Zhitong Finance App learned that on March 29, the China National Drug Administration Drug Evaluation Center (CDE) official website announced that Cinda Biotech (01801) IBI310 (an anti-CTLA-4 monoclonal antibody) and cindilimab (IBI308, anti-PD-1 monoclonal antibody) products are intended to be included in breakthrough treatment varieties. The indications are IBI310 combined with cindilimab for resectable high-microsatellite instability (MSI-H) or mismatch to repair genodefective (dMMR) colon cancer.
According to a press release recently released by Cindilizumab, a randomized, controlled, multi-center phase 3 clinical study (Neosshot) of iBi310 combined with cindilimab as an adjuvant treatment for resectable MSI-H/dMMR colon cancer (CT4 or CN+ stage) patients completed the first patient administration in China in March of this year.
According to reports, IBI310 is a recombinant all-human anti-CTLA-4 monoclonal antibody injection independently developed by Cinda Biotech. This product can specifically bind CTLA-4 to block CTLA-4 mediated T-cell inhibition, promote T-cell activation and proliferation, enhance tumor immune response, and achieve anti-tumor effects. Cindilizumab is an anti-PD-1 monoclonal antibody jointly developed by Cinda Biotech and Eli Lilly and Company (Eli Lilly and Company). It has been approved for seven indications in China, covering classic Hodgkin lymphoma, non-small cell lung cancer, hepatocellular carcinoma, esophageal squamous cell carcinoma, gastric cancer, etc.