China Nears First Approval of Fully AI Designed Drug
China could become one of the first countries globally to approve a drug entirely designed by artificial intelligence, signalling a major shift in how new medicines are discovered and developed. Pharmaceutical executives say advances in AI and human genetics are accelerating China’s transition from an AI assisted research model to fully AI generated drug candidates entering clinical pipelines. The prospect reflects rapid progress in data driven biology, where algorithms can identify targets, design molecules and optimise candidates faster than traditional methods. For China, early approval of a fully AI designed drug would reinforce its emergence as a leading centre for biotech innovation rather than a manufacturing base for generics. It would also highlight how policy support and access to large patient data sets are reshaping the country’s pharmaceutical landscape at a critical moment for global drug development.
Executives from multinational drugmakers point to China’s scale and policy direction as key advantages. Marc Horn, president of Merck China, said the industry is approaching a point where AI moves beyond supporting discovery to generating complete compounds that progress into development. China’s biopharmaceutical sector has evolved rapidly over the past decade, with domestic companies increasingly competitive in innovation. Out licensing activity reached record levels last year, underlining the global demand for Chinese developed drug assets. Horn noted that roughly 30 percent of new drug pipelines now originate in China, a figure that reflects both growing scientific capability and a regulatory environment more open to novel technologies.
A major driver behind this momentum is China’s access to vast health and genetics data sets, combined with state backed initiatives to integrate AI across industries. The government recently unveiled its AI Plus programme, a long term national blueprint aimed at embedding artificial intelligence into sectors ranging from manufacturing to healthcare. For drugmakers, this creates an ecosystem where AI tools can be trained on large, diverse data pools to improve molecule selection, safety profiling and development efficiency. Executives argue that AI will enable better targeting of disease biology and reduce costly late stage failures, a persistent challenge in pharmaceutical R&D worldwide.
If China does approve a fully AI designed drug in 2026, it would mark a symbolic and practical milestone in the global race to harness AI in medicine. While regulators elsewhere are still grappling with how to evaluate algorithm generated candidates, China’s willingness to move quickly could give its biotech sector a first mover advantage. The development would also underscore Beijing’s ambition to lead in next generation technologies that combine AI, life sciences and advanced manufacturing. Even if early approvals are limited in scope, they would set precedents that shape regulatory thinking globally, positioning China at the forefront of the future of drug discovery.
