Celltrion is leaping forward as a "global new drug company" through its robust research and development (R&D) experience and the introduction of external technology assets.
Celltrion said Thursday that it has signed a global license-in agreement for 'KG013,' a new drug candidate for autoimmune diseases, with Kaigene, a biotech company located in Maryland, US. Under the agreement, Celltrion will hold exclusive worldwide development and sales rights, while Kaigene will retain the right to participate in co-sales limited to the Korean market in the future.
The total contract value reaches up to 580.5 million dollars (769 billion won), including upfront payments and milestone payments to be made sequentially upon achieving development, regulatory approval, and commercialization milestones. Following commercialization, royalties will be paid separately based on net sales.
KG013, secured by Celltrion, is a next-generation antibody new drug candidate that targets 'APRIL (A Proliferation-Inducing Ligand),' a signaling protein involved in the survival and functional maintenance of B cells that produce antibodies, to treat various immune diseases such as IgA nephropathy (IgAN). As IgA nephropathy, its primary indication, is a chronic disease requiring long-term treatment and management, ensuring the long-term safety of the therapy is considered a critical challenge.
While existing treatments broadly suppress immune cells or lower blood pressure to delay kidney damage, APRIL-targeted therapy acts more selectively on the disease's underlying mechanism by reducing pathogenic IgA involved in the core pathophysiology of IgA nephropathy. Based on this differentiation, APRIL is gaining attention as a "Best Target" suitable for long-term treatment.
KG013 is a next-generation APRIL-targeted therapy that attacks this target, being developed to enable effective disease control with lower dosages and longer dosing intervals by significantly improving drug efficacy and in-body persistence compared to existing first-generation therapies. Celltrion plans to develop KG013 into a Best-in-class (best drug within its class) new drug that enhances patient medication convenience and treatment continuity, based on its differentiated drug characteristics.
With this contract, Celltrion has completed a pipeline of three autoimmune disease new drugs, including an anti-APRIL antibody, following two candidates introduced from Kaigene last year, such as a Neonatal Fc Receptor (FcRn) inhibitor. Analysts note that by adding KG013, which suppresses the production of IgA and IgM, to the FcRn inhibitor 'KG006,' which works via an IgG degradation mechanism, Celltrion has secured mutually complementary mechanisms from multiple angles, creating strong portfolio synergy that dramatically expands disease coverage.
Celltrion aims to further solidify its dominance in the autoimmune disease market by organically combining this next-generation new drug lineup with the powerful infrastructure and commercialization know-how of its biosimilar (biologic copy drug) product lines for Tumor Necrosis Factor-alpha (TNF-α) inhibitors and Interleukin (IL) inhibitors, which have already established their position in the global market.
In particular, it is accelerating a two-track strategy of in-house development and open innovation, setting autoimmune diseases as a core pillar of new drug development alongside oncology and obesity/metabolic diseases.
A Celltrion official said, "Our next-generation autoimmune disease pipeline has become even more robust through strategic open innovation," adding, "We will continue to maintain an unparalleled competitive advantage in the global autoimmune disease therapy market by maximizing synergy with our existing core product lines."
in THEBIO
