Anifrolumab-FNIA

在阿斯利康2025年第一季度财报会议上，这位制药巨头掷出调整战略的重磅炸弹：正式退出神经科学领域，转而将资源聚焦于‌减重、免疫学‌等核心领域。1.斩断管线阿斯利康2025年一季度财报显示，公司终止了多款神经科学项目的开发，包括与礼来合作开发治疗阿尔茨海默症的MEDI1814、处于2期临床的偏头痛单抗MEDI0618、治疗糖尿病神经痛的双抗MEDI7352，至此公司神经科学在研管线清零。图片来源：阿斯利康2025年Q1财报神经科学领域因大脑及神经系统复杂性极高、发病机制模糊，导致临床试验成功率低、研发周期长，被公认为充满挑战的“研发黑洞”。以艾伯维为例，其在精神分裂症治疗领域的关键候选药物Emraclidine于2024年11月遭遇重大挫折：两项关键3期临床试验均未达到主要疗效终点。这一失利直接引发市场剧烈反应，公司股价单日暴跌超过12%，市值一夜之间缩水超400亿美元。此次失败促使艾伯维反思中枢神经系统疾病领域的研发策略，在2025年的JPM医疗健康大会上明确表示，未来在早期研究阶段大额资金投入将采取更审慎的评估机制。美国药物生产与研发协会数据显示，作为最复杂的神经系统疾病之一，阿尔茨海默症过去20多年全球累计研发投入超6000亿美元，300余款药物折戟，研发失败率高达99.6%。强生、罗氏、默沙东等全球大药企均曾在这一领域遭遇滑铁卢。在神经系统疾病治疗领域，即便药物成功获批上市，其商业化进程仍面临患者支付能力的挑战。以中国市场为例，Leqembi（仑卡奈单抗）等进口药暂未进入国家医保目录，患者需全额自费承担治疗费用，年均数十万的支出对普通家庭构成沉重经济负担。而在美国，联邦医疗保险（Medicare）对部分神经科学药物设置的报销限制，为其商业化之路增添阻力。从阿斯利康2025年第一季度财务表现来看，其总营收达135.88亿美元，产品总收入达13.51亿美元，其中肿瘤业务以56.43亿美元收入占据42%的核心比重。糖尿病药物Farxiga同比增长15%至20.58亿美元，成为拉动营收增长的核心引擎。与以上优势业务的强劲表现相比，其神经科学领域管线贡献偏低。用于治疗罕见病视神经脊髓炎谱系疾病（为该药物获批适应症之一）的Soliris（依库珠单抗），2025年第一季度收入下降40%至4.44亿美元，仅占公司总营收3%。面对如此现实，为提升整体投资回报率，阿斯利康不得不将有限资源向市场规模庞大的肿瘤、免疫及代谢疾病领域倾斜。正如CEO Pascal Soriot所言：“我们无法为所有项目提供资金，中枢神经系统疾病领域更适合由专注于此的公司来深耕。”在当前的竞争格局中，渤健的阿尔茨海默症药物Leqembi和礼来的Donanemab已率先在该领域建立市场优势，而偏头痛治疗领域的竞争则集中于安进和梯瓦的CGRP抑制剂。基于对资源优化配置的考量，阿斯利康最终宣布全面退出神经科学领域，聚焦高增长治疗赛道。2.押注高成长赛道阿斯利康退出神经科学并非简单的减法，而是基于价值坐标系的重新定位。阿斯利康生物制药研发执行副总裁Sharon Barr强调，退出神经科学领域，是为了集中资源支持核心治疗领域和高价值项目，资金将重新投入体重管理、血脂异常、呼吸系统疾病和免疫学等领域。阿斯利康在2025年第一季度财报中提出，拟在2030年实现800亿美元的营收目标，较2024年的营收541亿美元增长接近50%。而在阿斯利康披露的驱动其业绩增长的多款具有销售峰值超过50亿美元潜力管线中，就包括体重管理的GLP-1类管线。随着全球肥胖人口突破20亿，减重赛道迎来爆发式增长，以GLP-1受体激动剂为代表的减重疗法已展现出千亿级市场潜力。例如，诺和诺德的司美格鲁肽2024年全球销售额约293亿美元，同比增加38%，礼来的替尔泊肽2024年实现销售额164亿美元。当前GLP-1类减肥药以注射剂为主，全球市场还没有口服小分子GLP-1受体激动剂获批上市，阿斯利康早在2023年11月，就从中国企业诚益生物引入小分子GLP-1受体激动剂AZD5004（ECC5004），选择以差异化策略切入火热的GLP-1减重赛道，小分子药物是当前GLP-1赛道的重要补充。AZD5004在1期试验中，4周实现减重5.8%，并且改善患者的血糖指标。同时，阿斯利康还计划将AZD5004与SGLT2抑制剂Dapagliflozin联用，治疗2型糖尿病、慢性肾病和心力衰竭患者。AZD5004与口服PCSK9抑制剂AZD0780联用具有进一步降低高风险心血管疾病的潜力。虽然基于GLP-1的疗法在肥胖及相关共病的治疗中展现出良好效果，但其普遍存在的肌肉质量流失这一潜在副作用，可能对该类疗法的长期应用形成限制。阿斯利康与SixPeaks Bio展开合作，致力于开发以“保留肌肉质量”为核心差异化优势的减肥药物。该药物通过靶向激活素受体IIA/B的抗体机制，旨在解决现有疗法的肌肉流失问题。此外，阿斯利康还在肥胖治疗领域进行了多元化的药物布局，积极开发具有新型作用机制的产品。其中包括胰淀素疗法药物AZD6234，以及GHSR反向激动剂、MCHR1拮抗剂、IGFBP2类似物、GPR75调节剂等多种不同靶点的药物。肿瘤领域向来是阿斯利康的“现金牛”，2025年第一季度肿瘤相关产品合计销售额超过56亿美元，占公司总营收超过四成。第三代EGFR抑制剂奥希替尼（Tagrisso）收入16.79亿美元，同比增长5%。PD-L1单抗度伐利尤单抗（Imfinzi）实现销售额12.61亿美元，同比增加13%。与第一三共合作开发的HER2 ADC药物德曲妥珠单抗（Enhertu）实现销售额5.96亿美元，同比增加29%。阿斯利康2025年第一季度财报显示，呼吸与免疫（R&I）业务同比增长11%至20.84亿美元，成为增速最快的板块。阿斯利康已在哮喘、慢阻肺（COPD）治疗领域已建立稳固的市场地位。Saphnelo 2025年第一季度实现销售额7.23亿美元。哮喘用药Tezspire已在全球近60个国家/地区获得批准，销售额以81%的增幅达2.17亿美元。面对特应性皮炎、狼疮等免疫疾病的庞大患者基数与未满足需求，阿斯利康与和铂医药达成1.75亿美元合作，共同开发多特异性抗体疗法，目标瞄准系统性红斑狼疮等适应症。同时，收购亘喜生物的GC012F CAR-T疗法，探索其在自身免疫性疾病治疗中的应用，试图在自免领域抢占一席之地。3.聚焦和瘦身策略阿斯利康全面退出神经科学领域并非孤例，而是全球药企“聚焦和瘦身”浪潮的缩影。辉瑞于2019年分拆仿制药业务，与迈蓝合并成立晖致，彻底剥离非核心资产，全力聚焦创新药研发。诺华也分拆仿制药部门Sandoz独立上市，同样将重心转向创新药业务。BMS因核心产品面临专利到期，2024年启动15亿美元瘦身计划，裁员2200人、关闭癌症免疫学研究中心，终止12个早期项目，将资源集中于Reblozyl和Opdualag等核心产品。2023年，武田制药大规模精简管线，停止开发18款覆盖肿瘤、神经科学等多个治疗领域的药物，集中资源于最有潜力和符合公司长期战略的项目。2024财年一季度实现1208亿日元的全球收入，同比增长2.1%。在市场竞争日益激烈的当下，这些“聚焦策略”与“瘦身行动”底层逻辑基本一致：剥离低回报资产，将资源集中于免疫、减重、肿瘤等高增长、高确定性领域，以应对专利到期压力与研发效率挑战。然而，硬币的另一面是：聚焦策略也可能带来潜在问题，当行业集体逃离神经科学、罕见病等“难啃的骨头”，未满足临床需求领域可能出现创新真空。因此，药企在追求高回报的同时，需要找到效率与创新的平衡。4.结语阿斯利康的战略转向，本质上是对医药行业“研发高风险与市场高回报”规律的主动顺应。在商业目标与科学探索的平衡中，每一次战略取舍都是对生命健康研发价值的重新权衡。退出神经科学领域，体现了阿斯利康对市场趋势的预判。当药企将资源集中投向高增长赛道时，如何在追逐商业回报的同时，确保对复杂疾病领域的长期投入，成为整个行业需要思考的课题。参考资料：1、《直面99.6%研发失败率：全球药企如何在阿尔茨海默病市场“掘金”？》21世纪经济报道2、AstraZeneca Abandons Neuroscience,Prioritizes Weight Loss,Immunology，biospace3、阿斯利康官网、财报声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 史蒂文合作、投稿、转载开白 | 马老师 18323856316（同微信） 阅读原文，是受欢迎的文章哦

