Press Releases / Notices

KYOTO, Japan, July 30, 2026 – Nippon Shinyaku Co., Ltd. (Headquarters: Kyoto, Japan, President: Toru Nakai) announced that it has exercised its option rights under the option agreement entered into with AB2 BIO Ltd. (Headquarters: Lausanne, Switzerland, CEO: Djordje Filipovic) in January 2025 regarding Tadekinig alfa for the treatment of NLRC4 mutation and XIAP deficiency. Through the exercise of the option rights, Nippon Shinyaku has obtained exclusive commercialization rights for Tadekinig alfa in the United States for the treatment of monogenic IL-18 driven Hyperinflammatory Syndrome in patients with NLRC4 and XIAP mutations.

NLRC4 mutation and XIAP deficiency are types of rare and serious hereditary autoinflammatory diseases, and elevated levels of interleukin-18 (IL-18) cause a variety of inflammatory symptoms. Most patients show symptoms in infancy, and the inflammation persists throughout their lives. There are currently no approved therapies specifically indicated for either disease, and new effective treatments are needed.

Tadekinig alfa is a recombinant human IL-18 binding protein, and it suppresses pathological IL-18-related immune and inflammatory responses by specifically binding to excessively produced IL-18. Tadekinig alfa has received Orphan Drug Designation, Breakthrough Therapy Designation, and Rare Pediatric Disease Designation in the United States, as well as Orphan Drug Designation in Europe. Following regulatory approval in the United States, Tadekinig alfa is expected to be commercialized by NS Pharma, Inc. (Paramus, New Jersey, USA, President: Yukiteru Sugiyama), a wholly owned subsidiary of Nippon Shinyaku.

Based on Nippon Shinyaku’s business philosophy, “Helping people lead healthier, happier lives,” we aim to be an organization trusted by the community through creating unique medicines that will bring hope to patients and families suffering from illness. 

Please visit our website (https://www.nippon-shinyaku.co.jp/english/) for products or detailed information.

AB2 Bio is a biotech company developing innovative therapies for the treatment of severe systemic autoinflammatory diseases and conditions driven by IL-18. The company is advancing Tadekinig alfa in a wide range of IL-18 mediated hyperinflammatory diseases and conditions, including rare orphan diseases with high unmet medical needs, at clinical and pre-clinical phase.

AB2 Bio was founded in 2010 and is headquartered in the Innovation Park at the Ecole Polytechnique Fédérale de Lausanne (EPFL), Switzerland. More information can be found on http://www.ab2bio.com.