REMEGEN (09995): The marketing application for Vedolizumab for the treatment of HER2-expressing urothelial carcinoma indication has been approved.

REMEGEN (09995) announced that the company has received the Drug Registration Certificate issued by the China National Medical Products Administration (NMPA). Vedesituzumab Vedotin (Code: RC48, trade name: Aidianxi, approval number: National Medical License S20210017, certificate number: 2026S01078), used in combination with Trastuzumab for the treatment of HER2-expressing (IHC 1+2+3+) locally advanced or metastatic urothelial carcinoma, has been approved for a new indication. This is the fifth indication for Vedesituzumab Vedotin approved in China. This approval is based on a randomized controlled, multicenter Phase III clinical trial (RC48-C016) conducted in China, led by Professor Guo Jun from Peking University Cancer Hospital, with participation from 74 clinical research centers nationwide and a total of 484 subjects enrolled. It is the world's first Phase III trial to confirm the significant superiority of HER2-ADC combined with immunotherapy over platinum-containing chemotherapy in the first-line treatment of HER2-expressing advanced urothelial carcinoma. The results were announced at the European Society for Medical Oncology (ESMO) annual meeting in October 2025 and simultaneously published in the New England Journal of Medicine (NEJM). As of March 31, 2025, the study met the dual primary endpoints of progression-free survival (PFS) and overall survival (OS), with statistically significant differences and clinical benefits. Specifically, the median PFS was extended to 13.1 months, doubling that of the platinum-containing chemotherapy group, with a 64% reduced risk of disease progression or death; the median OS reached 31.5 months, nearly doubling that of the platinum-containing chemotherapy group, with a 46% reduced risk of patient death. The objective response rate (ORR) was as high as 76.1% (65.5% in the HER2 IHC 1+ population), and the disease control rate (DCR) was 91.4%. The median duration of response was 14.6 months, significantly longer than the chemotherapy group. The study covered the entire population of HER2 expressors (IHC 1+2+3+), with consistent benefits in PFS and OS regardless of whether patients were suitable for cisplatin treatment or their HER2 expression status. Safety was also improved, with an overall incidence of grade 3 treatment-related adverse events of 55.1%. Urothelial carcinoma (UC) is one of the most common malignant tumors worldwide, with incidence and mortality rates ranking first in male genitourinary tumors, about 90% originating in the bladder but also found in the renal pelvis and ureters. According to reports by Frost & Sullivan, it is estimated that there will be 662,000 new cases of UC globally in 2030, with approximately 106,000 new cases in China, where the incidence rate is higher than the global average. The high recurrence and metastasis rates of the disease result in about 20% of patients being diagnosed with metastases or in unresectable stages, indicating significant unmet clinical needs. Currently, platinum-containing chemotherapy is the standard first-line treatment for advanced or metastatic UC, but over half of the patients are intolerant to it. Vedesituzumab Vedotin is the first domestically developed antibody-drug conjugate (ADC) drug targeting HER2 protein on tumor cells in China. It has achieved leading clinical data in clinical trials for gastric cancer, urothelial carcinoma, breast cancer, and other tumors, making it the first ADC drug in China to be recognized as a breakthrough therapy by both the US FDA and the NMPA. With this latest approval, Vedesituzumab Vedotin now has five approved indications in China, including locally advanced or metastatic gastric cancer with HER2 overexpression, locally advanced or metastatic urothelial carcinoma with HER2 overexpression, advanced breast cancer with HER2 positivity and liver metastases, advanced breast cancer with low HER2 expression and liver metastases, and the combination therapy for HER2-expressing locally advanced or metastatic urothelial carcinoma with Trastuzumab. This new indication approval further enhances the market competitiveness of Vedesituzumab Vedotin. Given the characteristics of the pharmaceutical industry, the commercialization of drugs post-approval will be influenced by various factors such as policy environment, market demand, and competitive conditions, leading to certain uncertainties. The company will fulfill its disclosure obligations promptly based on subsequent developments.