Heidelberg Pharma AG (FSE: HPHA) and its partner Huadong Medicine Co., Ltd. have received approval from China’s National Medical Products Administration (NMPA) to conduct a Phase Ib/II clinical trial of pamlectabart tismanitin (HDP-101), a novel BCMA-targeting antibody drug conjugate (ADC), in combination with established treatments for relapsed/refractory multiple myeloma. The approval, announced on August 26, 2026, marks a significant step in the companies’ strategy to evaluate the drug in combination settings, potentially broadening its use across earlier treatment lines and larger patient populations.
The trial will assess the safety, tolerability, and preliminary efficacy of pamlectabart tismanitin when combined either with pomalidomide and dexamethasone or with daratumumab and dexamethasone in adult patients who have received at least one prior line of therapy. Huadong Medicine, which holds exclusive development and commercialization rights to HDP-101 in 20 Asian markets, will conduct the trial and bear its development costs. This partnership, established in February 2022, also made Huadong Medicine the second-largest shareholder of Heidelberg Pharma.
Pamlectabart tismanitin is already being evaluated as a monotherapy in an ongoing Phase I/IIa clinical trial in the U.S. and Europe since 2022. After dose-escalation and determination of the recommended Phase II dose, a monotherapy bridging study was initiated in China in March 2026. The drug has also received key regulatory designations from the U.S. Food and Drug Administration, including Orphan Drug Designation in March 2024 and Fast Track Designation in October 2025, underscoring its potential to address unmet medical needs in multiple myeloma.
The approval of the combination trial in China is a key component of Heidelberg Pharma’s clinical development strategy for pamlectabart tismanitin. By evaluating the ADC with standard regimens, the company aims to generate data that could support its use in earlier lines of therapy and in a wider range of patients. This is particularly important as multiple myeloma remains an incurable disease, and patients often relapse after initial treatments, creating a high demand for novel therapeutic options.
Heidelberg Pharma is a pioneer in developing cancer therapies using amanitin, a toxin derived from the death cap mushroom, through its ATAC technology. The company’s lead candidate, HDP-101, is designed to target BCMA, a protein highly expressed on myeloma cells, delivering a potent cytotoxic payload. Other pipeline candidates include HDP-102 for Non-Hodgkin Lymphoma, and HDP-103 and HDP-104 for solid tumors, all at various stages of development and available for partnering.
The collaboration between Heidelberg Pharma and Huadong Medicine is a testament to the growing interest in ADCs as a powerful modality in oncology. With the NMPA’s approval, the companies can now proceed with the combination trial, which could yield valuable insights into how pamlectabart tismanitin performs alongside existing therapies. If successful, this could lead to expanded indications and improved outcomes for multiple myeloma patients in China and across Asia, where the disease burden is significant.
For more information, visit Heidelberg Pharma’s website.
