Heidelberg Pharma AG (FSE: HPHA) and its partner Huadong Medicine Co., Ltd. have received Clinical Trial Approval from the China National Medical Products Administration (NMPA) for a Phase Ib/II study evaluating pamlectabart tismanitin (HDP-101) in combination therapies for patients with relapsed/refractory multiple myeloma. The announcement, made on August 26, 2026, marks a significant step in the clinical development of this novel BCMA-targeting antibody drug conjugate (ADC).
The trial will assess the safety, tolerability, and preliminary efficacy of pamlectabart tismanitin 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 development costs, as part of a strategic partnership established in February 2022 that granted Huadong exclusive rights to HDP-101 across 20 Asian markets.
This approval is crucial for Heidelberg Pharma's strategy to explore combination regimens, which could potentially position the ADC for earlier treatment lines and broader patient populations. The company has been evaluating pamlectabart tismanitin as a monotherapy in an ongoing Phase I/IIa trial in the U.S. and Europe since 2022, and a monotherapy bridging study in China was initiated in March 2026. The drug has already received Orphan Drug Designation (ODD) from the U.S. FDA in March 2024 and Fast Track Designation (FTD) in October 2025, underscoring its potential to address unmet medical needs in multiple myeloma.
Multiple myeloma remains an incurable malignancy with high relapse rates, and new treatment options are urgently needed. The combination of HDP-101 with established regimens like pomalidomide or daratumumab could enhance efficacy and overcome resistance, offering hope to patients who have exhausted standard therapies. For Heidelberg Pharma, the approval expands its clinical footprint into China, a major pharmaceutical market, and validates its ATAC technology platform, which uses amanitin derived from the death cap mushroom as a novel cytotoxic payload.
The trial's success could lead to regulatory submissions in China and potentially worldwide, impacting treatment paradigms and providing a new option for relapsed/refractory patients. For the industry, this highlights the growing interest in ADCs with novel mechanisms of action and the importance of international partnerships in accelerating drug development. Heidelberg Pharma's ATAC technology represents a unique approach in oncology, and positive results from this combination trial would further differentiate it from other ADCs.
As the study progresses, data on safety and efficacy will be closely watched by oncologists and investors. If successful, HDP-101 could become a backbone therapy in multiple myeloma, potentially reshaping treatment algorithms and offering a much-needed alternative for patients with limited options. The approval also reinforces the strategic collaboration between Heidelberg Pharma and Huadong Medicine, which has already made Huadong the second-largest shareholder of the German biotech.
For more information about Heidelberg Pharma and its pipeline, visit www.heidelberg-pharma.com.
