China Reins In Cancer Drug Trials, Stressing Patient Needs and Benefits
Tougher Comparator Requirements
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.
You may also be interested in...
The nation’s top drug regulator vows to adopt ICH’s guidelines on drug safety and efficacy, after dropping the industry a bombshell with the tightening of oncology drug clinical trials a week ago.
First DIDI, then other recently US-listed tech companies and now biotech companies are seeing share drops as China widens its cybersecurity reviews. But investors are also seeing other corrections from recent highs.
Sheer volume of studies and fierce competition to recruit and enroll required numbers of patients in trials, even in a populous country like China, can quickly jack up new drug development costs.