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Innovent Announces IBI363 (PD-1/IL-2α-bias Bispecific Fusion Protein) Received Third NMPA Breakthrough Therapy Designation for MSS/pMMR Metastatic Colorectal Cancer

On Sunday, May 10, 2026, Innovent Biologics announced that China's National Medical Products Administration granted a third Breakthrough Therapy Designation to IBI363 in combination with bevacizumab for advanced MSS/pMMR colorectal cancer.
MSS/pMMR colorectal cancer accounts for approximately 95% of advanced CRC cases, with patients who have failed standard therapies facing significant unmet medical needs and poor prognosis.
IBI363 is a first-in-class PD-1/IL-2-bias bispecific fusion protein that blocks PD-1/PD-L1 pathways while selectively activating IL-2, demonstrating promising efficacy in data presented at the 2025 ASCO conference.
This BTD qualifies IBI363 for accelerated review by the NMPA, providing timely regulatory advice to expedite approval; Innovent has now secured three BTDs in China and two U.S. FDA Fast Track Designations.
In partnership with Takeda, Innovent is accelerating global development of the drug, designated TAK-928, and plans to initiate a Phase III clinical trial in China for this indication in the near term.

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Innovent Announces IBI363 (PD-1/IL-2α-bias Bispecific Fusion Protein) Received Third NMPA Breakthrough Therapy Designation for MSS/pMMR Metastatic Colorectal Cancer

SAN FRANCISCO and SUZHOU, China, May 10, 2026 /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…

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