Zasocitinib

OSAKA, Japan--(BUSINESS WIRE)--Takeda (TOKYO:4502/NYSE:TAK) today announced earnings results for the first half of fiscal year 2025 (six months ended Sep 30, 2025) and updated its full-year outlook. Takeda chief executive officer, Christophe Weber, commented: “Takeda’s fiscal year 2025 first half results are consistent with our expectations for core business progress in this year of transition to a new phase focusing on new product launches. Our updated full-year outlook reflects impairment charges associated with strategic pipeline decisions taken in Q2, as well as transactional FX. “Looking ahead, our current Growth and Launch Products portfolio will continue to generate moderate growth, which will accelerate in the future with new launches. We see FY2025 as a pivotal year for Takeda with regulatory filings for rusfertide and oveporexton expected in the second half of the year, as well as Phase 3 results for zasocitinib. We continue to expand our external partnerships to enhance the depth and breadth of our R&D pipeline and recently announced a global strategic partnership with Innovent Biologics to further strengthen our position in oncology. “With this momentum in our pipeline, we’re confident in Takeda’s ability to deliver life-transforming treatments and long-term value for patients and shareholders, and we’re excited for the future.” Takeda chief financial officer, Milano Furuta, commented: “Our financial results for the first half of FY2025 were driven by year-over-year impact from generic erosion of VYVANSE, as anticipated. In the second half, we expect this generic erosion impact to moderate and Growth and Launch Product growth to increase. Our updated outlook for the full year reflects the effects of transactional FX fluctuations and impairment losses on intangible assets associated with the gamma delta T-cell therapy platform—with strong OPEX management offsetting changes in product mix. “We are confident in our business fundamentals as we look to the second half of this transitional year for Takeda.” FINANCIAL HIGHLIGHTS for FY2025 H1 Ended September 30, 2025 (Billion yen, except percentages and per share amounts) FY2025 H1 FY2024 H1 vs. PRIOR YEAR (Actual % change) Revenue 2,219.5 2,384.0 -6.9% Operating Profit 253.6 350.6 -27.7% Net Profit 112.4 187.3 -40.0% EPS (Yen) 72 119 -39.8% Operating Cash Flow 593.7 451.3 +31.6% Adjusted Free Cash Flow (Non-IFRS) 525.4 247.5 +112.3% Core (Non-IFRS) (Billion yen, except percentages and per share amounts) FY2025 H1 FY2024 H1 vs. PRIOR YEAR (Actual % change) vs. PRIOR YEAR (CER % change) Revenue 2,219.5 2,384.0 -6.9% -3.9% Operating Profit 639.2 719.9 -11.2 % -8.8% Margin 28.8% 30.2% -1.4 pp ― Net Profit 438.6 489.1 -10.3% -11.1% EPS (Yen) 279 310 -10.0% -10.8% FY2025 Outlook Updating Full Year Management Guidance, and Reported and Core Forecasts Takeda has updated its full year outlook to reflect foreign exchange impacts and impairment charges related to the cell therapy platform. FY2025 Management Guidance Core Change at CER (Non-IFRS) FY2025 ORIGINAL MANAGEMENT GUIDANCE (May 2025) FY2025 REVISED MANAGEMENT GUIDANCE (October 2025) Core Revenue Broadly flat Broadly flat Core Operating Profit Broadly flat Low-single-digit % decline Core EPS (Yen) Broadly flat Low-single-digit % decline FY2025 Reported and Core Forecasts (Billion yen, except percentages and per share amounts) FY2025 ORIGINAL FORECAST (May 2025) FY2025 REVISED FORECAST (October 2025) Revenue 4,530.0 4,500.0 Core Revenue (Non-IFRS) 4,530.0 4,500.0 Operating Profit 475.0 400.0 Core Operating Profit (Non-IFRS) 1,140.0 1,130.0 Net Profit 228.0 153.0 EPS (Yen) 145 97 Core EPS (Yen) (Non-IFRS) 485 479 Adjusted Free Cash Flow (Non-IFRS) 750.0-850.0 600.0-700.0 Annual Dividend per Share (Yen) 200 200 Additional Information About Takeda’s FY2025 H1 Results For more details about Takeda’s FY2025 H1 results, commercial progress, pipeline updates and other financial information, including key assumptions in the FY2025 forecast and management guidance as well as definitions of non-IFRS measures, please refer to Takeda’s FY2025 H1 investor presentation (available at https://www.takeda.com/investors/financial-results/quarterly-results/). 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 www.takeda.com. 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 press release. This press release (including any oral briefing 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. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. 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Forward-Looking Statements This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”, “outlook” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security-reports/or at www.sec.gov.Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results. Financial information and Non-IFRS Measures Takeda’s financial statements are prepared in accordance with International Financial Reporting Standards (“IFRS”). This press release and materials distributed in connection with this press release include certain financial measures not presented in accordance with IFRS, such as Core Revenue, Core Operating Profit, Core Net Profit for the year attributable to owners of the Company, Core EPS, Constant Exchange Rate (“CER”) change, Net Debt, Adjusted Net Debt, EBITDA, Adjusted EBITDA, Free Cash Flow and Adjusted Free Cash Flow. Takeda’s management evaluates results and makes operating and investment decisions using both IFRS and non-IFRS measures included in this press release. These non-IFRS measures exclude certain income, cost and cash flow items which are included in, or are calculated differently from, the most closely comparable measures presented in accordance with IFRS. Takeda’s non-IFRS measures are not prepared in accordance with IFRS and such non-IFRS measures should be considered a supplement to, and not a substitute for, measures prepared in accordance with IFRS (which we sometimes refer to as “reported” measures). Investors are encouraged to review the definitions and reconciliations of non-IFRS measures to their most directly comparable IFRS measures, which are in the Financial Appendix appearing at the end of our FY2025 H1 investor presentation (available at www.takeda.com/investors). Medical information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. Please refer to slide 7 of Takeda’s FY2025 H1 investor presentation (available at　https://www.takeda.com/investors/financial-results/quarterly-results/) for the definition of Growth & Launch Products.

