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), a novel BCMA-targeting antibody drug conjugate (ADC), in combination therapies for patients with relapsed/refractory multiple myeloma. The approval marks a significant step in the clinical development of HDP-101, which has already shown promise as a monotherapy in earlier trials.
The upcoming trial will assess the safety, tolerability, and preliminary efficacy of pamlectabart tismanitin when combined with either pomalidomide and dexamethasone, or with daratumumab and dexamethasone, in adult patients who have received at least one prior line of therapy. This trial will be conducted by Huadong Medicine in China, which will bear the development costs under the existing partnership agreement between the two companies.
Pamlectabart tismanitin is currently being evaluated as a monotherapy in an ongoing Phase I/IIa trial in the U.S. and Europe, which began in 2022. After dose-escalation and determination of the recommended Phase II dose (RP2D), a monotherapy bridging study was initiated in China in March 2026. The compound has received key regulatory designations from the U.S. FDA, including Orphan Drug Designation (ODD) in March 2024 and Fast Track Designation (FTD) in October 2025, underscoring its potential to address unmet medical needs in multiple myeloma.
Combination therapy is a central element of Heidelberg Pharma's clinical development strategy for pamlectabart tismanitin. By evaluating the ADC in combination with established treatment regimens, the company aims to potentially expand its use across earlier treatment lines and broader patient populations, which could improve outcomes for patients with relapsed/refractory multiple myeloma.
The collaboration between Heidelberg Pharma and Huadong Medicine began in February 2022, with a strategic partnership that included an equity investment. Under the 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 partnership leverages Huadong Medicine's regional expertise and resources to accelerate the development and potential approval of HDP-101 in Asia.
Heidelberg Pharma is a pioneer in developing cancer therapies using Amanitin, a toxin derived from the green death cap mushroom. This unique mechanism of action is utilized in the company's ATAC technology, which forms the basis of its ADC pipeline. The lead candidate, HDP-101 (INN: pamlectabart tismanitin), targets BCMA and is in clinical development for multiple myeloma. Other pipeline candidates include HDP-102 for Non-Hodgkin Lymphoma, HDP-103 for metastatic castration-resistant prostate cancer, and HDP-104 for gastrointestinal tumors such as colorectal cancer, with the latter two having completed preclinical development and available for partnering.
The approval from the NMPA is a notable milestone for Heidelberg Pharma and Huadong Medicine, as it allows the advancement of combination therapy trials in a major pharmaceutical market. If successful, these trials could lead to new treatment options for multiple myeloma patients in China and potentially influence global treatment paradigms. The company's focus on combination strategies reflects a broader industry trend toward developing more effective and durable therapies for hematologic malignancies.
For more information about Heidelberg Pharma and its pipeline, visit Heidelberg Pharma's website.
