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 novel BCMA-targeting antibody drug conjugate (ADC), in combination regimens for relapsed/refractory multiple myeloma. The approval marks a significant step in the companies' strategic partnership and underscores the growing importance of the Chinese market in global oncology drug development.
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 Huadong Medicine in China, the study will be fully funded by the partner, aligning with the 2022 collaboration agreement that granted Huadong exclusive development and commercialization rights across 20 Asian markets.
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 dose escalation established a recommended Phase II dose, a monotherapy bridging study was initiated in China in March 2026. The compound has garnered 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 in a disease area with high unmet need.
Combination therapy is a cornerstone of Heidelberg Pharma's clinical development strategy for HDP-101. By exploring its use alongside established regimens, the company aims to potentially expand the ADC's application to earlier treatment lines and broader patient populations. This approach could address the inevitable relapse observed in multiple myeloma and improve long-term outcomes.
The NMPA approval is particularly timely, as China has become a hub for innovative cancer research, offering a large patient pool and accelerated regulatory pathways. Huadong Medicine's local expertise and infrastructure will facilitate efficient trial execution, potentially expediting patient recruitment and data collection.
For Heidelberg Pharma, this development reinforces its commitment to advancing its proprietary ATAC technology, which leverages amanitin, a toxin from the death cap mushroom, as a novel payload. The company's lead candidate HDP-101 is at the forefront of this approach, and the combination trial in China could generate pivotal data to support global registration.
The collaboration with Huadong Medicine, which also holds a significant equity stake in Heidelberg Pharma, provides a strong foundation for commercializing HDP-101 in Asia. This partnership model is increasingly common in the biotech industry, enabling smaller companies to access large markets while sharing development risks and costs.
As the trial progresses, stakeholders will closely monitor safety and efficacy signals. The outcomes could influence treatment paradigms for relapsed/refractory multiple myeloma, potentially offering new options for patients who have exhausted existing therapies.
