Lanadelumab

2025年5月8日，武田制药发布了2024财年第四季度及全年财务报告。报告显示，尽管面临全球宏观经济波动和汇率影响，武田制药在核心业务领域实现了稳健增长，研发管线取得多项突破，为未来增长奠定了坚实基础。财务亮点：核心业务驱动增长2024财年，武田制药实现总收入4.58万亿日元（约合305.6亿美元），同比增长7.5%（按实际汇率计算，AER），按恒定汇率（CER）计算增长2.9%。核心收入（Core Revenue）达到4.58万亿日元，同比增长7.4%（AER），2.8%（CER）。核心营业利润（Core Operating Profit）为1.16万亿日元，同比增长10.2%（AER），4.9%（CER）。尽管净利润因一次性费用和汇率波动影响同比下降25.1%至1079亿日元，但核心业务表现强劲，展现了公司持续的增长潜力。分业务领域表现：胃肠病学（GI）：收入同比增长11.6%至1.36万亿日元，主要得益于核心产品ENTYVIO（维多珠单抗）的强劲表现，其销售额增长14.1%至9141亿日元，皮下制剂的推出进一步推动了市场渗透。罕见病（Rare Diseases）：收入增长9.4%至7528亿日元，其中TAKHZYRO（拉那芦人单抗）增长24.9%至2232亿日元，成为增长的主要驱动力。血浆衍生疗法（PDT）：收入增长14.3%至1.03万亿日元，免疫球蛋白产品组合表现突出，销售额增长17.6%至7578亿日元。肿瘤学（Oncology）：收入增长21.2%至5604亿日元，主要得益于FRUZAQLA（呋喹替尼）的快速放量，其销售额增长375.7%至480亿日元。神经科学（Neuroscience）：收入下降9.8%至5658亿日元，主要由于VYVANSE（赖右安非他命）在美国市场面临仿制药竞争。研发管线进展：多项关键里程碑达成武田制药在2024财年持续推进创新研发，核心治疗领域取得多项突破：胃肠病学与炎症领域：ENTYVIO（维多珠单抗）：美国FDA于2024年4月批准其皮下制剂用于克罗恩病（CD）维持治疗，基于VISIBLE 2研究的积极数据。TAK-755（阿帕达酶）：欧盟委员会于2024年8月批准其用于先天性血栓性血小板减少性紫癜（cTTP）治疗，日本也于2025年3月提交了儿科适应症的申请。TAK-625（马拉利昔单抗）：日本厚生劳动省于2025年3月批准其用于阿拉杰综合征（ALGS）和进行性家族性肝内胆汁淤积症（PFIC）的瘙痒治疗。神经科学领域：TAK-861（奥维泊雷顿）：在发作性睡病1型（NT1）的IIb期试验中显示出显著疗效，并获得美国FDA的突破性疗法认定。TAK-935（索替司他）：由于III期研究未达到主要终点，公司决定终止其在Dravet综合征和Lennox-Gastaut综合征中的开发计划。肿瘤学领域：ADCETRIS（维布妥昔单抗）：欧盟CHMP于2025年4月推荐批准其联合化疗（BrECADD方案）用于新诊断的霍奇金淋巴瘤。FRUZAQLA（呋喹替尼）：欧盟和日本分别于2024年6月和9月批准其用于转移性结直肠癌（mCRC）治疗。TAK-121（鲁斯铁肽）：III期VERIFY研究达到主要终点，显著减少真性红细胞增多症（PV）患者的放血需求。财务与资本配置：稳健的现金流与股东回报2024财年，武田制药实现经营活动现金流1.06万亿日元，同比增长47.6%，调整后自由现金流（Adjusted Free Cash Flow）大幅增长171.3%至7690亿日元。公司持续优化资本结构，净债务与调整后EBITDA比率从3.1倍降至2.8倍，展现了良好的财务健康状况。股东回报方面，武田宣布2024财年每股股息为196日元，并计划在2025财年将股息提高至200日元，体现了公司对股东回报的承诺。此外，公司于2025年1月启动了一项1000亿日元的股票回购计划，进一步优化资本配置。2025财年展望：聚焦核心增长与创新武田制药预计2025财年收入将小幅下降1.1%至4.53万亿日元，主要由于VYVANSE在美国市场的仿制药影响。然而，核心营业利润预计保持稳定，公司将继续投资于研发和核心增长产品，包括ENTYVIO、TAKHZYRO和QDENGA（登革热疫苗）等。管理层指引：2025财年核心收入（CER）预计基本持平，核心营业利润和核心每股收益（Core EPS）也将保持稳定。公司强调，尽管面临短期挑战，但长期增长动力充足，研发管线中超过40个临床阶段项目将为未来提供持续增长引擎。结语武田制药总裁兼首席执行官Christophe Weber表示：“2024财年的业绩证明了我们核心业务的韧性和创新管线的潜力。尽管面临外部挑战，我们通过战略执行实现了稳健增长，并在研发领域取得了重要进展。未来，我们将继续专注于为全球患者提供变革性疗法，同时为股东创造可持续价值。”药事纵横投稿须知：稿费已上调，欢迎投稿

TAKHZYRO Solution for Injection in 2 mL Pre-Filled Pen is Now Approved to Facilitate Subcutaneous Administration in Adolescent (Aged 12 Years and Above) and Adult Patients with HAE.1 The Pre-Filled Pen Option is Designed to Allow for An Individualized Treatment Approach for Adolescent and Adult HAE Patients. In the EU, TAKHZYRO is Approved for Routine Prevention of Recurrent HAE Attacks in Patients Aged 2 Years and Older.1 ZURICH, Feb. 24, 2025 /PRNewswire/ -- Takeda (TSE: 4502) (NYSE: TAK) announced today that the EMA has approved an additional 2 mL pre-filled pen option for TAKHZYRO® (lanadelumab) for subcutaneous administration in adolescents (aged 12 years and above) and adult patients with Hereditary Angioedema (HAE).1 The additional subcutaneous administration option expands Takeda's offering in this space, showing dedication to the HAE community while providing individualized treatment options to support patients with a life-threatening disease, by helping to reduce HAE burden and improving their Quality of Life. "HAE affects an estimated 1 in 50,000 people worldwide and is often under recognised, under diagnosed and under treated.3 We welcome the swift approval by the EMA on this additional subcutaneous administration option," said Irmgard Andresen, Global Medical Lead HAE at Takeda. "HAE patients 12 years and older now have an additional individualized treatment option available to them." TAKHZYRO® (lanadelumab) is currently approved as 150 mg solution for injection in pre-filled syringe, 300 mg solution for injection in pre-filled syringe, and 300 mg solution for injection in vial.1 This approval for an additional subcutaneous administration option, TAKHZYRO® 300 mg solution for injection in pre-filled pen, containing 300 mg of lanadelumab in 2 mL of solution, was supported by a clinical study.2 Takeda is dedicated to providing innovative treatment options to support patients, particularly those from underserved communities, and continues its leadership in HAE treatment, supported by a noteworthy data pool from historical engagement in this area. Notes to editors: About HAE Hereditary angioedema (HAE) is a rare genetic disorder that results in recurring attacks of oedema – swelling – in various parts of the body, including the abdomen, face, feet, genitals, hands