Recent policy
In December 2021, CDE intensively issued a number of policies aimed at further improving the standardization of supervision, which is conducive to the long-term, high-quality and healthy development of China Meheco Group Co.Ltd(600056) industry. Among them, the introduction of two policies, the technical guiding principles for clinical pharmacology research of innovative drugs and the start-up procedure for drug registration verification and inspection (for Trial Implementation), has laid a solid foundation for further standardizing the clinical pharmacology research and drug registration of innovative drugs in China, which is conducive to the healthy development of the industry and improve the R & D efficiency of enterprises.
make a concise evaluation
This month, the new pharmaceutical policy was intensively introduced, and the degree of regulatory standardization was improved, which was conducive to the healthy development of the industry. Since December, the guiding principles issued by CDE have covered many fields, such as gene therapy, cell therapy, intravenous anesthesia, covid-19 chemical drugs, covid-19 neutralizing antibodies, weight control and other drug types. Specific guiding principles have been issued for its non clinical and clinical research, For example, the technical guidelines for non clinical research and evaluation of gene therapy products (Trial) and the technical guidelines for clinical evaluation of intravenous anesthetics have been continuously refined and further standardized, which is conducive to the high-quality and healthy development of the China Meheco Group Co.Ltd(600056) industry.
The work procedure for the start-up of drug registration verification and inspection was promulgated, and the transparency and clarity of the process were further improved. The working procedure specifies the principles, procedures, time limit and requirements for the start-up of drug registration verification and registration inspection, and the relevant processes are further clarified. Compared with the 2007 version of the measures for the administration of drug registration, the “must check every review” has been changed to “start verification based on risk”, and the on-site verification of registration of different drug registration applications is started according to the corresponding proportion according to the risk level, so as to further improve the pertinence and efficiency of registration verification. The verification will be based on risk considerations and compliance factors of R & D and production entities, and further divided into three risk levels: high, medium and low. It is worth mentioning that chemicals, traditional Chinese medicine preparations and biological products are included in high-risk situations. 100% of high-risk will be checked, and 10% and 2% of medium and low-risk will be checked respectively. In addition, the workflow of drug registration review and approval has changed from “inspection, review and verification in series” to “inspection, review and verification in parallel”. The time limit of conventional variety review is expected to be completed within 200 days, the verification time has been shortened and the efficiency has been further improved. We believe that the introduction of the starting working procedure for drug registration verification and inspection (Trial) is conducive to further standardizing the starting working procedure for drug registration verification and inspection, improving the efficiency, clarity and transparency of the verification workflow, and conducive to the research and development of high-quality innovative drugs in China.
The importance of clinical pharmacology research is highlighted, and the guiding principles are conducive to improving R & D efficiency. Clinical pharmacology research is an important research content before the launch of innovative drugs, This guiding principle puts forward suggestions on the research content, research opportunity, overall design and other key issues of clinical pharmacology research in the R & D process of innovative drugs (chemical drugs and biological drugs), such as single dose escalation (SAD) and multiple dose escalation The research content of mad should include safety tolerance evaluation and PK evaluation, etc. we believe that scientific and reasonable clinical pharmacology research is helpful to deeply understand the action process and mechanism of drugs in vivo. This technical guiding principles for clinical pharmacology research of innovative drugs The introduction of is conducive to further standardize the research of innovative drugs, improve the R & D efficiency and success rate, and benefit China’s top innovative pharmaceutical enterprises and high-quality CXO leaders.
Investment advice
Continue to be optimistic about China Meheco Group Co.Ltd(600056) innovation and innovation Shenzhen New Industries Biomedical Engineering Co.Ltd(300832) chain.
It is suggested to focus on: Asymchem Laboratories (Tianjin) Co.Ltd(002821) , Wuxi Apptec Co.Ltd(603259) , Joinn Laboratories (China) Co.Ltd(603127) , Kingsley biotechnology, Jiangsu Hengrui Medicine Co.Ltd(600276) .
Risk statement
The risk of new drug R & D failure, the risk of investment and financing lower than expected, the risk of intensified competition in China and overseas markets, the risk of medical insurance negotiation lower than expected, the risk of industrial regulatory policies, etc.
