Zhitong Finance App News, Chuangsheng Group Pharmaceutical-B (06628) issued an announcement. The invention patent application entitled “Anti-CLDN18.2 Antibody and Its Diagnostic Use” (Application Number: CN202180041601.5) was granted an invention patent by the State Intellectual Property Office of China (State Intellectual Property Office). The authorization notice number is CN115836090B. The authorization notice date is September 25, 2026 (the patent).
The patent covers the anti-CLDN18.2 antibody independently developed by the Group and its diagnostic use to detect CLDN18.2 expression, and the related antibody is a proprietary Claudin18.2 antibody developed by the Group to develop osemitamab (TST001) accompanying diagnostic reagents. The Group continues to cooperate with Agilent Technologies, a global leader in companion diagnostic development, to advance the development of Claudin18.2 companion diagnosis (CDx) to support Transtar301, an osemitamab (TST001) combination immune checkpoint inhibitor and chemotherapy as a first-line global phase III clinical trial for patients with locally advanced or metastatic gastric or gastroesophageal adenocarcinoma expressed by Claudin18.2.
Previously, on August 2, 2024, Suzhou Chuangsheng was granted an invention patent entitled “Novel Anti-CLDN18.2 Antibody” by the State Intellectual Property Office (Authorization Notice No.: CN114630840B). In addition, patents related to osemitamab (TST001) have also been granted by the Russian Federal Intellectual Property Office and the Hong Kong Intellectual Property Office. The Board believes that the grant of this patent provides a key foundation for the Group's intellectual property protection around Claudin18.2 and its CDX development, further consolidates osemitamab (TST001)'s intellectual property position, and supports its precision medicine strategy, clinical development, and future registration and commercialization in China.
Our main project, osemitamab (TST001), is a high-affinity humanized monoclonal antibody against Claudin 18.2 and has enhanced antibody-dependent cytotoxicity (ADCC). The initiation of osemitamab (TST001) combined checkpoint inhibitor and chemotherapy as a global phase III registration trial (TranStar301) for the first-line treatment of gastric or gastroesophageal adenocarcinoma expression with ClauDIN18.2 has been approved by the US Food and Drug Administration (FDA), the Drug Evaluation Center of the China National Drug Administration, and the Ministry of Food and Drug Safety of Korea. The FDA has granted osemitamab (TST001) an orphan drug for the treatment of gastric or gastroesophageal adenocarcinoma and pancreatic cancer.