Heidelberg Pharma and Huadong Medicine Secure NMPA Approval for HDP-101 Combination Trial in China

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 of pamlectabart tismanitin (HDP-101), a BCMA-targeting antibody-drug conjugate (ADC), in combination therapies for relapsed/refractory multiple myeloma. The approval marks a significant step in the global development of HDP-101, which has already shown promise as a monotherapy and now moves into combination regimens that could broaden its clinical utility.

The trial will evaluate 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. Huadong Medicine will conduct the trial in China and bear the development costs, as part of the strategic partnership established in February 2022, which granted Huadong exclusive rights to HDP-101 across 20 Asian markets.

This approval is particularly notable because it expands the clinical evaluation of HDP-101 into combination settings, a key element of Heidelberg Pharma's development strategy. By testing the ADC with established treatment regimens, the company aims to potentially position HDP-101 for earlier lines of therapy and broader patient populations. The combination approach is expected to enhance treatment outcomes by leveraging synergistic mechanisms, and the data generated will inform future registration trials.

The monotherapy development of HDP-101 has been progressing steadily. An ongoing Phase I/IIa trial in the U.S. and Europe began in 2022, and after dose escalation and determination of the recommended Phase II dose, a bridging study was initiated in China in March 2026. HDP-101 has 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 hematologic malignancy, and despite advances in treatment, most patients eventually relapse or become refractory to existing therapies. The approval of this combination trial in China, a major pharmaceutical market, is a critical step toward making HDP-101 available to patients in Asia and globally. It also strengthens the partnership between Heidelberg Pharma and Huadong Medicine, with Huadong becoming the second-largest shareholder of Heidelberg Pharma as part of the deal.

The initiation of this trial will provide valuable insights into the safety and efficacy of HDP-101 in combination with standard-of-care agents, potentially leading to new treatment options for patients with limited choices. As Heidelberg Pharma continues to advance its ATAC technology platform, this approval underscores the company's commitment to developing innovative cancer therapies based on amanitin, a toxin derived from the death cap mushroom, which offers a unique mechanism of action for ADC design.