TRANSCENTA-B (06628) invention patent application for "Anti-CLDN18.2 Antibody and Its Diagnostic Use" granted an invention patent by the China National Intellectual Property Administration

TRANSCENTA-B (06628) announces that the invention patent application submitted by Suzhou Transcenta Therapeutics Co., Ltd. (Suzhou Transcenta), a wholly-owned subsidiary of the Company, titled "Anti-CLDN18.2 Antibody and Its Diagnostic Use" (Application No.: CN202180041601.5), has been granted an invention patent by the China National Intellectual Property Administration (CNIPA), with the grant publication number CN115836090B and the grant publication date of September 25, 2026 (the Patent). The Patent covers the Group's independently developed anti-CLDN18.2 antibody and its diagnostic use for detecting CLDN18.2 expression, and the relevant antibody is the proprietary Claudin18.2 antibody developed by the Group for the development of a companion diagnostic reagent for osemitamab (TST001). The Group continues to collaborate with Agilent Technologies, a global leader in companion diagnostic development, to advance the development of the Claudin18.2 companion diagnostic (CDx) to support TranStar301, a global Phase III pivotal clinical trial of osemitamab (TST001) in combination with immune checkpoint inhibitors and chemotherapy as first-line treatment for patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma expressing Claudin18.2. Previously, on August 2, 2024, Suzhou Transcenta was granted an invention patent titled "Novel Anti-CLDN18.2 Antibody" (Grant Publication No.: CN114630840B) by the CNIPA. In addition, patents related to osemitamab (TST001) have also been granted by the Federal Service for Intellectual Property of Russia and the Hong Kong Intellectual Property Department. The Board believes that the grant of the Patent provides a key foundation for the Group's intellectual property protection surrounding Claudin18.2 and its CDx development, further consolidating the intellectual property position of osemitamab (TST001) and supporting its precision medicine strategy, clinical development, and future registration and commercialization in China. The Company's major project, osemitamab (TST001), is a high-affinity humanized monoclonal antibody against Claudin18.2 with enhanced antibody-dependent cellular cytotoxicity (ADCC). The initiation of the global Phase III registrational trial (TranStar301) of osemitamab (TST001) in combination with checkpoint inhibitors and chemotherapy as first-line treatment for Claudin18.2-expressing gastric or gastroesophageal junction adenocarcinoma has been approved by the U.S. Food and Drug Administration (FDA), the Center for Drug Evaluation of the China National Medical Products Administration, and the Ministry of Food and Drug Safety of Korea. The FDA has granted osemitamab (TST001) orphan drug designation for the treatment of gastric or gastroesophageal junction adenocarcinoma and pancreatic cancer.