Core Viewpoint - The China National Medical Products Administration (NMPA) has included two products from Innovent Biologics, IBI310 (an anti-CTLA-4 monoclonal antibody) and IBI308 (an anti-PD-1 monoclonal antibody), in the list of breakthrough therapies for the treatment of resectable high microsatellite instability (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancer as neoadjuvant therapy [1] Group 1 - The application for IBI310 and IBI308 has been approved under the breakthrough therapy program, complying with the relevant regulations [1] - The clinical study (Neoshot) for IBI310 in combination with IBI308 has completed the first patient dosing in China as of March this year [1] - IBI310 is a fully human anti-CTLA-4 monoclonal antibody that enhances T-cell activation and proliferation, thereby improving anti-tumor immune responses [2] Group 2 - IBI308, developed in collaboration with Eli Lilly, has received approval for seven indications in China, including classic Hodgkin lymphoma, non-small cell lung cancer, hepatocellular carcinoma, esophageal squamous cell carcinoma, and gastric cancer [2] - The breakthrough therapy designation is aimed at expediting the development and review of drugs that treat serious conditions and fill an unmet medical need [1]
信达生物(01801)抗CTLA-4单抗+抗PD-1单抗拟纳入突破性治疗品种