Under the froth of the "Innovative Era", the "involution" of biological products is becoming fierce

In order to fully grasp the progress of clinical trials in China's new drug registration and strengthen drug regulatory capacity building, CDE based on the registration information of the drug clinical trial registration and information disclosure platform, on November 10, 2021, the CDE official website released the "China New Drug Registration Clinical Trials Annual Report (" 2020)”, this is the first time that CDE has conducted a comprehensive analysis of the current status of clinical trials of new drug registration in China.

PART 01.

(1) GMP Appendix-"Biological Products" on November 03, 2005 (Draft for Solicitation of Comments):

Biological products are microorganisms (bacteria, viruses, bacteriophages, ricks Secondary bodies, parasites, etc.

(2) The three general rules of the 2020 edition of the Pharmacopoeia on December 30, 2020:

Biological Products (Biological Products) refer to preparations that use microorganisms, cells, animal or human-derived tissues and body fluids as starting materials and are made with biological technology for the prevention, treatment and diagnosis of human diseases, such as vaccines, blood products, biotech drugs, probiotics, immunomodulators, diagnostic agents and the like

PART 02.

PART 03.

PART 04.

The "Annual Report on the Current Status of Clinical Trials for New Drug Registration in China (2020)" sorts out and analyzes the outstanding issues in the current status of clinical trials for new drug registration in China.

(1) The "Annual Report on the Current Status of Clinical Trials of New Drug Registration in China (2020)" shows that there has been an "involution" in the field of bio-innovative drugs.

(2) The top 10 targets with the largest number of clinical trials are also mainly concentrated in PD-1, etc.

The PD-1 series of drugs is just a microcosm of the homogenization of R&D by domestic pharmaceutical companies.

Subsequent CDE will report on new drug registration clinical trials on an annual basis, relying on China's new drug registration clinical trial registration data, focus on regulatory innovation, improve regulatory efficiency, strengthen communication with the industry in the modernization of drug regulatory capabilities, increase information transparency, and promote High-quality and healthy development of clinical trials of new drugs in China

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