Heidelberg Pharma AG (FSE: HPHA) and its partner Huadong Medicine Co., Ltd. have received approval from the China National Medical Products Administration (NMPA) to initiate a Phase Ib/II clinical trial evaluating pamlectabart tismanitin (HDP-101) in combination therapies for patients with relapsed/refractory multiple myeloma. The approval marks a significant step in the company's strategy to explore combination regimens that could broaden the ADC's use across earlier treatment lines and larger patient populations.
The trial will assess the safety, tolerability, and preliminary efficacy of pamlectabart tismanitin 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 outlined in the strategic partnership established in February 2022, which granted Huadong Medicine exclusive development and commercialization rights for HDP-101 across 20 Asian markets.
Pamlectabart tismanitin, a BCMA-targeting antibody drug conjugate (ADC), is currently being evaluated as a monotherapy in an ongoing Phase I/IIa trial in the U.S. and Europe since 2022. Following 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 in addressing unmet medical needs in multiple myeloma.
Heidelberg Pharma's ATAC technology, which utilizes amanitin derived from the death cap mushroom, represents a novel therapeutic approach in oncology. The company's lead candidate, HDP-101, is one of several ATACs in development, with others targeting non-Hodgkin lymphoma, prostate cancer, and gastrointestinal tumors. The collaboration with Huadong Medicine not only provides access to the Chinese market but also strengthens Heidelberg Pharma's financial position, with Huadong Medicine becoming its second-largest shareholder.
This approval is a crucial milestone for Heidelberg Pharma, as it expands the clinical development of HDP-101 into combination settings, potentially improving treatment outcomes for multiple myeloma patients who have limited options after relapse. The trial's results could inform future registration strategies and support the expansion of HDP-101's label, should the combinations prove successful. For patients, the combination approach may offer enhanced efficacy and overcome resistance mechanisms, ultimately improving survival and quality of life.
The news also highlights the growing importance of China as a key market for innovative cancer therapies, with regulatory approvals enabling faster patient access. As Heidelberg Pharma continues to advance its pipeline, the partnership with Huadong Medicine underscores the global effort to bring novel treatments to patients worldwide. The company remains committed to exploring the full potential of its ATAC platform through strategic collaborations and rigorous clinical development.
