Remegen Co., Ltd. (688331.SH) has announced that it recently obtained a drug registration certificate from the National Medical Products Administration. The new indication application for disitamab vedotin (development code: RC48, brand name: Aidixi®) for the treatment of HER2-low expressing breast cancer with liver metastases has been approved. This marks the fourth approved indication for disitamab vedotin in China.

Disitamab vedotin is the first original antibody-drug conjugate (ADC) drug independently developed by Remegen in China. It targets the HER2 protein on the surface of tumor cells, enabling precise identification and elimination of cancerous cells. The therapy has demonstrated globally leading clinical data in trials for various cancers, including gastric cancer, urothelial carcinoma, and breast cancer. It is also the first ADC drug in China to receive breakthrough therapy designation from both the U.S. FDA and China’s NMPA.

As of the announcement date, disitamab vedotin has been approved for four indications: HER2-overexpressing locally advanced or metastatic gastric cancer, HER2-overexpressing locally advanced or metastatic urothelial carcinoma, HER2-positive advanced breast cancer with liver metastases, and HER2-low expressing breast cancer with liver metastases.