National Medical Products Administration / Center for Drug Evaluation
China's drug regulator and its review centre, whose reforms since 2015 turned China into the world's second-largest source of new cancer drugs and a leader in ADCs and bispecifics.
The National Medical Products Administration (formerly CFDA) and its Center for Drug Evaluation regulate medicines in China. Reforms beginning in 2015 cleared a backlog of applications, accepted overseas clinical data, introduced breakthrough, conditional and priority review pathways, and brought China into ICH in 2017, cutting approval times and enabling domestic companies to develop PD-1 antibodies, antibody-drug conjugates, bispecifics and CAR-T at pace. The CDE publishes technical guidelines including those on single-arm trials and oncology endpoints, and its decisions on domestic PD-1s, ivonescimab and Chinese ADCs are followed closely by global companies licensing Chinese assets. Reimbursement is decided separately through the National Reimbursement Drug List negotiations.
- Breakthrough, conditional and priority review pathways
- ICH implementation and acceptance of overseas data
- Oncology endpoint and single-arm trial guidance
- Cell and gene therapy regulation
Pages like this
not linked directly; found by shared links- Key paperHARMONi-2: ivonescimab, a PD-1 x VEGF bispecific, beats pembrolizumab head-to-head in PD-L1-positive lung cancer
Shares Akeso, Ivonescimab, Bispecific antibodies, Trials do not represent the people who get cancer.
- PersonWenfeng Fang
Shares Akeso, Sun Yat-sen University Cancer Center, Ivonescimab.
- InstitutionPharmaceuticals and Medical Devices Agency
Shares Clinical Data Interchange Standards Consortium, FDA Oncology Center of Excellence, Regulatory divergence between regions, Antibody-drug conjugate (ADC).
- PersonDingwei Ye
Shares Fudan University Shanghai Cancer Center, Disitamab vedotin.
- PersonJie Wang
Shares BeOne Medicines (formerly BeiGene), Cancer Hospital, Chinese Academy of Medical Sciences.
- PersonJin Li
Shares Fudan University Shanghai Cancer Center, Chinese Society of Clinical Oncology.
- CollectionCSCO guidelines (China)
Shares Cancer Hospital, Chinese Academy of Medical Sciences, Chinese Society of Clinical Oncology, Sun Yat-sen University Cancer Center.
- PersonBinghe Xu
Shares Sichuan Kelun-Biotech, Cancer Hospital, Chinese Academy of Medical Sciences.