China’s First CAR-T Is From Fosun Kite; Overseas Data Played Key Role
Executive Summary
Confounding earlier speculation, the Fosun-Kite joint venture rather than Juno-WuXi AppTec, gains the first CAR-T cell therapy approval in China. The clearance is expected to be followed by several others in the highly active area.
You may also be interested in...
Project Orbis Nears 30 Approvals In Oncology; Could China Be Added?
A review of drugs and supplemental uses since the project’s inception shows roughly one-third of the products reviewed have been NMEs.
China's CARsgen Raises $400m In Third-Largest Biotech IPO This Year
Chinese CAR-T therapy developer raises new funds to progress pipeline in over-subscribed IPO which ranks as the third-largest globally in the biotech sector to date this year.
China Cancer Drug Off-Label Use: A Crossed Line?
Off-label use of cancer drugs in China is legal and even common in certain cases. But a line has been crossed in cases of active promotion and even conflicts of interest for some high-priced products and unproven cell therapies, unveiled by a Chinese physician whistleblower, regulatory observers say.