Heidelberg Pharma AG and Huadong Medicine Receive NMPA Approval for Clinical Trial of HDP-101 Combination Therapy in China

· Heidelberg Pharma AG

Heidelberg Pharma AG, a clinical-stage biotech company developing innovative Antibody Drug Conjugates (ADCs), today announced that the China National Medical Products Administration (NMPA) has granted Clinical Trial Approval for a Phase Ib/II clinical trial evaluating pamlectabart tismanitin (HDP-101), the Company’s novel BCMA-targeting ADC, in combination therapy for the treatment of patients with relapsed/refractory multiple myeloma.

The trial will evaluate the safety, tolerability, and preliminary efficacy of pamlectabart tismanitin in combination either with pomalidomide and dexamethasone, or with daratumumab and dexamethasone, in adult patients with relapsed/refractory multiple myeloma 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 who will bear the development cost.

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