Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that the international multi-center Phase 3 clinical study (G-HOPE-001, NCT06238843) of arcotatug tavatecan (IBI343; Takeda R&D code: TAK-921, an innovative TOPO1i CLDN18.2 ADC) has completed the per-protocol first interim analysis and reached the primary endpoint. Arcotatug tavatecan demonstrated excellent efficacy and a tolerable safety profile in the treatment of advanced gastric cancer. Based on the positive clinical results, Innovent has submitted the new drug application (NDA) for arcotatug tavatecan to the National Medical Products Administration (NMPA) of China, for the treatment of previously treated locally advanced unresectable or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma (G/GEJA) who have received at least two prior systemic therapies. This application has been accepted with priority review.

Arcotatug tavatecan is a biomarker-guided, CLDN18.2-targeted ADC developed as a precision medicine for the treatment of CLDN18.2-expressing cancers. It is designed to selectively deliver a high-potency exatecan payload (TOPO1i) to tumor cells via a cleavable linker, and incorporates Fc silencing to minimize off-tumor toxicities. It is the world's first CLDN18.2 ADC to be submitted for regulatory review.

The G-HOPE-001 study is an international, multicenter, randomized, open-label Phase 3 clinical trial conducted in China and Japan to evaluate the efficacy and safety of IBI343 monotherapy vs. investigator-selected therapy in subjects with previously treated, Claudin 18.2-positive, locally advanced unresectable or metastatic G/GEJA who have received at least two prior systemic therapies. The primary endpoints of the study are PFS and overall survival (OS). The clinical study data are planned to be published in future academic conferences or journals.

Professor Lin Shen, Director of Department of Gastrointestinal Oncology, Beijing Cancer Hospital, said: " We are delighted to see that the pivotal Phase 3 clinical trial of arcotatug tavatecan has been successfully conducted in China and Japan, and achieved its primary endpoint at the first interim analysis. This marks a major breakthrough in targeted precision therapy for gastrointestinal oncology. Meanwhile, the NDA for arcotatug tavatecan has been accepted by the NMPA. The excellent efficacy and manageable safety profile of this product will potentially bring new standardized treatment options and help the adoption of precision diagnosis and treatment for gastrointestinal tumors with targeted therapies."

"Arcotatug tavatecan is a next-generation ADC drug targeting CLDN18.2," said Professor Kohei Shitara, Director of the Department of Gastrointestinal Oncology, National Cancer Center Hospital East. "Clinical study data showed that Arcotatug tavatecan has good overall safety and tolerability, and a low incidence of gastrointestinal-related toxicity. At the same time, it has shown potential and encouraging anti-tumor therapeutic effects in patients with gastric cancer/gastroesophageal junction adenocarcinoma who have high expression of CLDN18.2. The G-HOPE-001 study completed the first interim analysis according to the established study protocol and successfully reached the preset primary endpoint of progression-free survival, which laid a solid foundation for subsequent clinical application."

Dr. Hui Zhou, Chief R&D Officer (oncology pipeline) of Innovent Biologics, said, " Patients with advanced gastric cancer generally have a poor prognosis after initial lines of treatment and are prone to rapid disease progression. There is a lack of effective subsequent treatment options, with median survival of only around six months, highlighting a significant and urgent unmet clinical need. We are excited that the international multicenter Phase 3 study of Arcotatug tavatecan has successfully met its primary endpoint of progression-free survival and that the marketing application in China has been accepted. We look forward to this innovative therapy offering a new and more effective treatment option for patients with advanced gastric cancer."