SINO BIOPHARM (01177): The study data of the first-line treatment of advanced stage III breast cancer with the combination of Comorsi and Fluvisq was announced at ESMO 2025.

SINO BIOPHARM (01177) announced that the group has released the mid-term analysis results of the Phase III clinical study (CULMINATE-2) of the national Class 1 innovative drug camocillin capsules (CDK2/4/6 inhibitor) for first-line treatment of HR+/HER2- advanced breast cancer at the 2025 European Society for Medical Oncology (ESMO) in the form of the latest heavyweight abstract (LBA). CULMINATE-2 is the world's first Phase III clinical trial to achieve positive results for the oral CDK2/4/6 inhibitor combined with hormonal therapy for first-line HR+/HER2- advanced breast cancer. This randomized, double-blind, multicenter parallel-controlled study aims to evaluate the efficacy and safety of camocillin combined with fulvestrant (experimental group) compared to placebo combined with fulvestrant (control group) in first-line hormonal treatment of HR+/HER2- advanced breast cancer patients. The principal investigators are Academician Song Erwei of Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University and Professor Yin Yongmei of Jiangsu Provincial People's Hospital. Camocillin is a new oral CDK2/4/6 inhibitor that has varying degrees of inhibition on the kinases CDK2, CDK4, and CDK6, with a strong selective inhibitory effect on CDK4 kinase and a weaker inhibitory effect on CDK6 kinase. This characteristic helps to delay the clinical resistance of CDK4/6 inhibitors, reduce bone marrow suppression, and is expected to show breakthrough advantages in efficacy and safety, becoming a potential Best-in-Class therapy. The China National Medical Products Administration Drug Evaluation Center (CDE) accepted the market application for camocillin combined with fulvestrant for the indication of locally advanced or metastatic HR+/HER2- breast cancer previously treated with hormonal therapy in July 2024, and accepted the market application for its second indication in July 2025, for initial hormonal therapy in patients with locally advanced or metastatic HR+/HER2- breast cancer. Currently, the group is actively advancing the Phase III clinical trial of camocillin for adjuvant treatment of breast cancer, with all subjects already enrolled and expected to submit a market application in the next two years. Camocillin is expected to comprehensively cover the entire treatment cycle of first-line, second-line, and adjuvant therapy for HR+/HER2- breast cancer, providing innovative treatment options for more patients.