Heidelberg Pharma AG (FSE: HPHA) and its partner Huadong Medicine Co., Ltd. have obtained Clinical Trial Approval from China's National Medical Products Administration (NMPA) to initiate a Phase Ib/II study of pamlectabart tismanitin (HDP-101), a BCMA-targeting antibody-drug conjugate (ADC), in combination with standard regimens for relapsed/refractory multiple myeloma.
The trial will assess the safety, tolerability, and preliminary efficacy of HDP-101 when combined either with pomalidomide and dexamethasone or with daratumumab and dexamethasone in adult patients who have received at least one prior line of therapy. Huadong Medicine, which holds exclusive development and commercialization rights for HDP-101 across 20 Asian markets under a strategic partnership established in February 2022, will conduct the study and bear its costs.
This approval follows the initiation of a monotherapy bridging study with pamlectabart tismanitin in China in March 2026, after the recommended Phase II dose was determined in the ongoing Phase I/IIa trial in the U.S. and Europe. The drug has already received Orphan Drug Designation from the U.S. FDA in March 2024 and Fast Track Designation in October 2025.
Combination therapy is a cornerstone of Heidelberg Pharma's development strategy for HDP-101, aiming to expand its potential use to earlier treatment lines and broader patient populations. The company's ATAC technology, based on amanitin derived from the death cap mushroom, offers a novel mechanism of action distinct from conventional ADCs.
Heidelberg Pharma's pipeline includes HDP-102 for Non-Hodgkin Lymphoma, and HDP-103 and HDP-104 for solid tumors, which are available for partnering. The company is listed on the Frankfurt Stock Exchange and more information is available at www.heidelberg-pharma.com.
