The board of directors of RemeGen Co., Ltd. announced that on December 31, 2021, the National Medical Products Administration of the People's Republic of China (NMPA) has granted conditional marketing approval for disitamab vedotin, the anti-HER2 antibody-drug conjugate (ADC) independently developed in-house by the Company, for the treatment of HER2 expressing locally advanced or metastatic urothelial carcinoma (UC). NMPA has published relevant announcement at its website on January 5, 2022. This is the second marketing approval for disitamab vedotin after it successfully received conditional marketing approval by the NMPA for the treatment of locally advanced or metastatic gastric cancer (including gastroesophageal junction carcinoma) (GC) on June 9, 2021.

It takes only approximately five months to obtain the approval for marketing for this indication since its new drug application (NDA) being submitted to NMPA by the Company in July 2021.