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) for a Phase Ib/II study evaluating the novel BCMA-targeting antibody-drug conjugate (ADC) pamlectabart tismanitin (HDP-101) in combination regimens for patients with relapsed/refractory multiple myeloma. The approval marks a significant step in the global development of HDP-101, which has already shown promise as a monotherapy.
The upcoming 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. Huadong Medicine will conduct the trial in China and bear the associated development costs, reflecting the strategic partnership the companies established in February 2022.
HDP-101 has been under evaluation as a monotherapy in an ongoing Phase I/IIa study in the United States and Europe since 2022. After completing dose escalation and identifying the recommended Phase II dose, a monotherapy bridging study was initiated in China in March 2026. The drug has also received key regulatory designations from the U.S. Food and Drug Administration, including Orphan Drug Designation in March 2024 and Fast Track Designation in October 2025.
Combination therapy is a cornerstone of Heidelberg Pharma's clinical strategy for HDP-101. By testing the ADC with established treatments, the company aims to potentially broaden its use across earlier lines of therapy and reach a wider patient population. This approach is particularly relevant in multiple myeloma, where combination regimens have become the standard of care.
The partnership with Huadong Medicine, which also made the Chinese company Heidelberg Pharma's second-largest shareholder, grants Huadong exclusive development and commercialization rights for HDP-101 in 20 Asian markets. This regional focus is expected to accelerate patient access to the therapy in Asia, complementing Heidelberg Pharma's efforts in Western markets.
Heidelberg Pharma specializes in developing cancer therapies based on amanitin, a toxin derived from the death cap mushroom. This unique mechanism, known as ATAC technology, distinguishes its ADC pipeline. Beyond HDP-101, the company has HDP-102 in clinical development for non-Hodgkin lymphoma, and HDP-103 and HDP-104 in preclinical stages for prostate and gastrointestinal cancers, respectively.
The NMPA approval for the combination trial is a milestone that could have far-reaching implications. If successful, it may support the registration of HDP-101 in China and other Asian countries, potentially offering a new treatment option for multiple myeloma patients who have exhausted standard therapies. Moreover, the data from this trial will inform future development strategies, including possible registrational studies, and could enhance the drug's commercial prospects.
The company's forward-looking statements highlight the potential of HDP-101, but also acknowledge the risks and uncertainties inherent in clinical development. Nevertheless, this approval underscores the progress being made in the fight against multiple myeloma and the growing role of ADCs in oncology.
