Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology, and other major diseases, announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted a second Breakthrough Therapy Designation (BTD) to its first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363, for the treatment of unresectable, locally advanced, or metastatic squamous non-small cell lung cancer (sqNSCLC) that has progressed following anti-PD-(L)1 immunotherapy and platinum-based chemotherapy. To date, IBI363 has received BTDs from China's NMPA CDE and Fast Track Designations (FTDs) from the U.S. FDA for two indications—sqNSCLC and melanoma. The latest BTD further advances IBI363's potential in addressing immunotherapy resistance and cold tumor challenges.

The latest data from the Phase 1 clinical study of IBI363 in subjects with squamous non-small cell lung cancer (sqNSCLC) who previously received immunotherapy were reported in an oral presentation at the 2025 ASCO Annual Meeting. Manageable safety, encouraging efficacy, and long-term survival benefits were observed in both immunotherapy-resistant squamous non-small cell lung cancer and wild-type lung adenocarcinoma, offering new therapeutic hope for immunotherapy-resistant patients. At this year's ASCO conference, IBI363 presented breakthrough clinical findings in three immunotherapy-resistant and cold tumor types: non-small cell lung cancer, colorectal cancer, and melanoma, garnering significant attention.

Dr. Hui Zhou, Senior Vice President of Innovent, stated, "IBI363 could potentially be a promising next-generation IO agent by combining dual mechanisms—PD-1 blockade and IL-2-driven tumor-specific T-cell populations expansion—thus reshape the tumor microenvironment. Recent regulatory milestones, including multiple FTDs and BTDs, underscore its clinical value in addressing unmet needs. We are accelerating IBI363's global development across multiple tumor types: the first registrational study in acral and mucosal melanoma, a head-to-head trial against pembrolizumab, has already been initiated. We will communicate with regulatory authorities about additional registrational clinical trials for lung cancer and colorectal cancer, bringing innovation therapies at the forefront of immunotherapy to benefit global patients."

NMPA Breakthrough Therapy Designation is intended to facilitate and expedite the development and review of investigational drugs for serious diseases or conditions when preliminary clinical evidence indicates substantial improvement over current therapies. BTD qualifies a drug candidate for accelerated review by the CDE and provides the sponsor with timely advice and communication to expedite the approval process, helping to address the unmet clinical needs of patients more swiftly.