Xinda Bio publishes key data from IBI305 clinical studies

Cinda Biopharmaceuticals announced today that at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO), IBI305 (Beva Pearl Monobiogenic Similar Drug) was published in the form of a poster (poster) comparing the trial data for the first-line treatment of advanced non-scale non-small cell lung cancer (NCT02954172).IBI305 is a recombinant anti-vascular endostropheric growth factor (VEGF) humanized monoclonal antibody injection for non-small cell lung cancer and colorectal cancer and other malignant tumors. The original research drug beva bead monoantin has been approved for the treatment of a number of malignant tumors, including non-small cell lung cancer, its remarkable efficacy and good safety has been widely recognized. In 2010, Bevalju single resistance entered China, although the efficacy is accurate, but its high price limits the access of domestic patients.The NCT02954172 study, announced at asCO's annual meeting, was led by a team of professors of internal medicine at Sun Yat-sen University-affiliated Oncology Hospital, and is a multi-center, random, double-blind study for patients with advanced non-squamous non-small cell lung cancer. The parallel and positive control phase III study was designed to evaluate the efficacy and safety of IBI305 first-line treatment of patients with advanced non-squamous non-small cell lung cancer compared to the original drug beva bead monoantigen, and the main endpoint index was objective remission rate (ORR).NCT02954172 was divided into a group of 450 patients, of which IBI305 group of a total of 224 patients, a total of 226 patients in the beval bead single resistance group. The main clinical data include: 10,000 clinical data, which was fully assessed by the Independent Centre's Imaging Assessment ; The ORR in the IBI305 group was 44.3% (98/221), the ORR in the Beval Bead monoantin group was 46.4% (102/220), and the risk ratio was 0.95 (90% CI: 0.803, 1.135);In the medium non-progression lifetime (PFS), the IBI305 group was 7.9 months, the beva bead monoantion group was 7.8 months, and the remission duration (DoR) of the two groups was very similar;therapeutic adverse events (TEAEs) were controllable and consistent with the known adverse events of the beval bead monoant.based on this clinical data, the National Drug Administration (NMPA) accepted IBI305's New Drug Listing Application (NDA) in January 2019 and included it in its priority review. Thysta Bio hopes to provide more Chinese patients with high-quality and affordable bevaldisant anti-replacement drugs, further reducing the burden on patients and benefiting the vast majority of patients and their families. (U.S. News Agency)