The board of directors of the RemeGen Co., Ltd. announced that the randomized, open, parallel-controlled, multi-center Phase III clinical study of the Company ' s product, Disitamab Vedotin for Injection (brand name: for the treatment of patients with HER2- positive advanced breast cancer with liver metastases, has achieved a positive result and met the primary study endpoint of the clinical trial. The project has been granted breakthrough therapy designation by the National Medical Products Administration (the NMPA) in June 2021. The Company plans to submit a marketing application to the Centre for Drug Evaluation (CDE) of the NMPA in the near future.

According to the data of GLOBOCAN 2022, the number of new cases of the year in the world reached 2.3 million, and the number of deaths reached 660,000 in respect of breast cancer, which was the cancer with the highest incidence rate among women. In China, the incidence and mortality rate of breast cancer ranked 6th and 7th among malignant tumors, respectively. The number of new cases of the year reached 360,000, and the number of deaths reached 70,000.

The incidence of HER-2 positive breast cancer with liver metastasis was 44.5%. Without active treatment, the median survival was only 4-8 months, but there was a lack of specific treatment options. RC48-C006 (NCT03500380) is an open, parallel-controlled, multi-center Phase III clinical study conducted in China.

It aims to evaluate the efficacy and safety of Disitamab Vedotin for Injection versus Lapatinib (brand name: Tykerb in combination with Capecitabine (brand name: Xeloda for the treatment of patients with HER2-positive advanced breast cancer. According to the final analysis of this study, Disitamab Vedotin for Injection significantly prolonged progression-free survival (PFS) in patients compared with Lapatinib in combination with Capecitabine. Safety data of Disitamab Vedotin for Injection are similar to the known risks, and no new safety signals have been identified Disitamab Vedotin (RC48, brand name: is an anti-HER2 antibody-drug conjugate (ADC) targeting a number of 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 the NMPA to treat locally advanced or metastatic gastric cancer (including gastroesophageal junction (GEJ) carcinoma) in China on June 9, 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 December 31, 2021. Disitamab Vedotin has gained approval to conduct Phase III clinical trials and received the breakthrough therapy and fast track designations for the treatment of locally advanced or metastatic urothelial carcinoma following platinum-containing chemotherapy from the U.S. Food and Drug Administration (the "FDA").

It has also received breakthrough therapy designation for patients with HER2 expressing locally advanced or metastatic urothelial carcinoma and HER2-positive breast cancer with liver metastasis who were previously treated with pertuzumab (brand name: Perjeta®) and taxane from NMPA. The Company is implementing a differentiated development and commercialisation strategy for Disitamab Vedotin, targeting HER2 expressing indications with unmeet medical needs currently, including (i) gastric cancer (GC); (ii) urothelial carcinoma (UC); (iii) breast cancer (BC); and (iv) other HER2 expressing cancer indications.