CSL has launched ANDEMBRY® Subcutaneous Injection 200 mg Pen (garadacimab) in Japan for the prevention of acute attacks in people with Hereditary Angioedema (HAE).

CSL在日本推出了ANDEMBRY® 皮下注射 200 毫克注射笔（garadacimab），用于预防遗传性血管性水肿 (HAE) 患者的急性发作。

HAE is a rare and serious genetic condition that causes unpredictable and painful swelling episodes in various parts of the body, including the face, abdomen, limbs, and airway. It is listed in Japan as an intractable disease under 'Primary Immunodeficiency Syndrome.' Around 430 patients are currently diagnosed and receiving treatment in Japan.

HAE是一种罕见且严重的遗传性疾病，会导致身体各部位出现不可预测且痛苦的肿胀发作，包括面部、腹部、四肢和呼吸道。在日本，它被列为“原发性免疫缺陷综合征”下的难治性疾病。目前日本大约有430名患者被诊断并接受治疗。

However, based on global prevalence data (1 in 50,000), the actual number of patients in Japan may be closer to 2,500..

然而，根据全球患病率数据（1/50,000），日本的实际患者数量可能更接近2,500人。

ANDEMBRY® is a monoclonal antibody that targets FXIIa, the protein that starts the chain reaction causing swelling in HAE. By stopping this process early, ANDEMBRY® helps prevent attacks. It is now available as a once-monthly injection using a pre-filled pen, offering a new option for long-term prevention in people living with HAE..

ANDEMBRY® 是一种单克隆抗体，靶向 FXIIa，这种蛋白质会引发导致 HAE 肿胀的连锁反应。通过早期阻止这一过程，ANDEMBRY® 有助于预防发作。它现在可以作为每月一次的预充式注射笔使用，为患有 HAE 的人群提供了长期预防的新选择。

ANDEMBRY® is a first-in-class human monoclonal antibody that blocks activated Factor XII (FXIIa), a protein involved in triggering swelling attacks. It is the first pre-filled pen approved for HAE in Japan, designed for once-monthly subcutaneous use, making it more convenient for patients.

ANDEMBRY® 是一种首创的人源单克隆抗体，可阻断激活的因子 XII（FXIIa），这是一种参与触发肿胀发作的蛋白质。它是日本首个获批用于遗传性血管性水肿（HAE）的预填充注射笔，设计为每月一次皮下注射，为患者提供了更大的便利。

The Ministry of Health, Labour and Welfare (MHLW) approved ANDEMBRY® on 20 February 2025. Approval was based on results from the global Phase III VANGUARD trial and its open-label extension, which included Japanese patients and showed the treatment to be both effective and safe.

厚生劳动省（MHLW）于2025年2月20日批准了ANDEMBRY®。该批准基于全球III期VANGUARD试验及其开放扩展研究的结果，这些研究包括日本患者，并显示该治疗既有效又安全。

The launch strengthens CSL’s portfolio in the HAE space, adding to its existing treatments, Berinert® IV and Berinert® SC. ANDEMBRY® is expected to help reduce the frequency of attacks, ease the burden of the condition, and improve quality of life for patients.

此次上市加强了CSL在遗传性血管性水肿（HAE）领域的布局，丰富了其现有的治疗方案，包括Berinert® IV和Berinert® SC。ANDEMBRY®有望帮助减少发作频率、减轻疾病负担，并改善患者的生活质量。