On February 12, the State Food and Drug Administration announced that in accordance with the relevant provisions of the drug administration law and in accordance with the special drug approval procedures, the emergency review and approval were carried out, and the import registration of the combined packaging of nevitavir tablets / ritonavir tablets (i.e. paxlovid) for covid-19 virus treatment drug of Pfizer (hereinafter the same as Pfizer) was approved conditionally.
For paxlovid's future pricing and production and supply capacity in China, the reporter of Securities Daily asked Pfizer, but relevant people said that there was no further information at present.
It is worth mentioning that covid-19 oral drug is a hot spot in the current market. The listing of covid-19 oral drug of Pfizer has triggered the "daily limit" of A-share related concept stocks in advance. In addition, some Chinese enterprises said they had received "big orders" from Pfizer.
Pfizer covid-19 oral drug approved
According to the information issued by the State Administration of drug control, Paxlovid is a small molecule COVID-19 virus for the treatment of mild to moderate New Coronavirus pneumonia (COVID-19) in adults with severe risk factors, such as elderly, chronic kidney disease, diabetes, cardiovascular disease, and chronic lung disease. Patients should use drugs in strict accordance with the instructions under the guidance of doctors, and pay close attention to the interaction information with other drugs listed in the instructions.
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.
With the global covid-19 epidemic spreading, Pfizer launched two heavy products, including covid-19 vaccine and covid-19 oral drugs. Among them, in December 2021, the US Food and Drug Administration (FDA) urgently approved Pfizer's oral covid-19 drug paxlovid for high-risk groups over the age of 12, which is the first approved oral covid-19 drug in the United States.
On February 10, Pfizer official micro released its 2021 report card. In 2021, the company realized an operating revenue of 81.3 billion US dollars, with a year-on-year increase of 92%. Revenue excluding covid-19 vaccine comirnaty and covid-19 oral drug paxlovid was US $44.4 billion, a year-on-year increase of 6%. In addition, Pfizer provides record revenue guidance for the whole year of 2022, which is expected to be $98 billion to $102 billion. Comirnaty's revenue is expected to reach approximately $32 billion in 2022. Paxlovid's revenue in 2022 is expected to be about $22 billion.
related concept stocks have risen by the limit
Covid-19 oral drug concept stock has become a hot spot. According to the research report released by Sinolink Securities Co.Ltd(600109) , with the progress of oral covid-19 drugs (original research + imitation), we are optimistic about the large-scale expectation of cdmo and related products in the upstream fine chemical supply chain of the pharmaceutical industry.
The reporter noted that on the investor interaction platform, investors have asked whether listed companies have received orders related to covid-19 oral drugs.
On February 11, Porton Pharma Solutions Ltd(300363) announced that recently, the company received from multinational pharmaceutical company Pfizer Inc. (hereinafter referred to as "Pfizer") will provide contract customized R & D and production (cdmo) services for the new batch of purchase orders of Pfizer Ireland pharmaceuticals. As of the disclosure date of this announcement, the total amount of newly obtained orders was 681 million US dollars, exceeding 50% of the audited operating revenue of the company in the latest fiscal year.
It is worth mentioning that covid-19 concept stocks Jinghua Pharmaceutical Group Co.Ltd(002349) , Aba Chemicals Corporation(300261) once soared.
Since December 21, 2021, Jinghua Pharmaceutical Group Co.Ltd(002349) once rose from 6 yuan / share to 22.45 yuan / share on January 21, 2022, an increase of more than 200%. Jinghua Pharmaceutical Group Co.Ltd(002349) previously, in the announcement of stock price changes, the company's holding subsidiary Jiangsu senxuan Pharmaceutical Co., Ltd. (hereinafter referred to as "senxuan pharmaceutical") produced and sold ritonavir series pharmaceutical intermediates, and has not yet carried out the production and sales of ritonavir API; At present, senxuan pharmaceutical has not signed the purchase and sales contract related to ritonavir pharmaceutical intermediates with Pfizer; The intermediate of ritonavir, which has been sold by Sen Xuan medicine, is mainly used in the synthesis of the anti HIV drug ritonavir.
