HanchorBio's (TPE:7827) subsidiary, FBD Biologics, has submitted an Investigational New Drug application to the Taiwan Food and Drug Administration (TFDA) for clinical trial review of HCB303, a trispecific fusion protein being developed for the potential treatment of solid tumors.
The application follows the recent receipt of approval from the U.S. Food and Drug Administration for HCB303, according to a Wednesday filing to the Taiwan Stock Exchange.
TFDA approval and applicable institutional ethics approval will pave the way for patient enrollment for the trial in Taiwan.
Following receipt of the required regulatory and institutional ethics approvals, the company plans to conduct Phase I, Phase II, and Phase III clinical trials sequentially.