REMEGEN's stock surged 5.09% during intraday trading on Monday, reflecting positive market reaction to significant company developments.

The biopharmaceutical company announced that the New Drug Application for its drug Disitamab Vedotin (RC48, brand name: Aidixi®) for the treatment of HER2-expressing urothelial carcinoma has been approved by China's National Medical Products Administration. This approval marks the fifth approved indication for Disitamab Vedotin in China, specifically for use in combination with Toripalimab for treating locally advanced or metastatic urothelial carcinoma with HER2 expression.

Additionally, REMEGEN reported that its 2025 operating revenue increased by 89.36% year-on-year, primarily driven by rapid sales growth of its core products Telitacicept and Disitamab Vedotin in the domestic market, along with a significant increase in technology licensing revenue from granting exclusive rights to develop and commercialize Telitacicept outside Greater China. The company's financial statements have been audited and received an unqualified opinion, confirming the accuracy of these results.