June 9, 2021 -- RemeGen Co., Ltd. (RemeGen, 9995.HK) announces that disitamab vedotin (RC48, Brand Name: 爱地希®), the novel anti-HER2 antibody-drug conjugate (ADC) independently developed in-house by the Company, has been granted conditional marketing approval by the National Medical Products Administration of the People’s Republic of China for the treatment of locally advanced or metastatic gastric cancer (gastroesophageal junction (GEJ) carcinoma) (GC).
Disitamab vedotin (RC48, Brand Name: 爱地希®) is the second approved marketing product following the approval granted for telitacicept in March this year in China and is also a significant accomplishment of RemeGen. It signifies the Company’s achievements in the field of oncology. It also demonstrates RemeGen’s ability to develop biologic drugs and reflects the Company’s strong inhouse research and development capabilities, especially the ability to develop ADC products.
ABOUT DISITAMAB VEDOTIN (RC48, Brand Name: 爱地希®)
Disitamab vedotin (RC48, Brand Name: 爱地希®) is an anti-HER2 antibody drug conjugate targeting prevalent cancers with significant unmet medical needs, and it is the first domestically developed ADC in China to have entered clinical development. We are implementing a differentiated development and commercial strategy for disitamab vedotin, targeting prevalent HER2 expressing indications that are currently underserved, including HER2 expressing and HER2 low-expressing breast cancer (BC), HER2 expressing gastric cancer (GC) and urothelial carcinoma (UC), and other HER2 expressing cancer indications. These therapeutic areas represent a less crowded and underserved field for HER2 targeted therapies, and a broad addressable patient population for disitamab vedotin.