SAN FRANCISCO and SUZHOU, China, May 10, 2026
Innovent Biologics, Inc. announced that China’s National Medical Products Administration (NMPA) has granted a third Breakthrough Therapy Designation (BTD) to its investigational PD-1/IL-2α-bias bispecific fusion protein IBI363 in combination with bevacizumab for the treatment of advanced microsatellite stable or proficient mismatch repair (MSS/pMMR) metastatic colorectal cancer (CRC) in patients who have failed at least two prior lines of therapy. The designation represents another major regulatory milestone for Innovent’s rapidly expanding immuno-oncology pipeline and further strengthens the company’s position in next-generation cancer immunotherapy development.
IBI363 Demonstrates Promise in Difficult-to-Treat Colorectal Cancer
The latest regulatory recognition follows encouraging early-stage clinical findings presented at the 2025 ASCO Annual Meeting, where IBI363 combined with bevacizumab demonstrated promising anti-tumor activity in heavily pretreated MSS/pMMR colorectal cancer patients. MSS/pMMR colorectal cancer represents nearly 95% of advanced colorectal cancer cases worldwide, yet most patients in this subgroup show limited response to conventional checkpoint inhibitor therapies, creating a significant unmet medical need within oncology treatment.
Innovent stated that a Phase III clinical trial in China is expected to begin in the near term, highlighting the company’s accelerated development strategy for IBI363. The therapy has already received two previous Breakthrough Therapy Designations from China’s NMPA and two Fast Track Designations from the U.S. FDA across indications including non-small cell lung cancer and melanoma. Industry experts continue to monitor IBI363 closely due to its potential to overcome immunotherapy resistance and cold tumor challenges, two of the most difficult barriers in modern cancer treatment.
Dual-Mechanism Immunotherapy Platform Drives Innovation
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IBI363 is designed as a first-in-class bispecific fusion protein that combines PD-1 blockade with selective IL-2 pathway activation, allowing it to stimulate tumor-specific immune responses while reducing systemic toxicity commonly associated with traditional IL-2 therapies. According to Innovent, the molecule selectively expands tumor-targeting T-cell populations while reshaping the tumor microenvironment to enhance anti-cancer immune activity. This differentiated mechanism has positioned IBI363 among the most closely watched emerging immuno-oncology candidates globally.
Dr. Hui Zhou, Chief R&D Officer of Innovent’s oncology pipeline, noted that the therapy reflects the company’s commitment to advancing innovative cancer treatments for patients with limited therapeutic options. The company emphasized that the latest NMPA designation validates the scientific rationale and clinical potential of IBI363 across multiple tumor types.
The NMPA’s Breakthrough Therapy Designation program is designed to accelerate the development and review of investigational medicines intended for serious diseases where preliminary clinical evidence suggests meaningful improvement over existing treatment options. Products receiving the designation benefit from enhanced regulatory communication and expedited review pathways, potentially shortening approval timelines for patients with urgent medical needs.
Global Development Collaboration Expands Commercial Potential
Innovent continues to expand the global development footprint of IBI363 through its collaboration with Takeda, announced in October 2025. Under the agreement, both companies will co-develop the therapy globally while jointly commercializing the product in the United States. Takeda retains exclusive commercialization rights outside the U.S. and greater China, strengthening the program’s international commercial prospects.
In addition to colorectal cancer, IBI363 is currently being evaluated in multiple global clinical trials involving non-small cell lung cancer, melanoma, and other solid tumors. The broader pipeline reflects increasing industry focus on next-generation bispecific immunotherapies capable of improving response rates in difficult-to-treat cancers.
The latest breakthrough designation further reinforces Innovent’s growing reputation within the global biopharmaceutical sector while highlighting the accelerating momentum behind advanced immuno-oncology research, precision medicine strategies, and innovative biologic drug development.
Source: Innovent press release
