• ANDEMBRY® received manufacturing and marketing approval in Japan on February 20, 2025, for the prevention of acute attacks in hereditary angioedema (HAE)
• ANDEMBRY® is the first-in-class monoclonal antibody treatment that inhibits activated Factor XII (FXIIa), the initiating factor in the HAE pathway, and offers the first pre-filled pen presentation enabling once-monthly subcutaneous administration
• CSL has proudly supported the HAE community for over 40 years, developing and delivering innovative therapies for HAE.

TOKYO- 18 April 2025 – CSL Behring K.K. (Headquarters: Minato-ku, Tokyo; President and Representative Director: Izumi Yoshida) today announced that it launched ANDEMBRY® Subcutaneous Injection 200 mg Pen (garadacimab), a novel human anti-activated Factor XII monoclonal antibody for the Prevention of Acute Attacks of Hereditary Angioedema (HAE) in Japan.

ANDEMBRY® is a novel Factor XIIa-inhibitory monoclonal antibody (anti-FXIIa mAb) designed to inhibit activated Factor XII (Factor XIIa), which initiates the cascade of events leading to angioedema at various sites of the body. It is the first prefilled pen formulation for HAE treatment, offering the convenience of once-monthly administration. On February 20, 2025, CSL received manufacturing and marketing approval for ANDEMBRY® from Japan’s Ministry of Health, Labour and Welfare (MHLW), based on efficacy and safety data from the global Phase III "VANGUARD" trial ¹ and its open-label extension study², which included HAE patients, including those from Japan.

Izumi Yoshida, President and Representative Director of CSL Behring K.K., stated:
“We are extremely proud to offer ANDEMBRY® to patients in Japan as a new treatment option for HAE. Featuring a first-in-class mechanism of action and the convenience of a once-monthly pre-filled pen, ANDEMBRY® represents a significant advancement in HAE care. This milestone is the culmination of CSL Behring’s 40 years of dedication to delivering innovative therapies in the HAE field. We are confident that ANDEMBRY® will provide effective long-term prophylaxis of recurrent attacks, reducing the disease burden on patients and enhancing their quality of life (QOL)¹.

With the approval of ANDEMBRY®, CSL has further strengthened its comprehensive portfolio, complementing Berinert® IV and Berinert® SC. This reinforces our long-standing commitment to the HAE community and enhances our ability to meet the evolving needs of patients.

About HAE
HAE is a rare, chronic, debilitating, and potentially life-threatening genetic disorder characterized by recurrent and unpredictable attacks of angioedema. Attacks are often painful and can occur in multiple sites of the body, including the abdomen, larynx, face, and extremities³. HAE is designated as one of Japan's intractable diseases under the category of "Primary Immunodeficiency Syndrome." Reports indicate that approximately 430 patients in Japan are currently diagnosed and receiving treatment.⁴ According to global data, the prevalence of HAE is estimated to be 1 in 50,000 people,⁵ suggesting there may be approximately 2,500 patients in Japan.³

About ANDEMBRY^® (garadacimab)
ANDEMBRY® (garadacimab) is a novel Factor XIIa-inhibitory monoclonal antibody (anti-FXIIa mAb) that has completed Phase 3 clinical development as a new type of once-monthly subcutaneous prophylactic treatment for attacks related to HAE, a form of bradykinin-mediated angioedema. ANDEMBRY® uniquely inhibits the plasma protein, FXIIa. When FXII is activated, it initiates the cascade of events leading to edema formation. By targeting FXIIa, ANDEMBRY® inhibits this cascade at the top as compared to other HAE therapies that target downstream mediators.

As of April 2025, ANDEMBRY® has been granted regulatory approval by the Therapeutic Goods Administration (TGA) in Australia (January 14), the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (January 24), the European Commission (EC) (February 11), and Swissmedic in Switzerland (February 24).

About “ANDEMBRY® S.C. Injection 200mg Pens”

About CSL Behring K.K.
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. In Japan, our core focus areas include immunology and rare diseases, hemophilia, as well as critical care and hemostasis. For more information, please visit https://www.cslbehring.co.jp.

About CSL
CSL (ASX: CSL; USOTC:CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSL. For more information about CSL, visit www.CSL.com.

Reference：

1. The LANVET, Volume 401, Issue 10382p1079-1090April 01, 2023
2. Allergy 2025 Feb;80(2):545-556. doi: 10.1111/all.16351. Epub 2024 Oct 7.
3. Longhurst HJ, Bork K. Hereditary angioedema: causes, manifestations, and treatment. Br J Hosp Med. 2006;67(12):654-657.
4. Osawa I. Hereditary Angioedema. Iyaku Journal
5. Ghazi A et al., Biologics. 2013; 7:103-13. doi: 10.2147/BTT.S27566

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