A study published in Health Affairs by scientists at the University of Pennsylvania and Friends of Cancer Research compared new cancer drug approvals in China and the US from 2020 to 2025. In 2025 alone, China approved almost three times as many cancer drugs as the US did that year.
Jeff Allen, who serves as both president and CEO of Friends of Cancer Research and co-authored the study, stated in an interview, "It does demonstrate a continued very rapid shift in China's investment in the biotechnology industry and the success that they're achieving."
In China, three of the six first-in-class drugs were authorized in 2025, and these are regarded as innovative because they address two established cancer pathways using a single medication rather than several therapies. The three developers are BeBetter Med Inc. and Lepu Biopharma Co., both from China, together with a Hong Kong-based subsidiary of Sino Biopharmaceutical Ltd.
The rapid growth in China's drug approvals reflects years of strategic investment and regulatory reforms. The National Medical Products Administration has implemented measures to expedite reviews for innovative therapies, while domestic biotech firms have benefited from government incentives and a large patient population for clinical trials. This combination has enabled China to emerge as a significant player in global oncology drug development.
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The shift is notable because until 2022, the FDA approved more drugs annually. But starting in 2023, China's approvals outpaced those of the US, a trend that continued through 2025. This reflects not only China's growing regulatory efficiency but also its deepening pipeline of domestically developed therapies.
China's regulatory agency has also introduced priority review and conditional approval pathways, which shorten the time from application to market. The country's vast and diverse patient base allows for quicker enrollment in clinical trials, while generous government subsidies and tax incentives have encouraged domestic companies to invest heavily in R&D. These factors together have accelerated the transition from a generic manufacturing hub to an innovation-driven biotech powerhouse, a shift that has been building for more than a decade.
According to Allen, the results indicate that the Chinese industry has transformed over the last 15 years, shifting from generic manufacturing to the creation and sale of innovative treatments.
In November, a report from a US congressional advisory panel on economic and security relations with China stated that the country has made targeted investments in its biopharma industry over the past ten years to boost competitiveness and become a preferred collaborator for global pharma firms. The report stated: "China's sophisticated laboratory infrastructure and growing biotech manufacturing base are positioning it to become a leader in commercializing global scientific discoveries."
Allen also noted: "There is a highly focused domestic industry in China that has not gone global."
On average, the FDA processed new drug applications 117 days quicker than China's regulatory body.
Nonetheless, a growing number of international brand-name drug companies are depending on Chinese enterprises as key development collaborators. The approvals demonstrate a continued shift in China's biotechnology investment and success.
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