Novelty Nobility Expands Partnership with AGC Biologics for First-in-Class Bispecific Antibody NN4101
核心洞察
Novelty Nobility (搜索) expanded its manufacturing agreement with AGC Biologics to advance bispecific antibody NN4101 (搜索) through GMP manufacturing at the Chiba, Japan facility.
NN4101 (搜索) is a first-in-class bispecific antibody combining anti-c-Kit (搜索) monoclonal antibody with VEGF (搜索) trap for treating neovascular retinal diseases (搜索).
The partnership leverages AGC Biologics' global network, with cell line development completed in Copenhagen and tech transfer proceeding to Chiba for critical manufacturing stages.
South Korean clinical-stage biotech company Novelty Nobility (搜索) has expanded its manufacturing partnership with AGC Biologics to advance its first-in-class bispecific antibody drug candidate NN4101 (搜索) through process development and Good Manufacturing Practice (GMP) manufacturing at AGC Biologics' facility in Chiba, Japan.
The expanded agreement represents the second partnership between the companies, building on a successful collaboration from the previous year. The project demonstrates AGC Biologics' integrated global network capabilities, having completed cell line development in Copenhagen, Denmark, with the program now transitioning to the Chiba site for critical manufacturing stages.
Novel Bispecific Antibody for Retinal Disease
NN4101 (搜索) represents a unique therapeutic approach for neovascular retinal diseases (搜索), combining a fully human anti-c-Kit (搜索) monoclonal antibody with a vascular endothelial growth factor (VEGF (搜索)) trap. This first-in-class design positions the candidate as a potentially differentiated treatment option for patients with these vision-threatening conditions.
"AGC Biologics has proven to be an ideal manufacturing partner for advancing our most complex programs," said Sang Gyu Park, CEO of Novelty Nobility (搜索). "Their seamless global network — from cell line development to GMP manufacturing — gives us the confidence to move NN4101 (搜索) forward with speed and precision. We believe this bispecific antibody has the potential to offer a truly differentiated treatment option for patients with neovascular retinal diseases (搜索)."
Manufacturing Excellence and Global Network
The partnership highlights AGC Biologics' expertise in handling complex biologics through its mammalian expression teams and world-leading single-use bioreactor technology. The company's integrated global facility network spans the United States, Europe, and Asia, with locations in Seattle, Copenhagen, Heidelberg, Milan, and Japan.
"Our continued partnership with Novelty Nobility (搜索) is a testament to the trust and confidence customers have in our technical expertise and our global network's capabilities," said Tadashi Murano, President of the AGC Life Science Company. "Our mammalian expression teams are adept at handling complex proteins, and we are a world leader in applying flexible, single-use bioreactor technology."
Expanding Japanese Manufacturing Capacity
To support growing regional and global demand, AGC Biologics is expanding its Japanese operations with a new state-of-the-art facility in Yokohama. The facility will utilize advanced single-use bioreactor technology for large-scale GMP manufacturing, positioning it as one of the most advanced facilities of its kind in Japan.
"When clients work with us, they tap into our entire global network which brings teams together for a seamless experience," noted Susumu Zen-in, Senior Vice President and General Manager of AGC Biologics' Chiba site. "This approach is creating wins for our partners and for AGC Biologics throughout the APAC region. The upcoming capacity at our new Yokohama site will only strengthen our ability to meet the global demand for vital biopharmaceuticals."
Company Profiles
Novelty Nobility (搜索) operates as a clinical-stage biotech company focused on maximizing therapeutic antibody potential for immunology and inflammatory diseases. The company leverages its proprietary PREXISE-D fully human antibody discovery platform and protein engineering expertise to advance a diverse pipeline including monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates.
AGC Biologics functions as a leading global biopharmaceutical Contract Development and Manufacturing Organization, providing development and manufacturing services for mammalian and microbial-based therapeutic proteins, plasmid DNA, messenger RNA, viral vectors, and genetically engineered cells. The company operates as part of AGC Inc.'s Life Science Business, which runs eight facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals.