By Fineline Cube 
China-based Innovent Biologics, Inc. (HKG: 1801) announced that its first-in-class PD-1/IL-2α-bias bispecific antibody (BsAb) fusion protein, IBI363, has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) in China. This designation is for the treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) that has progressed after platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy.
Clinical Data and Previous Designations
IBI363 has demonstrated positive clinical data in treating patients with immune-resistant cold tumors, including non-small cell lung cancer, colorectal cancer, and melanoma. These results were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Additionally, the drug previously received fast track designation from the US Food and Drug Administration (FDA) for use in melanoma.-Fineline Info & Tech