Core Insights - The National Medical Products Administration (NMPA) has proposed to include Innovent Biologics' IBI363, a PD-1/IL-2 bispecific antibody fusion protein, in its breakthrough therapy designation for treating locally advanced or metastatic squamous non-small cell lung cancer that has failed platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy [1][2] Group 1: Product Development - IBI363 is a globally innovative PD-1/IL-2α-bias bispecific fusion protein developed by Innovent Biologics, designed to block the PD-1/PD-L1 pathway while activating the IL-2 pathway [1] - The IL-2 arm of IBI363 has been engineered to retain affinity for IL-2 Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby lowering toxicity [1] - IBI363 has demonstrated good anti-tumor activity in various tumor-bearing pharmacology models and has shown significant tumor suppression efficacy in PD-1 resistant and metastatic models [1] Group 2: Clinical Research and Regulatory Status - IBI363 has previously been included in the breakthrough therapy drug (BTD) list by CDE, targeting unresectable locally advanced or metastatic acral and mucosal melanoma that has not undergone systemic treatment [2] - Innovent Biologics is conducting clinical studies in China, the United States, and Australia to explore the efficacy and safety of IBI363 against various malignancies [2] - IBI363 has received two Fast Track designations from the U.S. FDA for the treatment of advanced squamous non-small cell lung cancer and melanoma [2]
信达生物(01801)全球首创PD-1/IL-2α双特异性抗体融合蛋白拟纳入突破性疗法