Key Highlights

• Kaigene grants Celltrion exclusive worldwide development and commercialization rights to KG013, while retaining an option to participate in co-marketing in South Korea under the agreement.
• KG013 is a next-generation, half-life-extended, fully human anti-APRIL monoclonal antibody with femtomolar binding affinity, being developed for long-acting subcutaneous administration, initially for IgA nephropathy (IgAN).
• The agreement provides for up to $580.5 million in aggregate upfront and milestone payments, plus royalties on net sales.

ROCKVILLE, Md., Oct. 22, 2026 /PRNewswire/ — Kaigene, Inc., a biotechnology company developing antibody medicines for autoimmune diseases, today announced an exclusive worldwide licensing agreement with Celltrion Inc. for KG013, its next-generation monoclonal antibody targeting A Proliferation-Inducing Ligand (APRIL).

Under the agreement, Kaigene grants Celltrion exclusive worldwide rights to develop and commercialize KG013. Kaigene is eligible to receive up to $580.5 million (approximately KRW 769 billion) in total consideration comprising an upfront payment and development, regulatory and commercialization milestone payments, with milestone payments contingent on achieving the relevant objectives. Royalties on net sales are payable separately. Kaigene retains the option to participate in co-marketing in South Korea, subject to the terms of the agreement.

KG013 is a half-life-extended, fully human anti-APRIL monoclonal antibody with femtomolar binding affinity, being developed for long-acting subcutaneous administration. APRIL is a signaling protein that supports plasma cell survival and immunoglobulin production. By inhibiting this pathway, KG013 is intended to suppress the production of pathogenic IgA and IgM antibodies. Its development aims to deliver sustained target inhibition while reducing treatment burden for patients who may require long-term therapy. KG013 is being developed with the goal of enabling lower doses and longer dosing intervals through enhanced potency and prolonged activity, potentially improving dosing convenience and helping patients maintain long-term treatment.

The initial indication is IgAN, a progressive kidney disease in which pathogenic IgA-containing immune complexes accumulate in the kidneys and cause inflammation and damage. Following its work in IgG-mediated diseases, Kaigene is extending its portfolio into IgA- and IgM-mediated autoimmune diseases through KG013. This agreement enables Kaigene to advance the development and commercialization of KG013 in collaboration with Celltrion, a partner with comprehensive infrastructure for the global manufacturing, development and commercialization of antibody therapeutics.

“Kaigene is building a comprehensive portfolio of therapies for pathogenic antibody-mediated diseases, and we believe KG013 has the potential to become a best-in-class treatment for IgA- and IgM-mediated diseases,” said Minjae Shin, Chief Executive Officer of Kaigene. “IgAN, our first planned indication, affects approximately 160,000 diagnosed patients in the United States alone and is particularly common in Asian populations. Patients, including approximately 30,000 in South Korea, need highly effective treatments with durable benefits. By working with Celltrion, a partner with comprehensive infrastructure for the global manufacturing, development and commercialization of antibody therapeutics, we aim to bring KG013 to patients worldwide and make a meaningful contribution to care in South Korea.”

About KG013

KG013 is an investigational, half-life-extended, fully human anti-APRIL monoclonal antibody with femtomolar binding affinity. It is being developed as a long-acting subcutaneous therapy, with IgAN as the first planned indication and potential applications across other IgA- and IgM-mediated autoimmune diseases.

About Kaigene, Inc.

Kaigene, Inc. is a U.S.-based biotechnology company building a comprehensive portfolio of therapeutics for autoimmune diseases. The company’s research and development spans diverse technology platforms, including PDEG™ (Pathogenic Antibody Degrader), NanoBx™ (Nanobody-based Brain Shuttle), multispecific monoclonal antibodies and oral peptide therapeutics. Together, these technologies support the development of treatments across a broad spectrum of autoimmune diseases, including those affecting the central nervous system.

For more information, please visit www.kaigene.com.

About Celltrion, Inc.

Celltrion is a biopharmaceutical company with comprehensive infrastructure for the global manufacturing, development and commercialization of antibody therapeutics. Building on its biosimilar business, the company is expanding its innovative drug pipeline through internal research and external partnerships, including in autoimmune diseases. 

For more information, please visit www.celltrion.com.

Media Contact

media@kaigene.com 

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SOURCE Kaigene