Immune checkpoint inhibitors (ICIs) have been approved across an increasing number of oncology indications in China, many of them developed by Chinese companies.
Many more domestically-developed ICIs are in the pre-registrational phase, awaiting regulatory approval by China’s National Medical Products Administration (NMPA).
However, concerns over their clinical trial diversity, trial conduct, and lack of appropriate comparator arm will be major hurdles for their approval in the West, according to GlobalData.
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