日本新药行使Tadekinig alfa美国商业化选择权，但尚非获批上市事件

PARAMUS, N.J., July 30, 2026 /PRNewswire/ -- NS Pharma, Inc. (Headquarters: Paramus, New Jersey; President: Yukiteru Sugiyama) announced today that its parent company, Nippon Shinyaku Co., Ltd. (Headquarters: Kyoto, Japan; President: Toru Nakai), 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. 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.
"The exercise of this option agreement further exemplifies our long-term commitment to shepherding therapeutic advances into novel treatments that profoundly improve the lives of rare disease patients and address unmet needs," said Dr. Yukiteru Sugiyama, NS Pharma President. "We are proud to partner with AB2 BIO to bring this much needed treatment to an underserved patient population."
About NLRC4 mutation and XIAP deficiency
NLRC4 mutation and XIAP deficiency are rare and serious hereditary autoinflammatory diseases that cause elevated levels of interleukin-18 (IL-18) leading to a variety of inflammatory symptoms. Most patients show symptoms in infancy, with inflammation persisting throughout their lives. There are currently no approved therapies specifically indicated for either disease.
About Tadekinig alfa
Tadekinig alfa is a recombinant human IL-18 binding protein that 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. a wholly owned subsidiary of Nippon Shinyaku.
About 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.
About AB2 BIO Ltd.
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.
About NS Pharma, Inc.
NS Pharma, Inc., is a wholly owned subsidiary and registered trademark of Nippon Shinyaku Co., Ltd. Backed by over one hundred years of development expertise, NS Pharma is dedicated to delivering life-changing care to people living with complex, rare diseases. For more information, please visit nspharma.com
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SOURCE NS Pharma, Inc.