Heidelberg Pharma AG (FSE: HPHA) announced that China's National Medical Products Administration (NMPA) has granted Clinical Trial Approval for a Phase Ib/II study of its novel BCMA-targeting antibody-drug conjugate (ADC), pamlectabart tismanitin (HDP-101), in combination therapy for patients with relapsed/refractory multiple myeloma. This regulatory milestone enables the company and its partner Huadong Medicine to evaluate the ADC in combination with established treatment regimens, a strategic move that could expand its use across earlier lines of therapy and wider patient populations.
The approved trial will assess the safety, tolerability, and preliminary efficacy of pamlectabart tismanitin combined with either pomalidomide and dexamethasone or daratumumab and dexamethasone. The study will enroll 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, leveraging its regional expertise and infrastructure.
Pamlectabart tismanitin is currently being evaluated 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 drug has already received Orphan Drug Designation and Fast Track Designation from the U.S. FDA, underscoring its potential in treating multiple myeloma, a disease with high unmet medical need.
The shift toward combination therapies is a key component of Heidelberg Pharma's clinical strategy. By combining HDP-101 with standard-of-care agents like pomalidomide or daratumumab, the company aims to enhance treatment efficacy and potentially overcome resistance mechanisms, positioning the ADC as a backbone therapy in multiple myeloma. This approach could also accelerate the drug's development timeline and broaden its market potential.
The partnership with Huadong Medicine, established in February 2022, grants the Chinese company exclusive development and commercialization rights to HDP-101 across 20 Asian markets. Huadong Medicine also became Heidelberg Pharma's second-largest shareholder, reflecting a deep strategic alignment. The NMPA approval marks a significant advancement in this collaboration, potentially expediting the availability of innovative therapies for multiple myeloma patients in Asia.
Heidelberg Pharma's proprietary ATAC technology, derived from amanitin, offers a novel mechanism of action distinct from conventional ADCs. The company's lead candidate, HDP-101, targets BCMA, a validated antigen in multiple myeloma. With this new trial approval, Heidelberg Pharma and Huadong Medicine are poised to generate critical data that could reshape treatment paradigms for relapsed/refractory multiple myeloma, offering hope to patients who have exhausted existing options.
For more information on Heidelberg Pharma's pipeline and partnerships, visit Heidelberg Pharma.
