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Monday, June 16, 2025
Hinge Health started at Buy by 10 sell siders
China proposes shorter clinical trial reviews in efforts to accelerate drug development
China, already gaining speed in biotechnology, is looking to further accelerate novel drug development by reducing the time that regulators take to review clinical trials.
In a draft policy posted (Chinese) Monday, China’s National Medical Products Administration (NMPA) is proposing to cut the clinical trial review waiting period for novel medicines to 30 working days, down from the current 60 working days.
In its current proposed form, the 30-day timeline will apply to key medicines with clear clinical value that are supported by the Chinese government, pediatric drugs for cancers and rare diseases that are included in two projects overseen by the NMPA’s Center for Drug Evaluation (CDE), as well as global studies that are simultaneously conducted in China and multinational trials led by Chinese investigators.
Similar to the U.S. FDA, the NMPA adopts an objection-based method toward clinical trial review. Under this pathway, a clinical trial may automatically proceed if the sponsor doesn’t receive any objection from the regulators within a certain timeframe.
The NMPA is soliciting public comments on the new rule until July 16. If implemented, the new review timeline would match the FDA’s 30-day period.
The move comes as China’s biotech industry is getting a boost fueled by a wave of licensing deals featuring foreign companies tapping into drugs developed by Chinese biopharmas. Large pharma companies in-licensed about 31% of their external molecules from China in 2024, compared with 10% in 2020 or 3% in 2015, a recent Stifel report found based on data from Dealforma.
The trend has continued into 2025. About a month ago, Pfizer reached a deal to pay China’s 3SBio $1.25 billion upfront to obtain ex-China rights to a PD-1xVEGF bispecific antibody as a potential challenger to Merck & Co.’s mainstay cancer therapy Keytruda. Then Regeneron inked a potential $2 billion pact for a GLP-1/GIP agonist from China’s Hansoh Pharma to go after Eli Lilly’s Zepbound in obesity.
China’s growth in biotech aligns with an increase in clinical trials conducted in the country. China’s share in the world of new clinical trials sponsored by the biopharma industry has jumped from 8% in 2013 to 29% in 2023, according to a recent IQVIA report.
The rise of China’s biotech capabilities has drawn global attention as some feared that the U.S. is losing out to China in the biotech race. Among five critical tech sectors, “China has the most immediate opportunity to overtake the United States in biotechnology,” according to a June report by Harvard’s Belfer Center for Science and International Affairs.
The ability to quickly launch clinical trials has been attributed as one important reason for China’s biotech boom.
“A major challenge for U.S. firms is the long and costly process of obtaining FDA approval for phase 1 studies,” former FDA Commissioner Scott Gottlieb, M.D., wrote in an opinion piece in Stat last month.
Because launching first-in-human clinical trials is simpler in China, Chinese biotech companies get a competitive advantage over American firms by more quickly obtaining information on the most promising compounds, Gottlieb explained.
“What absolutely fascinates me when you go to China [is] to see how advanced, how fast and the high quality with which they’re moving INDs through the system,” Teresa Bitetti, president of Takeda’s global oncology business unit, said during a panel discussion at the Fierce JPM Week in January.
Thanks to the fast generation of proof-of-concept clinical data, Chinese biotechs can offer actionable insights early for potential buyers who are eager to snatch up promising assets at the drop of a hat.
“The fact that the clinical data is being generated quickly is enabling some of these business development decisions to be made appropriately,” Hesham Abdullah, M.D., global head of oncology R&D at GSK, said during the same January panel.
Both Takeda and GSK have in-licensed drug candidates from Chinese companies in recent years.
During an FDA roundtable this month on cell and gene therapies, CAR-T cell therapy pioneer and serial biotech entrepreneur Carl June, M.D., suggested that the FDA should follow China’s regulatory approach and only get involved when is therapy is ready for larger, multisite trials.
China’s regulation of clinical trials has undergone rapid and dramatic changes in the past 10 years. It was only in 2015 that the country started to allow foreign medicines to conduct multiregional clinical trials in China. In 2017, China officially joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, which devises global guidelines for the conduct of clinical trials.
In 2018, the NMPA introduced the 60-day policy for its clinical trial review time and shifted from a previous authorization-based approach to the current objection-based method mirroring the practice at other global regulatory bodies. Before that, China’s CDE had estimated that its standard waiting period for IND applications was six months to sometimes longer than a year.
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