and throat. The swelling can be debilitating and painful.4 Attacks that obstruct the airways can cause asphyxiation and are potentially life threatening.5 HAE affects an estimated 1 in 50,000 people worldwide.3 It is often under recognised, under diagnosed and under treated.3 HAE, like so many other rare diseases, is highly complex, and patients, their families and caregivers often undergo years of strain trying to understand their disease, get a definitive diagnosis and gain access to the medicines they need. At Takeda we are a committed champion for the patients we serve. Every individual living with HAE is unique and by listening and reacting to their needs, we translate the insights we gain into innovative solutions – from diagnosis to ongoing management. Advancing the science is crucial to the way we operate and we are bold in our mission to accelerate diagnosis and develop treatments that will make a difference to the lives of HAE patients, their support networks and those medical professionals who care for them. About Lanadelumab (TAKHZYRO®)1 Lanadelumab is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein and is indicated for routine prevention of recurrent attacks of HAE in patients aged 2 years and older.1 It was studied in one of the largest prevention studies in HAE with the longest active treatment duration, and Lanadelumab consistently demonstrated HAE attack reduction. Lanadelumab is formulated for subcutaneous administration and has a half-life of approximately two weeks.1 Lanadelumab is intended for self-administration or administration by a caregiver once trained by a healthcare professional.1 About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit . Guidance for use TAKHZYRO treatment should be initiated under the supervision of a physician experienced in the management of patients with hereditary angioedema (HAE). For adults and adolescents (12 to less than 18 years of age), TAKHZYRO may be self-administered or administered by a caregiver only after training on subcutaneous injection technique by a healthcare professional. For children (2 to less than 12 years of age), TAKHZYRO should only be administered by a caregiver after training on SC subcutaneous injection technique by a healthcare professional. Contraindication Hypersensitivity to the active substance or to any of the excipients. Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, administration of TAKHZYRO must be stopped immediately and appropriate treatment must be initiated. The most commonly observed adverse reaction (52.4%) associated with TAKHZYRO was injection site reactions (ISR) including injection site pain, injection site erythema and injection site bruising. Of these ISRs, 97% were of mild intensity, 90% resolved within 1 day after onset with a median duration of 6 minutes. Hypersensitivity reaction (mild and moderate pruritus, discomfort and tingling of tongue) was observed (1.2%) Very common adverse reactions (frequency ≥1/10) were injection site reactions including: pain, erythema, bruising, discomfort, haematoma, haemorrhage, pruritus, swelling, induration, paraesthesia, reaction, warmth, oedema and rash. Please consult the EMA TAKHZYRO® Summary of Product Characteristics before prescribing.1 Important Notice For the purposes of this notice, "press release" means this document, any oral presentation, any question-and-answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited ("Takeda") regarding this release. This press release (including any oral briefings and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. 1 . Relevant documents to be published here as soon as publicly available. 2 . Last accessed: February 2025. 3 Longhurst, H. J., & Bork, K. (2019). Hereditary angioedema: an update on causes, manifestations and treatment. British Journal of Hospital Medicine, 80(7), 391-398. 4 Maurer, M., et al. (2022). The international WAO/EAACI guideline for the management of hereditary angioedema—The 2021 revision and update. Allergy, 77(7), 1961–1990. . 5 Banerji, A., Davis, K. H., Brown, T. M., Hollis, K., Hunter, S. M., Long, J., ... & Devercelli, G. (2020). Patient-reported burden of hereditary angioedema: findings from a patient survey in the United States. Annals of Allergy, Asthma & Immunology, 124(6), 600-607. Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED