According to Zhitong Finance APP, Mayway Biotechnology (688062.SH) announced that 9MW2821 is an innovative drug developed independently by the company. The company has submitted a plan titled "A Phase III Clinical Study of the Randomized, Controlled, Open-label, Multicenter Evaluation of 9MW2821 in Combination with Teripranalytic Monoclonal Antibodies Compared with Standard First-Line Chemotherapy in Locally Advanced or Metastatic Urothelial Carcinoma Patients" to the China Drug Evaluation Center (CDE) of the National Medical Products Administration (NMPA) and has been approved. The company has initiated a Phase III clinical study of 9MW2821 in combination with PD-1 monoclonal antibodies as first-line treatment for urothelial carcinoma, which is currently in the enrollment stage.

It is reported that 9MW2821 is a targeted ADC drug developed by Mayway Biotechnology that targets Nectin-4. It is an innovative variety developed by the company using the ADC drug development platform. Through the coupling technology with independent intellectual property rights and optimized ADC coupling process, the antibody can be site-specifically modified. After injection into the body, 9MW2821 can bind to Nectin-4 on the surface of tumor cells and enter the cells. Through enzymatic degradation, it can selectively release cytotoxins, thereby achieving precise killing of tumors. The company is conducting multiple clinical studies for indications such as urothelial carcinoma, cervical cancer, esophageal cancer, and breast cancer. As of now, more than 400 subjects have been enrolled, and the clinical study results have demonstrated outstanding effectiveness and safety.