Biocytogen reports FDA IND clearance for NEOK Bio’s NEOK002 targeting solid tumours
Friday, March 27, 2026
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. has announced that its partner, NEOK Bio, Inc., has received investigational new drug (IND) clearance from the U.S. Food and Drug Administration for NEOK002, an antibody-drug conjugate (ADC) targeting EGFR and MUC1 for the treatment of solid tumours.
NEOK Bio plans to begin a Phase 1 clinical study in the second quarter of 2026, with initial data expected in 2027.
The clearance marks a key step for NEOK002, which is based on a bispecific antibody originally developed by Biocytogen and licensed to NEOK Bio in 2024. The programme is being advanced for solid tumours and is expected to offer improved efficacy and safety compared with single-target ADC approaches.
Biocytogen stated that the milestone highlights the potential and developability of its fully human bispecific antibodies developed using its RenLite platform, which incorporates a common light chain design. The company expects further clinical progress of the programme.
Source: businesswire.com
