Spesolimab

药械追踪No.1 / 拜耳非奈利酮获FDA批准，用于治疗射血分数≥40%的心衰患者2025年7月14日，拜耳宣布，美国食品药品监督管理局（FDA）已批准非奈利酮（商品名：可申达/ Kerendia）用于治疗射血分数≥40%的成年心力衰竭（HF）患者。非奈利酮是一种非甾体类、选择性盐皮质激素受体拮抗剂（nsMRA），此次获批规格为10mg、20mg和40mg，旨在降低此类患者的心血管死亡、心力衰竭住院和紧急心力衰竭就诊风险。此次获批基于关键性III期FINEARTS-HF研究的积极结果，该研究证实，非奈利酮显著降低了心血管死亡和总心力衰竭（首次及复发）事件。拜耳还在中国、欧盟和日本提交了该适应证的上市许可申请。->点击文末阅读原文，解锁完整双语新闻企业动态No.1 / 麦济生物拟赴港交所IPO，专注免疫炎症性疾病新药研发近日，湖南麦济生物技术股份有限公司（简称“麦济生物”）发布招股书，拟赴香港联交所主板上市。麦济生物是一家处于注册临床阶段的生物制药公司，专注于发现、开发及商业化创新生物制剂，以解决有关过敏性及自身免疫疾病以及其他炎症与免疫性疾病方面尚未满足的医疗需求。自2016年成立以来，麦济生物已自主研发并建立一条由八款创新候选产品组成的强大管线，包括核心产品MG-K10、关键产品MG-014及MG-013等，所有候选产品均为麦济生物基于其自有技术平台发现及开发的新一代长效抗体。其中，MG-K10是一种潜在同类最佳、自主研发、处于注册临床阶段的长效抗IL-4Rα抗体，目前正针对特应性皮炎及哮喘等八种适应证进行或计划进行临床试验。->点击文末阅读原文，解锁完整双语新闻No.2 / 信达生物与京东健康达成全渠道营销合作2025年7月14日，信达生物（1801.HK）与京东健康（6618.HK）正式签署战略合作协议，双方将在药品供应、全渠道销售、数字营销等多个领域展开深度合作，整合各自优势资源，为消费者提供多样、优质的药品及健康服务。此次，信达生物与京东健康的战略合作覆盖供应链合作、全渠道销售和数字营销等领域。在供应链合作方面，信达生物作为中国领先的生物制药公司，目前已拥有16款创新药品上市，覆盖肿瘤、自身免疫、代谢、眼科等重大疾病领域。后续，双方将基于药品的不同特性，开展定制化的供应链合作。在全渠道销售领域，京东健康凭借其丰富的业态，通过线上线下的京东大药房及相关医疗机构，覆盖了多样化的用户群体，满足了不同用户需求。信达生物将根据药品特性，与京东健康在全渠道上开展相应销售合作。在数字营销方面，信达生物联合京东健康将携手开展针对减重及降糖的知识普及、资讯传播和医学教育等科普活动。双方将与行业内专家及机构合作，制作并发布相关减重及降糖内容，并整合线上线下多渠道资源，向公众传播普及健康信息。->点击文末阅读原文，解锁完整双语新闻No.3 / BI合作利奥制药推进圣利卓开发及商业化，获9000万欧元预付款2025年7月14日，勃林格殷格翰（BI）与利奥制药宣布达成一项全球独家许可和转让协议，以推进圣利卓（佩索利单抗）的商业化与进一步开发。圣利卓是一款新型人源化选择性单克隆抗体，可靶向并阻断白介素-36（IL-36）受体的激活，目前已在包括美国、日本、中国和欧盟在内的40多个国家上市，用于治疗成人泛发性脓疱型银屑病（GPP）发作，是首个专门靶向IL-36通路的GPP发作治疗药物。根据协议条款，利奥制药将负责圣利卓的商业化和进一步开发，利用其在医学皮肤领域的全球商业平台，提高疾病认知度并确保GPP患者的治疗可及性。此次合作不仅限于GPP，还将探索圣利卓在IL-36介导的其他有着高度未满足需求的皮肤病中的治疗潜力。此次交易预计将在2025年下半年完成，BI将获得9000万欧元的预付款，以及里程碑付款和分级特许权使用费。->点击文末阅读原文，解锁完整双语新闻行业政策No.1 / 医保局发布2024年全国医保事业发展统计公报2025年7月14日，国家医保局发布《2024年全国医疗保障事业发展统计公报》，截至2024年底，全国基本医疗保险（以下简称基本医保）参保132662.08万人，参保率巩固在95%。2024年全国基本医疗保险（含生育保险）基金总收入34913.37亿元，基金总支出29764.03亿元。统筹基金当期结存4639.17亿元，累计结存38628.52亿元。自2018年国家医保局成立以来，连续7年开展医保药品目录动态调整，累计835种药品新增进入目录范围。2024年协议期内谈判药品报销2.8亿人次。截至2024年底，基本实现按病种付费统筹地区、符合条件的医疗机构全覆盖，按病种付费出院人次占比超过90%，按病种付费的基金占全部符合条件住院医保基金支出比例达到80%左右。2024年，开展第十批国家组织药品集采，涉及62种药品；开展第五批国家组织高值医用耗材集采，涉及外周血管支架、人工耳蜗2个品种。截至目前，已累计开展10批国家组织药品集采，共纳入435种药品，已累计开展5批国家组织高值医用耗材集采，覆盖心内科、骨科、眼科等领域7大类高值医用耗材。->点击阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力 关于 G B I”自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作▶ olivia.xu@generalbiologic.com数据库 | 咨询服务 | 资讯追踪▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

INGELHEIM, Germany & BALLERUP, Denmark I July 14, 2025 I Boehringer Ingelheim and LEO Pharma today announced an exclusive global license and transfer agreement to commercialize and advance the development of SPEVIGO ® (spesolimab). SPEVIGO ® is an innovative, humanized, and selective monoclonal antibody that targets and blocks the activation of the interleukin-36 (IL-36) receptor – a key signaling pathway in the immune system implicated in the pathogenesis of several autoinflammatory diseases, including generalized pustular psoriasis (GPP). 