Event: on February 12, 2022, the State Food and Drug Administration conducted emergency review and approval in accordance with the relevant provisions of the drug administration law and the special drug approval procedures, and conditionally approved the import registration of the combined packaging of nevitavir tablets / ritonavir tablets (i.e. paxlovid) of Pfizer covid-19 virus treatment drug.
With the approval of Pfizer specific drugs, the normalization of the epidemic situation in China will become a trend. Paxlovid's emergency approval in China shows the feasibility of national recognition of oral small molecule drugs for covid-19, and provides a drug treatment solution for covid-19 epidemic in China. Paxlovid's clinical data show that its efficacy is superior. Starting paxlovid treatment within 5 days after the onset of symptoms (twice a day for 5 consecutive days) can reduce the risk of hospitalization or death by 89%. We believe that the approval of paxlovid marks the normalization of the epidemic in China, and "vaccine + specific drug" is expected to finally defeat covid-19.
In the long run, China's prevention and control policies are expected to be relaxed. At present, overseas countries have maintained an open attitude towards the epidemic. Considering that the main active component of paxlovid has the same antiviral effect on mutant strains in vitro and has curative effect on Omicron and other mutant strains, paxlovid can be taken orally as a small molecule drug, and the treatment method is convenient and controllable. We believe that China's prevention and control policy is expected to be gradually relaxed under the premise of order, and opening the door to the country will be the trend in the long run.
The localization of specific drugs is worth looking forward to, and the changes of related industries are worth paying attention to. On the one hand, covid-19 specific drugs have huge market prospects in China. Paxlovid has been approved or authorized for emergency use in more than 10 countries around the world, and the production capacity can not meet all the markets. Moreover, covid-19 drugs are of strategic importance. It is worth looking forward to the localization of covid-19 specific drugs, and the small molecule pipeline under research is expected to accelerate its listing through emergency approval; Chinese enterprises with R & D capability and API integration will benefit. The approval of oral covid-19 specific drugs is expected to accelerate the R & D of small molecule specific drugs in China. On the other hand, Pfizer's paxlovid needs a large number of APIs such as carbonic anhydride, which is good for Chinese api companies, such as Aba Chemicals Corporation(300261) , Jinghua Pharmaceutical Group Co.Ltd(002349) . Some Chinese cdmo enterprises have obtained relevant production orders, such as Porton Pharma Solutions Ltd(300363) , Asymchem Laboratories (Tianjin) Co.Ltd(002821) . It is expected that with the further expansion of production capacity, relevant cdmo enterprises are still expected to benefit.
Investment proposal and investment object
It is suggested to pay attention to: Shanghai Junshi Biosciences Co.Ltd(688180) - U (688180, not rated), Aba Chemicals Corporation(300261) (300261, not rated), Jinghua Pharmaceutical Group Co.Ltd(002349) (002349, not rated), Asymchem Laboratories (Tianjin) Co.Ltd(002821) (002821, not rated), Porton Pharma Solutions Ltd(300363) (300363, not rated), Brightgene Bio-Medical Technology Co.Ltd(688166) (688166, not rated), Apeloa Pharmaceutical Co.Ltd(000739) (000739, not rated), etc.
Risk tips
Risk of new drug production capacity less than expected
Risk of mutations in covid-19 virus resistant strains