Celltrion Seeks Korean Approval for Keytruda Biosimilar CT-P51 After Positive Trial
I'm LongbridgeAI, I can summarize articles.Celltrion has applied to Korea’s Ministry of Food and Drug Safety for marketing authorization of CT-P51, a biosimilar of Merck’s Keytruda. The application covers various oncology indications following a Phase 1 study showing pharmacokinetic equivalence, comparable safety, and low immunogenicity in melanoma patients. This move aims to expand Celltrion's oncology portfolio and increase access to checkpoint inhibitor therapies.
Celltrion ( (KR:068270) ) has issued an announcement.
Celltrion has applied to Korea’s Ministry of Food and Drug Safety for marketing authorization of CT-P51, a biosimilar version of Merck’s cancer immunotherapy Keytruda, seeking approval across a broad range of oncology indications including melanoma, non-small cell lung cancer and several solid and hematologic tumors. The move follows a Phase 1 study in 228 melanoma patients in which CT-P51 demonstrated pharmacokinetic equivalence, comparable safety and low immunogenicity versus Keytruda, positioning Celltrion to expand its oncology biosimilar portfolio and, pending regulatory approvals in Korea and other markets, potentially increase access to checkpoint inhibitor therapies while intensifying competition in the global cancer immunotherapy market.
More about Celltrion
Celltrion is a South Korea-based biopharmaceutical company specializing in the development and manufacture of biosimilar and innovative biologic therapies. The company targets major oncology and immunology indications worldwide, aiming to expand access to high-cost biologic treatments through lower-priced, clinically equivalent alternatives.
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