Ø With the third indication approved in China, disitamab vedotin now is the first ADC clinically available for patients with HER2-positive advanced breast cancer with liver metastasis globally
Ø In the pivotal phase 3 study, disitamab vedotin demonstrated significant improvements in progression-free survival (PFS). The median PFS of the DV group doubled that of the standard-of-care group (9.9 months vs. 4.9 months, HR:0.56, P=0.0143)
Ø DV has been granted breakthrough therapy designation by the Center for Drug Evaluation in China
On May 9, 2025, RemeGen Co., Ltd. (“RemeGen”, stock symbols: 688331.SH/09995.HK) announced that disitamab vedotin (DV, brand name: Aidixi®), a novel HER2-targeted antibody-drug conjugate (ADC) initially developed by RemeGen, has been granted approval by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for its third indication of HER2-positive advanced breast cancer with liver metastasis (BCLM) previously treated with trastuzumab or its biosimilar and taxanes.
DV has been approved by NMPA before for HER2-overexpressing locally advanced or metastatic gastric carcinoma previously treated with at least two lines of systemic chemotherapies and HER2-overexpressing locally advanced or metastatic urothelium carcinoma previously treated with platinum-based chemotherapies.
This approval was granted based on a phase 3 clinical trial (NCT0350038, study ID: RC48-C006). Detailed data has been presented at San Antonio Breast Cancer Symposium (SABCS) in December, 2024. The study showed that:
Compared with lapatinib plus capecitabine, DV significantly improved PFS and reduced the risk of disease progression or death by 44% (median PFS: 9.9 months vs. 4.9 moths; HR=0.561, P=0.0143)
The overall survival (OS) data, though immature, indicated a benefit trend in favor of DV, with median OS of NE vs. 25.9 months (HR=0.56; 95%CI, 0.25-1.29)
DV demonstrated manageable safety profile with no new safety signal detected
“It’s amazing that DV got approved for HER2-positive BCLM in China. RC48-C006 is the first phase 3 clinical trial investigating a HER2-targeted ADC in patients with HER2-positive advanced breast cancer, and the results were encouraging. In 2021, DV was granted breakthrough therapy designation by NMPA for this indication. The approval this year means a new treatment option for this population in China and a step forward in clinical practice. I sincerely hope more therapeutic options from RemeGen will be available for patients with refractory advanced breast cancer.” observed Professor Jiayu Wang from the Cancer Hospital, Chinese Academy of Medical Sciences, the sub-investigator of the RC48-C006 study.
“Breast cancer poses a significant threat to global health with huge unmet clinical needs. As the first and only approved ADC for HER2-positive BCLM, DV represents a new regimen with favorable efficacy and manageable safety profile, which I believe is a valuable breakthrough. I would like to appreciate the clinical research team and all participants for their hard work and cooperation. Meanwhile, promising efficacy and manageable safety profile of DV were also observed in other clinical trials on breast cancer with different HER2 expression levels, and we are also evaluating the efficacy and safety of several DV combination therapy options to expand its indication and benefit more patients.” said Jianmin Fang, CEO of RemeGen.
Breast cancer is one of the most common cancers in the world. In 2022, there were around 2.3 million new cases diagnosed and 67,000 death, and the disease risk is steadily rising each year. Approximately 20%-25% breast cancer cases are HER2-positive. HER2 is an important cancer driver gene and serves as a prognostic indicator in breast cancer. HER2-positive breast cancer is highly aggressive and malignant, associated with rapid disease progression and poor prognosis. Liver is one of the most common sites for breast cancer metastases. There was no standard of care (SOC) for HER2-positive breast cancer liver metastasis previously and exploring new treatment and improving patient benefit remain the research hotspots of breast cancer management. As a novel HER2-targeted ADC, DV can prolong the progression-free survival of HER2-positive breast cancer patients with liver metastasis and shows manageable safety. The approval of DV provides solid evidence for clinical decision-making and brings better treatment option for the target patients.
