US EditionIBI363 Earns Second Breakthrough Therapy Status for Lung Cancer in China
- Innovent Biologics announced on June 3, 2025, that its drug IBI363 earned a second Breakthrough Therapy designation in China for treating advanced non-small cell lung cancer .
- This recognition follows encouraging Phase 1/2 clinical data showing IBI363's efficacy and safety in immunotherapy-resistant squamous NSCLC and wild-type lung adenocarcinoma patients.
- IBI363, a novel PD-1/IL-2–biased bispecific immunotherapy created by Innovent, has shown strong antitumor activity, manageable safety profiles, and promising potential for extending long-term survival regardless of PD-L1 expression levels.
- Data from 136 NSCLC patients, including 67 with squamous cell carcinoma, showed a median overall survival of 15.3 months, with higher efficacy trends at increased doses, as Senior Vice President Hui Zhou reported at ASCO 2025.
- Innovent intends to initiate a Phase 3 pivotal trial targeting patients with squamous non-small cell lung cancer that is locally advanced or has spread, who have not responded to prior platinum-based chemotherapy and PD-1/PD-L1 immunotherapy, highlighting the potential of IBI363 to address significant unmet needs in lung cancer treatment.
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Innovent's IBI363 (PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) Receives Second NMPA Breakthrough Therapy Designation for Immuno-resistant Squamous Non-Small Cell Lung Cancer
SAN FRANCISCO and SUZHOU, China, June 4, 2025 /PRNewswire/ -- 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…
Helena Independent Record
2025 ASCO Oral Presentation: Innovent Biologics Announces Updated Data of IBI363 (First-in-class PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) from the Phase 1 PoC Clinical Study in Advanced Non-small Cell Lung Cancer
SAN FRANCISCO and SUZHOU, China, June 3, 2025 /PRNewswire/ -- 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…
IBI363 earns second breakthrough therapy status for lung cancer in China
SAN FRANCISCO and SUZHOU, China, June 5, 2025 /PRNewswire/ -- 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…
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