REMEGEN (688331.SH): Application for the first-line treatment indication of HER2-expressing urothelial carcinoma with Vendubotinib monoclonal antibody has been approved for marketing.

REMEGEN (688331.SH) announced that the company has recently received the "Drug Registration Certificate" approved and issued by the National Medical Products Administration. The new indication for the market application of Vedolizumab (code name: RC48, trade name: Aide Xi) in combination with Trastuzumab for the treatment of locally advanced or metastatic urothelial carcinoma with HER2 expression has been approved. This is the fifth indication approved domestically for Vedolizumab. New approved indication: This product is indicated for patients with locally advanced or metastatic urothelial carcinoma with HER2 expression, with HER2 expression defined as HER2 immunohistochemistry results of 1+, 2+ or 3+.