China’s First CAR-T Is From Fosun Kite; Overseas Data Played Key Role
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.
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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.
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.
Using PD-1 immuno-oncology drugs to treat post-surgery gastric cancer and prescribing unapproved targeted therapies for colon cancer are just two examples of the apparently widespread misuse of oncology drugs in China, as alleged by an oncologist at a prestigious Peking university hospital.