Rongchang Biological (09995.HK) submits application for new indication of Vedolizumab and gains acceptance.

Zhtng Cijng APP learned that the China National Medical Products Administration Center for Drug Evaluation (CDE) recently announced that the application for marketing approval of the new indication for injection of vedolizumab monoclonal antibody submitted by Rongchang Biotech (09995.HK) has been accepted, but the specific indication has not been disclosed. According to a news release by Rongchang Biotech in May this year, it is speculated that the indication for marketing application this time may be for the treatment of first-line locally advanced or metastatic urothelial carcinoma with HER2 expression, or for HER2 low-expression breast cancer.