A Phase III, Randomised, Double-blind, Multicentre Clinical Study to Compare the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Between SB16 (Proposed Denosumab Biosimilar) and Prolia® in Postmenopausal Women With Osteoporosis

This is a randomised, double-blind, multicentre study to evaluate the efficacy, safety, PK, PD, and immunogenicity of SB16 compared to Prolia® in postmenopausal women with osteoporosis.

开始日期2020-11-26

申办/合作机构

Samsung Bioepis Co., Ltd.

NCT04621318

/ Completed临床1期

A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Denosumab (SB16, EU Sourced Prolia®, and US Sourced Prolia®) in Healthy Male Subjects

This study is to compare PK, PD, safety, tolerability, and immunogenicity profiles of SB16, EU sourced Prolia, and US sourced Prolia in healthy male subjects.

开始日期2020-10-19

申办/合作机构

Samsung Bioepis Co., Ltd.

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项与地舒单抗生物类似药 (Samsung Bioepis) 相关的文献（医药）

2025-12-01·ANTONIE VAN LEEUWENHOEK INTERNATIONAL JOURNAL OF GENERAL AND MOLECULAR MICROBIOLOGY

Multifunctional lactic acid bacteria isolated from traditional Makdous

Article

作者: Koçan, Deniz ; Aydın, Furkan ; Kahve, Halil İbrahim

This study aimed to isolate and identify lactic acid bacteria from traditionally fermented Makdous, with a focus on selecting strains suitable for safe and functional fermentation. A total of 33 isolates were identified by 16S rRNA gene sequencing as Levilactobacillus brevis (n = 29) and Lactiplantibacillus plantarum (n = 4). Technological characterisation, comprising acidification, exopolysaccharide production, and tolerance to salt, acid, and acetic acid, was followed by multivariate analysis, which identified five promising strains: Lev. brevis SB4 and Lp. plantarum SB6, SB12, SB14, and SB16. These strains, alongside the reference Lacticaseibacillus rhamnosus GG, were further evaluated for in vitro probiotic properties. Among them, Lev. brevis SB4 and Lp. plantarum SB14 stood out due to high autoaggregation, surface hydrophobicity, antioxidant activity, and antimicrobial effects. Notably, Lp. plantarum SB14 showed the highest radical scavenging activity, while SB4 demonstrated potent inhibition against Listeria monocytogenes ATCC 13932 and Staphylococcus aureus ATCC 43300. These findings suggest that SB4 and SB14 are strong candidates as multifunctional starters to enhance the safety, quality, and health-promoting potential of fermented vegetable products and other functional food applications.

2025-05-19·JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM

Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12

Article

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

Abstract:

Context:

SB16 is a proposed biosimilar to reference denosumab (DEN; brand name: Prolia).

Objective:

This phase 3 randomized, double-blind, multicenter study evaluated the biosimilarity of SB16 to DEN in women with postmenopausal osteoporosis (NCT04664959).

Design:

The study included 457 postmenopausal osteoporosis patients who had a lumbar spine or total hip T-score between −2.5 and −4. Patients were randomized in a 1:1 ratio to receive either 60 mg of SB16 or DEN subcutaneously at month 0 and month 6. At month 12, patients were rerandomized to continue with the assigned treatment or switch from DEN to SB16 up to month 18. This report includes results up to month 12.

Methods:

The primary endpoint was the percent change from baseline in lumbar spine bone mineral density (BMD) at month 12. Secondary endpoints including the percent change from baseline in BMD of the lumbar spine (except for month 12), total hip, and femoral neck; pharmacokinetic, pharmacodynamic (serum C-telopeptide of type I collagen, and procollagen type I N-terminal propeptide), safety, and immunogenicity profiles were measured up to month 12.

Results:

The least-squares mean differences in percent change from baseline in lumbar spine BMD at month 12 were 0.33% (90% CI, −0.25 to 0.91) in the full analysis set and 0.39% (95% CI, −0.36 to 1.13) in the per-protocol set; both within the predefined equivalence margin. The secondary endpoints were comparable between the 2 treatment groups.

Conclusion:

The reported efficacy, pharmacokinetic, pharmacodynamic, safety, and immunogenicity data support the biosimilarity of SB16 to DEN.