123 This partnership extends beyond GPP, with an opportunity to investigate the potential of spesolimab in additional skin conditions with high unmet medical need in which IL-36 is implicated. Under the terms of the agreement, LEO Pharma will be responsible for commercialization and further development of SPEVIGO® leveraging its global commercial platform within medical dermatology to raise disease awareness and secure access for patients with GPP. The addition of Boehringer Ingelheim’s flagship dermatology product, SPEVIGO ® , for the treatment of GPP, complements LEO Pharma’s existing strategic dermatology portfolio and reinforces its long-standing commitment to delivering transformational medicines to patients. “We are immensely proud of what SPEVIGO ® represents for people living with GPP and bringing innovation to this community of patients has been a powerful reflection of our purpose to transform lives,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. “SPEVIGO ® holds a significant promise, and ensuring it reaches its full potential requires continued focus, and expertise in medical dermatology. With over six decades of singular dedication to this field, LEO Pharma is exceptionally well-positioned to build on the strong foundation we’ve laid. We remain profoundly grateful to the patients, caregivers, and healthcare professionals who have walked this journey with us.” “Skin diseases can profoundly impact people’s lives – and at LEO Pharma, we are here to change that,” said Christophe Bourdon, CEO of LEO Pharma. “Partnering to bring SPEVIGO® to more patients is more than a strategic step – it means the opportunity to help people living with GPP by addressing a disease with limited treatment options and aiming to improve their quality of life. We are inspired by Boehringer Ingelheim’s pioneering efforts and thrilled to build on that foundation. Together, we have a powerful opportunity to expand access to innovative care and deliver meaningful progress for patients who have long been underserved.” GPP is a rare, heterogeneous, and potentially life-threatening skin disease. It is characterized by the accumulation of neutrophils (a type of white blood cell) in the skin, leading to painful, sterile pustules across the body. The disease course varies, with some patients experiencing relapsing episodes with recurrent flares – often accompanied by fever, malaise, fatigue, and a risk of organ failure – while others endure persistent disease with intermittent flares. 7891011 SPEVIGO ® is available in more than 40 countries including the U.S., Japan, China, and most European countries to treat GPP flares in adults. 4 It is the first approved treatment for GPP flares that specifically targets the IL-36 pathway and that has been evaluated in a statistically powered, randomized, placebo-controlled trial. 5 Additionally, SPEVIGO® has also been approved for expanded indications in generalized pustular psoriasis in the EU, U.S. and China. 6 SPEVIGO ® is also under investigation for the treatment of other IL-36 mediated skin diseases. The transaction is anticipated to close in the second half of 2025, subject to merger control clearance, with Boehringer Ingelheim set to receive EUR 90 million as upfront payment, along with milestone payments and tiered royalties. July, 2025 About Spevigo SPEVIGO® is a novel, humanized, selective antibody that specifically blocks the activation of the IL-36R, a signalling pathway within the immune system shown to be involved in the pathogenesis of several autoinflammatory diseases, including GPP. It is the first targeted therapy for the treatment of GPP and has been evaluated in the largest clinical program specifically for the treatment of patients with GPP. 123 About generalized pustular psoriasis (GPP) GPP is a chronic, heterogenous, neutrophilic inflammatory disease associated with skin and systemic symptoms that is distinct from plaque psoriasis. GPP is recognized as a separate clinical entity from other forms of psoriasis, with the IL-36 pathway being a key driver of GPP and triggering response to treatment. 