Novelty Nobility Expands Partnership with AGC Biologics to Advance Bispecific Antibody NN4101 into GMP Manufacturing
Collaboration highlights global bioprocessing capabilities as first-in-class retinal disease therapy progresses toward clinical manufacturing
From left to right: Seul Eunjin, AGC Biologics; Kunii Shigeru, AGC Biologics; Sung Gong, Novelty Nobility; Park Chan-Hee, Novelty Nobility; Tadashi Murano; AGC Life Sciences Company; Keiko Nakazono, AGC Biologics
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Novelty Nobility, a clinical-stage biotechnology company based in South Korea, today announced the expansion of its manufacturing partnership with AGC Biologics to advance its bispecific antibody candidate, NN4101, through process development and Good Manufacturing Practice (GMP) production at AGC Biologics’ Chiba facility in Japan.
This renewed agreement builds on a successful collaboration established last year and reflects continued confidence in AGC Biologics’ expertise in developing complex biologics. The program has already achieved key milestones, including cell line development completed in Copenhagen, Denmark, and is now transitioning to the next phase of manufacturing through a seamless technology transfer to Japan.
NN4101 is a first-in-class bispecific antibody designed for the treatment of neovascular retinal diseases. The candidate combines a fully human anti-c-Kit monoclonal antibody with a vascular endothelial growth factor (VEGF) trap, offering a novel therapeutic approach aimed at improving outcomes for patients with vision-threatening conditions.
“AGC Biologics has proven to be an ideal partner for advancing our most complex programs,” said Sang Gyu Park, CEO of Novelty Nobility. “Their integrated global network—from early development to GMP manufacturing—enables us to move NN4101 forward efficiently and with confidence. We believe this therapy has the potential to deliver meaningful differentiation in the treatment of retinal diseases.”
AGC Biologics emphasized that the collaboration underscores its strong capabilities in handling advanced biologics and leveraging its global infrastructure. The company’s expertise in mammalian expression systems and single-use bioreactor technologies plays a critical role in supporting the scalable production of innovative therapies like NN4101.
“Our continued partnership with Novelty Nobility reflects the trust our customers place in our scientific expertise and global network,” said Tadashi Murano, President of the AGC Life Science Company. “We are proud to support the development of this promising bispecific antibody as it advances toward clinical application.”
The project also highlights Japan’s growing importance as a hub for advanced biopharmaceutical manufacturing. To meet increasing global demand, AGC Biologics is expanding its footprint with a new state-of-the-art facility in Yokohama, designed to deliver large-scale GMP manufacturing using next-generation single-use bioreactor systems.
With this expanded collaboration, both companies aim to accelerate the development of NN4101 and bring innovative treatment options closer to patients worldwide.
About Novelty Nobility
Novelty Nobility is a clinical-stage biotechnology company focused on unlocking the full potential of therapeutic antibodies. The company develops next-generation treatments for immunology and inflammatory diseases using its proprietary fully human antibody discovery platform, PREXISE®-D, alongside advanced protein engineering capabilities. Its pipeline includes monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates.
About AGC Biologics
AGC Biologics is a global Contract Development and Manufacturing Organization (CDMO) delivering end-to-end biopharmaceutical development and manufacturing services. With facilities across the U.S., Europe, and Asia, the company specializes in mammalian and microbial-based therapeutics, including proteins, plasmid DNA, mRNA, viral vectors, and cell therapies.
Source: GlobeNewswire
Novelty Nobility, a clinical-stage biotechnology company based in South Korea, today announced the expansion of its manufacturing partnership with AGC Biologics to advance its bispecific antibody candidate, NN4101, through process development and Good Manufacturing Practice (GMP) production at AGC Biologics’ Chiba facility in Japan.
This renewed agreement builds on a successful collaboration established last year and reflects continued confidence in AGC Biologics’ expertise in developing complex biologics. The program has already achieved key milestones, including cell line development completed in Copenhagen, Denmark, and is now transitioning to the next phase of manufacturing through a seamless technology transfer to Japan.
NN4101 is a first-in-class bispecific antibody designed for the treatment of neovascular retinal diseases. The candidate combines a fully human anti-c-Kit monoclonal antibody with a vascular endothelial growth factor (VEGF) trap, offering a novel therapeutic approach aimed at improving outcomes for patients with vision-threatening conditions.
