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Julie Zhang

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.
The go-ahead awarded to the private firm, founded in 2011, marked the world’s first approval of such a device for commercial use in patients.


Meanwhile, China’s cross-border deals with global pharmaceutical giants show no sign of abating, despite looming headwinds of US curbs on investment in the country’s biotech sector.
On July 8, Sino Biopharmaceutical announced it had entered an exclusive licensing agreement with AstraZeneca for TQC3721, an inhaled drug designed to treat chronic obstructive pulmonary disease.
Under the deal, Sino Biopharmaceutical will receive an upfront payment of US$200 million, with additional development and sales milestones that could raise the total deal value to as much as US$1.9 billion, along with royalties reaching double-digit percentages of net sales.
The deal would “ease investor concerns about the slowing down of China’s molecule out-licensing trend, thus helping the current sector rebounding momentum”, said Zhang Jialin, Nomura’s head of China healthcare research.
On July 14, AstraZeneca struck a licensing agreement worth up to US$1.5 billion with Shanghai-headquartered Dizal Pharma for an oral lung cancer drug, according to a filing with the Shanghai Stock Exchange.
Chinese biotech firms have also struck a growing number of cross-border deals involving artificial intelligence. On July 10, Hong Kong-listed Simcere Pharmaceutical announced a global drug discovery collaboration with US-based Schrodinger. The US firm will apply its AI-driven computational platform to help Simcere design and optimise drug candidates, according to Simcere.
Responding to the US move to curb investment, Tony Ren, head of Asia Healthcare Research at Macquarie Capital, said it would be “rather difficult to ban drug licensing from China”.
“We believe the health benefits for US patients and the financial profits of the large pharma companies and the venture capitalists involved in licensing will likely prevail over the proponents of such a ban,” he said.


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Home-grown therapies account for 80 per cent of approvals in first six months of the year


Home-grown therapies account for 80 per cent of approvals in first six months of the year.


‘Systemic leap’: China’s drug innovation push yields bumper crop

.css-1c6uqr6{color:inherit;font-weight:inherit;font-size:inherit;font-family:inherit;line-height:inherit;overflow-wrap:break-word;}Home-grown therapies account for 80 per cent of approvals in first six months of the year

Home-grown therapies account for 80 per cent of approvals in first six months of the year