Hanmi Pharm to start global clinical trials for immune-oncology drug

South Korea's Hanmi Pharmaceutical Co. announced on Tuesday that it has received approval for the phase 1 clinical trial plan of the immune-oncology drug BH3120, which is being jointly developed with its Chinese subsidiary Beijing Hanmi Pharm by the Korean Ministry of Food and Drug Safety.

Hanmi Pharmaceutical plans to initiate multinational clinical trials simultaneously in South Korea and the US within the year. The company had already obtained approval for the phase 1 clinical trial plan for the same substance from the US Food and Drug Administration (FDA) in May this year.

According to the company, BH3120 is a new drug candidate that applies the bispecific antibody platform technology called Pentambody, enabling a single antibody to simultaneously bind to two different targets.

The company explained that by targeting the protein PD-L1 on cancer cells and the molecule 4-1BB that activates immune cells, BH3120 can facilitate both immune-oncology therapy and targeted oncology therapy at the same time.

"BH3120 is our first project to conduct global clinical research using the next-generation bispecific antibody platform technology, Pentambody," a Hanmi Pharmaceutical source said. "Pentambody will continue to generate Hanmi's strong future value."

Write to Ji-Hyun Lee at bluesky@hankyung.com