What is the follow-up of domestic new crown drugs? Answers to the new guidelines for new crown drugs

Recently, the Center for Drug Evaluation of the Food and Drug Administration issued the “Questions and Answers on the Non-clinical and Clinical Evaluation Criteria for New Antiviral Drugs Infected by New Epidemic Strain of Novel Coronavirus”, from which it can be seen that the regulatory agency’s response to the research and development of new coronavirus drugs guidelines.

I. Requirements for non-clinical pharmacodynamics research of new drugs based on circulating virus strains?

Answer:For COVID-19 treatment and preventive medicine, The in vitro antiviral activity test of the current circulating strain of the true virus, combined with the PK data, comprehensively evaluate whether its non-clinical data supports entering the clinical trial; if necessary, conduct the in vivo infection model pharmacodynamics study of the current circulating strain.

Interpretation:It is well known that clinical medicine needs to go through Long preclinical and clinical phase I-III trials, and the new crown virus has a large number of infected people, strong infectivity, and a very fast mutation rate. So far, the new crown virus has mutated from the original strain to delta, and from delta to Austrian. Mikron, and Omikron has changed from BA.1 to BA.4/5, and the mutation speed is very fast.

With the current medical and pharmaceutical knowledge that humans have, there is no ability to effectively deal with the mutation of the new crown, and the speed of drug development is far less than the speed of virus mutation. This regulation means that the difficulty of research and development has been greatly increased, and preclinical research must be carried out on the current popular strains.

Second, the clinical value of nasal and pharyngeal sprays and the requirements for non-clinical pharmacodynamics research?

Answer:There are currently nasal and pharyngeal sprays for Drug application The drug application is intended to be used for the treatment or prevention of new coronary pneumonia. For such cases, combined with expert opinions, it is believed that the research and development of this route of administration for antiviral treatment and prevention should be cautious. There may be some clinical value for preventive indications.

For such species, in addition to in vitro pharmacodynamics tests, animal pharmacodynamics studies should be used to investigate the preventive effectiveness under the proposed route of administration.

Interpretation: Emphasizes the need for caution in the development of treatment or prevention of nasopharyngeal sprays. It shows that there will be higher requirements for the new dosage form of the new crown drug for treatment or prevention, and both safety and efficacy need to be better in order to reduce the risk brought by the new dosage form of drugs.

Traditional mature oral or injectable drugs cannot be solved yet. This immature new dosage form has higher risks and must be approved with sufficient certainty.

3. Considerations for clinical trials for asymptomatic infections?

Answer:Currently it is believed that asymptomatic infections are administered with drugs The therapeutic significance of the intervention is limited. If the applicant plans to conduct clinical research and development for this population, it should be considered comprehensively in conjunction with the opinions of the national disease control department.

Interpretation: The indications for the treatment of asymptomatic infections are completely discouraged. There are too many clinical manifestations, and it is only after the event that they know whether they are asymptomatic infected through nucleic acid testing, and the therapeutic value is indeed very limited.

However, if it is a preventive drug, there may still be a chance, such as reducing the transmission effect of asymptomatic infection, but even if this kind of research is developed, it is better than after being diagnosed as asymptomatic. It is still unclear whether comprehensive isolation is better or worse. If it can replace isolation, it is very valuable, but if not, the value is limited.

4. Consideration of the primary efficacy endpoint of the study for mild/normal patients?

Answer:For COVID-19 treatment drugs for light/general Confirmatory clinical trials in subjects with type 2 type

, both domestic and foreign guidelines mainly recommend clinical outcomes as the primary efficacy endpoints. However, with the emergence of the Omicron variant, its pathogenicity has weakened, and the proportion of severe/critical or death is low, and it is difficult to observe the improvement of clinical outcomes. Therefore, the selection of clinical efficacy indicators can be considered. Improvement (time to sustained clinical recovery as assessed at an appropriate time) served as the primary efficacy endpoint, with virology as the key secondary efficacy endpoint.

Interpretation:This is a compromise to the weakened pathogenicity but still strong infectivity after the virus mutates, just as OS in the field of oncology is the gold standard, and the gold standard for the new coronavirus should also be to reduce the ratio of severe/critical illness or death.

However, human beings currently have limited science. In the game between effectiveness and clinical value, mutual compromise is a regulatory strategy. It can meet the urgent unmet clinical needs, in other words, it tells the companies that develop new crown drugs to change the clinical trial plan.

5. Considerations for drug development with backward immune technology?

Answer:There are some outdated immunization techniques For example, yellow antibodies are still being declared, and they are not encouraged to continue their research and development.

Interpretation:It is more clear than the answer for drug development for asymptomatic infections, asymptomatic is “Limited significance” and “comprehensive consideration”, while yellow antibodies are “discouraged”. This type of drug development can basically be said to be wiped out.

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