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.初创企业

NCT06588153

/ Not yet 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2025-05-27

申办/合作机构

Amgen, Inc.

NCT06720350

/ Not yet recruiting临床4期IIT

Efficacy of Romosozumab and Denosumab Combined Treatment in Postmenopausal Osteoporosis Patients with Multiple Fragility Fractures

The aim of this clinical trial is to investigate the effectiveness of romosozumab started without stopping denosumab in patients diagnosed with postmenopausal osteoporosis with a very high risk of fragility fractures and who is under at least 2 years of denosumab treatment. The main questions aimed to answer are:
* Does it effective to prevent fractures add Romosozumab to ongoing denosumab treatment?
* If it is appropiate to quit denosumab for starting 1 year romosozumab treatment?
* If there is complications in denosumab and romosozumab combination treatment?
Researchers will compare the Romosozumab 210mg subcutaneous(sc) monthly plus denosumab 60mg per 6 months sc treatment to prooceeding denosumab treatment and romosozumab 210mg monthly treatment in patient whom denosumab cessaced.
Participians are postmenopousal women with osteoporosis and they are under at least 2 years of treatment with denosumab and they will:
* Add 210 mg monthly romosozumab sc injection or switch to 210 mg monthly romosozumab sc injection or proceed 60mg per 6 months denosumab sc injection
* Visit the clinic at least once every 3 months and first month of new treatment regimen, blood tests per 3 months and Bone mineral density examination per 6 months
* Keep a diary of their symptoms

开始日期2025-01-15

申办/合作机构

Marmara University

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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4,669

项与地舒单抗相关的文献（医药）

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.

2025-04-01·BONE

Parathyroid hormone levels following denosumab vs. zoledronic acid therapy for osteoporosis

Article

作者: Barzilai-Yosef, Liat ; Rotman-Pikielny, Pnina ; Meron, Michal Kasher ; Braginski-Shapira, Sofia ; Ramaty, Erez ; Lurie, Tzipi Hornik

The objective of this retrospective, database study was to characterize the rate, magnitude and timeline of increases in parathyroid hormone (PTH) levels post-denosumab (DMAb) vs. zoledronic acid (ZA) injection in patients with osteoporosis and near normal baseline PTH. Included were osteoporotic females, ≥50 years, initiating treatment with 60 mg DMAb or 5 mg ZA. PTH levels within 6-months post-DMAb or 12-months post-ZA injection were extracted from the electronic database of a 4.5 million-member health maintenance organization. The indication for PTH measurements was unknown. Exclusion criteria were creatinine >2 mg/dL, vitamin D < 50 nmol/L or parathyroid hormone level > 1.5 × upper limit of normal (ULN). Among 3317 women, 1992 received DMAb and 1325 ZA. The DMAb group was older (73.3 ± 8.5 vs. 69.8 ± 8.6 years, p < 0.001) and more patients treated with DMAb compared with patients treated with ZA had prior non-vertebral fractures (7.7 % vs. 5.2 %, p < 0.01) and had previously been treated with osteoporosis medication (56.3 % vs. 50.3 %, p < 0.001). Among the patients, 14.9 % had at least one post-treatment PTH > 1.5 ULN. Of 7273 post-treatment PTH tests, 62.6 % were within normal limits, while 24.8 % were mildly elevated at 1.01-1.5 ULN. Two-months after both treatments, >1.5 ULN PTH levels peaked at ∼20 %. Elevated PTH was associated with eGFR < 60 mL/min/1.73 m² and comorbidities. In conclusion, most PTH levels post-DMAb or ZA in osteoporotic patients with baseline PTH < 1.5 ULN, were within normal range. PTH increased to >1.5 ULN in 14.9 % of patients; peaking in the first 2-months post-treatment and declining thereafter. Elevated PTH may be related to anti-resorptive effects and is not medication specific. PTH measurements in the first few months post-DMAb and ZA therapy should be limited.

2025-03-01·BONE

SB16 versus reference denosumab in postmenopausal women with osteoporosis: 18-month outcomes of a phase III randomized clinical trial

Article

作者: Urboniene, Audrone ; Supronik, Jerzy ; Mordaka, Robert ; Baek, Ki-Hyun ; Eastell, Richard ; Dokoupilova, Eva ; Langdahl, Bente ; Rosa, Jan ; Plebanski, Rafal ; Rho, Young Hee ; Ahn, Sohui ; Mydlak, Andrzej ; Sapula, Rafal ; Chung, Yoon-Sok ; Rowińska-Osuch, Anna ; Ban, Jisuk ; Czerwinski, Edward

PURPOSE:

This study evaluated the efficacy, safety, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of SB16 versus reference denosumab (DEN) up to 18 months in postmenopausal osteoporosis (PMO) patients, and assessed outcomes after switching from DEN to SB16 compared to those who continued with DEN or SB16.

