Huadong Medicine Gets NMPA Green Light for BCMA-Targeted ADC HDM2027 Phase I/IIa Study

Huadong Medicine Gets NMPA Green Light for BCMA-Targeted ADC HDM2027 Phase I/IIa Study

Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to initiate a Phase I/IIa study for its drug candidate HDM2027 (HDP-101). This antibody drug conjugate (ADC), co-developed with Heidelberg Pharma, targets the B cell maturation antigen (BCMA) and will be evaluated for safety, tolerability, pharmacokinetic characteristics, and efficacy in patients with BCMA-positive clonal hematological diseases, such as relapsed/refractory multiple myeloma.

The strategic partnership between Huadong and Heidelberg Pharma, established in February 2022, saw Huadong acquire a 35% stake in Heidelberg, making it the second-largest shareholder of the German firm. Additionally, a licensing agreement granted Huadong exclusive rights to develop and commercialize the pipeline candidates HDP-101 and HDP-103 in mainland China, Hong Kong, Macau, Taiwan, South Korea, Singapore, and a total of 20 Asian countries and regions.- Flcube.com

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