Upadacitinib hemihydrate

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。时间从来不语，却回答了所有问题。当年的倔强，成就了今日的创新传奇。作为中国创新药一哥，从2011年到今年3月，恒瑞医药已有19个1类创新药获批上市，涉及肿瘤、代谢和心血管疾病、免疫和呼吸系统疾病以及神经科学等治疗领域。2024年，公司实现营业收入279.85亿元，同比增长22.63%；实现扣非净利润61.78亿元，同比增长49.18%，全年研发投入82.28亿元，其中费用化研发投入65.83亿元。截止目前，恒瑞医药累计研发投入已超440亿元，持续的研发投入成果显著，公司创新药营收占比从2015年不足5%飙升至2024年的50%。其中2024年实现创新药销售收入138.92亿元（含税），同比增长30.60%。图：恒瑞医药已上市1类创新药（2021-2025.3）备注：以上研发费用来源公司公告2011年恒瑞医药14年磨一剑的品种——艾瑞昔布获批，标志着公司正式进入创新。2014年10月阿帕替尼获批上市，恒瑞开启了抗肿瘤靶向药新时代。2015年开始，国家药政改革大幕拉开，支持创新药的政策陆续出台，恒瑞医药研发费用支出不断加大，从2011年的4亿元增加到2024年的80多亿。大量的研发投入带来的是新药成果不断涌出。2018到2025年3月有17个创新药获批上市，其中包括PD-1等重磅品种，公司的营收规模也从2015年的93亿元上升到2024年的279.85亿元，复合增长13%。从以上表格数据来看，公司19款创新药研发费用投入超过60亿元。从研发费用投入绝对金额来看，最大的是2025年3月获批上市的艾玛西替尼，研发费用达到10.71亿元。该产品适应症为：用于对一种或多种TNF抑制剂疗效不佳或不耐受的活动性强直性脊柱炎（AS）成人患者。这标志着强直性脊柱炎口服靶向治疗领域首次实现了中国原研。针对强直性脊柱炎，目前国内和国外已有辉瑞的托法替布片（XELJANZ®）和艾伯维的乌帕替尼缓释片（RINVOQ®）等口服JAK抑制剂获批上市。经查询Evaluate Pharma 数据库，2024年托法替布片和乌帕替尼缓释片全球销售额合计约为71.39亿美元。从这一点来看，艾玛西替尼是一个大品种。在政策支持和潜力大单品驱动下，恒瑞医药这样的管线厚重的企业或将全面受益。管线资产全球排名13位除了是中国的创新药一哥，恒瑞医药的管线资产正在受到国际关注。据Joanna Sadowska LinkedIn近期公布的2025年全球制药企业管线资产（包括临床前）排名显示，有恒瑞医药、中国生物制药、石药集团和百济神州4家中国企业上榜，其中恒瑞医药以173个在研项目高居全球第十三位，紧跟武田，公司自研项目高达163个，外部引进仅为10个。这一数字不仅反映出恒瑞强烈的自主创新导向，也体现出其研发团队在肿瘤、自身免疫、麻醉镇痛等多个核心领域的持续深耕。据2024年报显示，公司在肿瘤领域建立了PROTAC（蛋白水解靶向嵌合物）、肽类、单克隆抗体、双特异性抗体、多特异性抗体、ADC（抗体偶联药物）及放射性配体疗法等一批国际领先的技术平台，为创新研发提供强大基础保障。除了深耕传统优势的肿瘤领域，公司还在代谢和心血管疾病、免疫和呼吸系统疾病、神经科学等领域也进行了广泛布局，不断塑造发展新动能、新优势。目前ADC和出海国际化是两大看点。图：公司疾病领域及主要管线布局ADC即将破局在ADC研发方面，基于恒瑞医药模块化ADC创新平台（HRMAP），经过10余年的ADC研发积累，公司已成为国内在热门靶点上布局进展靠前、兼具诸多差异化ADC产品的企业，公司ADC平台已有10余个新型、具有差异化的ADC分子成功获批临床。其中，瑞康曲妥珠单抗（HER2 ADC）已提交NDA在审，SHR-A1921（Trop2 ADC）、SHR-A1904（Claudin18.2 ADC）、SHR-A2009（HER3 ADC）、SHR-A2102（Nectin-4 ADC）已步入III期临床阶段。创新药出海和国际化加速2024年10月有媒体报道恒瑞新任命全球BD负责人（前强生创新中心创新合作事务部副总裁），公司针对出海下重注。目前，公司已实现13项创新药海外授权，交易总额约为140亿美元。2024年，公司收到Merck Healthcare 1.6亿欧元对外许可首付款以及Kailera Therapeutics 1亿美元对外许可首付款等许可合作对价，并确认为收入。针对未来出海策略，恒瑞医药总裁、首席运营官冯佶在2024年度业绩暨现金分红说明会上表示，公司的国际化策略还是内生发展与对外合作并重，稳步推进国际化进程。在当下国际形势及地缘政治不确定性较大的环境下，公司会优先选择与全球领先医药企业的合作机会，在保留国内开发权益的前提下，尽可能覆盖海外市场。公司会尝试继续通过Newco模式合作开发，可通过融资与上市等方式实现投资增值，公司拥有Newco公司的股权，也可以在深度参与产品推进过程中学习到先进的研发甚至商业化经验。公司希望未来能自主在海外做研发和商业化。公司会在控制好风险的前提下，继续采取谨慎策略，尝试在个别优势领域自主推进全球开发。总结关税铁幕难锁破冰志，目前恒瑞医药正在积极推进港股上市，加速国际化进程。公司预计2025年上市项目达11项，未来三年（2025年-2027年）获批上市创新产品及适应症约47项。今日长缨在手，何时缚住苍龙？2024年公司海外销售业务占比仅为2.56%，我们期待公司早日成为真正的跨国大药企。附录：未来三年（2025-2027年）预计获批上市创新产品及适应症参考资料：恒瑞医药公告

Reports First-Quarter Diluted EPS of $0.72 on a GAAP Basis, a Decrease of 6.5 Percent; Adjusted Diluted EPS of $2.46, an Increase of 6.5 Percent; These Results Include an Unfavorable Impact of $0.13 Per Share Related to Acquired IPR&D and Milestones Expense Delivers First-Quarter Net Revenues of $13.343 Billion, an Increase of 8.4 Percent on a Reported Basis or 9.8 Percent on an Operational Basis First-Quarter Global Net Revenues from the Immunology Portfolio Were $6.264 Billion, an Increase of 16.6 Percent on a Reported Basis, or 18.1 Percent on an Operational Basis; Global Skyrizi Net Revenues Were $3.425 Billion; Global Rinvoq Net Revenues Were $1.718 Billion; Global Humira Net Revenues Were $1.121 Billion First-Quarter Global Net Revenues from the Neuroscience Portfolio Were $2.282 Billion, an Increase of 16.1 Percent on a Reported Basis, or 17.0 Percent on an Operational Basis; Global Vraylar Net Revenues Were $765 Million; Global Botox Therapeutic Net Revenues Were $866 