On May 6, 2026 InnoCare Pharma (HKEX: 9969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application to initiate a clinical trial of its novel CDH17 targeted ADC, ICP-B208.
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CDH17 is a calcium-dependent cell adhesion protein that plays a key role in tumor cell proliferation, migration, and metastasis. Its tumor-restricted expression and functional role in cancer biology make CDH17 an attractive and differentiated target for ADC therapy, which can be developed for the treatment of gastrointestinal cancers, including colorectal, gastric, pancreatic ductal adenocarcinoma, and biliary tract cancer. Currently, there are no approved CDH17 targeted ADCs globally.
ICP-B208 is a novel ADC comprising a humanized anti-CDH17 monoclonal antibody conjugated to a potent, in-house developed payload via a protease-cleavable linker. This design enables significantly enhanced tumor-killing effects with improved stability and safety. Preclinical studies show that ICP-B208 demonstrates good anti-tumor activity even in CDH17-low tumors, and improved cell killing activity compared to similar drugs.
ICP-B208 is the second novel ADC to enter into clinical development by the Company’s in-house developed ADC platform, following ICP-B794, a novel B7-H3 targeted ADC. As the platform continues to evolve, the Company is poised to expand its portfolio with multiple differentiated ADC candidates.
Dr. Jasmine Cui, Co-Founder, Chairwoman, and CEO of InnoCare, said, "The approval of the clinical trial of ICP-B208 marks another milestone in our solid tumor pipeline and validates the huge drug development potential of our ADC platform. We will continue to expand our portfolio with multiple ADC candidates and bring new hope to cancer patients worldwide."
(Press release, InnoCare Pharma, MAY 6, 2026, View Source [SID1234665235])