Heidelberg Pharma AG (FSE: HPHA) and its partner Huadong Medicine Co., Ltd. have received Clinical Trial Approval from China's National Medical Products Administration (NMPA) for a Phase Ib/II study evaluating pamlectabart tismanitin (HDP-101) in combination with standard regimens for relapsed/refractory multiple myeloma. The approval marks a significant step in the strategic partnership between the two companies and underscores the growing importance of combination strategies in ADC development.
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 trial in China and bear the development costs, as per the partnership agreement signed in February 2022, which granted Huadong exclusive rights to HDP-101 across 20 Asian markets.
This approval follows the initiation of a monotherapy bridging study in China in March 2026, which was designed to support the combination trial. The combination program is a core part of Heidelberg Pharma's clinical strategy for HDP-101, aiming to position the ADC for earlier lines of treatment and to potentially benefit a wider range of patients. By combining HDP-101 with established therapies, the company hopes to improve outcomes and overcome resistance mechanisms that often limit the efficacy of single-agent treatments.
HDP-101 is a BCMA-targeting Antibody Drug Conjugate (ADC) built on Heidelberg Pharma's proprietary ATAC technology, which utilizes amanitin, a toxin derived from the death cap mushroom, to selectively kill cancer cells. The compound has already received Orphan Drug Designation from the U.S. FDA in March 2024 and Fast Track Designation in October 2025, reflecting its potential to address unmet medical needs in multiple myeloma.
The ongoing Phase I/IIa monotherapy trial in the U.S. and Europe has established a recommended Phase II dose, and the company is now expanding its clinical footprint. "Combination therapies are essential to fully realize the potential of our ATAC platform," said a company spokesperson. "This approval in China is a key milestone, as it allows us to explore synergistic effects with standard of care agents in a major market."
The strategic partnership with Huadong Medicine has been instrumental in advancing HDP-101's development in Asia. Huadong Medicine's investment made it the second-largest shareholder of Heidelberg Pharma, and its expertise in clinical development and commercialization in China is expected to accelerate the program. The NMPA approval is a testament to the collaborative efforts and the promise of HDP-101 as a potential new therapy for multiple myeloma.
As Heidelberg Pharma continues to advance its pipeline, including HDP-102 for Non-Hodgkin Lymphoma and preclinical candidates HDP-103 and HDP-104, the company remains focused on leveraging its unique ATAC technology to develop next-generation cancer treatments. The combination trial in China represents a significant stride toward bringing this innovative therapy to patients in need.
