On June 9, 2021, the National Medical Products Administration (NMPA) granted
conditional approval for Disitamab Vedotin for Injection (brand name: Aidixi),
developed by Rongchang Biologics (Yantai) Co., Ltd., through the priority review
and approval procedure.
As an innovative antibody-drug conjugate (ADC) independently researched and developed in China, this medicinal product is indicated for the treatment of patients with HER2-overexpressing locally advanced or metastatic gastric cancer (including adenocarcinoma of the esophagogastric junction) who have received at least two prior systemic chemotherapy regimens.
Disitamab Vedotin for Injection is an antibody-drug conjugate composed of a human epidermal growth factor receptor 2 (HER2) antibody moiety, a linker, and the cytotoxic agent monomethyl auristatin E (MMAE).
The marketing approval of this product offers a new therapeutic option for patients with locally advanced or metastatic gastric cancer.
