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China’s drug regulator clears wave of home-grown innovative medicines amid biotech boom
Domestic firms dominate China’s drug approvals amid jump in spending and out-licensing deals as regulator speeds path to market
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Home-grown innovative drugs make up most of the medicines China’s drug regulator has approved for sale so far this year, underscoring the country’s biotech boom.
Of the 19 innovative drugs cleared by the National Medical Products Administration (NMPA), 15 came from domestic companies, according to the regulator’s website as of May 21. These include sonrotoclax, developed by global biopharmaceutical firm BeOne, for treating certain adult blood cancers.
The regulator overhauled its approval process to accelerate the path to market for home-grown innovative drugs, state media reported on Wednesday.
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Biotech companies are ramping up research and development (R&D) spending. Fosun Pharma, for example, invested 4.3 billion yuan (US$634 million) in innovative drug R&D last year, up about 16 per cent from 2024 and accounting for more than 80 per cent of its total research budget.
The country elevated the pharmaceutical sector to a national economic growth engine in this year’s government work report for the first time. Last year, China approved 76 innovative drugs, up from 48 in 2024.
Chinese biotech firms struck a record US$60 billion in cross-border licensing deals in the first quarter of 2026 as multinational corporations snapped up early-stage drugs from the country’s pipeline, according to NMPA data. The figure marked a 73 per cent year-on-year surge and equalled nearly half of the US$135.7 billion in total out-licensing agreements signed in 2025.
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