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Celltrion Secures IND Application Amendment Approvals for CT-P44, CT-P51 Phase 3 Trial

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Celltrion (KRX:068270) received approval for amendments to the investigational new drug (IND) applications for the phase three clinical trials of CT-P44, a biosimilar to Darzalex, in South Korea, and CT-P51, a biosimilar to Keytruda, in the U.S., according to two separate bourse filings on Monday.

The phase three clinical trial of CT-P44 will compare the efficacy and safety of the drug's subcutaneous formulation with Darzalex Faspro, both in combination with lenalidomide and dexamethasone. The trial involves patients with relapsed or refractory multiple myeloma. Celltrion aims to demonstrate CT-P44's biosimilarity to the original drug through efficacy and safety outcomes, the filing said.

The phase three clinical trial of CT-P51 will compare the efficacy and safety of the drug with Keytruda in patients with previously untreated metastatic non-squamous non-small cell lung cancer. Celltrion plans to compare CT-P51's efficacy and safety outcomes with those of Keytruda, it said.

Shares of Celltrion fell nearly 1% in recent trade.

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