Remegen (09995) announced that its product, injection of Vicizumab-_-dinantibody (trade name: Aidi Xi), used to treat late-stage breast cancer patients with HER2-positive liver metastasis, has achieved positive results in a randomized, open, parallel-controlled, multicenter phase III clinical study and has reached the main research endpoint of clinical trials. This project has been granted a breakthrough therapy designation by National Medical Products Administration in June 2021. The company plans to submit an application for approval to the Center for Drug Evaluation (CDE) of the National Medical Products Administration soon.

According to GLOBOCAN 2022 data, the annual incidence of breast cancer worldwide is 2.3 million and the death toll is 660,000, making it the most common cancer among women. In China, the incidence and mortality rates of breast cancer rank sixth and seventh among malignant tumors, respectively, with an annual incidence rate of 360,000 and a death toll of 70,000. The rate of liver metastases in HER-2 positive breast cancer is 44.5%. Without active treatment, the median survival period is only 4-8 months, but specific treatment options are still lacking.

RC48-C006 (NCT03500380) is an open, parallel-controlled, multicenter phase III clinical study conducted in China to evaluate the efficacy and safety of injection of Vicizumab-_-dinantibody compared with the combination of Lapatinib (trade name: Tykerb) and capecitabine (trade name: Xeloda) in the treatment of HER2-positive advanced breast cancer patients. According to the final analysis of this study, injection of Vicizumab-_-dinantibody can significantly prolong the progression-free survival (PFS) of patients compared with Lapatinib and capecitabine. The safety data of injection of Vicizumab-_-dinantibody is similar to known risks and no new safety signals were found.