Medical Affairs

Clinical Development and Medical Affairs (CDMA) has a leading scale and highly professional clinical R&D medical team in China. Led by R&G CMO Jigang Li, the department was established in 2009 and currently has a size of more than 60 people, including more than 35 medical writing and monitoring personnel with a physician background.

The team has rich project experience and is familiar with various therapeutic fields and molecular targets, is implementing more than 200 projects every year, with 1/3 new projects; and has completed more than 60 clinical R&D projects of innovative drugs and devices in multiple fields such as ADC, bispecific antibodies, CAR-T, stem cells, oncolytic viruses, therapeutic vaccines, antisense nucleic acids, and gene editing in the past 3 years, covering PD-1, LAG3, CD38, CD47, CDK4/6, PI3K, MEK, ERK, PDL1/TGF, LSD1, JAK, CD19, EGFR, NTRK, GLP-1, RANKL, AR, TROP-2 and other target products. It successfully supported the marketing of several products such as icaritin and furmonertinib and completion of pivotal phase 2 studies on CD38 monoclonal antibody, MEKi and others.

Medical department can help customers clearly locate the target characteristics and differentiation advantages of the product and accurately recommend the best indication selection and clinical research path. Risks could be effectively controlled to improve R&D success rate during trial implementation, particularly when there are ethnic effects, regional effects, or baseline deviations. For example, the Phase 3 RCT study of icaritin in liver cancer showed negative in the whole population, but the reduction of risk of death by 57% in 71 enriched populations, and the drug was approved for marketing; bevacizumab biosimilar, for which colorectal cancer is selected as the indication, was initiated 5, 7, and 10 months later than the 3 competitor products, and the approval time was catch-up to within 3 weeks late.

Scope of services include:

Product due diligence support;

IND and NDA strategy;

Clinical development plan;

Study protocol design;

Medical monitoring;

Medical training;

Study report writing, etc.