On June 10, 2019, the "Regulations on the Administration of Human Genetic Resources of the People's Republic of China" was officially announced and was determined to be implemented on July 1.
The management of human genetic resources in clinical trials in China has a long way to go. On the one hand, it is necessary to promote the progress of clinical trials. On the other hand, it is necessary to manage the collection, preservation, international cooperation and exit of genetic resources.
The "Approval of Scientific Research on International Cooperation in Human Genetic Resources" is applicable to the regulation and management of international collaborative scientific research using Chinese human genetic resources.
China Human Genetic Resources International Cooperation Scientific Research Examination and Approval (fourteenth batch in 2019) (2019-09-27), the key trials approved for clinical trials are:
Novo Concord, oral somaglutide, hypoglycemic rookie: oral somaglutide, priced at 5,500 yuan per month; domestic is also fast;
India Natco, Gleevec-Imatinib generic drug, "I am not a drug god" Glein prototype drug company Natco will focus on the development of oncology drugs in China!
Novartis, Kanalimum, China NSCLC Phase 3 clinical;
Zhuhai Rundu, lidocaine prilocaine cream;
BMS, 986165, moderate to severe psoriasis phase 3 clinical;
Yide Biological, budesonide aerosol;
Zee Bio, Jacketini Cream, Phase 2 alopecia areata clinically, the company's valuation is nearly 5 billion, Zeyake Jackini cream for alopecia areata!
Yifang Biological, URAT1, clinical;
Junshi Biological, PD-1, Nasopharyngeal Carcinoma Phase 3;
Novartis, Brolucizumab and Aberysip Phase 3 clinical; and so on.
