RemeGen announced that China’s National Medical Products Administration has issued a Drug Registration Certificate permitting Disitamab Vedotin (RC48, trade name: 愛地希®) in combination with Toripalimab for first-line treatment of HER2-expressing (IHC 1+/2+/3+) locally advanced or metastatic urothelial carcinoma (UC). The decision marks the antibody-drug conjugate’s fifth approved indication in the domestic market.

The approval relied on data from the randomized, controlled, multi-center Phase III trial RC48-C016. Conducted at 74 Chinese hospitals and enrolling 484 patients, the study is the first global head-to-head trial to prove that a HER2-targeted ADC plus immunotherapy outperforms platinum-based chemotherapy in UC. As of 31 March 2025, dual primary endpoints were met: • Median progression-free survival reached 13.10 months, double the chemotherapy arm and translating into a 64 % reduction in risk of progression or death. • Median overall survival hit 31.50 months, nearly twice that of chemotherapy, corresponding to a 46 % reduction in mortality risk. • Objective response rate stood at 76.10 % (65.50 % in the HER2 IHC 1+ subgroup), and disease control rate reached 91.40 %. • Grade ≥3 treatment-related adverse events occurred in 55.10 % of patients, indicating an improved safety profile versus chemotherapy.

Urothelial carcinoma remains the most prevalent malignancy of the male genitourinary system. Frost & Sullivan projects global new cases will climb to 0.66 million by 2030, with China accounting for about 0.11 million. Roughly 20 % of patients present with metastatic or unresectable disease at diagnosis, and over half cannot tolerate platinum regimens, underscoring the unmet need addressed by the new therapy.

Disitamab Vedotin is China’s first domestically developed ADC to earn Breakthrough Therapy designation from both the U.S. FDA and China’s NMPA. Current Chinese approvals now cover: 1) HER2-overexpressing locally advanced or metastatic gastric cancer, 2) HER2-overexpressing locally advanced or metastatic urothelial carcinoma, 3) HER2-positive advanced breast cancer with liver metastases, 4) HER2-low expressing breast cancer with liver metastases, and 5) HER2-expressing locally advanced or metastatic urothelial carcinoma in combination with Toripalimab.

RemeGen notes that commercial performance will depend on policy, demand and competitive dynamics, and pledges timely disclosure of subsequent developments. Shareholders and prospective investors are advised to exercise caution when dealing in the company’s shares.