Heidelberg Pharma AG Granted Approval for Clinical Trial in China

Heidelberg Pharma AG, a biotech company in Germany, along with Huadong Medicine, has received approval from China's NMPA for a clinical trial of HDP-101 therapy. This Phase Ib/II trial will study the combination therapy in patients with relapsed/refractory multiple myeloma. Participants will receive the treatment in combination with either pomalidomide and dexamethasone or daratumumab and dexamethasone. Conducted by partner Huadong Medicine, the trial aims to assess the safety and efficacy of the therapy.

HDP-101, targeting BCMA, is already under study in the U.S. and Europe as a monotherapy. The treatment has earned the FDA's Orphan Drug Designation and Fast Track Designation. Heidelberg Pharma's strategy includes developing combination therapies to broaden the use of their ADC in multiple treatment regimens. The collaboration with Huadong, formed in 2022, gives them rights to develop and commercialize HDP-101 in many Asian markets.