Sino Biopharm (01177): Positive results obtained in Phase III study comparing the combination of Bevacizumab Injection with chemotherapy followed by sequential combination of Anlotinib Hydrochloride Capsules to the combination of Ramucirumab Injection with chemotherapy for first-line treatment of advanced squamous non-small cell lung cancer.

SINO BIOPHARM (01177) announced that the Phase III study (TQB2450-III-12) of the independently developed innovative drug Bevosuzumab monovalent antibody injection in combination with chemotherapy followed by sequential combination with anlotinib hydrochloride capsules compared to Tecrelizumab monovalent antibody injection in combination with chemotherapy for the first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC) has completed the pre-specified interim analysis, with the Independent Data Monitoring Committee (IDMC) determining that the primary endpoint of progression-free survival (PFS) has reached the pre-specified favorable boundary. The group has communicated with the China National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) regarding the application for marketing approval for this indication and has obtained written consent from the CDE to submit marketing applications for the Bevosuzumab monovalent antibody injection and anlotinib hydrochloride capsules for this first-line indication. The group plans to file for marketing approval in the near future. The combination of Bevosuzumab monovalent antibody with chemotherapy followed by sequential combination with anlotinib for the first-line treatment of advanced sq-NSCLC is the 13th indication that anlotinib is about to apply for marketing, and the 6th indication that Bevosuzumab is about to apply for marketing, potentially bringing new clinical treatment options for sq-NSCLC patients. Lung cancer is the leading cause of incidence and mortality among all malignant tumors in the Chinese and global populations, with non-small cell lung cancer accounting for approximately 80-85% of all lung cancer cases. Sq-NSCLC is one of the main subtypes of non-small cell lung cancer, accounting for about 30% of all cases. Currently, research and treatment for sq-NSCLC lags significantly behind other subtypes of non-small cell lung cancer, with less than 10% of the population having targetable mutations that can benefit from targeted therapy. While immune checkpoint inhibitors combined with chemotherapy have become the standard treatment for sq-NSCLC, their clinical efficacy remains limited, necessitating new treatment approaches to further improve patient outcomes. The TQB2450-III-12 study (NCT05718167) is a multicenter, randomized, double-blind, parallel-controlled Phase III clinical study aimed at evaluating the efficacy and safety of Bevosuzumab in combination with chemotherapy followed by sequential Bevosuzumab in combination with anlotinib compared to Tecrelizumab in combination with chemotherapy for the first-line treatment of advanced sq-NSCLC. The interim analysis results of this study show that compared to the Tecrelizumab in combination with chemotherapy group, Bevosuzumab in combination with chemotherapy followed by sequential combination with anlotinib significantly prolongs the PFS of patients and reduces the risk of disease progression. The safety data is consistent with known risks and no new safety signals were identified. This study is the world's first Phase III clinical study to achieve positive results in comparing immunotherapy (PD-1) combined with chemotherapy as first-line treatment for sq-NSCLC. The group plans to announce detailed research data at an upcoming international academic conference. Currently, Bevosuzumab in combination with anlotinib has been approved by the NMPA for first-line extensive-stage small cell lung cancer and second- and third-line endometrial cancer, with a new indication for first-line renal cell carcinoma submitted for market approval, and several Phase III studies in the field of non-small cell lung cancer are ongoing. The group will accelerate the clinical development of this combination therapy to bring more hope to cancer patients through "immunotherapy combined with anti-angiogenesis therapy".