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China clears 38 innovative drugs in first half, mostly homegrown
The Ministry of Industry and Information Technology said more than 80.0% of innovative drug approvals in the first half were domestically produced, including CAR-T and a brain-computer interface clearance.
China’s regulators cleared 38 innovative drugs for sale in the first half of the year, with domestically produced medicines accounting for more than 80.0% of approvals, according to a government spokesman cited by the South China Morning Post.
The Ministry of Industry and Information Technology said 31 of the 38 cleared medicines were homegrown. Among the most closely watched approvals was Sati-cel, a personalized cell therapy developed by Shanghai-based CARsgen Therapeutics, which was cleared on June 22 for late-stage stomach cancer patients who have not benefited from at least two earlier rounds of treatment.
Sati-cel is a CAR-T therapy that engineers a patient’s own immune cells to target cancer proteins and then returns the engineered cells to the body, and it was described by the company as the world’s first CAR-T treatment cleared for solid tumors, according to its Hong Kong stock exchange filing.
The Chinese drug regulator also cleared an implantable brain-computer interface system developed by Neuracle Medical Technology in March, which is designed to restore hand motor function in patients with spinal cord injuries.