Since December 20, 2021, Aba Chemicals Corporation(300261) has risen from 7.34 yuan / share to the highest price of 27.32 yuan / share on January 14, 2022, with a cumulative increase of more than 270%. Because the stock price fluctuated abnormally continuously, Aba Chemicals Corporation(300261) received the attention letter from the exchange. Aba Chemicals Corporation(300261) said that the company has no business contact and cooperation with Pfizer, has not signed a cooperation agreement with Pfizer, has not supplied carlon anhydride products to Pfizer, and Pfizer has not provided the company with any quality standards for the purchase of covid-19 oral front-end raw materials.
However, Jinghua Pharmaceutical Group Co.Ltd(002349) , Aba Chemicals Corporation(300261) have continued to adjust in recent days. As of February 11, the closing price of Jinghua Pharmaceutical Group Co.Ltd(002349) was 11.33 yuan / share, and the closing price of Aba Chemicals Corporation(300261) was 15.3 yuan / share.
accelerated research and development of oral drugs in China
The target of nirmatrelvir, a specific drug molecule of Pfizer paxlovid, is 3CL protease. At present, many covid-19 virus candidate drugs distributed by many pharmaceutical enterprises in China also target 3CL protease.
With the urgent approval of Pfizer paxlovid in China, the development of covid-19 oral drugs under research in China has attracted the attention of the market.
In January 25, 2022, the global health drug research and Development Center (GHDDI) announced that the pre clinical candidate specific drug GDI-4405, targeting New Coronavirus 3CL protease, has accelerated the clinical trials and drug production, and is expected to enter clinical practice in the second half of 2022.
"As the main protease of covid-19 virus, 3CL protease is necessary for virus replication and growth, so it is also an excellent target of antiviral drugs." Relevant people from the global health drug R & D center told reporters.
On January 17, it was reported that vv116, the only covid-19 small molecule drug approved for clinical trial in China, is expected to submit an application for new drug listing (NDA) in the second half of 2022 after passing the clinical trial within this year. Vv116 was jointly developed by Shanghai Institute of pharmacy, Chinese Academy of Sciences and Wangshan wangshui. In October 2021, Shanghai Junshi Biosciences Co.Ltd(688180) announced a cooperation with Wangshan wangshui to jointly undertake the global clinical development and industrialization of the drug.
On February 12, Shanghai Junshi Biosciences Co.Ltd(688180) CEO Li Ning and board secretary Chen Yingge held a teleconference. Relevant people said, "the approval of Pfizer paxlovid is good news, and the State takes oral drugs into account. We believe that oral drugs are one of the weapons to end the epidemic, indicating that the national attitude is also very positive and is really needed."
In addition, Shanghai Junshi Biosciences Co.Ltd(688180) introduced that three phase I clinical trials of vv116 in China have been completed and international multicenter phase II / III clinical trials are under way. There are mild to moderate people similar to Pfizer's clinic, and the enrollment will be completed in 2-3 months. There is a considerable patient reserve in many countries in the world, and the enrollment speed will be relatively fast. There are relatively few patients in China. Try to enter as many as possible. Through communication with CDE (National Drug Evaluation Center), the results based on overseas data can support China's declaration. The research focus will be overseas, and other countries are also striving for it. Ind of the United States is also actively communicating and will declare in a relatively short time.
\u3000\u3000 "The number of people infected with covid-19 epidemic in the world is still increasing. There is an urgent need for more effective and convenient oral anti-covid-19 drugs to meet the global drug accessibility. The commercial value of drugs depends on whether the epidemic will evolve further. First, so far, 3CL protease needle is still effective for the current mutant strains. Second, there may be changes in drug resistance in the future The xenovirus appeared. " An insider who declined to be named told our reporter
