Pharmaceutical industry review report: recent covid-19 policy dynamic review

Key investment points:

Event: in March 11, 2022, the COVID-19 virus antigen detection application plan (Trial Implementation) was released. In March 15th, China issued the notice on the issuance of New Coronavirus pneumonia diagnosis and treatment plan (trial version ninth).

Omicron and its mutants spread widely in the short term. According to the epidemiological prevention and control requirements, it is necessary to quickly identify the source of infection in large-scale populations, conduct large-scale investigation and hierarchical control; Thus, it brings the demand of more simple, easy and easy to popularize detection technology. Antigen detection is approved in this context. At present, antigen detection is an effective supplement to the existing nucleic acid detection methods. Its advantage is fast and convenient, but its disadvantage is that it is not sensitive enough, and there may be missed diagnosis. Therefore, nucleic acid detection is still the gold standard for the diagnosis of covid-19 pneumonia.

From the perspective of detection mechanism, antigen detection and nucleic acid detection are different. Antigen detection is mainly aimed at the envelope of covid-19 virus, while nucleic acid detection is mainly aimed at the genetic material of the virus. In addition, the sensitivity and specificity of antigen detection and nucleic acid detection are also different. The sensitivity of the approved antigen detection reagents in China is 75% – 98%. The specificity is 95-99%. Sensitivity is the sensitivity of virus detection. When the virus is just infected, the content of virus is low. The sensitivity of nucleic acid detection is relatively high because it needs manual amplification, while antigen detection will be false negative because of its low sensitivity; Specificity refers to the probability that the test result is positive and covid-19 virus is indeed infected. Because there is false positive in antigen test, residents are not recommended to test at will.

At present, antigen detection is applicable to three groups of people. The first group is to see a doctor in grass-roots medical institutions, such as those who have clinical symptoms, fever and whose symptoms are determined to be within 5 days. If the nucleic acid test is negative, they can be tested at home for 5 consecutive days; The second category is isolation personnel, including those who are isolated and observed at home, those who are isolated and observed at entry, and those who are in close contact, secondary close contact and those who do not leave home in the risk control community when the epidemic situation occurs. This kind of people will be tested for antigen for 5 consecutive days, once a day. If there is a positive, it will be reported, and if there is a negative, there is no need for intervention until the last nucleic acid test when the isolation is lifted; The third group is the residents who want to do their own testing. If they are positive, they should do nucleic acid testing at the first time.

Before the sampling of antigen detection, it is necessary to clean the nose and saliva in a relatively clean environment to avoid environmental pollution. In addition, the mucosal surface and exfoliated cells need to be collected for sampling. Insufficient sampling depth or frequency may affect the accuracy of the results.

From the comparison of covid-19 pneumonia diagnosis and treatment schemes in the ninth edition and the eighth edition, the main differences are as follows: first, add antigen detection as a supplement; Second, light cases (including asymptomatic infections) do not need to be treated in isolation in designated hospitals, but only need centralized isolation management. If the condition is aggravated, they need to be transferred to designated hospitals for treatment; Third, Pfizer’s paxlovid was added as covid-19 oral drug, and the neutralizing antibody ambacizumab / romistimab injection of tengshengbo drug was added, while ribavirin and chloroquine phosphate were removed; Fourth, during the observation period, the recommendation of Chinese patent medicines was increased for light and ordinary patients, and the varieties of Chinese patent medicines for heavy patients were enriched at the same time. Acupuncture and moxibustion treatment and traditional Chinese medicine treatment for children have been added; Fifth, the contact isolation and discharge criteria were modified, and the CT values of N gene and ORF gene were greater than or equal to 35 for two consecutive nucleic acid tests, which was greater than or equal to 40 before; Sixth: release the isolation management or continue the 7-day home health monitoring after discharge (previously, continue the 14-day isolation management and health status testing after discharge).

The modification of the diagnosis and treatment plan is also determined based on the new characteristics of Omicron and its variants. Under the normal prevention and control of the epidemic, it is optimized in order to reasonably allocate medical resources and avoid a run on medical resources.

The recent policy is a dynamic adjustment made by the state according to the development of the epidemic situation. Considering China’s basic national conditions, China’s “dynamic clearing” epidemic prevention policy has not been shaken. It is suggested to focus on the R & D Progress of covid-19 oral drug related companies and the sales dynamics of covid-19 antigen enterprises. At the same time, focus on covid-19 oral drug raw materials and service related enterprises, such as Ningbo Menovo Pharmaceutical Co.Ltd(603538) ( Ningbo Menovo Pharmaceutical Co.Ltd(603538) ), Nanjing Hicin Pharmaceutical Co.Ltd(300584) ( Nanjing Hicin Pharmaceutical Co.Ltd(300584) ), Zhejiang Nhu Company Ltd(002001) ( Zhejiang Nhu Company Ltd(002001) ), Porton Pharma Solutions Ltd(300363) ( Porton Pharma Solutions Ltd(300363) ), Asymchem Laboratories (Tianjin) Co.Ltd(002821) ( Asymchem Laboratories (Tianjin) Co.Ltd(002821) ), etc.

Risk tip: the epidemic development exceeded expectations

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