As a novel calcineurin inhibitor with proven efficacy in improving renal outcomes, LUPKYNIS addresses a high unmet medical need. With increasing awareness, supportive guidelines, and potential global expansion, it is well-positioned for steady market growth. LAS VEGAS, May 8, 2025 /PRNewswire/ -- DelveInsight's " LUPKYNIS Market Size, Forecast, and Market Insight Report" highlights the details around LUPKYNIS, the first oral lupus nephritis-specific treatment, which has expanded the therapeutic arsenal. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of LUPKYNIS. The report also highlights the historical and forecasted sales from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Aurinia Pharmaceuticals/Otsuka Pharmaceutical's LUPKYNIS (voclosporin) Overview LUPKYNIS (voclosporin) is an oral immunosuppressant classified as a calcineurin inhibitor (CNI), shown to improve both short- and long-term outcomes in adult patients with active lupus nephritis when used alongside standard immunosuppressive therapies. By targeting calcineurin, LUPKYNIS helps suppress cytokine activity, inhibits interleukin-2 (IL-2) production, and reduces T-cell driven immune responses. Although the exact mechanism by which voclosporin inhibits calcineurin is not fully understood, it is known that lymphocyte activation increases intracellular calcium, which binds to calcineurin's regulatory site. This activates the calmodulin-binding catalytic subunit, leading to dephosphorylation and activation of the transcription factor NFATc (nuclear factor of activated T-cells, cytoplasmic). The drug's immunosuppressive effect results in decreased lymphocyte proliferation, reduced cytokine production, and lower expression of T-cell activation markers. The recommended initial dose of LUPKYNIS is 23.7 mg twice daily. It should be used in conjunction with mycophenolate mofetil (MMF) and corticosteroids. Learn more about LUPKYNIS projected market size for lupus nephritis @ LUPKYNIS Market Potential Lupus nephritis is a serious and potentially life-threatening complication of systemic lupus erythematosus (SLE), affecting 40–60% of those diagnosed with the disease. It is typically characterized by symptoms such as hematuria (blood in the urine) and proteinuria (protein in the urine). This condition is more prevalent in women, particularly between the ages of 20 and 40. In 2023, the United States recorded the highest number of lupus nephritis cases among the 7MM, with approximately 211K cases, a figure projected to grow by 2034. Treatment strategies for lupus nephritis depend on the kidney biopsy classification of the disease. Standard therapy often includes corticosteroids in combination with immunosuppressive drugs like cyclophosphamide, mycophenolate mofetil, azathioprine, and calcineurin inhibitors. Rituximab, a monoclonal antibody, is widely used, especially for patients with relapsing or treatment-resistant LN, due to its ability to reduce reliance on steroids. Currently, there are only two FDA-approved medications for lupus nephritis: BENLYSTA (belimumab), available as an intravenous or subcutaneous formulation, and LUPKYNIS (voclosporin), a novel oral calcineurin inhibitor. Leading pharmaceutical companies such as Novartis, AstraZeneca, Roche, and Kezar Life Sciences, among others, are actively developing innovative therapies that could redefine the treatment