A Randomized, Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia® Sourced From the European Union in Postmenopausal Women With Osteoporosis

Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia®

开始日期2025-10-01

申办/合作机构

Xentria, Inc.

NCT06588153

/ Recruiting临床4期

A Phase 4 Single-arm Open-label Study for the Efficacy and Safety of Prolia® in Subjects With Glucocorticoid-induced Osteoporosis in Mainland China

The main objective of this study is to evaluate the efficacy of Prolia® in improving bone mass density (BMD) of lumbar spine at month 12.

开始日期2025-05-24

申办/合作机构

Amgen, Inc.

NCT07034391

/ Recruiting临床2期IIT

A Phase II Single-Arm Study Evaluating the Efficacy of PD-1 Inhibitor Combined With Denosumab and Chemotherapy in Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Patients With Driver Gene-Negative Status

This is an interventional study to explore the efficacy and safety of denosumab combined chemotherapy and anti-PD-1/PD-L1 inhibitor in locally advanced or metastatic NSCLC.

开始日期2025-05-12

申办/合作机构

中国医科大学

100 项与地舒单抗相关的临床结果

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100 项与地舒单抗相关的转化医学

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100 项与地舒单抗相关的专利（医药）

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6,572

项与地舒单抗相关的文献（医药）

2025-12-01·Current Osteoporosis Reports

Sequential and Long-term Therapy for Osteoporosis

Review

作者: McClung, Michael R

PURPOSE OF THE REVIEW:

Osteoporosis requires life-long management. This involves the use of different drugs in various sequences followed by long-term maintenance therapy. This review highlights the important transitions among osteoporosis therapies and outlines a strategy of intermittent bisphosphonate therapy for long-term maintenance.

RECENT FINDINGS:

Over the past few years, the effects and limitations of long-term treatment with bisphosphonates and denosumab have become apparent as have several key factors in the sequential use of anti-remodeling drugs and osteoanabolic agents. Strategies for transitions from estrogen, bisphosphonates, denosumab and the bone-forming drugs will be discussed, based on extant evidence, clinical experience and expert opinion. By appropriate selection of both the initial and subsequent drugs for the prevention and treatment of osteoporosis, therapeutic benefits can be optimized and safety issues minimized. Developing a strategy for long-term maintenance of the benefits of the initial therapies can provide a life plan for managing patients with osteoporosis.

2025-12-01·Current Osteoporosis Reports

Management of Adverse Skeletal Effects Following Bariatric Surgery Procedures in People Living with Obesity

Review

作者: Paccou, Julien ; Karam, Léa

Abstract:

Purpose:

This review focuses on recent findi+ngs regarding the management of adverse skeletal effects following weight loss in people living with obesity (PwO). We summarize the guidelines provided by various societies for the prevention and treatment of osteoporosis resulting from bariatric surgery. Next, we discuss the use of traditional antiosteoporosis medications in this population.

Recent Findings:

Guidelines for preventing and treating osteoporosis resulting from bariatric surgery have been recently provided by various societies setting specific treatment criteria for postmenopausal women and men aged ≥ 50 years, based on the occurrence of fragility fractures and/or T-score thresholds. Several studies have highlighted the positive effects of lifestyle changes in preventing high-turnover bone loss; however, data on fracture outcomes are currently unavailable. It is generally accepted that following bariatric procedures, sufficient intake of calcium, vitamin D, and protein, along with regular exercise incorporating progressive, supervised resistance training, is crucial to counteract negative impacts on bone. Regarding the need for medications to combat osteoporosis, most societies recommend zoledronic acid as the preferred choice. This preference is due to the problems associated with oral bisphosphonates, including poor tolerance and absorption issues. Denosumab is typically considered the second choice when bisphosphonates are not suitable or well tolerated. Two randomized controlled studies have recently demonstrated the effectiveness and safety of zoledronic acid and denosumab in addressing high-turnover bone loss.

Summary:

Although guidelines exist for managing skeletal health before and after bariatric surgery, more research is required to validate these recommendations and the use of anti-osteoporosis medications.

2025-12-01·European Journal of Trauma and Emergency Surgery

Effectiveness of a co-management program with internal medicine on hip fracture patients at a regional hospital in northwest Spain. Co-inter-Monf study

Article

作者: Marchán-López, Álvaro ; Cambón Cotelo, Javier ; Rodríguez Álvarez, Ana ; Quevedo Vila, Victor ; López-Castro, José

BACKGROUND:

Hip fractures represent a serious public health problem with a high burden of mortality, morbidity, and resource use. Co-management has proven to enhance the clinical outcomes of hip fracture patients hospitalized in various settings.

AIM:

This study aims to evaluate whether the previously observed benefits of co-management can be achieved when such a program is implemented in a rural-based district hospital.

METHODS:

A prospective, single-center observational study was conducted on hip fracture patients hospitalized for hip fracture. Patients were either co-managed by an internal medicine specialist with part-time dedication or not co-managed. The study was conducted in a rural hospital located in Galicia, Northwestern Spain, which serves a population of 45,000.

RESULTS:

A total of 207 patients were included in the study, of whom 97 received co-management. The majority of the patients who were co-managed were female (69.1%) and had a median age of 88 years (interquartile range 83-92). The study showed a high burden of comorbidity with a median Charlson index of 6 points, along with high prevalence rates of dementia (46%), functional disability (50%), and chronic anticoagulant therapy (25%). Despite no differences in age, sex, or preadmission cognitive or functional status, the study found lower 30-day postdischarge mortality in co-managed patients (9.3%) compared with the 110 controls (20.0%, p = 0.049). The prevalence of osteoporosis treatment, both calcium/vitamin D (87.8% vs. 60.7%, p < 0.001) and bisphosphonates/denosumab/teriparatide (42.4% vs. 15.7%, p < 0.001), was higher in the co-managed patients at 30 days after discharge. No differences were observed between the two groups in terms of in-hospital mortality and length of stay.

CONCLUSIONS:

The implementation of internal medicine co-management for hip fracture patients resulted in enhanced outcomes, particularly in the reduction of mortality within 30 days of discharge as well as in the prevalence of osteoporosis treatment.

586

项与地舒单抗相关的新闻（医药）

2025-06-19

·科兴制药

出海新动作！科兴制药引进博安生物阿柏西普类似药，开拓新兴市场眼科蓝海

2025年6月18日，科兴制药全资子公司深圳科兴医药有限公司，与绿叶制药集团控股子公司山东博安生物技术股份有限公司（以下简称：博安生物，股票代码：06955.HK）正式签署阿柏西普眼内注射溶液（BA9101）在除中国大陆地区、欧盟（以2024年欧盟成员国为准）、英国、美国、日本以外的全球所有国家和地区的海外商业化战略合作协议。今年1月，公司与博安生物刚达成地舒单抗注射液在中国香港和中国澳门的商业化合作，5月产品即在中国澳门获批上市，6月又再度达成阿柏西普的新兴市场商业化合作，双方国际化进程正在高速、高效、高质的推进。明星产品蓄势待发新兴市场眼科需求可观根据医药魔方数据统计，阿柏西普原研药2024年全球销售额95.54亿美元，位列眼科用药销售额榜首。博安生物自主研发的阿柏西普生物类似药，是国内第二款申报上市的阿柏西普生物类似药。采用VEGFR-Fc融合蛋白结构，在临床前研究中，理化特性及生物学活性上与原研药具有高度相似性；III期临床试验（有效性、安全性比对研究）数据显示，BA9101组与原研参照药组在4周、8周、12周、16周、20周和24周时眼最佳矫正视力（BCVA）均较基线显示出具有临床意义的显著改善（采用ETDRS视力表），疗效高度可比、起效迅速并持久，达到了所有研究终点。该产品已于2024年7月获得中国国家药品监督管理局药品审评中心（CDE）受理，拟用于治疗成人新生血管（湿性）年龄相关性黄斑变性（nAMD）及糖尿病性黄斑水肿（DME）。世界卫生组织曾经发布的《世界视力报告》显示，全球约22亿人视力受损或失明。根据《中国年龄相关性黄斑变性临床诊疗指南（2023年）》，年龄相关性黄斑变性的全球总患病率在45-85岁的人群中约为 8.69%，2020年全球患者规模约1.9亿例，预计到2040年，患者数量将增长至2.88亿例。目前，全世界的糖尿病患者数量呈上升趋势，糖尿病患者可能会出现多种并发症，其中糖尿病视网膜病变是其视力丧失的主要原因，而糖尿病性黄斑水肿(DME)是糖尿病视网膜病变患者视力下降的主要原因。国际糖尿病联盟（IDF）2025年发布的《全球糖尿病地图（第11版）》预测，全球糖尿病患者人数将从2024年的5.887亿人增加到2050年的8.525亿人，增幅达45%。其中非洲地区增幅最大，达142%；中东与北非地区为92%；东南亚地区为73%等。近四分之一的成年糖尿病患者患有某种形式的糖尿病相关视网膜病变，超过十分之一的糖尿病相关视网膜病变患者面临失明风险或已经失明。在临床需求的推动下，作为nAMD和DME的一线用药，阿柏西普市场前景广阔。出海平台持续壮大药械出海联合体初显成效近几年，科兴制药坚持"创新+国际化"战略，围绕抗病毒、抗肿瘤、自免等领域布局创新药管线的同时，积极引进国内高品质生物类似药和高端复杂制剂，尤其在乳腺癌、糖尿病治疗领域已形成产品矩阵。糖尿病药物方面，公司已引进通化东宝的利拉鲁肽和九源基因的司美格鲁肽，本次与博安生物合作阿柏西普类似药，不仅是在眼科领域补充了一款全球重磅药，同时也进一步拓展糖尿病患者并发症的治疗药物矩阵。科兴制药成熟的国际注册和营销推广体系，结合博安生物的研发和产业化实力，形成了阿柏西普类似药的国际竞争优势。中国创新药和生物类似药开始步入发展的爆发期，5月24日，深圳市首个药械产业出海联合体成立，深圳科兴医药作为联合体发起人单位，凭借“全球选品+全球覆盖”的海外商业化平台模式，引领行业出海风潮，为业内药械企业提供一站式专业出海服务。随着越来越多的中国高品质药走出国门，医药产业全球化进程加速，将为更多患者带来可负担的创新治疗方案。关于科兴制药科兴生物制药股份有限公司（简称：科兴制药，股票代码：688136）是一家主要从事重组蛋白药物和微生态制剂的研发、生产、销售一体化的创新型国际化生物制药企业。专注于抗病毒、肿瘤与免疫、血液、消化、退行性疾病等治疗领域，打造新型蛋白、新型抗体、核酸药物等前沿生物技术平台，坚持“创新+国际化”双轮驱动的平台型发展模式，同时探索生物技术在大健康领域的广泛应用，积极培育孵化新产业，致力于成为高品质生物药领导者，服务全球患者。公司核心产品稳居国内同类品种前列，覆盖全国各省市地区约20000家终端，其中等级医院约8000家，已通过欧盟、巴西、菲律宾、印度尼西亚等全球70多个国家的市场准入并实现销售。推荐阅读*中医药出海是本“好生意经”吗？*中国药企加速布局越南医药市场*泰国医药市场：健康养老与医疗旅游并重的新蓝海

临床3期生物类似药上市批准

2025-06-04

·汇聚南药

欧美给生物类似药适度“松绑”的新机遇

近期，欧洲药品管理局(EMA)发布了《生物类似药研发中临床数据个案化方式的反思文件》草案（Reflection paper on a tailored clinical approach in biosimilar development，以下简称草案）,讨论在适当情况下可以减少对疗效对比研究（comparative efficacy studies）的要求，为生物类似药研发和在欧盟获取批准提供更大的灵活性。EMA并非唯一对生物类似药监管适当“松绑”的机构，2024年，美国FDA也有类似举措。这些政策背后反映怎样的趋势？企业如何应对？本文分析生物类似药批准情况、相关审批标准和欧美最近政策走向，为中国企业生物类似药研发上市出海提供建议。市场空间待挖潜截至5月，FDA已累计批准71个生物类似药产品（以biosimilar name计）。其中，1-5月新批准8个生物类似药，包括：Avtozma（tocilizumab-anoh）、Bomyntra和Conexxence（denosumab-bnht）、Omlyclo（omalizumab-igec）、Osenvelt和Stoboclo（denosumab-bmwo）、Merilog（insulin aspart-szjj）、Ospomyv和Xbryk（denosumab-dssb）、Jobevne（bevacizumab-nwgd）以及Starjemza (ustekinumab-hmny)。另外，据不完全统计，自2006年4月起，EMA共计批准了132生物类似药。仅2025年1-5月，欧洲药品管理局批准了18款生物类似药,包括Denbrayce(denosumab)，Qoyvolma(ustekinumab)，Dazublys(trastuzumab)，Enwylma(denosumab)，Dyrupeg(pegfilgrastim),Pavblu(aflibercept)，及Skojoy(aflibercept)等。IQVIA在2025年2月发布的一项报告显示，2025-2034年生物类似药研发市场广阔，预计有118款生物制品面临专利保护期到期，其中106款生物制品没有生物类似药竞争，市场潜力大。至少满足5项条件欧盟草案显示，基于质量分析技术的进步和近年来监管经验的积累，EMA考虑在适当情况下减免对疗效对比临床研究的要求。其指出，对于通过全面质量分析和药理学研究显示具有与原研药高度相似性的生物类似药，可不再要求申请人提供疗效对比临床研究数据。具体而言，若申请人能提供充分的质量数据证明生物类似药与原研药的相似性，可不必进行对比疗效研究。充分的相似性质量数据至少应当：1.对产品的作用机制以及结构-功能关系的良好理解；2.关键质量属性（CQA）明确，并且可以在质量风险评估中得以可靠评估；3.采用灵敏的质量分析方法；4.与足够数量的原研参比药品（RMP）批次进行分析以预计批次间差异,且保证生物类似药开发过程中所应用的质量目标产品特征（QTPP）应与原研参比药品中观察到的差异特质高度一致；5.提前设计和规划相似性评估，并在相似性评估方案中有记录。相似性评估所使用的条件和判定标准已事先定义并在评估中得以应用。对比临床药代研究仍是开发过程中必不可少的一环。草案指出，可灵活设计药代研究，对药代研究具体数据要求也可适当调整，如引入免疫原性相关参数或调整药代动力学（简称药代，PK）研究设计方案。留意不得豁免情形不过，需指出的是，并非所有生物类似药都可豁免此类研究。草案指出，在以下情形中不应豁免疗效对比数据：质量分析方法灵敏度不足，无法识别关键质量属性差异；对药品作用机制的理解尚不清晰。具体来说，如果对作用机制和结构-功能关系尚未完全理解，可能导致对药物关键质量属性无法充分识别并进行有效风险评估，因此不能免除对比疗效临床研究。值得注意的是，草案表示许多细胞类药物产品目前就属于这一类别。同时，草案强调对比疗效临床研究不能替代不完整的质量开发，也不能作为存在显著质量属性差异的正当理由。总体而言，如果申请人通过足够的对比质量分析、体外药理学以及比较药代研究等严格评估推断出生物类似药与原研药具有相似的临床疗效和安全性，即使不提供临床对比疗效研究甚至药动学数据，生物类似药可能获得批准。草案文件指出，是否在开发计划中免于开展对比疗效临床研究，取决于申请人是否已对参比药物的结构和功能进行充分研究，并明确关键质量属性的差异是否会对临床产生实质性影响，明确的药代对比研究仍然是必须要求之一。目前，EMA对该文件征求意见，意见征集截止日期为2025年9月30日。放宽互换性要求EMA并非首个对生物类似药“松绑”的监管机构。实际上，2024年6月，美国FDA也出台了《证明与原研药互换性的考量：更新》行业指南文件（Considerations in Demonstrating Interchangeability with Reference Product:Update）(Guidance for Industry）。FDA此前要求生物类似药相关企业开展研究，证明生物类似药和品牌药之间的转换不会引起任何额外的安全性或有效性问题。该指南文件则指出，近年来，FDA在评估原研药与生物类似药的质量分析差异及其临床影响方面积累了更多经验。同时，现有的质量分析技术也不断进步，能更高效地表征蛋白质结构。借助精确灵敏的体外生物学和生化检测手段，还可有效模拟其在体内的药理作用和生物学活性。在此基础上，指南文件指出，生物类似药研发企业可以通过分析申请中提交的质量分析和临床数据证明产品满足互换性标准，而无需额外开展传统意义上的临床转换研究(switching studies)。同年7月，FDA就生物类似药研发制定指南文件向行业征求意见。重点包括是否应按“产品类别”或“单一产品”制定指南文件；指南文件应优先覆盖尚无已批准生物类似药的领域，还是已有上市类似药的领域。企业应主动作为美国和欧盟对于生物类似药的批准均需申请人提交充分的质量分析数据、非临床和适当的临床数据证明生物类似药与原研药高度相似。在维持严格的法规监管标准下，监管者对于具体数据要求保持一定的灵活性。随着生物类似药开发质量科学方面工具的更新，欧盟相关文件和美国FDA最近的监管政策文件显示了生物类似药申请在提交具体数据方面保持一定的监管灵活性，可以在具有充分的质量对比分析数据证明高度类似性或者互换性的情况下，生物类似药申请者可以不必提供相关临床数据。这将进一步促进生物制品竞争，对于生物类似药的开发无疑是好消息。中国生物类似药研发虽然起步相对欧美国家较晚，但近年来发展势头迅猛。多款中国产生物类似药产品在美国和欧洲获得批准。鉴于欧盟和美国对生物类似药的灵活监管政策，企业应充分考虑监管机构在研发与批准过程中提出的要求，开展详细的质量分析，并对药品机理进行有效验证，明确关键质量属性，为证明相似性提供坚实基础。在此基础上，可评估是否需要提供临床数据。坚实的质量分析和对药品性质和机理的研究是生物类似药成功研发的关键。此外，生物类似药企业应当制定充分的类似性评价评估方案，积极与监管者沟通，充分利用监管意见征询窗口，积极参与规则制定过程，将更多国产生物类似药带入欧美市场。（作者系Gunnercooke U.S.LLP纽约办公室生命科学领域合伙人）链接EMA/FDA相关审评标准一般来说，生物类似药的研发和批准需要研发企业提供相似性数据，证明生物类似药应与参照药“高度相似”，即使在非临床上存在略微差异，在安全性、纯度和疗效方面与参照药相比没有临床意义方面的差异。在欧盟，EMA对生物类似药申请人开展生物类似药和原研药“三步对比评价”框架，包括1.质量对比研究；2.体内及体外非临床对比数据研究；3.包括药代动力学(简称药代,PK)研究、药效动力学(简称药效,PD)研究、安全及疗效对比研究在内的临床数据。美国FDA同样也要求生物类似药申请人开展生物类似药和原研药对比评价证明生物类似药与原研药“高度相似”，具体包括提交质量研究，毒理学研究及药代研究、药效研究和免疫原性研究数据在内的临床研究方面的数据。根据具体案例如果认为没有必要，FDA可以豁免相关数据要求。（赵芳）作者系Gunnercooke U.S.LLP纽约办公室生命科学领域合伙人来源/《医药经济报》，原标题《欧美生物类似药管理趋势》喜欢我们文章的朋友点个“在看”和“赞”吧，不然微信推送规则改变，有可能每天都会错过我们哦~免责声明“汇聚南药”公众号所转载文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请在留言栏及时告知，我们会在24小时内删除相关信息。信息来源：医药经济报往期推荐本平台不对转载文章的观点负责，文章所包含内容的准确性、可靠性或完整性提供任何明示暗示的保证。

生物类似药专利到期

2025-06-02

·PipelineReview

Sandoz launches first and only interchangeable denosumab biosimilars in US, providing new affordable treatment options for over 10 million patients[1]

BASEL, Switzerland I June 2, 2025 I Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, has announced that WYOST® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz) are available to patients in the US starting today. WYOST® and Jubbonti® are the first and only interchangeable FDA-approved denosumab biosimilars and are approved to treat all indications of the reference medicines XGEVA®* (denosumab) and Prolia®* (denosumab), respectively.[2,3] This launch builds on Sandoz established leadership in biosimilars and oncology, dating back to the introduction of the first biosimilar in the US in 2015. WYOST® and Jubbonti® are key biosimilar value drivers that are integral to the Sandoz growth strategy, representing a significant step forward in advancing the Company’s ambition to be the biosimilar leader in the US. Keren Haruvi, President Sandoz North America, said: “Denosumab is a vital medicine for conditions such as osteoporosis and cancer-related skeletal events. Providing an additional high-quality, cost-effective treatment option helps improve access and affordability for US patients.” WYOST® and Jubbonti® have the same dosage form, route of administration, dosing regimen and presentation as the respective reference medicines. WYOST® and Jubbonti® are approved as interchangeable with the reference medicines for all indications. WYOST® and Jubbonti® will be launching with an established Q code. Sandoz is providing comprehensive support resources for patients who are prescribed WYOST® and Jubbonti®, including reimbursement and financial support. Claire Gill, Chief Executive Officer, Bone Health and Osteoporosis Foundation, said: “Bone loss and cancer-related skeletal complications can have a profound impact on patients’ lives, but access to effective treatments has often been impacted by cost. With the introduction of new biosimilar options, patients now have access to more treatments they need and deserve.” Bone metastases occur when cancer cells move away from the original tumor site and into the bone, weakening its structure and often causing significant skeletal-related events (SREs) such as pain and fractures.[4] They are most common in patients with breast, prostate, lung, kidney and thyroid cancers and approximately 330,000 people in the US are living with bone metastases.[4] Osteoporosis is a condition that develops when bone mineral density and bone mass decrease causing the bones to become thinner, weaker and more likely to break.[5] Over 10 million US adults 50 years of age or older live with osteoporosis, with over 43 million at risk due to low bone mass.[1,5] Half of all women and a quarter of all men over the age of 50 will break a bone due to osteoporosis.[6] *XGEVA® and Prolia® are registered trademarks of Amgen Inc. About WYOST® (denosumab-bbdz) WYOST® 120 mg/1.7 mL (70 mg/mL) injection has been approved by the FDA as interchangeable with the reference medicine, a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts (cells involved in breaking down bone tissue).[3,7] WYOST® is indicated in the US to prevent SREs in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.[7] This is not the complete list of all the safety information for Wyost. Please click to see full Prescribing Information for Wyost. About Jubbonti® (denosumab-bbdz) Jubbonti® 60 mg/1 mL injection has been approved by the FDA as interchangeable with the reference medicine, a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts (cells involved in breaking down bone tissue).[2,8] Jubbonti® is indicated in the US to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.[8] This is not the complete list of all the safety information for Jubbonti. Please click to see full Prescribing Information for Jubbonti. REFERENCES [1] Sarafrazi N, Wambogo EA, Shepherd JA. Osteoporosis or Low Bone Mass in Older Adults: United States, 2017–2018. Centers for Disease Control and Prevention. 2021;405. Available at: https://www-cdc-gov.libproxy1.nus.edu.sg/nchs/products/databriefs/db405.htm [Last accessed: June 2025] [2] Food and Drug Administration. Prolia® (Ustekinumab): Medication Guide. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125320s213lbl.pdf [Last accessed: June 2025] [3] Food and Drug Administration. XGEVA® (Ustekinumab): Medication Guide. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125320s0000lbl.pdf [Last accessed: June 2025] [4] Moffitt Cancer Center. Bone Metastasis. Available at: https://www.moffitt.org/cancers/bone-metastasis/ [Last accessed: June 2025] [5] Food and Drug Administration. Osteoporosis. Available at: https://www.fda.gov/consumers/womens-health-topics/osteoporosis [Last accessed: June 2025] [6] American Academy of Orthopaedic Surgeons. Osteoporosis. Available at: https://orthoinfo.aaos.org/en/diseases–conditions/osteoporosis/ [Last accessed: June 2025] [7] WYOST®. Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761362s000lbl.pdf [Last accessed: June 2025] [8] Jubbonti®. Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761362s000lbl.pdf [Last accessed: June 2025] ABOUT SANDOZ Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion. SOURCE: Sandoz

上市批准

100 项与地舒单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03684	地舒单抗	M05BX04	DB06643

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
糖皮质激素诱导的骨质疏松症	美国	Amgen, Inc.	2018-05-18
恶性肿瘤体液性高钙血症	美国	Amgen, Inc.	2018-01-04
类风湿关节炎	日本	Daiichi Sankyo Co., Ltd.	2017-07-03
骨癌	日本	Amgen, Inc.	2012-01-18
多发性骨髓瘤	日本	Amgen, Inc.	2012-01-18
骨病	欧盟	Amgen Europe BV	2011-07-13
骨病	冰岛	Amgen Europe BV	2011-07-13
骨病	列支敦士登	Amgen Europe BV	2011-07-13
骨病	挪威	Amgen Europe BV	2011-07-13
骨巨细胞瘤	欧盟	Amgen Europe BV	2011-07-13
骨巨细胞瘤	冰岛	Amgen Europe BV	2011-07-13
骨巨细胞瘤	列支敦士登	Amgen Europe BV	2011-07-13
骨巨细胞瘤	挪威	Amgen Europe BV	2011-07-13
骨转移癌	美国	Amgen, Inc.	2010-11-18
骨质疏松症	澳大利亚	Amgen Australia Pty Ltd.	2010-06-07
代谢性骨病	欧盟	Amgen Europe BV	2010-05-26
代谢性骨病	冰岛	Amgen Europe BV	2010-05-26
代谢性骨病	列支敦士登	Amgen Europe BV	2010-05-26
代谢性骨病	挪威	Amgen Europe BV	2010-05-26
骨折	欧盟	Amgen Europe BV	2010-05-26

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
非典型神经性厌食	临床3期	美国	Amgen, Inc.	2017-10-25
喂食及进食障碍	临床3期	美国	Amgen, Inc.	2017-10-25
成骨不全	临床3期	美国	Amgen, Inc.	2015-06-24
成骨不全	临床3期	澳大利亚	Amgen, Inc.	2015-06-24
成骨不全	临床3期	比利时	Amgen, Inc.	2015-06-24
成骨不全	临床3期	保加利亚	Amgen, Inc.	2015-06-24
成骨不全	临床3期	加拿大	Amgen, Inc.	2015-06-24
成骨不全	临床3期	捷克	Amgen, Inc.	2015-06-24
成骨不全	临床3期	法国	Amgen, Inc.	2015-06-24
成骨不全	临床3期	德国	Amgen, Inc.	2015-06-24

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASCO2025	N/A	骨转移癌	340	Denosumab monotherapy	鹽遞膚繭鬱積糧齋夢膚(觸衊齋醖獵夢願壓網憲): P-Value = 0.027	积极	2025-05-30
				Bisphosphonate switching to Denosumab
ASCO2025	N/A	巨细胞瘤	-	Denosumab	網膚蓋壓憲網糧糧憲糧(淵願餘範蓋夢繭蓋鹽鹽) = 襯窪構範齋網範鹹製繭鹹顧膚築觸鏇壓淵選鬱 (築窪顧餘衊遞獵蓋築糧 ) 更多	积极	2025-05-30
				denosumab (Control Group)	網膚蓋壓憲網糧糧憲糧(淵願餘範蓋夢繭蓋鹽鹽) = 齋鹹餘選鹹醖艱獵糧餘鹹顧膚築觸鏇壓淵選鬱 (築窪顧餘衊遞獵蓋築糧 ) 更多
ASCO2025	N/A	骨巨细胞瘤新辅助 \| 辅助	31	Denosumab	鑰鹹遞製鬱構選襯膚築(鏇願憲繭壓鹽築憲範衊) = 簾醖獵膚築淵範齋鏇選壓糧製選鏇繭選鹹積鹹 (鑰鑰鹽繭窪鏇繭齋鑰糧, 1 ~ 150) 更多	-	2025-05-30
ESMO_BC2025	N/A	绝经前乳腺癌辅助	69	Denosumab	鑰選齋簾觸簾夢窪構壓(壓憲鑰遞齋鏇鏇獵淵顧) = One ONJ case occurred (1.4 %) with no fractures reported 鏇鹹選鹹夢鏇蓋選積鬱 (淵選壓選築鹽憲廠蓋鹹 )	积极	2025-05-14
ESMO_BC2025	N/A	二线 BRCA1/2	1,399	Denosumab	構蓋憲蓋衊淵憲積構鹽(蓋廠糧選衊餘鏇構築齋) = 鹹繭範壓憲衊構廠遞膚壓憲願選醖憲蓋窪網膚 (襯鏇網蓋淵窪憲獵鏇觸, 24 ~ NR)	积极	2025-05-14
				denosumab (BRCA1/2-mutated HR+/HER2- bone metastatic breast cancer patients)	構蓋憲蓋衊淵憲積構鹽(蓋廠糧選衊餘鏇構築齋) = 鑰鹹繭願選鑰醖襯憲齋壓憲願選醖憲蓋窪網膚 (襯鏇網蓋淵窪憲獵鏇觸, 9 ~ 27)
PS1717 (EHA2025)	N/A	多发性骨髓瘤 urinary N-terminal telopeptide of type 1 collagen \| bone alkaline phosphatase \| serum C-terminal telopeptide of type 1 collagen	236	Narlumosbart 120 mg SC Q4W	憲鏇願壓夢顧範鬱鑰餘(獵夢蓋獵獵廠網選壓觸) = 衊衊淵襯繭簾選膚窪餘構簾遞繭鏇醖獵鏇醖選 (夢廠憲膚淵願網壓選膚 ) 更多	积极	2025-05-14
				Denosumab 120 mg SC Q4W	憲鏇願壓夢顧範鬱鑰餘(獵夢蓋獵獵廠網選壓觸) = 積襯襯襯鏇鹹遞願顧積構簾遞繭鏇醖獵鏇醖選 (夢廠憲膚淵願網壓選膚 ) 更多
NCT02299817 (Pubmed \| BMC Res Notes)	临床2期	骨质溶解	-	Denosumab	夢範壓窪構鬱糧遞繭糧(構艱憲構簾網壓齋蓋窪) = 選膚積齋醖鏇淵壓選鬱鏇願積艱壓廠獵鹹淵鹹 (鹹壓鏇網構蓋願構鬱艱 )	积极	2025-04-08
				Placebo	夢範壓窪構鬱糧遞繭糧(構艱憲構簾網壓齋蓋窪) = 願廠夢繭製廠選遞蓋範鏇願積艱壓廠獵鹹淵鹹 (鹹壓鏇網構蓋願構鬱艱 )
ESMO_SRC2025	N/A	骨巨细胞瘤	-	Denosumab	艱築廠襯製鹽夢夢艱夢(齋選鹹淵積餘鏇蓋膚憲) = 醖糧憲簾衊構鏇窪憲艱糧憲齋鹽觸鑰壓網願遞 (廠範憲醖齋範蓋糧廠夢 ) 更多	积极	2025-03-21
				denosumab (Control Group)	艱築廠襯製鹽夢夢艱夢(齋選鹹淵積餘鏇蓋膚憲) = 襯壓窪願艱鹹窪淵製製糧憲齋鹽觸鑰壓網願遞 (廠範憲醖齋範蓋糧廠夢 ) 更多
NCT01345019 (Study 20090482, FDA_CDER) 人工标引	临床3期	多发性骨髓瘤	859	Denosumab (Study 20090482 Multiple Myeloma)	製襯鏇壓簾選襯願積鬱(鹽選窪觸鏇壓膚齋範餘) = 廠鏇範製憲築積齋壓願廠鏇鹹獵憲繭網簾壓網 (積衊製鏇觸窪齋築製壓 ) 更多	非劣	2025-02-28
				Zoledronic Acid	製襯鏇壓簾選襯願積鬱(鹽選窪觸鏇壓膚齋範餘) = 醖餘夢憲窪製餘顧蓋衊廠鏇鹹獵憲繭網簾壓網 (積衊製鏇觸窪齋築製壓 ) 更多
NCT00330759 \| NCT00321464 \| NCT00321620 (Study 20050103, FDA_CDER) 人工标引	临床3期	骨转移癌	-	Denosumab (Study 20050136 Metastatic Breast Cancer)	醖願鬱繭積獵醖蓋簾艱(鹽築壓製壓選簾壓網膚) = 夢壓窪壓網鬱遞齋築糧齋憲鹹顧獵壓簾積鑰壓 (簾構顧蓋積鏇顧壓艱鏇 ) 更多	积极	2025-02-28
				Zoledronic Acid (Study 20050136 Metastatic Breast Cancer)	醖願鬱繭積獵醖蓋簾艱(鹽築壓製壓選簾壓網膚) = 獵積顧窪窪憲餘簾網衊齋憲鹹顧獵壓簾積鑰壓 (簾構顧蓋積鏇顧壓艱鏇 ) 更多