid drug molecule, Nirmatrelvir, targets the 3CL protease.
At present, many new coronavirus drug candidates deployed by many domestic pharmaceutical companies are also targeting 3CL protease.
With the emergency approval of Pfizer's Paxlovid in China, the progress of domestic oral drugs under development for the new crown has attracted the attention of the market.
On January 25, 2022, the Global Health Drug Research and Development Center (GHDDI) announced that GDI-4405, a preclinical candidate specific drug molecule targeting the novel coronavirus 3CL protease, has accelerated the application of multiple clinical trials and drug production. Enter the clinic in the second half of the year.
"3CL protease, as the main protease of the new coronavirus, is necessary for the replication and growth of the virus, so it is also an excellent target for antiviral drugs." A relevant person from the Global Health Drug Research and Development Center told reporters.
On January 17, it was reported that VV116, the only small molecule drug for the treatment of COVID-19 that has been approved for clinical trials in China, is expected to submit a New Drug Listing (NDA) application in the second half of 2022 after passing the clinical trial within the year.
VV116 was jointly developed by Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Wangshan Wangshui, etc.
In October 2021, Junshi Bio announced a partnership with Wangshan Wangshui to jointly undertake the global clinical development and industrialization of the drug.
On February 12, Junshi Bio's CEO Li Ning and Board Secretary Chen Yingge held a conference call. Relevant persons said, "The approval of Pfizer's Paxlovid is good news, and the country has taken oral drugs into consideration. We believe that oral drugs are One of the weapons to end the epidemic shows that the country's attitude is also very positive, and it is really needed."
In addition, Junshi Bio introduced that VV116 has completed three domestic phase I clinical trials, and is undergoing international multi-center phase II/III clinical trials.
There is a mild-to-moderate population similar to Pfizer's clinic, and the enrollment is completed in 2-3 months. There is already a considerable patient reserve in many countries around the world, and the enrollment rate will be faster.
There are relatively few patients in China, and as many as possible are admitted.
We have communicated with CDE (National Center for Drug Evaluation) that the results based on overseas data can support domestic declaration.
The research focus will be overseas, and other countries are fighting for it.
The U.S. IND is also actively communicating and will report in the near future.
"The global new crown epidemic continues to develop, and there is an urgent need for more effective and convenient oral anti-new crown drugs to meet the global drug availability. So far, 3CL protease is still effective against the current mutant strains. In addition, there may be new drugs in the future. Drug-resistant mutant strains appeared." An industry insider who did not want to be named told this reporter.