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.
The approvals, along with a record high of about US$110 billion in out-licensing deals over the period, fully demonstrated that “the innovation quality of China’s pharmaceutical industry has achieved a systemic leap”, Tao said.
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.