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 pamlectabart tismanitin (HDP-101), a BCMA-targeting Antibody Drug Conjugate (ADC), in combination therapies for relapsed/refractory multiple myeloma. The approval enables the initiation of a trial that 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.
This regulatory milestone underscores the strategic importance of combination therapies in Heidelberg Pharma's clinical development plan for HDP-101. By evaluating the ADC with established regimens, the company aims to potentially expand its use to earlier treatment lines and broader patient populations, thereby addressing a significant unmet medical need in multiple myeloma. The trial will be conducted in China by Huadong Medicine, which bears the development costs under the existing partnership agreement.
HDP-101 has been under evaluation as a monotherapy in an ongoing Phase I/IIa trial in the U.S. and Europe since 2022, and a monotherapy bridging study was initiated in China in March 2026. The drug has received key regulatory designations from the U.S. FDA, including Orphan Drug Designation in March 2024 and Fast Track Designation in October 2025, highlighting its potential to address serious conditions.
The partnership between Heidelberg Pharma and Huadong Medicine dates back to February 2022, when they entered a strategic collaboration including an equity investment. Under this agreement, Huadong Medicine obtained exclusive development and commercialization rights to HDP-101 across 20 Asian markets and became the second-largest shareholder of Heidelberg Pharma. This collaboration leverages Huadong Medicine's regional expertise and resources to accelerate the development of HDP-101 in Asia.
Heidelberg Pharma is pioneering the use of amanitin, a toxin derived from the death cap mushroom, in its ATAC technology platform. Beyond HDP-101, the company has a pipeline of ATAC candidates targeting various cancers, including HDP-102 for Non-Hodgkin Lymphoma, HDP-103 for metastatic castration-resistant prostate cancer, and HDP-104 for gastrointestinal tumors, with the latter two available for partnering.
The approval of the combination trial in China is a pivotal step for Heidelberg Pharma as it seeks to maximize the therapeutic potential of HDP-101. By exploring combinations, the company aims to improve outcomes for multiple myeloma patients who have limited options after relapse. The trial's results could inform future registration studies and potentially lead to new treatment paradigms.
With this approval, Heidelberg Pharma and Huadong Medicine are well-positioned to advance the clinical development of HDP-101 in one of the world's largest pharmaceutical markets. The collaboration exemplifies a successful model for global drug development, combining innovative science with local expertise to bring promising therapies to patients faster.
