Heidelberg Pharma AG 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 BCMA-targeting antibody-drug conjugate (ADC), in combination with established therapies for relapsed/refractory multiple myeloma. This approval marks a significant step in Heidelberg Pharma's strategy to evaluate HDP-101 in combination regimens, potentially broadening its application across earlier treatment lines and larger patient populations.
The trial will assess the safety, tolerability, and preliminary efficacy of HDP-101 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 will conduct the trial in China and bear the development costs, as per the strategic partnership agreement signed in February 2022, which grants Huadong exclusive development and commercialization rights across 20 Asian markets.
HDP-101, developed using Heidelberg Pharma's proprietary ATAC technology based on amanitin, has already shown promise as a monotherapy in an ongoing Phase I/IIa trial in the U.S. and Europe. A bridging study for monotherapy in China was initiated in March 2026 following the determination of the recommended Phase II dose. The drug has received Orphan Drug Designation and Fast Track Designation from the U.S. FDA, underscoring its potential to address unmet medical needs in multiple myeloma.
The approval of this combination trial is crucial as it aligns with Heidelberg Pharma's clinical development strategy to integrate HDP-101 into standard treatment regimens. By combining with pomalidomide or daratumumab, both commonly used in multiple myeloma, the trial aims to enhance treatment efficacy and potentially improve outcomes for patients who have exhausted other options. This could also position HDP-101 as a viable option in earlier lines of therapy if results are positive.
For Heidelberg Pharma, this development reinforces its commitment to advancing innovative cancer therapies and expands its global footprint. For Huadong Medicine, it strengthens its oncology portfolio in China, a key market for multiple myeloma treatments. The collaboration exemplifies a strategic partnership that leverages regional expertise and resources to accelerate clinical development.
Heidelberg Pharma continues to explore HDP-101's full potential, with additional candidates in its pipeline targeting other hematologic and solid tumors. The company's ATAC technology offers a novel mechanism of action, distinguishing it from other ADC approaches. As the trial progresses, stakeholders will closely monitor the safety and efficacy data, which could influence future regulatory approvals and treatment paradigms in multiple myeloma.
