FBD Biologics, a subsidiary of HanchorBio (TPE:7827) has received U.S. Food and Drug Administration clearance for its Investigational New Drug application for HCB303, a trispecific fusion protein being developed for the potential treatment of solid tumors.

The FDA clearance will allow the company to proceed with clinical investigation of HCB303, according to a Saturday filing to the Taiwan stock exchange.

The company's shares were down nearly 2% in Monday's trade.

HanchorBio plans to initiate a Phase I first-in-human trial to evaluate the drug candidate's safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, biomarkers and preliminary antitumor activity.

Subsequently, depending on the clinical results and regulatory requirements, it plans to advance HCB303 through Phase II and Phase III trials before seeking marketing authorization.