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Han-Kang's Subsidiary Files IND with FDA for Novel Tri-specific Immunotherapy HCB303
Health Technology · Biotechnology · cnyes · 2026-09-04
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Han-Kang-KY's subsidiary, FBD Biologics, has submitted an IND application to the FDA for HCB303, a tri-specific immunotherapy targeting advanced solid tumors.
What Happened
Clinical Progress: FBD Biologics, a subsidiary of Han-Kang-KY, has officially submitted an Investigational New Drug (IND) application to the U.S. FDA for its tri-specific immunotherapy candidate, HCB303. This marks the company's second tri-specific immunotherapy to enter clinical development, following the HCB301 program.
Development Strategy: The submission incorporates feedback from the FDA's pre-IND meeting in August, including protocols for dose-limiting toxicity (DLT) assessment and dose optimization strategies. The Phase 1 clinical trial will evaluate the safety, tolerability, and preliminary anti-tumor activity of HCB303 in adult patients with advanced, relapsed, or refractory solid tumors.
Technical Innovation: Developed via the proprietary FBDB platform, HCB303 is a humanized tri-specific fusion protein. It simultaneously targets three immune pathways—SIRPα/CD47, PD-L1/PD-1, and TIGIT/PVR—to synergistically activate macrophages, T cells, and NK cells against complex tumor resistance mechanisms.
Strategic Outlook: Chairman Liu Shih-kao emphasized that the development of differentiated therapeutic assets remains the core mission of the FBDB platform. HCB303 is expected to become a key component of the company's oncology pipeline as it continues to expand its footprint in cancer and immune-mediated disease treatments.