BIOCYTOGEN-B Partner NEOK Bio Secures FDA IND Clearance for Bispecific ADC NEOK002, Reaching Critical Collaboration Milestone

Stock News03-26 22:39

BIOCYTOGEN-B (02315) announced that its partner, NEOK Bio, Inc., has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its investigational drug candidate NEOK002. NEOK002 is an antibody-drug conjugate (ADC) targeting EGFR/MUC1, intended for the treatment of solid tumors. NEOK Bio plans to initiate a Phase I clinical trial in the second quarter of 2026 and expects to release preliminary clinical data in 2027. This IND approval marks a significant milestone for the NEOK002 program. NEOK002 is built upon a bispecific antibody independently developed by BIOCYTOGEN-B and licensed externally in 2024, with NEOK Bio advancing the ADC development. According to disclosures from NEOK Bio, NEOK002 is being developed for solid tumor treatment and is expected to demonstrate differentiated advantages in efficacy and safety compared to ADCs targeting only a single antigen. Dr. Yue-Lei Shen, Chairman and CEO of BIOCYTOGEN-B, stated: "We are very pleased to see the collaborative project advance to this important stage. Achieving this milestone further validates the comprehensive advantages of the fully human bispecific antibodies developed on the RenLite® platform in terms of molecular quality, druggability, and clinical translation potential. The RenLite® platform utilizes a common light chain design, enabling efficient support for the development of innovative antibody drugs. We look forward to continued positive progress for this project during the clinical stage."

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