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.

项与地舒单抗生物类似药 (Samsung Bioepis) 相关的新闻（医药）

2026-04-27

·商业评论

Samsung Epis Holdings公布2026年第一季度财务业绩

• Samsung Bioepis 2026年第一季度营收达4549亿韩元，营业利润为1440亿韩元专注于生物制药和生物技术创新的投资公司Samsung Epis Holdings (KRX: 0126Z0)今日公布了其2026财年第一季度的财务业绩。 Samsung Epis Holdings总裁兼首席执行官Kyung-Ah Kim表示：“依托生物类似药产品组合的持续增长动力，Samsung Bioepis本季度实现稳健增长。我们正通过新的全球合作和持续的产品组合扩张，进一步巩固市场地位。值此公司首款生物类似药在欧洲上市十周年之际，我们将在既有基础上再接再厉，同时开展战略性投资以支持长期发展。我们将持续致力于为股东创造可持续价值。” 2026年第一季度业绩按单独基准计算，2026年第一季度，Samsung Bioepis实现营收4549亿韩元，营业利润1440亿韩元。第一季度营收和营业利润分别同比增长14%（543亿韩元）和13%（161亿韩元）。第一季度整体增速较2025年1月发布的业绩指引高出10%以上，反映出各项业务表现优于预期。 Samsung Epis Holdings实现合并营收4539亿韩元，营业利润905亿韩元。合并营收和营业利润包含收购价格分摊(PPA)相关研发成本的摊销等非现金会计调整项目；2025年11月至12月，公司合并营收为2517亿韩元，营业亏损为636亿韩元。 [Samsung Bioepis收益数据，单位：十亿韩元] 2024年第一季度 2025年第一季度 2026年第一季度同比变化营收 280.1 400.6 454.9 +54.3 (+14%) 营业利润 38.1 127.9 144.0 +16.1 (+13%) 业务近况 2025年10月，Samsung Bioepis与CVS Health旗下药房福利管理(PBM)部门CVS Caremark就Prolia1生物类似药OSPOMYV™ (denosumab-dssb)达成自有品牌合作。 BENEPALI™ (etanercept)是Samsung Bioepis的首款登陆欧洲的生物类似药，今年迎来欧洲上市十周年，持续稳固市场领先地位。今年3月，Samsung Bioepis扩大与Sandoz的研发和商业化合作关系，双方将在多个市场合作开发和推广至多五款生物类似药候选产品，包括参考Entyvio (vedolizumab)的生物类似药候选药物SB36。同样在3月，Samsung Bioepis首款新型抗体药物偶联物(ADC)候选药物SBE303正式启动一期首次人体临床试验。在此次宣布之后，公司于4月20日在2026年美国癌症研究协会(AACR)年会上以海报形式展示了该药物的临床前数据，这些数据显示其疗效、安全性和耐受性表现良好，具备与现有肿瘤免疫疗法联合用药的良好前景。 Samsung Bioepis的第二款新型ADC候选药物SBE313目前正与Phrontline Biopharma合作开展临床前研发工作。免责声明本文包含关于未来预期、预测、计划和展望的“前瞻性陈述”。“前瞻性陈述”涉及与公司未来业务和财务表现相关的事项，会受到诸如国内外金融市场趋势等各类不确定因素影响，包括但不限于汇率和/或利率波动。 “前瞻性陈述”本质上涉及可能存在不确定性的事项；实际业绩可能与本文所述存在重大差异。关于Samsung Epis Holdings Co., Ltd. Samsung Epis Holdings是一家专注于生物制药及生物技术领域的投资控股公司，致力于通过积极的研发投入与投资活动，实现公司与股东价值最大化，并为旗下子公司Samsung Bioepis和Epis NexLab优化业务战略。Samsung Epis Holdings始终积极应对未来挑战，通过发掘新的增长动力、强化全球合作平台来驱动创新发展，从而为子公司的持续成长奠定坚实基础。关于Samsung Bioepis Co., Ltd. Samsung Bioepis成立于2012年，是一家致力于实现普惠医疗保健的生物制药公司。通过产品开发领域的创新和对质量的坚定承诺，Samsung Bioepis旨在成为全球领先的生物制药企业。Samsung Bioepis持续推进涵盖广泛治疗领域的生物类似药候选药物管线，包括免疫学、肿瘤学、眼科学、血液学、肾病学、神经病学和内分泌学。关于Epis NexLab Co., Ltd. Epis NexLab成立于2025年，是Samsung Epis Holdings的全资子公司，致力于通过新一代生物技术平台的研发驱动创新发展。Epis NexLab将具备高度可扩展性的肽类相关技术转化为药物研发平台，专注于探索创新治疗模式，针对多种疾病开发多款候选治疗药物。

