BEIJING (dpa-AFX) - Innovent Biologics Inc. (IVBXF.OB) announced Wednesday that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted a second Breakthrough Therapy Designation to its first-in-class PD-1/IL-2?-bias bispecific antibody fusion protein, IBI363, for the treatment of unresectable, locally advanced, or metastatic squamous non-small cell lung cancer or sqNSCLC that has progressed following anti-PD-(L) immunotherapy and platinum-based chemotherapy.
To date, IBI363 has received Breakthrough Therapy Designations from China's NMPA CDE and Fast Track Designations from the U.S. FDA for two indications-sqNSCLC and melanoma. The latest Breakthrough Therapy Designation further advances IBI363's potential in addressing immunotherapy resistance and cold tumor challenges.
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