China's drug regulator clears wave of homegrown innovative medicines amid biotech boom

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.

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. Global pharmaceutical corporations "need to have a Chinese strategy", said Stephen Farrelly, managing director and global lead for pharmaceutical and healthcare at ING, a Dutch financial services group overseeing about US$15 billion in pharmaceutical and healthcare assets globally."It can be a partner, or it can be [competition], but you cannot be passive because this market is evolving at the speed that you simply must pay attention to it."
The "NewCo'' model - where financial sponsors acquire Chinese drug assets and spin them into stand-alone companies for overseas development - had emerged as a growing way for Chinese biotech firms to expand globally, according to a May report by L.E.K. Consulting. Deal activity increased from two in 2024 to 16 in 2025, accounting for about 12 per cent of out-of-China licensing deals by value last year.
Chuan Sun, managing partner at law firm Morrison Foerster's Shanghai and Hong Kong offices, said at the ChinaBio Partnering Forum 2026 on April 28 in Shanghai that cross-border biotech transactions increasingly needed to account for both Chinese and US regulatory considerations, including export controls, concerns related to the US Biosecure Act, and data-transfer rules.
Life sciences, however, remained in a relatively stronger position than sectors such as semiconductors or artificial intelligence, because medicines that addressed disease were harder to frame as national security risks, Sun added.
China accounted for about 30 per cent of the global early-stage drug pipeline, according to a January report from consultancy McKinsey & Company.
Originally published in the South China Morning Post: Opens in a new tabhttps://www.scmp.com/business/china-business/article/3355021/chinas-drug-regulator-clears-wave-home-grown-innovative-medicines-amid-biotech-boom