The drug, co-developed with U.S.-based Abpro, employs a T-cell engager mechanism that links immune cells directly to cancer cells expressing the HER2 protein. Celltrion plans to begin dosing patients next year following preparatory procedures, according to a company statement.
Preclinical studies presented at the Society for Immunotherapy of Cancer conference in November showed the drug suppressed tumors in mice with both high and low HER2 expression, while demonstrating tolerability in primate toxicity tests at doses up to 80 milligrams per kilogram.
"CT-P72/ABP-102 is a multispecific antibody candidate that showed potential for improved therapeutic index through antibody binding adjustments in preclinical stages," a Celltrion official said.
The approval marks Celltrion's second regulatory milestone for its novel drug pipeline in recent months, following the FDA's fast-track designation for its antibody-drug conjugate CT-P70.
Celltrion aims to expand its pipeline to 20 novel drug candidates by 2027, including 10 in clinical stages, as it seeks to reduce its reliance on biosimilar products.
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