Heidelberg Pharma AG (FSE: HPHA) and its partner Huadong Medicine Co., Ltd. have received Clinical Trial Approval from China's National Medical Products Administration (NMPA) to conduct a Phase Ib/II study of pamlectabart tismanitin (HDP-101), a novel BCMA-targeting antibody-drug conjugate (ADC), in combination regimens for relapsed/refractory multiple myeloma. This regulatory green light marks a significant step in expanding the drug's clinical development into combination settings, potentially broadening its use to earlier lines of therapy.
The approved trial will assess the safety, tolerability, and preliminary efficacy of HDP-101 when combined with either pomalidomide and dexamethasone or daratumumab and dexamethasone in adult patients who have received at least one prior line of therapy. Conducted by Huadong Medicine in China, the study will be fully funded by the partner, reflecting the strategic collaboration established in February 2022. Under that agreement, Huadong Medicine secured exclusive development and commercialization rights across 20 Asian markets and became Heidelberg Pharma's second-largest shareholder.
HDP-101 has been under evaluation as a monotherapy in an ongoing Phase I/IIa trial in the U.S. and Europe since 2022. After completing dose escalation and determining the recommended Phase II dose, a monotherapy bridging study was initiated in China in March 2026. The drug has already garnered important regulatory designations from the U.S. FDA, including Orphan Drug Designation (ODD) in March 2024 and Fast Track Designation (FTD) in October 2025, underscoring its potential in addressing unmet medical needs.
Combination therapy is a core component of Heidelberg Pharma's development strategy for HDP-101. By evaluating the ADC alongside established treatment regimens, the company aims to enhance its therapeutic impact and position it for earlier intervention and broader patient reach. The NMPA approval facilitates this strategy in one of the world's largest pharmaceutical markets.
Heidelberg Pharma is a pioneer in using amanitin, a toxin derived from the death cap mushroom, as a payload in its ATAC technology. This innovative approach offers a new mechanism of action for cancer therapy. HDP-101 is the lead candidate, targeting BCMA for multiple myeloma, and has received FDA's ODD and FTD. The pipeline also includes HDP-102 for non-Hodgkin lymphoma, and HDP-103 and HDP-104 for prostate and gastrointestinal cancers, respectively, which are available for partnership.
The approval not only validates the potential of HDP-101 in combination settings but also highlights the strength of the Heidelberg Pharma-Huadong collaboration. As the trial progresses, it could provide critical data to support expanded indications and potentially accelerate the drug's availability in Asian markets. The development aligns with the company's commitment to advancing novel ADC therapies for patients with limited options.
