Heidelberg Pharma and Huadong Medicine Receive NMPA Approval for Phase Ib/II Trial of BCMA-Targeting ADC HDP-101 in Multiple Myeloma
核心洞察
Heidelberg Pharma AG and Huadong Medicine received China NMPA Clinical Trial Approval for a Phase Ib/II study of pamlectabart tismanitin (搜索) (HDP-101) in relapsed/refractory multiple myeloma (搜索).
The trial will evaluate HDP-101 in combination with either pomalidomide and dexamethasone or daratumumab and dexamethasone in patients with at least one prior line of therapy.
HDP-101 is a BCMA (搜索)-targeting ADC using Amanitin-based ATAC technology and has received FDA Orphan Drug and Fast Track Designations.
Heidelberg Pharma AG (FSE: HPHA), a clinical-stage biotech company developing Antibody Drug Conjugates (ADCs), announced on 26 August 2026 that the China National Medical Products Administration (NMPA) has granted Clinical Trial Approval for a Phase Ib/II clinical trial evaluating pamlectabart tismanitin (搜索) (HDP-101), the Company's novel BCMA (搜索)-targeting ADC, in combination therapy for the treatment of patients with relapsed/refractory multiple myeloma (搜索).
The trial will evaluate the safety, tolerability, and preliminary efficacy of pamlectabart tismanitin (搜索) in combination either with pomalidomide and dexamethasone, or with daratumumab and dexamethasone, in adult patients with relapsed/refractory multiple myeloma (搜索) who have received at least one prior line of therapy. The trial will be conducted by Heidelberg Pharma's partner Huadong Medicine Co., Ltd. in China, which will bear the development cost.
A Novel Amanitin-Based ADC Platform
Heidelberg Pharma is the first company to develop cancer therapies using Amanitin, a compound derived from the green death cap mushroom. The biological mechanism of action of the toxin represents a new therapeutic modality and is used as a compound in the Amanitin-based ADC technology, known as the ATAC technology. The lead candidate HDP-101 (INN: pamlectabart tismanitin (搜索)) is a BCMA (搜索) ATAC in clinical development for multiple myeloma (搜索).
Clinical Development Status
Pamlectabart tismanitin (搜索) is being evaluated as a monotherapy in an ongoing Phase I/IIa clinical trial in the U.S. and Europe since 2022. Following dose-escalation in the Phase 1 part of the trial and the determination of the recommended Phase II dose (RP2D), a monotherapy bridging study with pamlectabart tismanitin has been initiated in China in March 2026.
The candidate has received key regulatory designations from the U.S. FDA, including Orphan Drug Designation (ODD) in March 2024 and Fast Track Designation (FTD) in October 2025.
Combination Strategy and Partnership
Combination therapies are an important part of Heidelberg Pharma's clinical development strategy for pamlectabart tismanitin (搜索), with the aim of evaluating the ADC in combination with established treatment regimens to potentially expand its use across earlier treatment lines and broader patient populations.
In February 2022, Heidelberg Pharma entered into a strategic partnership including equity investment with Huadong Medicine. Under the agreement, Huadong Medicine obtained exclusive development and commercialization rights to HDP-101 across 20 Asian markets. Huadong Medicine also became the second-largest shareholder of Heidelberg Pharma.
Pipeline Beyond HDP-101
A second ATAC candidate, HDP-102, is in clinical development stage in Non-Hodgkin Lymphoma. HDP-103 against metastatic castration-resistant prostate cancer and HDP-104 targeting gastrointestinal tumors such as colorectal cancer have completed preclinical development. These programs are available for partnering.