Heidelberg Pharma AG (FSE: HPHA) and its partner Huadong Medicine Co., Ltd. have obtained Clinical Trial Approval from China's National Medical Products Administration (NMPA) for a Phase Ib/II study evaluating pamlectabart tismanitin (HDP-101), a BCMA-targeting antibody-drug conjugate (ADC), in combination regimens for patients with relapsed/refractory multiple myeloma. The approval marks a significant step in Heidelberg Pharma's strategy to combine its novel ATAC technology with established treatments, potentially broadening its therapeutic application.
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. Huadong Medicine will conduct the study in China and bear the development costs, as per the strategic partnership agreement signed in February 2022. Under that agreement, Huadong Medicine obtained exclusive development and commercialization rights for HDP-101 across 20 Asian markets and became Heidelberg Pharma's second-largest shareholder.
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 and determination of the recommended Phase II dose, a monotherapy bridging study was initiated in China in March 2026. The candidate has received key regulatory designations from the U.S. FDA, including Orphan Drug Designation in March 2024 and Fast Track Designation in October 2025, underscoring its potential to address unmet medical needs.
The approval of the combination trial is particularly important because combination therapies are integral to Heidelberg Pharma's clinical development strategy. By evaluating HDP-101 in conjunction with standard regimens, the company aims to generate data that could support its use in earlier treatment lines and in a broader patient population. This approach is designed to maximize the therapeutic potential of the ADC and could ultimately lead to improved outcomes for multiple myeloma patients, who often face limited options after relapse.
Multiple myeloma is a challenging hematologic malignancy, and while recent advances have improved survival, most patients eventually relapse and become refractory to available treatments. The addition of HDP-101, which utilizes a unique amanitin-based payload, offers a novel mechanism of action that may overcome resistance to existing therapies. The combination trials will provide crucial insights into how this ADC can be integrated into current treatment paradigms, potentially enhancing efficacy without compromising safety.
Heidelberg Pharma is the first company to develop cancer therapies using amanitin, a toxin derived from the death cap mushroom, and its ATAC technology represents a new modality in oncology. Beyond HDP-101, the company has a pipeline including HDP-102 for non-Hodgkin lymphoma and preclinical candidates HDP-103 and HDP-104 for prostate and gastrointestinal cancers, respectively. These programs are available for partnering, indicating the company's commitment to advancing its platform through collaborations.
The NMPA approval not only advances HDP-101's clinical program but also strengthens the partnership between Heidelberg Pharma and Huadong Medicine, which is pivotal for accessing the large Chinese market. As the trial progresses, data will be critical in determining the future development path for HDP-101 and its potential role in transforming multiple myeloma treatment.
