REMEGEN (688331.SH): Vedolizumab has been approved for the indication of treating breast cancer with low HER2 expression and liver metastasis.

REMEGEN (688331.SH) announced that the company has recently received the Drug Registration Certificate issued by the National Medical Products Administration. The new indication for the marketing application of Vedolizumab monoclonal antibody (code: RC48, trade name: AidiXi) for the treatment of breast cancer with low expression of HER2 and liver metastasis has been approved. This is the fourth indication approved for Vedolizumab monoclonal antibody in China. Vedolizumab monoclonal antibody is the first original antibody-drug conjugate (ADC) developed independently by REMEGEN in China. Targeting the HER2 protein on the surface of tumors, it can accurately identify and kill tumor cells. Clinical trials in the treatment of gastric cancer, urothelial carcinoma, breast cancer and other tumors have achieved globally leading clinical data. It is the first ADC drug in China to be dually recognized as a breakthrough therapy by the U.S. FDA and the Chinese Medical Products Administration. As of the disclosure date of this announcement, the drug has been successively approved for the treatment of four indications: locally advanced or metastatic gastric cancer overexpressing HER2, locally advanced or metastatic urothelial carcinoma overexpressing HER2, advanced breast cancer with HER2 positive and liver metastasis, and breast cancer with low expression of HER2 and liver metastasis.