China's booster shot for drug innovation

China has emerged as a global powerhouse in drug innovation, and industry experts expect the rapid growth to continue in the years ahead.

Official data showed that China approved 38 new drugs in the first half of this year, 31 of which were developed domestically. All 11 drugs, featuring new molecular targets and mechanisms of action, were produced in China.

The approvals, combined with a record $110 billion in innovative drug out-licensing deals during the same period, have demonstrated that "China's pharmaceutical industry has achieved a systemic leap forward in innovation quality", Tao Qing, a spokeswoman for the Ministry of Industry and Information Technology, said at a recent news conference.

China's progress is also reshaping the global R&D landscape. Worldwide, the volume of early-stage drug development nearly doubled from 2015 to 2024, while the traditional United States-led model is giving way to a two-hub system centered on both the US and China, according to a study headed by health policy experts at Georgetown University in Washington.

The US share of early-stage programs during the period fell to 37 percent from 48 percent, while China's share surged to more than 32 percent from just 8 percent, said the study published online in the Journal of the American Medical Association in late March.

"China's drug development pipeline increasingly includes innovative and transformative therapies, moving beyond the older programs that succeeded in developing follow-on products," Richard Pazdur, former director of the US Food and Drug Administration's Center for Drug Evaluation and Research, wrote in an opinion piece accompanying the study.

"In some areas, including antibody-drug conjugates, bispecific antibodies and cell therapies, China now rivals or surpasses the US in scale and, in some areas, innovation. Regulators must prepare for an environment in which some therapies with substantial patient benefit may be studied primarily, or even exclusively, in China," he added.

Li Haiyan, chief director of the Drug Clinical Trial Center at Peking University Third Hospital, told an industry conference in July that while China ranks first globally in the volume of innovative drug molecules under development, only about 7 percent of the pipeline currently targets entirely new treatments, pointing to considerable untapped potential for first-in-class breakthroughs.

"We have strong momentum going forward, and the next five years are poised to see a surge in innovative drugs with truly novel targets," she said.