Huadong Medicine's subsidiary gets green light for HDM2005 trial

Huadong Medicine (SZSE:000963) announced that its wholly-owned subsidiary, Hangzhou Sino-American Donghua Pharmaceutical Co., Ltd. ("Sino-American Huadong"), has received approval from the National Medical Products Administration (NMPA) for clinical trials of its injectable HDM2005. Classified as a Class 1 therapeutic biological product, HDM2005 is intended for clinical trials to treat diffuse large B-cell lymphoma (DLBCL). HDM2005, a novel antibody-drug conjugate (ADC) targeting ROR1, has already been approved for clinical trials in both China and the U.S. in June 2024. The company emphasized that this clinical trial approval is a significant step forward in the drug's development, enhancing the company's competitiveness in the oncology field. Huadong Medicine will proceed with the clinical trials while adhering to regulatory requirements, but cautions that drug development is subject to various risks and uncertainties, and that the development will not have a material impact on the company's recent performance.