HanchorBio Receives TFDA Approval for HCB303 Clinical Trials in Taiwan
Following U.S. FDA clearance, HanchorBio has secured authorization from Taiwan’s TFDA to initiate Phase 1 clinical development of its trispecific antibody candidate, HCB303.
HanchorBio has received regulatory approval from the Taiwan Food and Drug Administration (TFDA) to commence Phase 1 clinical trials for HCB303. This authorization builds upon previous clearance granted by the U.S. FDA, enabling the company to expand its clinical evaluation of the therapy across multiple regions.
HCB303 utilizes a trispecific ligand-trap mechanism designed to mitigate the CD226 downregulation commonly observed with standard anti-TIGIT antibodies. By targeting this mechanism, the drug aims to sustain immune activity against tumor cells more effectively than conventional therapeutic approaches.
The upcoming Phase 1 trials will prioritize establishing the safety and dosage parameters for human patients. This milestone moves HCB303 further into the clinical development pipeline as HanchorBio seeks to address existing limitations in cancer immunotherapy.