78 GPP can become life-threatening (mortality rates ranging from 2% to 16%) due to severe complications, such as multisystem organ failure and sepsis requiring urgent hospital care; many GPP patients also suffer from various comorbidities, which contribute to the ongoing burden for the patient and healthcare systems. 89 GPP symptoms appear unpredictable and present on a continuum, which greatly impacts a patient’s quality of life, and may cause fear and anxiety over the disease course, as well as long-term impacts on quality of life related to work/school, emotional health, social activities, and finances. 81011 About Boehringer Ingelheim Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com . About LEO Pharma LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serve close to 100 million patients in over 70 countries annually. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. For more information, visit www.leo-pharma.com . 1 Morita A, Strober B, Burden AD, et al. Efficacy and safety of subcutaneous spesolimab for the prevention of generalised pustular psoriasis flares (Effisayil 2): an international, multicentre, randomised, placebo-controlled trial. Lancet. 2023;402:1541–1551. 2 Choon SE, Lebwohl MG, Marrakchi S, et al. Study protocol of the global Effisayil 1 Phase II, multicentre, randomised, double-blind, placebo-controlled trial of spesolimab in patients with generalized pustular psoriasis presenting with an acute flare. BMJ Open. 2021;11:e043666. 3 Bachelez H, Choon SE, Marrakchi S, et al. Trial of spesolimab for generalized pustular psoriasis. N Engl J Med. 2021;385:2431–2440. 4 Record on file. 5 Boehringer Ingelheim. Spesolimab prevented generalized pustular psoriasis flares in Effisayil™ 2 trial. 2023. https://www.boehringer-ingelheim.com/human-health/skin-and-inflammatory-diseases/gpp/spesolimab-prevents-gpp-flares (Accessed 22 July 2024). 6 Boehringer Ingelheim. European Commission approves SPEVIGO® for new and expanded indications in generalized pustular psoriasis. 2024. https://www.boehringer-ingelheim.com/human-health/european-commission-approves-spevigo-new-and-expanded-indications-generalized-pustular-psoriasis (Accessed 29 June 2025). 7 Marrakchi S, Puig L. Pathophysiology of generalized pustular psoriasis. Am J Clin Dermatol. 2022;23:13–19. 8 Prinz JC, Choon SE, Griffiths CEM, et al. Prevalence, comorbidities and mortality of generalized pustular psoriasis: A literature review. J Eur Acad Dermatol Venereol. 2023;37:256–273. 9 Choon SE, Navarini AA, Pinter A. Clinical course and characteristics of generalized pustular psoriasis. Am J Clin Dermatol. 2022;23:21–29. 10 Gooderham MJ, Van Voorhees AS, Lebwohl MG. An update on generalized pustular psoriasis. Expert Rev Clin Immunol. 2019;15:907–919. 11 Reisner DV, Johnsson FD, Kotowsky N, et al. Impact of generalized pustular psoriasis from the perspective of people living with the condition: Results of an online survey. Am J Clin Dermatol. 2022;23:65–71. SOURCE: LEO Pharma