China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to its 9MW2821, an antibody drug conjugate (ADC) targeting Nectin-4. The designation is for the use of 9MW2821 in combination with toripalimab for the treatment of unresectable locally advanced or metastatic urothelial carcinoma (UC) that has not been systematically treated in the past.
Mechanism of Action
Once injected into the body, 9MW2821 binds to Nectin-4 on the surface of tumor cells and enters the cells. Through enzymatic hydrolysis, it selectively releases cytotoxic substances, thereby achieving precise killing of tumors. This targeted approach aims to minimize damage to healthy cells and enhance the treatment’s efficacy.
Significance of the BTD
The Breakthrough Therapy Designation by the CDE highlights the potential of 9MW2821 to offer a significant therapeutic advantage for patients with urothelial carcinoma. This designation is expected to expedite the development and review process, bringing this innovative treatment option closer to market and potentially improving patient outcomes.-Fineline Info & Tech