2026-04-27

·华夏头条网

Samsung Epis Holdings公布2026年第

• Samsung Bioepis 2026年第一季度营收达4549亿韩元，营业利润为1440亿韩元专注于生物制药和生物技术创新的投资公司Samsung Epis Holdings (KRX: 0126Z0)今日公布了其2026财年第一季度的财务业绩。Samsung Epis Holdings总裁兼首席执行官Kyung-Ah Kim表示：“依托生物类似药产品组合的持续增长动力，Samsung Bioepis本季度实现稳健增长。我们正通过新的全球合作和持续的产品组合扩张，进一步巩固市场地位。值此公司首款生物类似药在欧洲上市十周年之际，我们将在既有基础上再接再厉，同时开展战略性投资以支持长期发展。我们将持续致力于为股东创造可持续价值。”2026年第一季度业绩按单独基准计算，2026年第一季度，Samsung Bioepis实现营收4549亿韩元，营业利润1440亿韩元。第一季度营收和营业利润分别同比增长14%（543亿韩元）和13%（161亿韩元）。第一季度整体增速较2025年1月发布的业绩指引高出10%以上，反映出各项业务表现优于预期。Samsung Epis Holdings实现合并营收4539亿韩元，营业利润905亿韩元。合并营收和营业利润包含收购价格分摊(PPA)相关研发成本的摊销等非现金会计调整项目；2025年11月至12月，公司合并营收为2517亿韩元，营业亏损为636亿韩元。[Samsung Bioepis收益数据，单位：十亿韩元]2024年第一季度2025年第一季度2026年第一季度同比变化营收280.1400.6454.9+54.3 (+14%)营业利润38.1127.9144.0+16.1 (+13%)业务近况2025年10月，Samsung Bioepis与CVS Health旗下药房福利管理(PBM)部门CVS Caremark就Prolia1生物类似药OSPOMYV™ (denosumab-dssb)达成自有品牌合作。BENEPALI™ (etanercept)是Samsung Bioepis的首款登陆欧洲的生物类似药，今年迎来欧洲上市十周年，持续稳固市场领先地位。今年3月，Samsung Bioepis扩大与Sandoz的研发和商业化合作关系，双方将在多个市场合作开发和推广至多五款生物类似药候选产品，包括参考Entyvio (vedolizumab)的生物类似药候选药物SB36。同样在3月，Samsung Bioepis首款新型抗体药物偶联物(ADC)候选药物SBE303正式启动一期首次人体临床试验。在此次宣布之后，公司于4月20日在2026年美国癌症研究协会(AACR)年会上以海报形式展示了该药物的临床前数据，这些数据显示其疗效、安全性和耐受性表现良好，具备与现有肿瘤免疫疗法联合用药的良好前景。Samsung Bioepis的第二款新型ADC候选药物SBE313目前正与Phrontline Biopharma合作开展临床前研发工作。免责声明本文包含关于未来预期、预测、计划和展望的“前瞻性陈述”。“前瞻性陈述”涉及与公司未来业务和财务表现相关的事项，会受到诸如国内外金融市场趋势等各类不确定因素影响，包括但不限于汇率和/或利率波动。“前瞻性陈述”本质上涉及可能存在不确定性的事项；实际业绩可能与本文所述存在重大差异。关于Samsung Epis Holdings Co., Ltd.Samsung Epis Holdings是一家专注于生物制药及生物技术领域的投资控股公司，致力于通过积极的研发投入与投资活动，实现公司与股东价值最大化，并为旗下子公司Samsung Bioepis和Epis NexLab优化业务战略。Samsung Epis Holdings始终积极应对未来挑战，通过发掘新的增长动力、强化全球合作平台来驱动创新发展，从而为子公司的持续成长奠定坚实基础。关于Samsung Bioepis Co., Ltd.Samsung Bioepis成立于2012年，是一家致力于实现普惠医疗保健的生物制药公司。通过产品开发领域的创新和对质量的坚定承诺，Samsung Bioepis旨在成为全球领先的生物制药企业。Samsung Bioepis持续推进涵盖广泛治疗领域的生物类似药候选药物管线，包括免疫学、肿瘤学、眼科学、血液学、肾病学、神经病学和内分泌学。关于Epis NexLab Co., Ltd.Epis NexLab成立于2025年，是Samsung Epis Holdings的全资子公司，致力于通过新一代生物技术平台的研发驱动创新发展。Epis NexLab将具备高度可扩展性的肽类相关技术转化为药物研发平台，专注于探索创新治疗模式，针对多种疾病开发多款候选治疗药物。

2026-04-24

·BioSpace

CORRECTING and REPLACING Samsung Epis Holdings Reports First Quarter 2026 Financial Results

Samsung Bioepis recorded Q1’26 revenue of KRW 454.9 billion and operating profit of KRW 144.0 billion INCHEON, Korea--(BUSINESS WIRE)-- #ADC --Third paragraph, second sentence of release should read: Revenue and operating profit in the first quarter increased by 14% (KRW 54.3 billion) and 13% (KRW 16.1 billion) in year-over-year (YoY), respectively. (instead of Revenue and operating profit in the fourth quarter increased by 14% (KRW 54.3 billion) and 13% (KRW 16.1 billion) in year-over-year (YoY), respectively.). The updated release reads: SAMSUNG EPIS HOLDINGS REPORTS FIRST QUARTER 2026 FINANCIAL RESULTS Samsung Epis Holdings (KRX: 0126Z0), an investment company dedicated to innovations in biopharmaceuticals and biotechnology, today announced its financial results for the first quarter of fiscal year 2026. “Samsung Bioepis delivered solid growth this quarter driven by continued momentum across our biosimilar portfolio," said Kyung-Ah Kim, President and Chief Executive Officer (CEO) of Samsung Epis Holdings. “We are further strengthening our position through new global partnerships and continued portfolio expansion. As we mark the 10 th anniversary of the launch of our first biosimilar in Europe, we remain focused on building on our legacy while investing strategically to support long-term growth. We remain committed to delivering sustainable value for our shareholders.” First Quarter 2026 Results On a standalone basis, in the first quarter of 2026, Samsung Bioepis posted a revenue of KRW 454.9 billion with an operating profit of KRW 144.0 billion. Revenue and operating profit in the first quarter increased by 14% (KRW 54.3 billion) and 13% (KRW 16.1 billion) in year-over-year (YoY), respectively. First quarter growth surpassed the January 2025 guidance by more than 10%, reflecting stronger-than-expected performance across the business. Samsung Epis Holdings posted a consolidated revenue of KRW 453.9 billion and operating profit of KRW 90.5 billion. Non-cash accounting adjustments, including amortization of purchase price allocation (PPA)-related development costs, are reflected in consolidated revenue and operating profit, following a consolidated revenue of KRW 251.7 billion and operating loss of KRW 63.6 billion in November and December 2025. [Samsung Bioepis Earnings, KRW billion] Q1’24 Q1’25 Q1’26 YoY Change Revenue 280.1 400.6 454.9 +54.3 (+14%) Operating Profit 38.1 127.9 144.0 +16.1 (+13%) Business Updates In October 2025, Samsung Bioepis entered into a private label partnership with CVS Caremark, the Pharmacy Benefit Manager (PBM) division of CVS Health, for OSPOMYV™ (denosumab-dssb), a biosimilar to Prolia 1 . BENEPALI™ (etanercept), Samsung Bioepis’ first biosimilar in Europe, continues to maintain its leadership position in the market as it celebrates its 10 th anniversary in Europe. In March, Samsung Bioepis expanded its development and commercialization partnership with Sandoz, on up to five biosimilar candidates including SB36, a biosimilar candidate referencing Entyvio (vedolizumab), in multiple markets. Also in March, a Phase 1 first-in-human clinical trial for Samsung Bioepis’s first novel antibody-drug conjugate (ADC) candidate, SBE303, has begun. Following the announcement, the company also presented a poster presentation of its nonclinical data at the American Association for Cancer Research (AACR) 2026 on April 20 th which demonstrates its encouraging efficacy, safety, tolerability and a promising ability to work in combination with existing immuno-oncology therapies. Samsung Bioepis’s second novel ADC candidate, SBE313, is currently in nonclinical development in collaboration with Phrontline Biopharma. Disclaimer This document contains ‘forward-looking statements’ regarding future expectations, projections, plans, and anticipation. ‘Forward-looking statements’ are matters that pertain to the Company’s future business and financial performance, and are subject to uncertainties such as trends in domestic and international financial markets, including but not limited to fluctuations in exchange rates and/or interest rates. ‘Forward-looking statements,’ by their nature, addresses matters that may be uncertain; actual results may be materially different from those expressed in this document. About Samsung Epis Holdings Co., Ltd. As an investment holdings company dedicated to biopharmaceuticals and biotechnology, Samsung Epis Holdings aims to maximize corporate and shareholder value through proactive R&D and investment and optimize business strategies for its subsidiaries, Samsung Bioepis and Epis NexLab. Samsung Epis Holdings continues to embrace future challenges and drive innovation by identifying new growth drivers and strengthening global collaboration platforms, thereby laying a solid foundation for the continued growth of its subsidiaries. For more information about Samsung Epis Holdings, please visit: . 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 biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit and follow us on LinkedIn and X . About Epis NexLab Co., Ltd. Established in 2025 as a 100% owned subsidiary of Samsung Epis Holdings, Epis NexLab is committed to driving innovation through the development of next-generation biotechnology platforms. By transforming highly scalable peptide-related technologies into development platforms, Epis NexLab is focused on the discovery of innovative treatment modalities for the development of multiple therapeutic candidates targeting a wide range of diseases. For more information about Epis NexLab, please visit: . Reference 1 Prolia is a registered trademark of Amgen Inc. Contacts Media Contact Yoon Kim, yoon1.kim@samsung.com Anna Nayun Kim, nayun86.kim@samsung.com

