Global biotechnology leader CSL announced today that the Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorization to ANDEMBRY® (garadacimab) for long-term prophylaxis of recurring attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.

全球生物技术领导者CSL今天宣布，瑞士治疗产品管理局（Swissmedic）已授予ANDEMBRY®（加拉达西单抗）上市许可，用于12岁及以上成人和青少年患者遗传性血管性水肿（HAE）复发性发作的长期预防。

ANDEMBRY®, a monoclonal antibody, inhibits plasma protein factor XIIa, which initiates the cascade of events leading to angioedema at various sites of the body. .

ANDEMBRY® 是一种单克隆抗体，可抑制血浆蛋白因子 XIIa，该因子会引发导致身体各部位血管性水肿的级联反应。

“This approval from Swissmedic marks the fifth regulatory approval of ANDEMBRY® for HAE, following recent approvals in Australia, the UK, the EU, and Japan,” said Emmanuelle Lecomte-Brisset, Global Head of Regulatory Affairs at CSL. “We are incredibly proud of these milestones, which reflect our decades-long commitment to delivering innovative medicines to the HAE community.

“瑞士医药管理局的这次批准是ANDEMBRY®在HAE领域的第五次监管批准，此前该药物已在澳大利亚、英国、欧盟和日本获得批准，”CSL全球监管事务主管Emmanuelle Lecomte-Brisset表示。“我们为这些里程碑感到无比自豪，这反映了我们数十年来为HAE群体提供创新药物的坚定承诺。”

Access and reimbursement negotiations are currently underway to ensure that ANDEMBRY® is made available to eligible people with HAE in Switzerland.”.

“目前正在进行获取和报销谈判，以确保ANDEMBRY®能够提供给瑞士符合资格的HAE患者。”

“With the approval of ANDEMBRY®, following Berinert® IV (intravenous) and Berinert® SC (subcutaneous), CSL Behring now offers an even more comprehensive portfolio for the management of HAE,” said Dr. Isabelle Dahinden, General Manager Switzerland, CSL Behring. “This allows us to meet the diverse needs of people living with HAE, a community we have supported for more than 40 years.”.

“随着ANDEMBRY®的获批，继Berinert® IV（静脉注射）和Berinert® SC（皮下注射）之后，CSL Behring现在为HAE的管理提供了更加全面的产品组合，”CSL Behring瑞士总经理伊莎贝尔·达辛登博士表示。“这使我们能够满足HAE患者的各种需求，这个群体我们已经支持了40多年。”

“While there are current treatments available for HAE, individual needs and responses to treatment vary,” said Dr. Michael Haslauer, Country Medical Lead Switzerland, CSL Behring. “ANDEMBRY® offers people living with HAE a vital new treatment option that provides long-term control over their disease.”.

“虽然目前已有针对 HAE 的治疗方法，但个体对治疗的需求和反应各不相同，”CSL Behring 瑞士国家医学负责人迈克尔·哈斯劳尔博士表示。“ANDEMBRY® 为 HAE 患者提供了一种重要的新治疗选择，能够帮助他们长期控制病情。”

About Hereditary Angioedema (HAE)

关于遗传性血管性水肿（HAE）

HAE is a rare, chronic, debilitating, and potentially life-threatening genetic disorder characterized by recurrent and unpredictable attacks of angioedema. Attacks of HAE are often painful and can spread to multiple sites of the body, including the abdomen, larynx, face, and extremities. HAE occurs in about 1 in 50,000 people of any ethnic group..

遗传性血管水肿（HAE）是一种罕见、慢性、衰弱且可能危及生命的遗传性疾病，其特征是反复和不可预测的血管性水肿发作。HAE的发作通常令人疼痛，并可能蔓延至身体多个部位，包括腹部、喉部、面部和四肢。HAE发生在任何种族群体中，约每5万人中有1人患病。

About ANDEMBRY® (garadacimab)

关于ANDEMBRY®（加拉达西单抗）

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 long-term prophylactic treatment for attacks related to HAE, a form of bradykinin-mediated angioedema. ANDEMBRY® is CSL's first homegrown recombinant monoclonal antibody to gain approval.

ANDEMBRY®（加拉达西单抗）是一种新型的因子XIIa抑制性单克隆抗体（抗FXIIa mAb），已完成作为治疗HAE（一种缓激肽介导的血管性水肿）相关发作的新型每月一次皮下长期预防疗法的3期临床开发。ANDEMBRY®是CSL首个获得批准的本土重组单克隆抗体。

It was discovered and optimized by scientists at CSL's Bio21-based research site, with formulation and manufacturing for the clinical programs completed at the CSL Broadmeadows Biotech Manufacturing Facility. ANDEMBRY® uniquely inhibits the plasma protein, FXIIa. When FXII is activated, it initiates the cascade of events leading to edema formation.

它由CSL位于Bio21的研究基地的科学家发现并优化，临床项目的配方和生产在CSL布罗德梅多斯生物技术制造工厂完成。ANDEMBRY®独特地抑制血浆蛋白FXIIa。当FXII被激活时，它会启动导致水肿形成的级联反应。

By targeting FXIIa, ANDEMBRY® inhibits this cascade at the initiating event rather than downstream mediators..

通过靶向FXIIa，ANDEMBRY®在引发事件处抑制这一级联反应，而不是下游介质。

The Swissmedic approval of ANDEMBRY® is based on efficacy and safety data from the pivotal international Phase 3 VANGUARD trial and its open-label extension study. The detailed results of the VANGUARD trial were published in The Lancet in April 2023 and the primary results of the ongoing open-label extension study were published in Allergy (October 2024)..

瑞士药监局对ANDEMBRY®的批准基于关键的国际III期VANGUARD试验及其开放标签扩展研究的有效性和安全性数据。VANGUARD试验的详细结果于2023年4月发表在《柳叶刀》上，而正在进行的开放标签扩展研究的主要结果则发表在《过敏》杂志（2024年10月）。

The most commonly observed side effects associated with ANDEMBRY® in the phase 3 clinical trial were injection site reactions (2/39, 5.1%) including redness, bruising and itchiness.

在第 3 阶段临床试验中，使用ANDEMBRY®观察到的最常见的副作用是注射部位反应 (2/39, 5.1%)，包括发红、瘀伤和瘙痒。

About CSL

关于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.

CSL（ASX：CSL；USOTC：CSLLY）是一家全球生物技术公司，拥有多种挽救生命的药物的动态组合，包括治疗血友病和免疫缺陷的药物、预防流感的疫苗以及治疗缺铁和肾病的疗法。自1916年成立以来，我们一直致力于通过最新技术实现拯救生命的承诺。

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..

如今，CSL（包括我们的三大业务：CSL Behring、CSL Seqirus 和 CSL Vifor）为全球 100 多个国家的患者提供拯救生命的产品，并雇用 32,000 名员工。我们独特的商业实力、研发专注和运营卓越性相结合，使我们能够识别、开发并交付创新成果，帮助患者充分享受生活。