- A recent regulatory overhaul designed to speed up development and approval of new drugs in China has been welcomed by global pharma giants and local startups alike, aimed at bringing their latest cutting-edge treatments more quickly to Chinese patients.
- One of the first to seize on the reforms was Legend Biotech Corp., which develops novel cell therapies for cancer treatment.
- Following Legend Biotech’s receipt of “breakthrough” status, a drug developed by U.S. giant Amgen received the same designation for a drug to treat metastatic non-small cell lung cancer, which is the most common form of lung cancer.
- A second key element in the amended regulations was the national expansion of the Marketing Authorization Holder system from July 1, 2020, expanding a pilot program dating back to 2015.
For further details see:
Drug Startups Eye Quicker Profits Under China's New Fast-Track Approvals