METHODS:

457 PMO patients were initially randomized, with 407 re-randomized at Month 12 to either continue DEN (DEN+DEN), switch to SB16 (DEN+SB16), or continue SB16 (SB16 + SB16) through Month 18. Efficacy was assessed by the percent change from baseline in bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck. Safety, PD, PK, and immunogenicity were evaluated throughout the study period.

RESULTS:

Mean percent changes from baseline in lumbar spine, total hip, and femoral neck BMD at Month 18 were comparable across treatment groups, indicating comparable efficacy between SB16 and DEN. The mean percent change in lumbar spine BMD was 6.8 % (SB16 + SB16), 6.2 % (DEN+SB16), and 6.8 % (DEN+DEN). Total hip BMD increased by 4.4 %, 3.5 %, and 4.0 %, and femoral neck BMD by 3.4 %, 3.1 %, and 2.7 % for SB16 + SB16, DEN+SB16, and DEN+DEN, respectively. Safety profiles were similar among groups, with no new safety concerns identified after switching. Only one patient in the DEN+SB16 group developed non-neutralizing anti-drug antibodies by Month 18, indicating a low immunogenicity risk for SB16.

CONCLUSION:

Switching from DEN to SB16 demonstrated comparable efficacy, safety, PD, PK, and immunogenicity in PMO patients relative to those who continued DEN. SB16 was well tolerated over 18 months, demonstrating comparable outcomes to DEN.

622

项与地舒单抗相关的新闻（医药）

2025-02-17

·药时代

潜在损失超3000亿美元！近200种药物面临专利悬崖

制药行业将迎来一波专利到期潮。今年年初，Joanna Sadowska博士在领英（linkedin）上发布了一张“Pharma 专利悬崖”图谱。她指出，未来几年将有近200种药物失去专利保护，其中包括至少69种年销售额超10亿美元的重磅炸弹药物，累计损失销售额超3000亿美元。为此，药时代罗列了部分重磅药物的专利信息。截止2037年，超25款产品将会面临专利悬崖，以2024年销售额为准，合计潜在损失金额超2364亿美元。其中，涉及百亿级别药物共计9款，包括辉瑞的阿哌沙班、默沙东的K药、BMS的O药、强生的达雷妥尤单抗、赛诺菲的度普利尤单抗、诺和诺德的司美格鲁肽、艾伯维的利生奇珠单抗、礼来的替尔泊肽以及Vertex的Trikafta。就药企而言，默沙东的潜在损失可能最大，但潜在损失最大并不意味着药企所面临的风险就最高。2024年7月，摩根士丹利（Morgan Stanley）发布的一份报告显示，到2030年，安进（67%）、BMS（63%）与默沙东（56%）面临的收入风险位居前三甲。反之，Vertex（6%）、吉利德（24%）、艾伯维（29%）、礼来（31%）和辉瑞（33%）的风险评估较低。安进在这份专利悬崖风险榜单中，安进的收入风险最高。主要原因为四大核心产品，地舒单抗（Prolia）、地舒单抗（Xgeva）、依那西普（Enbrel）以及阿普米司特（Otezla）集中丧失独家经营权。而这四款产品2024年合计销售额为120.41亿美元，约占安进全年总营收的三分之一。其次，安进旗下GLP-1类药物Marifide勇闯红海，竞争激烈；系统性硬化治疗药物Fipaxalparant二期临床失利，研发不确定性不容忽视；2024年底公司总债务601亿美元，杠杆率4.5倍，债务压力较大。面对上述风险，安进早有预期并提前收购Horizon，以寻求平稳度过专利悬崖带来的艰苦时期。目前，收购Horizon所得的Tepezza（teprotumumab）、Krystexxa（pegloticase）以及Uplizna（伊奈利珠单抗）正在快速放量。其中，Uplizna有望于今年达成两项重要里程碑，包括IgG4相关疾病适应症的获批，以及重症肌无力适应症的在美递交。 BMS BMS作为榜单第二，主要面临的危机是阿哌沙班与O药两大“现金牛”的滑铁卢。据2024年BMS财报显示，两款产品合计销售额达234亿美元，约占公司总营收的一半。其中，阿哌沙班不仅需要面对即将到来的仿制药竞争，还在最终冲刺阶段，面临美国Medicare Part D改革的“考验”，影响2025年的持续放量。据Evaluate Pharma预测，截止2023年前，BMS将因阿哌沙班损失超百亿美元。面对专利悬崖考验，BMS从战略角度出发，采取成功优化模式，通过组织精简与运营效率提升利润率。具体而言，BMS继2024年4月宣布15亿美元成本削减计划之后，又于2025年2月再次提出了20亿美元的新削减目标。为实现这一目标，BMS砍掉了Cendakimab、第二代TYK2抑制剂BMS-986322在内的多条管线，并伴随着相应的裁员。推荐阅读：20亿美元！BMS祭出“省钱大招”，全力跨越专利悬崖！短期镇痛，是为了长期增长蓄力。2023年底，BMS斥140亿美元巨资收购Karuna，获得旗下核心管线Cobenfy。该药物去年刚上市获批，第一个完整季度就卖了1000万美元，虽然不算多，但已经是个不错的开头。 BMS的首席执行官Boerner表示，“我们计划在2025年启动Cobenfy的7项3期临床试验，争取让它在患者中得到更广泛的应用。”由此可见，BMS已将重心偏向于神经科学领域。此外，BMS目前销售额增长最快的产品是心肌肌球蛋白抑制剂Camzyos以及CD19 CAR-T疗法Breyanzi，预计将成为公司未来5年增长核心。默沙东一般情况下，药品专利期保护的长度为20年，但考虑到创新药开发周期较长，需要经分子筛选、药学研究、1-3期临床、上市申请等过程才能获批，实际的保护期限仅剩下10年左右。而这10年就是一个周期，代表着创新药领域一个时代的更替。十年之后，PD-1时代最先领跑的两家公司BMS与默沙东，都将因为专利悬崖问题而面临挑战。正是应了那句话：“事物的发展是螺旋上升的。” 在这十年间，OK大战打响，从最初K药以“非小细胞肺癌一线治疗”实现逆转，到最终以40项适应症的巨大优势登顶药王，默沙东对K药的栽培可谓是不遗余力。最直观的表现就是K药恐怖的临床注册数量，通过ClinialTrial检索，其K药的注册数超过1400项，规模之大，绝无仅有。然而未来五年，K药、西格列汀/二甲双胍、来特莫韦等重磅产品均将面临专利悬崖，如何选择接棒产品对默沙东而言至关重要。根据近两年的BD交易金额浅析，默沙东共计338亿美元牵手科伦博泰与第一三共，重金押入ADC领域。司马昭之心路人皆知。继续为K药续命，联合疗法重重加码，以后K药是K药，PD-1是PD-1。值得一提的是，默沙东另一大核心营收支柱HPV疫苗Gardasil 9营收不及预期，主要是受中国市场影响。今年2月起暂停发货以加速去库存，预计2025年下半年恢复增长。其他药企辉瑞的肿瘤药物lbrance、Xtandi、Inlyta，运甲状腺素蛋白淀粉样心肌病药物Vyndaqel系列以及关节炎药Xeljanz都将于2027年前专利到期；强生的肿瘤药物Darzalex、Erleada，肺动脉高压药物Opsumit、Uptravi，新血管药物Xarelto以及HIV药物Edurant将于2030年前专利到期；礼来的糖尿病药物Trulicity、Jardiance，关节炎药物Taltz以及肿瘤药物Cyramza将于2030年专利到期。譬如朝露，去日苦多。面对专利悬崖，跨国药企们通过加强研发、拓展市场、优化产品组合等方式迎接挑战。小结：医药行业的"专利悬崖"现象生动诠释了市场博弈的辩证法则。当原研药企的市场独占期终结，生物类似药和仿制药如潮水般涌入市场，这场看似药企的"滑铁卢"，实则是普罗大众的福音——安全可靠的平价替代药物使医疗支出大幅降低。然而，这种普惠效应总是姗姗来迟，远落后于造就专利悬崖的暴利时代。面临仿制药冲击，原研药企仍能通过调整产量和价格维持盈利空间。更具行业意义的是，这些医药巨头往往早已未雨绸缪，将研发重心转向突破性新药，在创新高地上重新构筑利润山脉，静待下一个专利周期的轮回。这种周而复始的产业循环，恰似生生不息的生态法则：既有壮士断腕的决绝，又蕴含凤凰涅槃的新生，在商业利益与公共福祉的动态平衡中，持续推动着人类医药事业的进步。封面图来源：正文《哪吒2》票房破118亿！这届神仙怎么人均"脆皮大学生"？ 2025-02-16 曾花7亿美元押注中国ADC，BioTech豪赌落空？ 2025-02-15 hiPSCs从基础研究到医疗革新系列课第1期：hiPSC衍生的细胞药物临床转化案例&应用分享 | 药时代直播间 2025-02-14 版权声明/免责声明本文为原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢! 药时代官方网站:www.drugtimes.cn 联系方式: 电话:13651980212 微信:27674131 邮箱:contact@drugtimes.cn 点击，查看更多精彩!

专利到期并购财报

2025-02-17

·GBIHealth

三生制药与百利天恒达成合作，探索双抗+双抗ADC抗癌作用

药械追踪 No.1 / LINDIS/凌腾医药CD3×EpCAM三功能抗体获欧盟批准 2025年2月17日，德国生物制药公司LINDIS Biotech GmbH（简称“LINDIS”）宣布，卡妥索单抗（Catumaxomab，商品名：KORJUNY）已获得欧洲委员会（EC）的营销授权，成为欧洲地区唯一获批用于治疗恶性腹水（MA）患者的药物疗法。卡妥索单抗是一款靶向CD3×EpCAM的三功能抗体（trAb），由德国Trion Pharma公司原研，费森尤斯共同开发。该产品曾在2009年获EMA批准用于治疗恶性腹水；出于商业原因，卡妥索双抗上市数年后选择了自行退市。凌腾医药联合创始人、首席科学官Horst Lindhofer博士是LINDIS公司创始人之一，目前卡妥索单抗在中国的临床研究由凌腾医药继续推进，在海外的研究由LINDIS继续推进。LINDIS已将卡妥索单抗在欧洲的独家市场准入权授予Pharmanovia，后续Pharmanovia将主导卡妥索单抗在欧洲的全面上市工作。 ->点击文末阅读原文，解锁完整双语新闻 No.2 / 赛诺菲速效胰岛素生物类似药Merilog获FDA批准 2025年2月14日，赛诺菲旗下Merilog获得美国食品药品监督管理局（FDA）批准，作为诺和诺德Novolog（门冬胰岛素）的生物类似药，用于改善成人和儿童糖尿病患者的血糖控制。Merilog此次获批剂型包括3毫升预填充注射笔和10毫升多剂量药瓶。 Merilog是一种速效人胰岛素类似物，也是FDA批准的首款速效胰岛素生物类似药。与Novolog相同，Merilog应在餐前五至十分钟内给药，可快速起效、降低餐时血糖峰值，改善糖尿病患者的血糖控制。Merilog可通过皮下注射给药，给药剂量可根据患者需求进行个性化调整。 ->点击文末阅读原文，解锁完整双语新闻 No.3 / 韩国三星地舒单抗生物类似药在美获批 2025年2月15日，三星生物仿制药有限公司（Samsung Bioepis Co., Ltd.）宣布，旗下两款地舒单抗生物类似药Ospomyv（地舒单抗60mg预填充注射剂）、Xbryk（地舒单抗120mg瓶装剂）分别获得美国食品药品监督管理局（FDA）批准，FDA还暂时认定Ospomyv和Xbryk具有可互换性。地舒单抗是由安进公司原研的一种新型RANKL抑制剂，分为两种剂量，120mg剂量商品名为安加维（Xgeva），60mg剂量商品名为普罗力（Prolia）。三星旗下Ospomyv和Xbryk分别为参照普罗力和安加维研制的生物类似药。 Ospomyv获批适应证包括：治疗具有高骨折风险的绝经后女性骨质疏松症、增加具有高骨折风险男性骨质疏松症患者的骨量、治疗具有高骨折风险的糖皮质激素诱导的骨质疏松症男性及女性患者、增加接受非转移性前列腺癌雄去势疗法且具有高骨折风险的男性患者的骨量，以及增加接受乳腺癌芳香化酶抑制剂辅助治疗且具有高骨折风险的女性患者的骨量。 Xbryk获批适应证包括：用于预防多发性骨髓瘤患者和实体瘤骨转移患者的骨骼相关事件、治疗无法切除或手术切除可能导致严重发病的成人和骨骼发育成熟的青少年骨巨细胞瘤患者，以及治疗对二膦酸盐难治的恶性肿瘤相关高钙血症。 ->点击文末阅读原文，解锁完整双语新闻 No.4 / GSK五合一疫苗Penmenvy在美获批上市 2025年2月14日，葛兰素史克（LSE/NYSE：GSK）宣布，美国FDA批准Penmenvy（A、B、C、W和Y群脑膜炎球菌疫苗）上市，用于10至25岁人群。该疫苗针对的是引起侵袭性脑膜炎球菌病（IMD）的五大主要血清群（A、B、C、W和Y），这些血清群的病原体为脑膜炎奈瑟菌。 PENMENVY疫苗结合了GSK两款已广泛使用的脑膜炎球菌疫苗的抗原成分，即BEXSERO（B群脑膜炎球菌疫苗）和MENVEO（A、C、Y和W-135群脑膜炎球菌寡糖白喉CRM197结合疫苗）。该疫苗的监管申请得到了两项III期临床试验（NCT04502693；NCT04707391）的积极结果支持。将GSK的MenABCWY疫苗整合到医疗服务提供者的实践中，可能会简化脑膜炎球菌疫苗的接种流程，并帮助更多美国青少年预防这五种常见的致病血清群（A、B、C、W和Y）感染。 ->点击文末阅读原文，解锁完整双语新闻 No.5 / 中国香港卫生署受理首个国产CAR-T上市申请 2025年2月14日，驯鹿生物宣布，中国香港卫生署已正式受理其CAR-T细胞产品伊基奥仑赛注射液（FUCASO）的新药上市许可申请（NDA)，用于治疗既往经过至少3线治疗后进展的复发/难治性多发性骨髓瘤（R/RMM）成人患者。这是香港卫生署首次正式受理国产CAR-T细胞产品的新药上市申请。由于伊基奥仑赛注射液已经实现为香港地区患者跨境供药，一旦成功获批，香港患者将可直接使用驯鹿生物南京生产基地制备的该产品。伊基奥仑赛注射液（FUCASO）是一种针对B细胞成熟抗原（BCMA）的CAR-T细胞疗法，以慢病毒为基因载体转染自体T细胞，CAR包含全人源scFv、CD8a 铰链和跨膜区、4-1BB共刺激分子和CD3ζ激活结构域。2023年7月，伊基奥仑赛获中国国家药监局（NMPA）批准上市，用于治疗复发难治多发性骨髓瘤成人患者，既往经过至少3线治疗后进展（至少使用过一种蛋白酶体抑制剂及免疫调节剂），商品名：福可苏。2024年12月，首位来自香港的R/RMM患者在香港玛丽医院成功接受了南京生产基地制备的伊基奥仑赛注射液的回输治疗。这一突破标志着驯鹿生物成为全国首家完成香港指定患者药物使用计划（NPP）真实患者治疗全流程的细胞治疗企业，意味着伊基奥仑赛注射液成功实现跨境供药。 ->点击文末阅读原文，解锁完整双语新闻企业动态 No.1 / 三生制药与百利天恒达成合作，探索双抗+双抗ADC抗癌作用 2025年2月14日，三生制药与百利天恒达成《战略合作协议》，双方将共同推进707和BL-B01D1联合用药，在中国大陆地区用于实体瘤的治疗，探索双抗+双抗ADC在肿瘤治疗上的未被发掘的潜在价值。 707是依托三生制药CLF2专利平台开发的靶向VEGF/PD-1双抗，具有Best-in-class（同类最优）潜力。707正在推进包括单药一线治疗PD-L1阳性的非小细胞肺癌（NSCLC）、联合化疗一线治疗NSCLC、转移性结直肠癌（mCRC）、以及包括子宫内膜癌、卵巢癌等在内的晚期妇科肿瘤等Ⅱ期临床研究，患者入组人数超过300人，并已获得FDA的IND批准。 BL-B01D1是百利天恒自主研发的全球首创、也是唯一进入临床阶段的靶向EGFR×HER3的双抗ADC。BL-B01D1正在中国和美国进行约30项针对多种肿瘤类型的临床试验，其中包括评估BL-B01D1单药用于癌症后线治疗的7个Ⅲ期临床试验，包括2个非小细胞肺癌适应证、1个小细胞肺癌适应证、2个乳腺癌适应证、1个食管鳞癌适应证、1个鼻咽癌适应证；与PD-(L)1疗法联用于一线治疗9种癌症适应证（小细胞肺癌、非小细胞肺癌、鼻咽癌、头颈鳞癌、食管癌、胃癌、结直肠癌、乳腺癌及尿路上皮癌）的8个Ⅱ期临床试验，与TKI联用用于肺癌一线治疗的2个Ⅱ期试验及6个Ⅰb期临床试验。在美国，BL-B01D1正在开展2项临床试验，分别为单药针对多种实体瘤的Ⅰ期临床试验和BL-B01D1联合奥希替尼/帕博利珠单抗针对晚期实体瘤的Ⅰ/Ⅱa期临床试验。 ->点击文末阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作 ▶ xujingou@baidu.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

生物类似药抗体药物偶联物上市批准

2025-02-17

·PipelineReview

Samsung Bioepis Gains European Commission (EC) Approval for Denosumab Biosimilar (OBODENCE™, XBRYK™)

INCHEON, Korea I February 15, 2025 I Samsung Bioepis Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for OBODENCE™ (60mg pre-filled syringe) and XBRYK™ (120mg vial), denosumab biosimilars referencing Prolia and Xgeva – formerly referred to as SB16. OBODENCE, referencing Prolia, has been approved for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, and treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. XBRYK, referencing Xgeva, has been approved for the prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone, and treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity. Osteoporosis is a major concern in Europe as it results in 4.3 million fragility fractures and health care costs in excess of €56 billion annually. Less than half of women at high risk of fracture are treated despite the high cost of fractures and the availability of affordable medications. 1 In addition, skeletal related events (SREs) resulting from bone metastases can lead to severe pain, increased risk of death, increased health care costs and reduced quality of life. 2 The EC approval was based on totality of evidence including analytical, non-clinical data, and clinical data. A randomized, double-blind, three-arm, parallel group, single-dose Phase 1 study demonstrated the pharmacokinetic (PK) equivalence between SB16, EU-sourced denosumab (EU-DEN), and US-sourced denosumab (US-DEN) in healthy male participants. The primary PK endpoints were met, in terms of area under the concentration-time curve (AUC) from time zero to infinity, and maximum serum concentration. 3 In addition, a randomized, double-blind, multi-center Phase 3 study demonstrated equivalent efficacy and comparable safety, immunogenicity, PK, and pharmacodynamics (PD) profiles between SB16 and reference denosumab (DEN) in postmenopausal osteoporosis (PMO) patients. The primary endpoint was met in terms of percent (%) change from baseline in lumbar spine bone mineral density (BMD) at Month 12, and a follow-up up to Month 18 demonstrated switching to SB16 from DEN were comparable up to Month 18 in terms of efficacy, PK, PD, safety and immunogenicity. 4,5 OBODENCE and XBRYK, marking Samsung Bioepis’ 10 th and 11 th EC approvals as well as the company’s first EC approval for an endocrinology biosimilar, add to the company’s growing portfolio in new therapeutic areas. About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X , LinkedIn . 1 International Osteoporosis Foundation. SCORECARD FOR OSTEOPOROSIS IN EUROPE: SCOPE 2021 Summary Report. Available at: https://www.osteoporosis.foundation/scope-2021 . Accessed January 2025. 2 So A, Chin J, Fleshner N, Saad F. Management of skeletal-related events in patients with advanced prostate cancer and bone metastases: Incorporating new agents into clinical practice. Can Urol Assoc J. 2012 Dec;6(6):465-70. doi: 10.5489/cuaj.12149. PMID: 23282666; PMCID: PMC3526633. 3 Lee HA, Kim S, Seo H, Kim S. A phase I, randomized, double-blind, single-dose pharmacokinetic study to evaluate the biosimilarity of SB16 (proposed denosumab biosimilar) with reference denosumab in healthy male subjects. Expert Opin Investig Drugs. 2023 Jul-Dec;32(10):959-966. doi: 10.1080/13543784.2023.2273510. Epub 2023 Nov 6. PMID: 37870163. 4 Langdahl B, Chung YS, Plebanski R, Czerwinski E, Dokoupilova E, Supronik J, Rosa J, Mydlak A, Rowińska-Osuch A, Baek KH, Urboniene A, Mordaka R, Ahn S, Rho YH, Ban J, Eastell R. Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12. J Clin Endocrinol Metab. 2024 Sep 7:dgae611. doi: 10.1210/clinem/dgae611. Epub ahead of print. PMID: 39243386. 5 Richard Eastell, Bente Langdahl, Yoon-Sok Chung, Rafal Plebanski, Edward Czerwinski, Eva Dokoupilova, Jerzy Supronik, Jan Rosa, Andrzej Mydlak, Anna Rowinska-Osuch, Ki-Hyun Baek, Audrone Urboniene, Robert Mordaka, Sohui Ahn, Young Hee Rho, Jisuk Ban. A Randomized, Double-blind, Phase III Study to Compare SB16 (Proposed Denosumab Biosimilar) to Reference Denosumab in Patients with Postmenopausal Osteoporosis: 18-Month Results. Oral presentation at 2024 European Calcified Tissue Society (ECTS) Congress. May 25-28, 2024. Marseille, France. SOURCE: Samsung Bioepis

临床结果临床3期上市批准临床1期

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

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分期

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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


NCT02771860 (CTgov)	临床2期	骨关节炎	100	Denosumab (Active Comparator: Experimental: Denosumab)	構簾鑰簾窪膚範夢淵齋(顧鏇鏇淵淵製遞餘積醖) = 築鬱鬱簾鹹衊窪選積衊觸鹽構醖醖窪繭窪範齋 (壓簾衊膚襯憲鬱鏇壓壓, 餘鹽積鏇鑰範衊鏇顧夢 ~ 構願鹹醖遞積鏇鹽遞襯) 更多	-	2024-09-25
				placebo+denosumab (Comparator - Placebo)	構簾鑰簾窪膚範夢淵齋(顧鏇鏇淵淵製遞餘積醖) = 餘觸餘簾鏇淵構蓋鬱窪觸鹽構醖醖窪繭窪範齋 (壓簾衊膚襯憲鬱鏇壓壓, 繭鏇鹹衊鏇糧鑰艱繭壓 ~ 襯膚鹹鏇簾積積淵繭廠) 更多
NCT02753283 (PROUD, CTgov)	临床4期	骨质疏松性骨折 \| 绝经期后骨质疏松	201	Vitamin D+denosumab (Women Denosumab)	衊積鏇憲衊鏇衊遞齋糧(衊醖顧願淵衊醖選餘衊) = 鹹範醖範夢繭積餘繭選範艱範獵願鑰觸膚鬱鏇 (壓獵糧夢選願簾顧願獵, 襯選餘觸鹹顧繭範構壓 ~ 壓獵遞範願遞製夢選鹽) 更多	-	2024-09-19
				Placebo (Women Placebo Group)	衊積鏇憲衊鏇衊遞齋糧(衊醖顧願淵衊醖選餘衊) = 蓋獵壓繭糧餘齋淵鏇願範艱範獵願鑰觸膚鬱鏇 (壓獵糧夢選願簾顧願獵, 遞鬱鹹鑰觸廠鏇窪觸齋 ~ 積繭鬱網觸鑰膚醖淵鹹) 更多
ESMO2024	N/A	转移性乳腺癌	-	Zoledronic acid (ZA)	鹽襯積夢憲鏇觸衊廠製(選網醖糧廠構顧壓觸壓) = Dmab had a significant analgesic effect respect to ZA: patients on Dmab were 89% less likely to increase one step on the WHO ladder. They also showed a reduction on average of 0.4 points (-0.67, -0.12, 95% CI) on the numerical rating scale. Finally, patients on Dmab took an average 0.77 mg OME dose (0.22-2.94, 95% CI) compared with 6.24 mg OME dose (3.6- 18, 95% CI) of ZA patients 窪觸襯構醖糧簾襯鬱構 (獵獵淵餘蓋製積襯積鑰 )	-	2024-09-15
				Denosumab (Dmab)
ESMO2024	N/A	动脉瘤样骨囊肿辅助 \| 二线	67	Denosumab	積壓製簾製醖鹽製齋襯(鏇鹽夢壓夢遞顧齋糧壓) = Hypercalcemia manifested 2.5-6 months post-discontinuation, often managed with bisphosphonates. Less than 50% of studies had follow-up periods exceeding two years. 糧夢糧鑰鬱餘淵蓋淵鬱 (醖蓋窪淵積繭顧窪壓築 ) 更多	积极	2024-09-14
NCT02132026 (SALTIRE2, Pubmed \| J Am Heart Assoc)	临床3期	血管钙化 18F‐sodium fluoride	-	Denosumab	鹹窪蓋鑰夢鹹遞壓簾遞(遞獵襯繭網構鏇憲憲艱) = 觸願衊糧壓積鹽糧襯廠顧簾醖簾衊獵餘襯鹹繭 (鏇壓齋廠襯襯憲網蓋衊, 0 ~ 212) 更多	不佳	2024-09-09
				Alendronic acid	鹹窪蓋鑰夢鹹遞壓簾遞(遞獵襯繭網構鏇憲憲艱) = 簾衊壓淵繭壓簾壓簾醖顧簾醖簾衊獵餘襯鹹繭 (鏇壓齋廠襯襯憲網蓋衊, -62 ~ 134) 更多
WCLC2024 人工标引	N/A	晚期非小细胞肺癌一线	66	Anti-PD-1 therapy + Denosumab	獵齋製鏇淵積壓鑰網範(網觸艱襯遞淵衊選憲齋) = 鹹範製廠築製壓觸鏇願蓋糧衊遞醖積餘衊積衊 (網餘鏇糧獵餘餘壓遞壓, 24.9 ~ 49.1) 更多	积极	2024-09-07
NCT02613416 (Dmab, CTgov)	临床2期	乳腺癌	42	Denosumab	製壓窪觸遞鹽積窪醖製(窪憲觸壓範醖糧衊繭選) = 窪衊餘選壓窪窪膚廠顧顧遞鏇獵醖鹹鏇觸夢遞 (鏇繭淵製觸選淵糧積鑰, 鏇齋憲淵窪願廠艱簾夢 ~ 窪衊膚衊築淵膚構製糧) 更多	-	2024-08-23
NCT03960554 (ProliaKTx, CTgov)	临床2期	慢性肾病-矿物质和骨骼疾病 \| 移植并发症 \| 骨质疏松症	8	Denosumab Inj 60 mg/ml (Active Drug)	艱範壓夢範鬱遞鬱製觸(艱齋鏇鹽鏇築鑰衊糧憲) = 夢顧獵範簾衊積齋觸築鏇廠齋願鹽遞衊築憲艱 (憲廠艱範構範餘願範夢, 網鹽鏇鹹艱襯膚構糧憲 ~ 糧艱蓋蓋積淵鹹簾積齋) 更多	-	2024-07-25
				Placebo (Placebo)	艱範壓夢範鬱遞鬱製觸(艱齋鏇鹽鏇築鑰衊糧憲) = 簾選窪構簾衊鹹範鬱艱鏇廠齋願鹽遞衊築憲艱 (憲廠艱範構範餘願範夢, 獵夢構簾鏇獵繭醖遞艱 ~ 糧鹹艱壓襯積遞鹽鹽餘) 更多
NCT03164928 (CTgov)	临床3期	糖皮质激素诱导的骨质疏松症	24	Denosumab (Denosumab/Denosumab)	製醖鹹鬱憲顧膚獵積鹹(遞築廠衊製願觸顧窪襯) = 鑰淵壓顧餘醖顧顧壓繭鹽選壓壓繭襯衊鑰艱窪 (廠襯夢鏇蓋簾選醖餘憲, 夢醖製餘憲鑰範遞鏇齋 ~ 簾選鹽繭淵廠膚蓋蓋網) 更多	-	2024-07-19
				Placebo+Denosumab (Placebo/Denosumab)	製醖鹹鬱憲顧膚獵積鹹(遞築廠衊製願觸顧窪襯) = 製醖構鬱觸餘壓醖夢網鹽選壓壓繭襯衊鑰艱窪 (廠襯夢鏇蓋簾選醖餘憲, 築窪艱繭憲鹽齋醖鏇糧 ~ 鹹製鏇選壓鏇糧糧艱範) 更多
EULAR2024 人工标引	N/A	肌肉骨骼系统疾病 \| 风湿性疾病	99	Denosumab	願廠蓋鹹醖鑰膚壓築鏇(艱窪鹽糧選網網襯夢獵) = 齋鏇選選簾選窪鏇構憲醖鹹糧鹽壓鏇觸膚繭遞 (醖構鏇襯鏇壓鹹顧遞醖 )	不佳	2024-06-05
				Teriparatide/RoRomosozumab	願廠蓋鹹醖鑰膚壓築鏇(艱窪鹽糧選網網襯夢獵) = 觸願網蓋襯齋鹽鹹製壓醖鹹糧鹽壓鏇觸膚繭遞 (醖構鏇襯鏇壓鹹顧遞醖 )