Challenges in anticancer drug R&D in China

• Published in: The lancet oncology Vol. 20; no. 2; pp. 183 - 186
• Main Authors: Zhao, Shen, Lv, Cheng, Gong, Jifang, Wenfeng, Fang, Hu, Xichun, Ba, Yi, Xiaoyuan, Chen, Zhimin, Yang, Shen, Lin, Zhang, Li
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01-02-2019; Elsevier Limited
• Subjects: Biopharmaceuticals; Clinical trials; Epidermal growth factor receptors; Generic drugs; Innovations; Metastases; Mutation; PD-1 protein; PD-L1 protein; Pharmacovigilance; Protein-tyrosine kinase; Quality control; Regulatory reform; Studies; China
• ISSN: 1470-2045; 1474-5488
• DOI: 10.1016/S1470-2045(18)30865-9

[...]29 (16%) phase 1 studies targeted the PD-1/PD-L1 pathway. [...]far, there are 12 PD-1 inhibitors and eight PD-L1 inhibitors being developed by 15 Chinese biopharmaceutical companies. To deal with the shortage of clinical trial sites, the China Food and Drug Administration (CFDA) plans to abolish the current clinical trial agency accreditation system.3,5 Under the new record management system, medical facilities can avoid the lengthy certification process of registering a new trial, and only need to register on the CFDA's website to get approval for doing clinical trials.5 To cultivate a more innovation-friendly drug R&D ecosystem, the CFDA shifted their clinical trial regulatory policy from strict entry, tolerant exit, to tolerant entry, strict exit.3,5 Instead of overemphasising the approval of clinical trial applications, current policies focus more on the quality control of trials and post-marketing pharmacovigilance.5 Clinical trial data falsification is now a felony with at least 3 years in prison. According to the previous definition, novel molecular entities and drugs modified from existing molecular entities were both classified as innovative drugs and received the same treatment. [...]unlike phase 1 studies of other EGFR T790M tyrosine kinase inhibitors, the first-in-human study of ML007 (CTR20180977) includes patients with untreated, symptomatic brain metastasis.