1. Scrip
  2. >>Focus On Asia
  3. >>China

China Reins In Cancer Drug Trials, Stressing Patient Needs and Benefits

Tougher Comparator Requirements

 
• By Dexter Jie Yan

China's drug regulatory authority is taking aim at strengthening randomized, controlled clinical trials conducted domestically for cancer drugs, leaving biotech stocks reeling from the proposed stricter requirements.

clinical trial progress
China’s CDE stipulates clinical value is determined by whether clinical needs can be met to maximize patients’ benefits • Source: Alamy

China’s Center for Drug Evaluation (CDE) is taking steps to rein in the nation’s exploding anticancer drug clinical trials, with a draft document that would require sponsors to conduct randomized controlled studies using best-in-class existing therapies as comparators, where these are available.

When choosing control drugs for such trials, the main focus should be on whether the study products represent the best therapies for the target indications, the CDE said in its draft version of Guiding Principles on Clinical Value-Oriented Research and Development of Anti-Cancer Drugs

More from China

More from Focus On Asia

Zai’s R&D Head Touts ‘Beauty’ Of Novel Internal Assets

 
• By Dexter Jie Yan

Two potentially first-in-class molecules signify Zai Lab’s renewed drive for the in-house discovery of drugs that it requires “to be innovative, differentiated and to have the potential to make a big difference for patients,” its global R&D head tells Scrip.

CSPC’s Global-First Monospecific ADC Promising In Advanced NSCLC

 
• By Xu Hu

CSPC’s SYS6010, the first monospecific EGFR-targeting antibody-drug conjugate in the clinic for advanced NSCLC, has shown Phase I promise, but could face close competition with another China-originated bispecific.

NIH Funding Cut Left Less Money On R&D Table, Tariffs Would Add To Woes: Aragen’s CEO

 
• By Vibha Ravi

Funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, GCC partnerships and talks with the Indian government to solve intellectual property challenges are discussed in an interview with Aragen’s CEO, who is also keenly watching the Trump administration’s moves on pharma tariffs