paradigm for lupus nephritis. The treatment landscape is rapidly evolving, shifting away from broad immunosuppression toward more precise, targeted approaches. Recent drug approvals and a strong pipeline of candidates highlight both advancements and the ongoing challenges in creating treatments that are effective, safe, and long-lasting. Emerging therapies ranging from anti-CD20 antibodies and complement inhibitors to interferon-blocking agents and CAR-T cell therapies hold promise but must address key issues such as safety, sustained efficacy, and accessibility. As our understanding of the disease's underlying mechanisms continues to grow, the future of lupus nephritis treatment is expected to become increasingly personalized, offering renewed hope to patients battling this complex disorder. Discover more about the lupus nephritis market in detail @ Lupus Nephritis Market Report Emerging Competitors of LUPKYNIS The developing pipeline for lupus nephritis treatments shows a growing variety of approaches. Multiple candidates, both in early and late stages of development, are underway, including ianalumab (VAY736) (Novartis), GAZYVA (obinutuzumab) (Roche), SAPHNELO (anifrolumab) (AstraZeneca), FABHALTA (iptacopan) (Novartis), ULTOMIRIS (ravulizumab) (AstraZeneca), as well as advanced cellular therapies like CABA-201 (Cabaletta Bio) and YTB323 (Novartis). In March 2025, the FDA accepted a supplemental Biologics License Application based on data from the Phase III REGENCY trial, where obinutuzumab demonstrated a 46.4% Complete Renal Response (CRR), compared to 33.1% for placebo. Unlike previous anti-CD20 therapies such as rituximab, it provides enhanced B-cell depletion and is the first in its class to show efficacy in a randomized Phase III lupus nephritis trial. If approved, it will become the first CD20-targeted treatment specifically indicated for lupus nephritis, with anticipated sales of USD 400 million by 2034. To know more about the number of competing drugs in development, visit @ LUPKYNIS Market Positioning Compared to Other Drugs Key Milestones of LUPKYNIS In September 2024, Japan's Ministry of Health approved it for Lupus Nephritis treatment alongside mycophenolate mofetil. In September 2022, the European Commission approved LUPKYNIS for active Class III, IV, or V Lupus Nephritis. In January 2021, Aurinia Pharmaceuticals received US FDA approval for LUPKYNIS to treat adult lupus nephritis patients in combination with immunosuppressive therapy. Discover how LUPKYNIS is shaping the lupus nephritis treatment landscape @ LUPKYNIS Lupus LUPKYNIS Market Dynamics LUPKYNIS, developed by Aurinia Pharmaceuticals, is the first FDA-approved oral therapy specifically indicated for active lupus nephritis, a serious manifestation of systemic lupus erythematosus. Approved in January 2021 in the US, LUPKYNIS entered a previously underserved market where treatment was largely dependent on off-label use of immunosuppressants like mycophenolate mofetil and corticosteroids. The drug represents a significant advancement in lupus nephritis care, offering both improved efficacy and a better safety profile compared to existing options, especially in reducing proteinuria and preserving kidney function. The market dynamics for LUPKYNIS are shaped by several key factors. On the positive side, there is a strong unmet medical need, a growing prevalence of lupus nephritis, and increasing physician awareness about early diagnosis and