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 of pamlectabart tismanitin (HDP-101), a BCMA-targeting antibody-drug conjugate (ADC), in combination with established therapies for relapsed/refractory multiple myeloma. The trial will assess the safety, tolerability, and preliminary efficacy of HDP-101 in combination either with pomalidomide and dexamethasone or with daratumumab and dexamethasone, enrolling 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.
This approval is a pivotal advancement in Heidelberg Pharma's strategy to evaluate HDP-101 in combination regimens, which could facilitate its use in earlier lines of treatment and across broader patient populations. While HDP-101 has been studied as a monotherapy in an ongoing Phase I/IIa trial in the U.S. and Europe since 2022, the company has already initiated a monotherapy bridging study in China in March 2026 following the determination of the recommended Phase II dose. The U.S. Food and Drug Administration has granted HDP-101 Orphan Drug Designation (March 2024) and Fast Track Designation (October 2025), underscoring its potential in addressing unmet medical needs.
The collaboration with Huadong Medicine dates back to February 2022, when the two companies entered into a strategic partnership that included an equity investment. Under the agreement, Huadong Medicine secured exclusive development and commercialization rights to HDP-101 across 20 Asian markets and became the second-largest shareholder of Heidelberg Pharma. This latest approval strengthens the partnership and expands the clinical development footprint of HDP-101 in Asia.
Heidelberg Pharma is a pioneer in developing cancer therapies based on amanitin, a toxin derived from the green death cap mushroom. Its proprietary ATAC technology leverages this novel mechanism of action to create next-generation ADCs. Beyond HDP-101, the company's pipeline includes HDP-102 for non-Hodgkin lymphoma, HDP-103 for metastatic castration-resistant prostate cancer, and HDP-104 for gastrointestinal tumors, all of which are available for partnering.
The initiation of this combination trial in China represents a significant milestone for Heidelberg Pharma and Huadong Medicine, potentially accelerating the development of HDP-101 and offering new hope for patients with relapsed/refractory multiple myeloma in the region.