Million; Combined Global Ubrelvy and Qulipta Net Revenues Were $433 Million First-Quarter Global Net Revenues from the Oncology Portfolio Were $1.633 Billion, an Increase of 5.8 Percent on a Reported Basis, or 7.5 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $738 Million; Global Venclexta Net Revenues Were $665 Million; Global Elahere Net Revenues Were $179 Million First-Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.102 Billion, a Decrease of 11.7 Percent on a Reported Basis, or 10.2 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $556 Million; Global Juvederm Net Revenues Were $231 Million Raises 2025 Adjusted Diluted EPS Guidance Range from $11.99 - $12.19 to $12.09 - $12.29, which Includes an Unfavorable Impact of $0.13 Per Share Related to Acquired IPR&D and Milestones Expense Incurred Year-To-Date Through the First Quarter 2025 NORTH CHICAGO, Ill., April 25, 2025 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the first quarter ended March 31, 2025. "AbbVie's first-quarter results were well ahead of our expectations and reflect an excellent start to the year," said Robert A. Michael, chief executive officer, AbbVie. "The fundamentals of our business are strong and we continue to bolster our outlook with pipeline advancements and strategic investments. Based on the progress we are making, AbbVie is well positioned for the long term." First -Quarter Results Worldwide net revenues were $13.343 billion, an increase of 8.4 percent on a reported basis, or 9.8 percent on an operational basis. Global net revenues from the immunology portfolio were $6.264 billion, an increase of 16.6 percent on a reported basis, or 18.1 percent on an operational basis. Global Skyrizi net revenues were $3.425 billion, an increase of 70.5 percent on a reported basis, or 72.0 percent on an operational basis. Global Rinvoq net revenues were $1.718 billion, an increase of 57.2 percent on a reported basis, or 59.7 percent on an operational basis. Global Humira net revenues were $1.121 billion, a decrease of 50.6 percent on a reported basis, or 49.5 percent on an operational basis. Global net revenues from the neuroscience portfolio were $2.282 billion, an increase of 16.1 percent on a reported basis, or 17.0 percent on an operational basis. Global Vraylar net revenues were $765 million, an increase of 10.3 percent. Global Botox Therapeutic net revenues were $866 million, an increase of 15.8 percent on a reported basis, or 17.0 percent on an operational basis. Global Ubrelvy net revenues were $240 million, an increase of 17.8 percent on a reported basis, or 18.0 percent on an operational basis. Global Qulipta net revenues were $193 million, an increase of 47.6 percent on a reported basis, or 48.3 percent on an operational basis. Global net revenues from the oncology portfolio were $1.633 billion, an increase of 5.8 percent on a reported basis, or 7.5 percent on an operational basis. Global Imbruvica net revenues were $738 million, a decrease of 11.9 percent. Global Venclexta net revenues were $665 million, an increase of 8.3 percent on a reported basis, or 12.3 percent on an operational basis. Global Elahere net revenues were $179 million. Global net revenues from the aesthetics portfolio were $1.102 billion, a decrease of 11.7 percent on a reported basis, or 10.2 percent on an operational basis. Global Botox Cosmetic net revenues