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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, and patients who have failed standard therapies face a significant unmet medical need with 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 patients who failed multiple prior lines of therapy at the 2025 ASCO conference.
This BTD qualifies IBI363 for accelerated review by the NMPA, expediting the approval process; Innovent has now secured three BTDs in China and two U.S. FDA Fast Track Designations across indications.
Innovent is accelerating global development of IBI363 in partnership with Takeda 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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