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BeiGene announced today that the NMPA Drug Evaluation Center has accepted its anti-PD-1 antibody drug Bezan for the treatment of previously treated, locally advanced unresectable or metastatic highly microsatellite unstable (MSI-H) or wrong Application for new indications for patients with solid tumors with defective repair (dMMR)
.
The marketing application for this new indication is based on the results of a single-arm, multi-center, open phase 2 clinical trial (NCT03736889)
.
The trial aims to evaluate the efficacy and safety of Baizian® monotherapy in patients with previously treated, locally advanced unresectable or metastatic MSI-H or dMMR solid tumors.
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