SAN FRANCISCO and SUZHOU, China , June 4, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology, and other major diseases, announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted a second Breakthrough Therapy Designation (BTD) to its first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363, for the treatment of unresectable, locally advanced, or metastatic squamous non-small cell lung cancer (sqNSCLC) that has progressed following anti-PD-
1 immunotherapy and platinum-based chemotherapy. To date, IBI363 has received BTDs from China's NMPA CDE and Fast Track Designations (FTDs) from the U.S. FDA for two indications—sqNSCLC and melanoma.
