On May 10, 2026 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, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted a third Breakthrough Therapy Designation (BTD) to its first-in-class PD-1/IL-2α-bias bispecific fusion protein, IBI363, in combination with bevacizumab, for the treatment of patients with advanced microsatellite stable or proficient mismatch repair (MSS/pMMR) colorectal cancer (CRC) who have failed at least two prior lines of standard therapy. A Phase III clinical trial is about to initiate in China for this indication in the near term.
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Previously, IBI363 has received two BTDs from China’s NMPA CDE and two Fast Track Designations (FTDs) from the U.S. FDA, covering indications in non-small cell lung cancer and melanoma. The latest BTD further validates IBI363’s potential in addressing immunotherapy resistance and cold tumor challenges which represent a significant unmet medical need. The early-stage clinical data of IBI363 in advanced MSS/pMMR colorectal cancer were reported at 2025 ASCO (Free ASCO Whitepaper) conference (link), in which IBI363, in combination with bevacizumab, demonstrated promising efficacy in patients who have failed multiple prior lines of standard therapy.
Dr. Hui Zhou, Chief R&D Officer (Oncology Pipeline) of Innovent, stated: "IBI363 is a promising next-generation IO agent by combining dual mechanisms—PD-1 blockade and IL-2-driven tumor-specific T-cell populations expansion—thus reshaping the tumor microenvironment. The new regulatory milestone underscores its clinical value in addressing unmet needs. We are accelerating IBI363’s global development across multiple tumor types together with our partner Takeda, to bring innovation therapies at the forefront of immunotherapy to benefit global patients."
NMPA Breakthrough Therapy Designation is intended to facilitate and expedite the development and review of investigational drugs for serious diseases or conditions when preliminary clinical evidence indicates substantial improvement over current therapies. BTD qualifies a drug candidate for accelerated review by the CDE and provides the sponsor with timely advice and communication to expedite the approval process, helping to address the unmet clinical needs of patients more swiftly.
About MSS/pMMR Colorectal Cancer
Colorectal cancer (CRC) is one of the most common malignancies worldwide, with MSS/pMMR being the predominant subtype, accounting for approximately 95% of advanced CRC cases. For patients with advanced MSS/pMMR CRC who have failed standard therapies, there remains a significant unmet medical need. Treatment options are limited, and prognosis remains poor.
About IBI363
IBI363 is a first-in-class PD-1/IL-2α-bias bispecific fusion protein developed by Innovent Biologics. It functions by both blocking the PD-1/PD-L1 pathway and selectively activating the IL-2 pathway. The IL-2 arm of IBI363 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2 to the tumor.
IBI363 is being evaluated in a series of clinical trials globally, led by a pivotal Phase II study in China in previously untreated acral and mucosal melanoma and a global multi-regional Phase III trial in immunotherapy-resistant squamous NSCLC. In parallel, multiple Phase Ib/II trials are evaluating IBI363 in NSCLC and CRC including the first-line and later line settings, and in additional tumor types. IBI363 has received two Fast Track Designations (FTD) from the U.S. FDA and three Breakthrough Therapy Designations (BTD) from China NMPA so far.
In October 2025, Innovent entered into a license and collaboration agreement with Takeda, under which Innovent and Takeda will co-develop IBI363 (Takeda R&D code: TAK-928) globally and co-commercialize IBI363 in the U.S., and Takeda will exclusively commercialize IBI363 worldwide other than the U.S. and greater China.
(Press release, Innovent Biologics, MAY 10, 2026, View Source [SID1234665406])