Heidelberg Pharma AG (FSE: HPHA) announced that China's National Medical Products Administration (NMPA) has granted Clinical Trial Approval for a Phase Ib/II study evaluating pamlectabart tismanitin (HDP-101), its novel BCMA-targeting Antibody Drug Conjugate (ADC), in combination with established treatments for relapsed/refractory multiple myeloma. The trial, to be conducted by Heidelberg Pharma's partner Huadong Medicine Co., Ltd. in China, 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.
This approval marks a significant step in Heidelberg Pharma's clinical development strategy, which emphasizes combination therapies to potentially broaden HDP-101's use across earlier treatment lines and larger patient populations. The company is already evaluating HDP-101 as a monotherapy in an ongoing Phase I/IIa trial in the U.S. and Europe since 2022. Following dose-escalation and determination of the recommended Phase II dose, a monotherapy bridging study was initiated in China in March 2026. HDP-101 has also received key regulatory designations from the U.S. FDA, including Orphan Drug Designation in March 2024 and Fast Track Designation in October 2025.
The partnership with Huadong Medicine, established in February 2022, grants the Chinese firm exclusive development and commercialization rights to HDP-101 across 20 Asian markets. Huadong Medicine also became the second-largest shareholder of Heidelberg Pharma. Under the agreement, Huadong Medicine will bear the development costs for the newly approved combination trial.
Heidelberg Pharma is a pioneer in developing cancer therapies using Amanitin, a toxin derived from the green death cap mushroom, which is utilized in its proprietary ATAC technology. The lead candidate HDP-101 is a BCMA ATAC in clinical development for multiple myeloma, while other candidates target Non-Hodgkin Lymphoma, metastatic castration-resistant prostate cancer, and gastrointestinal tumors. These programs are available for partnering.
The approval underscores the growing importance of combination strategies in oncology and the potential of ADCs to enhance existing treatment regimens. By advancing HDP-101 in combination therapies, Heidelberg Pharma aims to improve outcomes for patients with multiple myeloma, a disease that remains incurable for many. The collaboration with Huadong Medicine also highlights the strategic value of partnerships in navigating regional regulatory landscapes and accelerating global development.
For more information about Heidelberg Pharma and its pipeline, visit Heidelberg Pharma.