点击蓝字 关注我们 导读 今天是第22个“世界银屑病日”。今年的主题——“银屑病及共病：解读多米诺骨牌效应”。但是呢，小编不想和大家聊银屑病工兵头疼的问题。小编今天想和大家一起看看，目前银屑病的新药，除了声名大噪的赛立奇单抗与夫那奇珠单抗外，银友们将有哪些“新武器”可以对抗银屑病。 精准打击的“王牌军”：生物制剂 生物制剂可以说是银屑病治疗的“革命性武器”，它们的问世，让银屑病药物不再“无差别轰炸”，而是像精确制导的导弹，直击发病的关键因子。 目前目前银屑病生物制剂主要针对三个靶点：  IL-23抑制剂：从源头阻断“发病源” IL-23是银屑病发病的“上游指挥官”，只要对它进行控制，就能够对银屑病进行一个有效的控制。 最新进展：首款国产抗IL-23p19单抗——匹康奇拜单抗目前Ⅲ期临床已经结束，且数据耀眼，是目前在Ⅲ期临床研究中唯一超过80%达到PASI 90的IL-23生物制剂。除此之外，mirikizumab（米吉珠单抗）已完成Ⅲ期临床，即将上市！ IL-12/23：双靶点治疗让用药更方便 IL-12/23抑制剂，通过阻断IL-12和IL-23共有的p40亚基与靶细胞表面的IL-12Rβ1受体蛋白的结合，从而抑制IL-12和IL-23介导的信号传导和细胞因子级联反应。使得该靶点药物一年四针就能够有效控制疾病。 最新进展：目前新上市的依若奇单抗已经成功通过医保初审，明年有很大概率成功进入医保。此外，百奥泰研发的喜达诺（乌司奴单抗）类似物Usymro已向我国药监局提出上市申请。预计将很快上市 IL-17抑制剂，快速见效的“火箭军” IL-17是导致银屑病患者出现皮肤发红、增厚、脱屑的“核心刺客”。对这个靶点进行控制，能够快速清除皮损，有效控制病情。因此，该靶点药物也是银屑病治疗中起效较快的一类药物 最新进展：在去年8月份，夫那奇珠单抗与赛立奇珠单抗两款国产原研IL-17A生物制剂成功，为中国患者带来全新选择。不仅如此，今年两款药物都通过了医保初审，如果没有大的以外的话，将于明年正式进入医保。除此之外古莫奇单抗也已提交上市申请，预计未来1–2年有望上市。 另外，国产的LZM012也在头对头的临床中战胜了进口“老大哥”可善挺。（可善挺被国产新药击败！国内银屑病患者的治疗有望更进一步吗？）目前该药物正在进行Ⅲ期临床，感兴趣的话可以长按或扫描下方二维码报名，或者是点击下方链接了解详情！！！ 【入组全部用药】双靶点生物制剂临床正在开展！有机会打可善挺 口服药物新突破，小分子靶向药 随着医疗技术的不断进步，银友们已经不再单纯追求治疗效果，而是在保障疗效的同时追求一种更加便利的治疗方法，因此，口服小分子靶向药进入了大家的视野 PDE-4抑制剂 阿普米司特是该靶点药物的重要代表，阿普米司特能有效抑制炎症、改善皮损。目前同靶点药物莫米司特也已上市。  TYK2 与 JAK 抑制剂 这类药物通过对细胞内的信号通路进行调节，控制炎症。 氘可来昔替尼（TYK2抑制剂）已于2023年获批，2024年进入医保，且目前在各项临床与实际应用中均有着非常亮眼的表现 目前相关靶点药物如扎索替尼、ICP-488、D-2570均已经进入临床的中后期，未来2–3年有望上市。同时，如果想参加这些临床，可以扫描下方二维码报名，或者是点击下方链接了解详情 【条件宽松】银屑病口服新药D-2570全国临床进行中，一年用药 不想打针的看这！多项口服药物临床正在开展！新疆等地均有院点！ 口服生物制剂，或将打来更大改善 强生公司研发的Icotrokinra（JNJ-2113），是全球首个可口服的IL-23通路调节剂。2025年7月已向美国FDA提交上市申请，且目前已经在与氘可来昔替尼的头对头临床中战胜氘可来昔替尼，有效证明了其实力 虽然目前口服IL-17抑制剂的研发因为肝毒性的问题停滞不前，不过相信随着医疗技术的不断进步，将会有更多的“口服生物制剂问世” 外用药物的“老法新治” 在很长的一段时间内，外用药物治疗一直是银屑病治疗的主流方法，随着技术的进步，外用药物也迎来了“新人” Roflumilast（罗氟司特）乳膏：国外已经成功上市，国内目前还在进行相关的临床 本维莫德：国产首创的芳香烃受体调节剂，2024年成功在美国获批，是国内新药出海的重要突破！ 小结 医疗技术的进步，让银屑病的治疗从无药可医到了“百花齐放”。众多药物问世让银友们有了更多的选择。同时药物之间的竞争也让银屑病患者们收获不少！相信在不久的将来，银屑病的治愈或许不再是一个梦！！ 本文仅做参考，不构成对任何药物或诊疗方案的推荐、推广或宣传，也不可替代专业医疗建议。如有问题，请咨询医疗卫生专业人士。