Biotechnology company Biocytogen Pharmaceuticals (Beijing) Co Ltd (SSE:688796) (HKEX:02315) announced on Friday that its partner NEOK Bio Inc has received US Food and Drug Administration (FDA) clearance for an investigational new drug application for NEOK002, an EGFR/MUC1-targeting antibody-drug conjugate (ADC) for solid tumours.

NEOK Bio plans to initiate a Phase 1 clinical trial in the second quarter of 2026, with initial data expected in 2027. The candidate is based on a bispecific antibody originally developed by Biocytogen and licensed to NEOK Bio in 2024.

IND clearance represents a development milestone for the programme, which is designed to target both EGFR and MUC1 and may offer differentiated efficacy and safety compared to monospecific approaches.

"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," said Dr Yuelei Shen, president and CEO of Biocytogen. "We look forward to the continued clinical advancement of the programme."