Matters:
The food and Drug Administration issued an announcement to conduct emergency review and approval in accordance with the special drug approval procedures, and conditionally approve the import registration of the combined packaging (paxlovid) of nevitavir tablets / ritonavir tablets, a covid-19 virus treatment drug of Pfizer.
Ping An View:
Paxlovid is the most effective covid-19 small molecule oral drug at present: so far, two covid-19 small molecule drugs have been approved to market in the world, molnupiravir and Pfizer paxlovid, priced at US $700 and US $529 / course of treatment respectively. Among them, paxlovid is a compound preparation of 3CL protease inhibitor nirmatrelvir and ritonavir. Previous clinical data showed that among high-risk patients treated with paxlovid within 3 days of symptom onset, the risk of hospitalization or death from any cause was reduced by 89% compared with placebo, Molnupiravir, another small molecule oral drug, can only reduce the risk of hospitalization and death in high-risk patients by 30%.
Covid-19 drugs under development are expected to further improve the accessibility: at present, there are still many covid-19 small molecular drugs in the research stage in the world, among which s-217622 of yanyeyi (global phase III), Shanghai Junshi Biosciences Co.Ltd(688180) vv116 (global phase II / III) and azvudine of real organisms (global phase III) are relatively fast. We believe that paxlovid's approval has a limited impact on the drugs under research, mainly because its bottleneck lies in Pfizer's production capacity, which is currently about 120 million people / year, and it is temporarily unable to supply a large amount of drugs. Therefore, if the drugs under research can pass the approval, it will further solve the accessibility problem of covid-19 drugs, and there is still a large market space after listing, It is suggested to pay attention to relevant R & D enterprises in China.
Vaccine + oral medicine is the best means of prevention and control, which is beneficial to the relevant industrial chain: covid-19 small molecule drug is the last key point of epidemic prevention and control, so that the diagnosed patients can take drugs at home, greatly reduce the severe rate, and help to solve the problem of medical run. According to the data, paxlovid and mRNA vaccine are the most effective treatment and epidemic prevention methods at present. Therefore, with the continuous promotion of mRNA vaccine research and development in China, the combination of effective vaccine and oral drugs makes it possible for China to enter the strategic stage of actively attacking covid-19 this year and usher in the opportunity to gradually open the door of the country. In addition, with the large-scale production and R & D promotion of paxlovid and mRNA vaccines, it has a large demand for upstream raw materials. As the world's largest producer of APIs, China has a mature industrial chain and undertakes the supply of important raw materials. The business volume of relevant CMO industrial chain enterprises is expected to grow rapidly, which is good for their performance.
Investment suggestion: as paxlovid is expensive and the cost of covid-19 treatment is mainly borne by the state, we think it may take time to fully open the door to the country. However, the approval of paxlovid reflects China's determination to end the epidemic as soon as possible. It is suggested to pay attention to relevant Chinese R & D enterprises, including Shanghai Junshi Biosciences Co.Ltd(688180) , Frontier Biotechnologies Inc(688221) , Xiansheng pharmaceutical, Guangdong Zhongsheng Pharmaceutical Co.Ltd(002317) . In addition, as the best combination of mRNA + oral drugs to combat the epidemic, relevant CMO industrial chains with the ability are expected to benefit from the increased demand of the global regulatory market and MPP market, including Asymchem Laboratories (Tianjin) Co.Ltd(002821) , Porton Pharma Solutions Ltd(300363) , Wuxi Apptec Co.Ltd(603259) , Great Chinasoft Technology Co.Ltd(002453) , Chengdu Easton Bio Pharmaceuticals Co.Ltd(688513) , Xinxiang Tuoxin Pharmaceutical Co.Ltd(301089) , Shandong Jincheng Pharmaceutical Group Co.Ltd(300233) , Nanjing Hicin Pharmaceutical Co.Ltd(300584) and geley pharmaceutical.
Risk warning: risk of R & D failure; Covid-19 virus mutation risk; The risk of being approved is less than expected.
