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On December 29, CDE also released three guiding principles related to the research and development of innovative drugs, namely, the technical guiding principles for the study of pharmacokinetics of single and multiple dose escalation of chemical innovative drugs, the technical guiding principles for the extended cohort study of the first human trial of antitumor drugs (Trial), and the guiding principles for the design of clinical trials of new drugs for advanced colorectal cancer, It has laid a solid foundation for further standardizing the R & D of innovative drugs, is conducive to the healthy development of the industry and improves the R & D efficiency of enterprises.
make a concise evaluation
The importance of pharmacokinetic research has been highlighted, and the research and development standardization of chemical innovative drugs has been further improved. Pharmacokinetic (PK) study aims to clarify the dynamic changes and laws of drug absorption, distribution, metabolism and excretion in vivo. Among them, the pharmacokinetic study of increasing clinical single and multiple doses is an important content of early clinical research of innovative drugs, which provides an important basis for supporting the exploration of clinical safe and effective doses and determining the administration scheme. The guidelines issued this time give specific suggestions on the PK research of single and multiple dose increments of chemical innovative drugs, such as the test population, sample size, dose selection, sampling design, test substances, etc., which is conducive to further standardizing the research and development of China National Chemical Engineering Co.Ltd(601117) innovative drugs and improving the research and development efficiency.
The rise of FIH extended cohort research needs to pay attention to its risks and challenges. In recent years, in the research and development of new antitumor drugs, sometimes the extended cohort study, namely “FIH extended cohort study”, is integrated after (or in) the traditional first human trial, so as to make early exploration on different aspects of drugs, such as antitumor activity, safety, PK and patient population, so as to speed up the progress of new drug research and development. However, it has the characteristics of rapid recruitment and changing information, which will expose more subjects to higher risk. The guidelines issued this time provide specific guidelines on the risks, challenges and risk management in the design and implementation of such studies, such as trial risk control, statistical considerations, research scheme and regulatory considerations, which are conducive to improving the standardization of FIH extended cohort research, reducing risks and protecting subjects.
Colorectal cancer is a hot spot in the research and development of antitumor drugs, and its clinical design and endpoint should be paid attention to. Colorectal cancer (CRC) is a hot spot in the research and development of new antitumor drugs. In the research and development of new drugs for advanced CRC, overall survival (OS) has always been the most commonly used primary endpoint. However, with the progress of new drug research and development, the survival time of patients with advanced colorectal cancer continues to prolong, which brings challenges to clinical trial design and endpoint selection. The guiding principles issued this time provide specific guidelines for the clinical R & D path and clinical trial design of colorectal cancer, such as biomarkers, population selection, clinical research design, combined drug design, endpoint study and key registration trial design in colorectal cancer, which is conducive to improve the R & D efficiency and benefit patients as soon as possible.
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 and given specific guiding principles for its clinical and non clinical research. Overall, the continuous refinement of supervision and further improvement of standardization are conducive to improving the R & D efficiency of innovative drugs and helping the high-quality and healthy development of China Meheco Group Co.Ltd(600056) industry.
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.
