The board of directors of the RemeGen Co., Ltd. (Board) announced that the National Medical Products Administration (NMPA) has approved an investigational new drug (IND) application for Disitamab Vedotin for Injection (RC48, brand name: ®), given as an intravenous infusion, in combination with Gemcitabine Hydrochloride for Injection (brand name: ®), given intravesically, for the treatment of patients without receiving Bacillus Calmette-Guerin (BCG) for intravesical instillation previously or patients with high-risk non-muscle invasive bladder cancer (NMIBC) who do not respond to BCG therapy. The study is a single-arm, open-label and single-centre phase II clinical trial to evaluate the efficacy and safety of Disitamab Vedotin for Injection, given as an intravenous infusion, in combination with Gemcitabine Hydrochloride for Injection, given intravesically, for the treatment of patients without receiving BCG for intravesical instillation previously or patients with high-risk NMIBC who do not respond to BCG therapy. Bladder cancer is a malignancy that starts from bladder urothelial carcinoma and is one of the most common malignancies involving the urinary system.

According to the Global Cancer Statistics 2020, bladder cancer accounts for 4.4% of new malignancy cases in male, ranking sixth, and 70%­80% of bladder cancers are NMIBC, for which there is still an unmet clinical need. Disitamab Vedotin for Injection (RC48, brand name: ®) is an anti-HER2 antibody- drug conjugate (ADC) targeting prevalent cancers with significant unmet medical needs, and it is the first domestically developed ADC in China to receive marketing approval. The product was granted conditional marketing approval by NMPA to treat locally advanced or metastatic gastric cancer (including gastroesophageal junction (GEJ) carcinoma) on 9 June 2021.

NMPA conditionally approved the marketing application for Disitamab Vedotin for Injection for the treatment of HER2 expressing locally advanced or metastatic urothelial carcinoma on 31 December 2021. Disitamab Vedotin for Injection has received the breakthrough therapy and fast track designations for the treatment of locally advanced or metastatic urothelial carcinoma by the U.S. Food and Drug Administration (FDA). It has also received breakthrough therapy designations for the treatment of patients with HER2 expressing locally advanced or metastatic urothelial carcinoma and HER2-positive breast cancer with liver metastasis who were previously treated with pertuzumab and taxane from NMPA.

The Company is implementing a differentiated development and commercialisation strategy for Disitamab Vedotin for Injection, targeting HER2 expressing indications that are currently underserved, including (i) gastric cancer (GC); (ii) urothelial carcinoma (UC) and (iii) breast cancer (BC); and (iv) other cancer indications expressed by HER2.