("AOSAIKANG") has completed the registration clinical phase III study of ASKB589, a bio-innovative drug independently developed by AskGene Limited ("AskGene"), for the treatment of first-line advanced gastric cancer. ASKB589, a bio-innovation drug independently developed by AskGene Limited ("AskGene"), for the treatment of first-line advanced gastric cancer, has been administered to the first patient in China in the Phase III registration study:

I. About the Registrational Clinical Phase III Study of ASKB589
The study is a multicenter, randomized, double-blind, standard treatment-controlled, efficacy-designed Phase III clinical study, which is planned to enroll 780 first-line gastric cancer patients in China, with the aim of evaluating the efficacy and efficacy of ASKB589 Injection or placebo in combination with CAPOX (oxaliplatin and capecitabine) and PD-1 inhibitor in the first-line treatment of CLDN18.2-positive unresectable locally advanced, recurrent or metastatic gastric and esophageal cancers, and to assess the efficacy and efficacy of the study. efficacy and safety in patients with CLDN18.2-positive, unresectable, locally advanced, recurrent or metastatic adenocarcinoma of the stomach and esophagogastric junction. The primary endpoint of the study is progression-free survival (PFS) as assessed by the Independent Review Committee (IRC), the key secondary endpoint is overall survival (OS), and other secondary endpoints include objective remission rate (ORR), duration of remission (DOR), and safety indicators.

II. Information about ASKB589
ASKB589 Injection is AskGene's ADCC-enhanced, second-generation, humanized monoclonal antibody against CLDN18.2, which was developed independently by AskGene and for which AskGene owns the intellectual property rights. AskGene announced the results of the latest Phase Ib/II study of ASKB589 in combination with CAPOX and PD-1 inhibitors in the first-line treatment of advanced gastric cancer in a poster session at the American Society of Clinical Oncology Gastrointestinal Cancer Symposium ("2024 ASCO GI") on January 18, 2024, where 45 patients with measurable lesions were identified. In a Phase Ib/II study, 45 G/GEJ adenocarcinoma subjects with measurable lesions, at least one post-treatment tumor evaluation, and CLDN18.2-positive moderate-to-high expression (≥40% & 2+/3+) were treated with 6 mg/kg ASKB589 in combination with CAPOX and a PD-1 inhibitor, and had an investigator-assessed objective tumor remission rate (ORR) of 80.0% and a disease control rate (DCR) of 100%. The objective tumor remission rate (ORR) and disease control rate (DCR) of ASKB589 was 80.0% and 100% respectively, including 36 cases of partial remission (PR) and 9 cases of stable disease (SD). As of the date of this announcement, ASKB589 has been subject to a number of Phase I/II clinical studies including single agent, combination chemotherapy, combination chemotherapy and PD-1 inhibitor, and has treated more than 200 patients with gastric cancer.

III. Impact on the Company
The completion of the first patient dosing in China in the clinical phase III study of ASKB589 marks the full commencement of the first international registrational clinical study of triple therapy (anti-CLDN 18.2 antibody in combination with chemotherapy and PD-1 inhibitor) for the first-line treatment of gastric cancer and adenocarcinoma of the esophagogastric junction patients. As of the date of disclosure of this announcement, no drug with the same target has been approved for marketing both domestically and internationally.

http://www.cninfo.com.cn/new/disclosure/detail?stockCode=002755&announcementId=1219006279&orgId=9900022950&announcementTime=2024-01-26