were $556 million, a decrease of 12.3 percent on a reported basis, or 10.7 percent on an operational basis. Global Juvederm net revenues were $231 million, a decrease of 22.2 percent on a reported basis, or 20.0 percent on an operational basis. On a GAAP basis, gross margin in the first quarter was 70.0 percent. The adjusted gross margin was 84.1 percent. On a GAAP basis, selling, general and administrative (SG&A) expense was 24.7 percent of net revenues. The adjusted SG&A expense was 24.6 percent of net revenues. On a GAAP basis, research and development (R&D) expense was 15.5 percent of net revenues. The adjusted R&D expense was 15.4 percent of net revenues. Acquired IPR&D and milestones expense was 1.9 percent of net revenues. On a GAAP basis, operating margin in the first quarter was 28.0 percent. The adjusted operating margin was 42.3 percent. Net interest expense was $627 million. On a GAAP basis, the tax rate in the quarter was 22.4 percent. The adjusted tax rate was 14.2 percent. Diluted EPS in the first quarter was $0.72 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.46. These results include an unfavorable impact of $0.13 per share related to acquired IPR&D and milestones expense. Recent Events AbbVie announced that its board of directors unanimously elected chief executive officer (CEO) Robert A. Michael to assume the additional position of chairman of the board of directors, effective July 1, 2025. He will succeed Richard A. Gonzalez, who formerly served as AbbVie's CEO and has been chairman since the Company's formation in 2013. AbbVie announced that the European Commission (EC) granted marketing authorization to Rinvoq (upadacitinib) for the treatment of giant cell arteritis (GCA) in adult patients. The approval was supported by data from the pivotal Phase 3 SELECT-GCA trial which demonstrated that Rinvoq achieved the primary endpoint of sustained remission and key secondary endpoints, including reduction in disease flares, lower cumulative steroid exposure and complete remission. This authorization marks the eighth approved indication for Rinvoq in the European Union (EU). At the Society of Gynecologic Oncology (SGO) Annual Meeting, AbbVie announced final data analysis from the Phase 3 MIRASOL trial evaluating the efficacy and safety of Elahere (mirvetuximab soravtansine-gynx) in women with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC) compared to chemotherapy. At 30.5 months median follow-up, treatment with Elahere continued to show significant improvements in progression-free survival (PFS) and overall survival (OS) compared to investigator's choice (IC) chemotherapy. AbbVie and Xilio Therapeutics, a clinical-stage biotechnology company, announced a collaboration and option-to-license agreement that will combine AbbVie's oncology expertise with Xilio's proprietary tumor-activation technology to develop novel immunotherapies, including masked T-cell engagers, for people living with cancer. AbbVie announced that it submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of trenibotulinumtoxinE (BoNT/E) for the treatment of moderate to severe glabellar lines. TrenibotulinumtoxinE is a first-in-class botulinum neurotoxin serotype E characterized by a rapid onset of action as early as 8 hours after administration and short duration of effect of 2-3 weeks. If approved, trenibotulinumtoxinE will be the first neurotoxin of its kind available to patients. Allergan Aesthetics announced that the Allergan Medical Institute (AMI) will open three new state-of-the-art training centers in the U.S., expanding access to high-quality, tailored training for licensed aesthetics providers. The first training center is scheduled to open in Irvine, CA, with additional locations to follow in Atlanta, GA and Austin, TX. AbbVie and Gubra announced a license agreement to develop GUB014295 (ABBV-295), a potential best-in-class, long-acting amylin analog for the treatment of obesity. This partnership marks AbbVie's entrance into the obesity field and under the terms of the agreement, AbbVie will lead development and commercialization of GUB014295 globally. Prior to the close of the agreement, Gubra announced positive interim results from Part A of a Phase 1 multiple ascending dose (MAD) study, which showed that GUB014295 was well tolerated with body weight loss that was sustained in a manner consistent with data from a previously announced single ascending dose (SAD) study. AbbVie announced that the FDA approved Emblaveo (aztreonam and avibactam), as the first monobactam/β-lactamase inhibitor combination antibiotic therapy to treat complicated intra-abdominal infections, including those caused by Gram-negative bacteria. The approval of Emblaveo was supported by prior findings regarding the efficacy and safety of aztreonam for the treatment of complicated intra-abdominal infections as well as clinical trial results from the Phase 3 REVISIT study, which evaluated the efficacy, safety, and tolerability of Emblaveo for the treatment of serious infections due to Gram-negative bacteria. Full-Year 2025 Outlook AbbVie is raising its adjusted diluted EPS guidance for the full year 2025 from $11.99 - $12.19 to $12.09 - $12.29, which includes an unfavorable impact of $0.13 per share related to acquired IPR&D and milestones expense incurred year-to-date through the first quarter 2025. The company's 2025 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the first quarter of 2025, as both cannot be reliably forecasted. This guidance does not reflect the acquired IPR&D and milestones impact related to AbbVie and Gubra's licensing agreement to develop GUB014295, as that transaction closed after the first quarter of 2025. Additionally, this guidance is based on the existing trade environment and does not reflect any trade policy shifts, including pharmaceutical sector tariffs, that could impact AbbVie's business. About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, neuroscience, oncology, and eye care - and products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X (formerly Twitter), Facebook, Instagram, YouTube or LinkedIn. Conference Call AbbVie will host an investor conference call today at 8:00 a.m. Central Time to discuss our first-quarter performance. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 11:00 a.m. Central Time. Non-GAAP Financial Results Financial results for 2025 and 2024 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with GAAP and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie's management believes non-GAAP financial measures provide useful information to investors regarding AbbVie's results of operations and assist management, analysts, and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED