What’s at stake as Beijing beats global peers with first approval of novel therapy

China’s drug regulator has for the first time approved a novel, globally trialled medicine ahead of authorities in the United States, Japan and Europe, marking a “historic breakthrough” as the country doubles down on biopharmaceuticals as one of its growth engines.

The drug was filed for market approval in multiple countries, and “China was the first in the world to approve it”, Xu Xiaoqiang, head of chemical drugs registration at the National Medical Products Administration (NMPA), told state broadcaster CCTV on Tuesday.

“It marks a historic breakthrough for China” in globally developed, first-in-class drug innovation, Xu said, noting that Chinese patients had been included from the outset in international clinical trials, enabling approval ahead of anywhere else.

The NMPA gave the green light for commercial sales of a rare-disease therapy for narcolepsy type 1 in people aged 16 and older, state media reported.

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