Biokin Pharmaceutical's BL-M07D1 Receives NMPA Approval for Phase II/III Study in HER2+ Breast Cancer

Biokin Pharmaceutical’s BL-M07D1 Receives NMPA Approval for Phase II/III Study in HER2+ Breast Cancer

China-based Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II/III clinical study of its antibody drug conjugate (ADC), BL-M07D1, for the treatment of HER2 positive breast cancer. The trial will evaluate BL-M07D1 in combination with other drugs as neoadjuvant therapy.

Drug Profile
BL-M07D1 is an ADC designed to treat breast cancer, gastric cancer, and other solid tumors. It is currently under investigation in nine clinical studies in the US and China, targeting solid tumors with HER2 expression or mutation, including non-small cell lung cancer, breast cancer, urothelial cancer, gynecological tumors, and gastrointestinal tumors. The drug is being tested both as monotherapy and in combination with other treatments.

Clinical Trial
The Phase II/III study will assess the efficacy and safety of BL-M07D1 in combination with other drugs for neoadjuvant therapy in HER2 positive breast cancer patients. The trial aims to provide further data on the drug’s potential to improve patient outcomes in this setting.-Fineline Info & Tech

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