Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies,  announced that its partner NEOK Bio, Inc. recently received clearance from the U.S. Food and Drug Administration (FDA) of an investigational new drug (IND) application for NEOK002, an EGFR/MUC1-targeting ADC program for solid tumors. NEOK Bio plans to initiate a Phase 1 clinical study in the second quarter of 2026 and expects to report initial data in 2027.

This IND clearance marks an important milestone for NEOK002, an EGFR/MUC1-targeting ADC candidate developed by NEOK Bio and built on a bispecific antibody originally developed by Biocytogen and licensed in 2024. According to NEOK Bio, NEOK002 is being advanced for solid tumors and may offer differentiated efficacy and safety compared with monospecific ADC approaches directed at either target alone.

Dr. Yuelei Shen, President and CEO of Biocytogen, said: “We are pleased to see one of our partnered molecules reach this important stage of development. This milestone further validates the quality, developability, and therapeutic potential of fully human bispecific antibodies discovered using our RenLite^® platform, which features a common light chain design. We look forward to the continued clinical advancement of the program.”