intervention. Moreover, LUPKYNIS benefits from a relatively high pricing strategy, supported by its novel mechanism and disease-modifying potential. Aurinia has also built a dedicated commercial infrastructure and patient support programs to drive uptake and adherence. However, LUPKYNIS faces competitive and reimbursement challenges. One of the main competitors is BENLYSTA (belimumab) from GSK, which gained FDA approval for lupus nephritis in December 2020, just a month before LUPKYNIS. Benlysta has the advantage of brand recognition and a longer track record in treating systemic lupus. Additionally, payers have shown some hesitancy in approving LUPKYNIS due to its cost, requiring extensive prior authorizations and documentation of clinical need. Patient compliance also remains an issue, given the need for frequent monitoring of kidney function and drug levels. Looking ahead, the market potential for LUPKYNIS will depend on its ability to expand its label, demonstrate long-term real-world effectiveness, and potentially enter international markets. Aurinia is also exploring lifecycle management strategies, including combination therapies and expanded indications. Partnerships or acquisitions could further boost market access and penetration. Overall, while LUPKYNIS is a pioneering therapy with strong clinical value, its commercial success will be defined by navigating payer landscapes, physician adoption, and sustained differentiation from competing therapies. Dive deeper to get more insight into LUPKYNIS's strengths & weaknesses relative to competitors @ LUPKYNIS Market Drug Report Table of Contents Related Reports Lupus Nephritis Market Lupus Nephritis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key lupus nephritis companies, including Hoffmann-La Roche, Chugai Pharmaceutical, Novartis Pharmaceuticals, among others. Lupus Nephritis Pipeline Lupus Nephritis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key lupus nephritis companies, including Hoffmann-La Roche, Qilu Pharmaceutical, Vera Therapeutics, Kyverna Therapeutics, Cabaletta Bio, Takeda, Nkarta Therapeutics, Annexon, Century Therapeutics, Lepton Pharmaceuticals, Transcenta Holding, Inflection Biosciences, among others. Systemic Lupus Erythematosus Market Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SLE companies, including Biogen, Novartis, MorphoSys, Idorsia Pharmaceuticals, Viatris, RemeGen, UCB Pharma, Genentech, Bristol Myers Squibb, AbbVie, among others. Systemic Lupus Erythematosus Pipeline Systemic Lupus Erythematosus Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key myasthenia gravis companies, including Yake Biotechnology, UCB, Sorrento Therapeutics, SinoMab Bioscience Ltd, Shanghai Junshi Biosciences, Sareum, Sanofi, Roche, Rheos Medicine, Resolve, Provention Bio, Pfizer, Novartis, Neovacs, Merck, Medsenic, Landos Biopharma, Kezar Life Sciences, Kangpu Biopharmaceuticals, Janssen Research & Development, Janssen, InnoCare, ImmuPharma, I-MAB Biopharma, ILTOO, Idorsia Pharmaceuticals, Horizon Therapeutics, Genovax, Exinda Thearapeutics, Equillium, Eli Lilly and Company, Eisai, Daiichi Sankyo Company, Corestem, Corbus Pharmaceuticals, Citryll BV, Chipscreen Biosciences, Carna Bioscience, Bristol-Myers Squibb, Brickell Biotech, Boston Pharmaceuticals, Biogen, Athos Therapeutics, Asahi Kasei Pharma, Aria Pharmaceuticals, Antengene Therapeutics, Amgen, Alpine Immune Sciences, Akeso Biopharma, AbbVie, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED