Vedolizumab

药品营销避坑”试读： 药品导入期管理视频课（试听） 药品生命周期管理（案例） 药品立项需要注意什么（案例） 2026年7月30日拜耳宣布，已向中国国家药品监督管理局药品审评中心递交了非奈利酮用于慢性肾脏病（非糖尿病相关的）成人患者的上市申请。 本次申请基于多中心、随机、双盲、安慰剂对照3期临床试验FIND-CKD的研究结果。FIND-CKD研究共纳入1584名接受稳定并最大耐受剂量血管紧张素抑制剂治疗的成人非糖尿病慢性肾脏病（CKD）患者。入组患者在原治疗的基础上随机接受非奈利酮（10或20mg）每天一天，或安慰剂。至第32周，非奈利酮组和安慰剂组，年化eGFR（肾小球滤过率估计值）分别下降3.3mL/min/1.73m²和4.0mL/min/1.73m²（差异0.7; 95% CI, 0.3–1.1; P<0.001）。非奈利酮组的复合肾脏和心血管不良事件发生风险（HR, 0.77; 95% CI, 0.60–0.99; P = 0.04）、肾脏不良事件发生风险（HR, 0.78 ; 95% CI, 0.60–1.01）和心血管不良事件发生风险（HR, 0.60 ; 95% CI, 0.27–1.33）均低于安慰剂组。在安全性方面，最常见的不良事件为高血钾，非奈利酮组和安慰剂组高血钾的发生率分别为17.0%和13.3%，非奈利酮组和安慰剂组分别有1.5%和0.1%的患者由于高血钾终止治疗，分别有0.9%和0.6%的患者由于高血钾接受住院治疗（Hiddo J L Heerspink., 2026）。 非奈利酮（Finerenone）为第三代非甾体类盐皮质激素受体拮抗剂。与第一代和第二代盐皮质激素受体拮抗剂螺内酯（Spironolactone）和依普利酮（Eplerenone）和相比，非奈利酮不具有甾体结构，不激动孕酮受体或拮抗雄激素受体，作用强，对盐皮质激素受体的选择性高。在此之前，非奈利酮已在国内获批用于与2型糖尿病相关的慢性肾脏病成人患者（伴白蛋白尿），以降低肾小球滤过率估计值（eGFR）持续下降、终末期肾病、心血管死亡和因心力衰竭住院的风险；以及用于射血分数（LVEF）≥40%的心力衰竭成人患者，以降低心血管死亡、因心力衰竭住院和因心力衰竭紧急就诊的风险。 推荐指数：★★★ 推荐原因：本次申请如能顺利获批，非奈利酮有望成为CKD的基础治疗药物。个人观点，仅限参考。 相关阅读： 洛索洛芬钠贴剂湖南九典&广东仁想首仿同日获批 海南赛立克磷霉素氨丁三醇颗粒首仿获批 博瑞医药长效舒张支气药物噻托溴铵吸入喷雾剂首仿获批 恒瑞HER3 ADC瑞康芦泽妥塔单抗申请上市用于EGFR突变NSCLC 科伦博泰芦康沙妥珠单抗申请新增一线用于晚期三阴性乳腺癌 辉瑞宣布利特昔替尼用于非节段性白癜风3期试验达到终点 首个中药凝胶贴膏九典制药椒七止痛凝胶贴膏获批上市 恒瑞医药基础胰岛素日制剂舒地胰岛素获批治疗成人2型糖尿病 西湖制药抗新冠新药伊司特韦获批 华海药业靶向IL-36R瑞西奇拜单抗获批用于泛发性脓疱型银屑病 福元医药申请上市复方降压药物奥美沙坦酯左氨氯地平片 翰森B7-H3 ADC HS-20093用于晚期骨肉瘤3期试验达到主要终点 戒酒，GLP-1/Gcg双激动剂PemvidutideⅡ期研究数据发布 石药集团SNRI类抗抑郁药物阿姆西汀肠溶片3期临床达到终点 阿斯利康CLDN18.2 ADC Sone-Ve晚期胃癌3期试验改善总生存期 维得利珠单抗治疗儿童溃疡性结肠炎和克罗恩病拟纳入优先审评 相关内容只作为药物研发的参信息。不构成任何与用药咨询有关的建议。 如需发稿，您可通过在药研苑公众号下以发送信息的方式将官网或官方公众号的稿件链接和标题发送给我们。我们将择优确定是否发布。

U.S. FDA and EMA acceptance for review of Biologics License Application (BLA) and Marketing Authorisation Application (MAA), respectively, of intravenous vedolizumab biosimilar candidate, an integrin receptor antagonist. Vedolizumab targets inflammatory bowel diseases, including moderately to severely active ulcerative colitis and Crohn’s disease in adults. Acceptance reinforces Fresenius Kabi’s strategy to expand its autoimmune biosimilars portfolio and broaden patient access to biologic medicines. BAD HOMBURG, Germany--(BUSINESS WIRE)-- #CommittedToLife --Fresenius Kabi, an operating company of Fresenius, announced today that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted for review the Biologics License Application (BLA) and Marketing Authorisation Application (MAA), respectively, for PB016, a proposed vedolizumab biosimilar candidate to the reference product Entyvio®* (vedolizumab) lyophilized vial for intravenous (IV) administration. The applications were submitted by Polpharma Biologics S.A., with Fresenius Kabi holding exclusive commercialization rights globally, excluding the Middle East and North Africa, pending regulatory approvals. “FDA and EMA acceptances for review of IV vedolizumab biosimilar marks important milestones in the development program and underscores our commitment to improving patient access to high-quality, affordable biologic medicines,” said Dr. Sang-Jin Pak, President Biopharma at Fresenius Kabi. “With IV vedolizumab, we are advancing our autoimmune biosimilars portfolio and taking another step toward providing additional treatment options for patients living with chronic inflammatory diseases.” PB016, in-licensed from Polpharma Biologics S.A. 1 , is a proposed biosimilar to IV vedolizumab, an integrin receptor antagonist indicated for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease in adults. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis, affects approximately 2.4 million patients in the US and 2.5-3 million patients in Europe and continues to rise every year. 2,3 It is a chronic, progressive condition with no definitive cure and can have a significant, long-term impact on patients’ quality of life. Once primarily associated with highly industrialized countries, IBD incidence continues to rise globally alongside increasing industrialization. In this context, biosimilars have the potential to expand access to effective biologic therapies. The submissions for the intravenous presentation are supported by a comprehensive development program evaluating the proposed biosimilar’s similarity to the reference product, consistent with regulatory requirements for biosimilar approval. Biopharma is a core pillar of Fresenius’ #FutureFresenius strategy. The company is building a vertically integrated, end‑to‑end biopharma business, covering the entire value chain - from research and development to manufacturing and global commercialization. By combining strong technical capabilities, global production expertise, and a balanced commercial footprint, Fresenius is well positioned to expand access to high‑quality, affordable biologic therapies. The FDA and EMA review acceptances represent the latest progression in Biopharma’s growth