研究称2020至2025年中国肿瘤新药获批数量超过美国

Cancer Drug Approvals in China Outpace Those in US, Study Finds
Takeaways by Bloomberg AI
- Chinese health authorities approved more novel cancer drugs than their US counterparts between 2020 and 2025, with 94 novel oncology drugs cleared for sale compared with 87 in the US.
- The US still dominates when it comes to bringing new classes of drugs to market, with 30 of 36 first-in-class drugs approved first in the US.
- China's biotechnology industry is becoming more competitive globally, with the country's own versions of existing US drugs being approved, and Chinese firms becoming important development partners for pharmaceutical companies around the world.
Chinese health authorities approved more novel cancer drugs than their US counterparts in the last several years, according to a study published Monday that shows investments in China’s biotechnology industry are enhancing its competitiveness globally.
Between 2020 and 2025, China’s National Medical Products Administration cleared 94 novel oncology drugs for sale compared with 87 green lit by the US Food and Drug Administration. China ended 2025 with almost three times as many cancer drug approvals as the US that year, according to the study published in the journal Health Affairs. It was conducted by researchers from the University of Pennsylvania and the advocacy group Friends of Cancer Research.
The data show the FDA approved more drugs through 2022 during the study’s time period and that flipped in 2023 with China outpacing the US through 2025.
Many of the oncology drugs approved in China are the country’s own versions of ones that have been on the market for some time in the US. The US does still dominate when it comes to bringing new classes of drugs to market, the data show.
Of 36 drugs during the time period covered by the study that were the first to fight cancer cells via certain pathways in the body, 30 were approved first in the US. The FDA reviewed new drug applications a median of 117 days faster than China’s National Medical Products Administration, the study said.
Still, the approvals are evidence of an evolution in the Chinese industry’s capabilities, going from making mainly generic drugs 15 years ago to developing and commercializing innovative medications, said Jeff Allen, president and chief executive officer of Friends of Cancer Research, based in Washington, D.C.
“It does demonstrate a continued very rapid shift in China’s investment in the biotechnology industry and the success that they’re achieving,” Allen, one of the study’s authors, said in an interview.
Three of the six first-in-class treatments approved in China were cleared last year, though they are mainly considered novel for targeting two known cancer pathways in the body in one medicine instead of multiple separate treatments.
All three are from drugmakers headquartered in China and Hong Kong, including BeBetter Med Inc., Lepu Biopharma Co. and Chia Tai Tianqing Pharmaceutical Group Co., a subsidiary of Sino Biopharmaceutical Ltd.
Only 14 of the drugs were approved in both the US and China in the study’s time frame.
“There is a highly focused domestic industry in China that has not gone global,” Allen said.
As they bring drugs to market in China, more brand-name pharmaceutical companies around the world are relying on Chinese firms as important development partners.
China has strategically invested in its biopharmaceutical sector over the last decade to make it more competitive and a go-to partner for pharmaceutical companies around the world to conduct early-stage research and end-stage manufacturing, according to a report released in November by the US-China Economic and Security Review Commission, a committee that monitors and reports to Congress on national security implications of US trade with China.
“China’s sophisticated laboratory infrastructure and growing biotech manufacturing base are positioning it to become a leader in commercializing global scientific discoveries,” the report said.
— With assistance from Robert Langreth