Curated News
By: NewsRamp Editorial Staff
August 26, 2026
Heidelberg Pharma Gets NMPA Nod for HDP-101 Combo Trial in China
TLDR
- Heidelberg Pharma gains NMPA approval for HDP-101 combo therapy in China, advancing market position and partnership value.
- NMPA approved a Phase Ib/II trial of HDP-101 with pomalidomide or daratumumab plus dexamethasone for relapsed/refractory multiple myeloma.
- This approval brings new combination treatment options for multiple myeloma patients in China, potentially improving outcomes and quality of life.
- Heidelberg Pharma uses amanitin from death cap mushrooms to create targeted cancer therapies, with HDP-101 now advancing in China.
Impact - Why it Matters
This approval is pivotal as it enables the evaluation of HDP-101 in combination regimens, which could significantly broaden its applicability and improve outcomes for multiple myeloma patients. By expanding into the Chinese market through a strategic partnership, Heidelberg Pharma is not only accelerating clinical development but also laying groundwork for future commercial access in Asia. For patients, this may lead to more effective treatment options and potentially earlier intervention. For the company, it strengthens its global footprint and validates its ATAC technology, while for the broader oncology community, it represents progress in ADC-based therapies beyond established targets.
Summary
Heidelberg Pharma AG (FSE: HPHA), a clinical-stage biotech company specializing in Antibody Drug Conjugates (ADCs), has received Clinical Trial Approval from China's National Medical Products Administration (NMPA) for a Phase Ib/II study of its novel BCMA-targeting ADC, pamlectabart tismanitin (HDP-101), in combination therapy for relapsed/refractory multiple myeloma. The trial will assess safety, tolerability, and preliminary efficacy when combined with either pomalidomide and dexamethasone or daratumumab and dexamethasone, in patients who have had at least one prior line of therapy. Conducted by partner Huadong Medicine Co., Ltd., who will cover development costs, this marks a significant step in expanding the drug's potential use.
Pamlectabart tismanitin is already in a Phase I/IIa monotherapy trial in the U.S. and Europe since 2022, with a bridging study initiated in China in March 2026. The drug has received Orphan Drug Designation (March 2024) and Fast Track Designation (October 2025) from the FDA. Combination therapy is a key part of Heidelberg Pharma's strategy to position the ADC in earlier treatment lines and broader patient populations. The partnership with Huadong Medicine, established in February 2022, grants exclusive development and commercialization rights across 20 Asian markets, and Huadong became Heidelberg's second-largest shareholder. This collaboration underscores the global expansion of innovative cancer treatments.
Heidelberg Pharma is pioneering ATAC technology, derived from the green death cap mushroom's amanitin toxin, and HDP-101 is its lead candidate. With this NMPA approval, the company is advancing its mission to offer new therapeutic options for multiple myeloma, a disease with high unmet need. The trial results will inform future combination strategies and potentially accelerate patient access to this promising therapy in China and beyond.
Source Statement
This curated news summary relied on content distributed by NewMediaWire. Read the original source here, Heidelberg Pharma Gets NMPA Nod for HDP-101 Combo Trial in China
