Innovent Biologics received a third Breakthrough Therapy Designation in China for IBI363 plus bevacizumab in previously treated advanced MSS/pMMR colorectal cancer. A Phase III trial is expected to begin soon in China.
Written By: Nikita Jha, BPharm
Reviewed By: Pharmacally Editorial Team
On 11 may 2026, Innovent Biologics announced that China’s National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has granted a third Breakthrough Therapy Designation (BTD) to IBI363, its investigational PD-1/IL-2α-bias bispecific fusion protein, in combination with bevacizumab for the treatment of advanced microsatellite stable or proficient mismatch repair (MSS/pMMR) colorectal cancer (CRC).
The designation covers patients with advanced MSS/pMMR CRC who have failed at least two prior lines of standard therapy. Innovent said a Phase III clinical trial in China is expected to begin in the near term for this indication.
IBI363 previously received two BTDs from China’s NMPA CDE and two Fast Track Designations from the U.S. Food and Drug Administration across indications including non-small cell lung cancer (NSCLC) and melanoma. The latest designation adds to the program’s regulatory momentum in difficult-to-treat solid tumors associated with resistance to immunotherapy.
Early-stage clinical data presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting showed that IBI363 combined with bevacizumab demonstrated encouraging anti-tumor activity in heavily pretreated patients with advanced MSS/pMMR colorectal cancer.
According to Innovent, IBI363 is designed to combine PD-1 blockade with selective IL-2 pathway activation to expand tumor-specific T-cell populations and modify the tumor microenvironment.
The company said the IL-2 component is engineered to maintain affinity for IL-2Rα while reducing interaction with IL-2Rβ and IL-2Rγ, an approach intended to limit toxicity while preserving anti-tumor immune activity.
Dr. Hui Zhou, Chief R&D Officer of Innovent’s oncology pipeline, said the latest designation highlights the therapy’s potential clinical value in addressing unmet needs in immunotherapy-resistant tumors. He added that Innovent and its partner Takeda are advancing the global development program for IBI363 across multiple cancer types.
MSS/pMMR disease represents the dominant subtype of colorectal cancer, accounting for about 95% of advanced CRC cases worldwide. Patients whose disease progresses after standard therapies continue to face limited treatment options and poor outcomes.
IBI363 is currently being evaluated across several global clinical studies. These include a pivotal Phase II study in China for previously untreated acral and mucosal melanoma, a global Phase III trial in immunotherapy-resistant squamous NSCLC, and multiple Phase Ib/II studies in NSCLC, CRC, and other tumor types.
In October 2025, Innovent entered a global licensing and collaboration agreement with Takeda for the co-development and commercialization of IBI363, known within Takeda’s pipeline as TAK-928. Under the agreement, the companies will co-commercialize the therapy in the United States, while Takeda will hold exclusive commercialization rights outside the U.S. and greater China.
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About the Writer
Nikita Jha, BPharm (LinkedIn) a pharmacy graduate specializing in medical writing, with a strong ability to interpret complex medical and regulatory information and translate it into clear, accurate, and evidence-based healthcare content. Known for her attention to detail and precision, she focuses on delivering high-quality scientific communication that supports drug safety and informed decision-making.