Celltrion is ramping up its development of novel therapies for autoimmune diseases by acquiring a new antibody candidate worth up to 770 billion KRW (approximately 583 million USD). The company has expanded its autoimmune disease drug pipeline to three candidates by adding an anti-APRIL antibody to its two previously secured FcRn inhibitors.
On Thursday, Celltrion announced a global licensing agreement with U.S. biotech firm Kaigene for the autoimmune disease drug candidate KG013. The deal, valued at up to 580.5 million USD, includes upfront payments and milestone payments for development, approval, and commercialization stages. Royalties based on post-commercialization net sales will be paid separately.
This agreement grants Celltrion exclusive global rights to develop and market KG013. Kaigene retains co-selling rights in the Korean market.
KG013 is an antibody drug candidate targeting APRIL, a signaling protein crucial for the survival and function of antibody-producing B cells. It’s being developed to treat immune disorders, including IgA nephropathy (IgAN).
IgA nephropathy is a chronic condition where immunoglobulin A (IgA) accumulates in the kidneys, causing damage. Given the need for long-term treatment and management, developing therapies that address the disease’s underlying mechanisms and can be administered over extended periods is vital.
APRIL-targeted therapies work by inhibiting pathways involved in pathogenic IgA production. Unlike conventional immunosuppressive treatments, they target the disease’s primary pathophysiology, making them a promising next-generation treatment strategy.
Celltrion aims to enhance KG013’s efficacy and in-body persistence to reduce dosage and extend administration intervals. This approach seeks to minimize patient treatment burden and secure a best-in-class drug that stands out from existing therapies. However, these are development goals, and actual efficacy and safety will require confirmation through future clinical trials.
By adding the anti-APRIL antibody to its existing FcRn inhibitors, Celltrion has bolstered its autoimmune disease drug pipeline to three candidates.
Last year, Celltrion expanded its pipeline by adding KG013 to two candidate substances, including an FcRn inhibitor introduced by Kaigene.
FcRn inhibitors work by suppressing FcRn, which is involved in immunoglobulin G (IgG) antibody circulation, thereby lowering IgG levels. KG013 targets the IgA production pathway. This strategy aims to broaden Celltrion’s autoimmune disease drug development scope by securing candidates that target different immune pathways.
Celltrion plans to leverage its global sales network and commercialization experience gained from its existing tumor necrosis factor-alpha (TNF-α) inhibitors and interleukin (IL) inhibitor biosimilars for its new drug business.
The company is positioning autoimmune diseases as a key pillar of its new drug development, alongside cancer and metabolic diseases. Its open innovation strategy, combining internal development with external technology acquisition, aims to secure new drug candidates and expand its global market presence.
A Celltrion spokesperson stated that following last year’s introduction of two next-generation autoimmune disease treatments, the acquisition of the anti-APRIL antibody license has further strengthened the new drug pipeline. It will maximize synergies with the existing core product lines to enhance the competitiveness in the global autoimmune disease treatment market.
In other news, Celltrion reported consolidated third-quarter revenues of 1.5 trillion KRW (approximately 1.14 billion USD) and an operating profit of 510 billion KRW (about 386 million USD). Compared to the same period last year, revenue increased by 45.8%, and operating profit rose by 69.2%. The operating profit margin reached 34%, up 4.7 percentage points from the previous year.
Celltrion had set operating profit targets of 300 billion KRW (around 227 million USD) for the first quarter, 400 billion KRW (about 303 million USD) for the second quarter, and over 500 billion KRW (approximately 378 million USD) for the third quarter. With these results, the company has exceeded its targets for three consecutive quarters.
