China's Domestic Novel Drugs Dominate H1 Market Approvals, Signaling Innovation Leap

Domestically produced novel drugs accounted for more than 80 per cent of market approvals in China in the first half of the year, reflecting a “leap” in the quality of the country’s pharmaceutical innovation, according to a government spokesman.

A total of 38 innovative drugs were cleared for sale in the six-month period, of which 31 were home-grown medicines, said Ministry of Industry and Information Technology spokesman Tao Qing, at a media briefing in Beijing on Monday.

Among the most closely watched approvals was Satri-cel, a personalised cell therapy that uses a patient’s own immune cells to attack cancer cells, developed by Shanghai-based CARsgen Therapeutics. It became the world’s first chimeric antigen receptor T-cell (CAR-T) treatment cleared for solid tumours, according to the company’s filing with the Hong Kong stock exchange.

Approved on June 22, the therapy targets patients with late-stage stomach cancer who have not benefited from at least two earlier rounds of treatment, a group with few remaining options. CAR-T therapies involve engineering the patient’s own immune cells in a lab to target specific cancer proteins, then placing them back into the body.

CARsgen’s Hong Kong-traded stock dropped about 9 per cent over the past month.

The Chinese drug regulator also cleared an implantable brain-computer interface (BCI) system developed by Neuracle Medical Technology in March. It is designed to restore hand motor function in patients with spinal cord injuries.