Maiwei Biology (688062.SH): 9MW2821 is included in the list of breakthrough therapeutic varieties.

"Maiwei Biotechnology (688062.SH) announced that the innovative drug 9MW2821, developed with independent intellectual property rights, is currently undergoing multiple clinical studies for indications such as urinary tract epithelial cancer, cervical cancer, esophageal cancer, and breast cancer. Recently, 9MW2821 has been included in the list of breakthrough therapeutic drugs by the National Medical Products Administration Drug Evaluation Center, with the indication for the use of combination therapy with trastuzumab for the treatment of locally advanced or metastatic urinary tract epithelial cancer that has not been previously treated systemically and is not amenable to surgical resection. This matter is still in the public announcement stage, with the public announcement period from January 8, 2025 to January 15, 2025. There is a risk of objections being raised during the public announcement period for breakthrough therapeutic drug programs. In addition, there are uncertainties such as the long research and development cycle of drugs and multiple approval processes."