Heidelberg Pharma AG (FSE: HPHA) has announced that China's National Medical Products Administration (NMPA) has granted Clinical Trial Approval for a Phase Ib/II study of pamlectabart tismanitin (HDP-101), its novel BCMA-targeting Antibody Drug Conjugate (ADC), in combination with standard therapies for relapsed/refractory multiple myeloma. This approval marks a significant step for the company's clinical development strategy, as it will evaluate the ADC alongside established treatment regimens in a major global market.
The 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 Heidelberg Pharma's partner, Huadong Medicine Co., Ltd., the study will be fully funded by Huadong, which holds exclusive development and commercialization rights for HDP-101 across 20 Asian markets under a strategic partnership established in February 2022. This collaboration, which also made Huadong the second-largest shareholder of Heidelberg Pharma, is pivotal for expanding the drug's reach in Asia.
HDP-101 is currently being evaluated as a monotherapy in an ongoing Phase I/IIa trial in the U.S. and Europe, initiated in 2022. After determining the recommended Phase II dose, a monotherapy bridging study began in China in March 2026. The compound has received Orphan Drug Designation (ODD) and Fast Track Designation (FTD) from the U.S. FDA, underscoring its potential to address unmet medical needs in multiple myeloma. The move to combination therapies is a strategic effort to potentially position HDP-101 earlier in the treatment paradigm and broaden its patient population.
The approval in China represents a regulatory milestone that could accelerate the clinical development of HDP-101 and reinforce the value of the Heidelberg Pharma-Huadong partnership. By leveraging Huadong's local expertise and resources, the trial aims to generate data that may support future registrations in China and other Asian markets. This development also highlights the growing importance of ADCs in oncology and the potential of HDP-101 to offer new options for patients who have exhausted standard treatments.
Heidelberg Pharma is known for its innovative ATAC technology, derived from amanitin, a toxin from the death cap mushroom. The company's lead candidate, HDP-101, targets BCMA and is in clinical development for multiple myeloma, with additional programs for other cancers. The company is listed on the Frankfurt Stock Exchange and continues to advance its pipeline through strategic partnerships and regulatory achievements.
