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Innovent Receives Second Fast Track Designation from the U.S. FDA for IBI363 (PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) in Squamous Non-Small Cell Lung Cancer

Innovent Biologics has received its second Fast Track Designation from the U.S. FDA for IBI363 in treating squamous non-small cell lung cancer .
IBI363 showed a 50% objective response rate in clinical trials among patients with sqNSCLC, indicating promising efficacy.
Dr. Hui Zhou of Innovent stated they are pleased with the Fast Track Designation, which may accelerate IBI363's clinical development.
The FDA's Fast Track Designation aims to expedite the development and approval process for drugs addressing serious conditions and unmet needs.

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The Billings Gazette

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Innovent Receives Second Fast Track Designation from the U.S. FDA for IBI363 (PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) in Squamous Non-Small Cell Lung Cancer

SAN FRANCISCO and SUZHOU, China, Feb. 16, 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…

6 days ago·Billings, United States

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pressreach.com

Innovent Receives Second Fast Track Designation from the U.S. FDA for IBI363 (PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) in Squamous Non-Small Cell Lung Cancer - PressReach

SAN FRANCISCO and SUZHOU, China, Feb. 16, 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 its first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363, has received it…

5 days ago

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