strategy and strengthens its global biosimilars position. About vedolizumab Vedolizumab (PB016) is a monoclonal antibody that selectively targets the α4β7 integrin, reducing gastrointestinal inflammation by inhibiting the migration of lymphocytes into the gut. 4 It is used in the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease in adults, chronic inflammatory diseases that can significantly impact patients’ quality of life. Vedolizumab is administered by intravenous infusion. PB016 is being developed by Polpharma Biologics S.A., and Fresenius Kabi has exclusive commercialization rights globally, excluding the Middle East and North Africa, pending regulatory approval. The biosimilar development program for vedolizumab is designed to demonstrate high similarity to the reference product through comprehensive analytical, non‑clinical, and clinical studies, in line with regulatory requirements for biosimilar approval. PB016 has been studied in a Phase 1 trial with healthy volunteers and a Phase 3 trial with ulcerative colitis patients (NCT05771155). 5 About Fresenius Kabi Fresenius Kabi, an operating company of the Fresenius Group, is a global healthcare company providing integrated medicines, technologies, and services for critically and chronically ill patients. With more than 41,000 employees and present in over 100 countries, the company’s broad portfolio enables access to high quality care across emergency medicine, surgery, oncology, intensive care, and at home – reaching 450 million patients each year. Through complementary business areas, Fresenius Kabi offers highly complex biopharmaceuticals for cancer, autoimmune and endocrine diseases; leading enteral, parenteral and homecare solutions within clinical nutrition; cutting-edge medical technology including infusion pumps, cell and gene therapy devices, disposables, and world-leading blood collection systems; and intravenous generic drugs and fluids that advance essential patient care worldwide. For more information, please visit . About Fresenius Fresenius SE & Co. KGaA (Frankfurt/Xetra: FRE) is a global healthcare company headquartered in Bad Homburg v. d. Höhe, Germany. In the 2025 fiscal year, Fresenius generated €22.6 billion in annual revenue. Fresenius currently counts over 178,000 employees. The Fresenius Group comprises the operating companies Fresenius Kabi and Fresenius Helios as well as an investment in Fresenius Medical Care. With around 140 hospitals and countless outpatient facilities, Fresenius Helios is the leading private hospital operator in Germany and Spain, treating around 27 million patients every year. Fresenius Kabi’s product portfolio touches the lives of 450 million patients annually and includes a range of highly complex biopharmaceuticals, clinical nutrition, medical technology, and intravenous generic drugs and fluids. Fresenius was established in 1912 by the Frankfurt pharmacist Dr. Eduard Fresenius. After his death, Else Kröner took over management of the company in 1952. She laid the foundations for a global enterprise that today pursues the goal of improving people’s health. The largest shareholder is the non-profit Else Kröner Fresenius Foundation, which is dedicated to advancing medical research and supporting humanitarian projects. For more information visit the Company’s website at . Visit our media center: . References [1] Fresenius Announces Licensing Agreement with Polpharma Biologics to Commercialize a Proposed Vedolizumab Biosimilar (2025). Available at: Fresenius Announces Licensing Agreement with Polpharma Biologics to Commercialize a Proposed Vedolizumab Biosimilar [last accessed: June 2026] [2] Lewis J.D., Parlett L.E., Jonsson Funk M.L, et al . (2023) Incidence, Prevalence, and Racial and Ethnic Distribution of Inflammatory Bowel Disease in the United States. Gastroenterology , 165: 1197–1205. [3] Kumar A., Yassin N., Marley A. et al . (2024) Crossing barriers: the burden of inflammatory bowel disease across Western Europe. Therapeutic advances in Gastroenterology , 16, 1-16. [4] Wyant T., Fedyk E., Abhyankar B. (2016) An Overview of the Mechanism of Action of the Monoclonal Antibody Vedolizumab. Journal of Crohn's and Colitis , 10(12), 1437–44. [5] ClinicalTrials.gov. Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio® (UCESIVE). Available at: Study Details | NCT05771155 | Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio® | ClinicalTrials.gov [last accessed: June 2026] * Entyvio ® is a registered trademark of Millennium Pharmaceuticals, Inc., a Takeda company. Contacts Global Contact Information For more information, please contact: Fresenius Kabi Business Communications Email: communication@fresenius-kabi.com . U.S. Contact Information For more information, please contact: matt.kuhn@fresenius-kabi.com .