Innovent Biologics (HKG:1801) said the new drug application for its anti-cancer drug ipilimumab injection "CTLA-4" monoclonal antibody was accepted by the Center for Drug Evaluation of the National Medical Products Administration of China, according to a Monday filing with the Hong Kong bourse.
The medicine also received a Priority Review designation in combination with sintilimab as neoadjuvant treatment for resectable microsatellite instability-high or mismatch repair deficient ("MSI-H/dMMR") colon cancer. This is China's first NDA for a domestic CTLA-4 inhibitor, the filing added.
The company's share prices were down over 3% in recent trading.
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