From antibody-drug conjugates to immuno-oncology checkpoint inhibitors, China is the world’s most closely watched rising biotechnology power.
The growth of China’s industry can be attributed to a number of factors, including beneficial state policies and fresh injections of funding. There has also been bold regulatory reform.
Since 2015, the country’s National Medical Products Administration has issued one milestone regulation after another, greatly accelerating the process of reviewing new drugs. The amount of time regulators take to approve applications for investigative new medicines to be tested in humans has been reduced to 60 working days, from nine to 18 months. And the NMPA has established four pathways to accelerate new drug approvals: a breakthrough therapy designation, conditional approval, a fast-track designation, and a specially designated pathway for treatments and vaccines to be used during public health crises.
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