
Highlights & Notes
RE: China’s Clinical Trial Boom
www.asimov.press
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Highlights & Notes
www.asimov.press
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About one-fourth of all clinical trials and early drug development now happens in China.
Large pharmaceutical companies in-license about a third of their experimental molecules from Chinese laboratories
Just a couple of years ago, this number was about 10 percent.
Chinese companies will often run the phase I trial in China for cheap, then flip it to a Western [pharmaceutical company] to run the expensive US trials and bring the drug to market.
the number of original, new drugs originating in China has climbed from almost zero in 2010 to a figure, in 2023, that approaches American totals.Â
In the early 2010s, the number of clinical trials performed by American companies increased steadily but then leveled out at about 1,900 studies each year. China’s clinical trial numbers, on the other hand, remained relatively low until the mid-2010s. After the government streamlined approval policies, though, the number of clinical trials soared. Chinese companies matched the American clinical trial volume in the span of a few years while sustaining their average enrollment trajectory (at a marginally higher rate).
Between 2017 and 2021, China’s median approval time for a new drug application was just 15.4 months, compared to ten years or more in the United States.
Chinese regulators introduced several measures to speed up clinical trial approvals, including priority review and conditional approvals for new drugs.
In 2017, the NMPA (China’s drug regulator) also launched an “implied license” policy, which automatically authorizes a clinical trial if regulators voice no objections within 60 days. That same year, China joined the International Council for Harmonisation (ICH) and updated its rules to accept overseas clinical trial data, reducing the need to repeat entire studies within China. This means that companies no longer need to repeat full trials in China if high-quality foreign results exist.
over three-quarters of recent trials now enroll fewer than 100 participants
Co-Founder @ Comend
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Nice and simple.
-Albert