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研发状态

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适应症	国家/地区	公司	日期
代谢性骨病	澳大利亚	Samsung Bioepis AU Pty Ltd	2025-07-09
骨转移癌	韩国	Samsung Bioepis NL B.V.	2025-05-30
恶性肿瘤体液性高钙血症	美国	Samsung Bioepis Co., Ltd.	2025-02-13
骨骼病变	美国	Samsung Bioepis Co., Ltd.	2025-02-13
骨癌	欧盟	Samsung Bioepis NL B.V.	2025-02-12
骨癌	冰岛	Samsung Bioepis NL B.V.	2025-02-12
骨癌	列支敦士登	Samsung Bioepis NL B.V.	2025-02-12
骨癌	挪威	Samsung Bioepis NL B.V.	2025-02-12
骨巨细胞瘤	欧盟	Samsung Bioepis NL B.V.	2025-02-12
骨巨细胞瘤	冰岛	Samsung Bioepis NL B.V.	2025-02-12
骨巨细胞瘤	列支敦士登	Samsung Bioepis NL B.V.	2025-02-12
骨巨细胞瘤	挪威	Samsung Bioepis NL B.V.	2025-02-12
糖皮质激素诱导的骨质疏松症	欧盟	Samsung Bioepis NL B.V.	2025-02-12
糖皮质激素诱导的骨质疏松症	冰岛	Samsung Bioepis NL B.V.	2025-02-12
糖皮质激素诱导的骨质疏松症	列支敦士登	Samsung Bioepis NL B.V.	2025-02-12
糖皮质激素诱导的骨质疏松症	挪威	Samsung Bioepis NL B.V.	2025-02-12
骨质疏松症	欧盟	Samsung Bioepis NL B.V.	2025-02-12
骨质疏松症	冰岛	Samsung Bioepis NL B.V.	2025-02-12
骨质疏松症	列支敦士登	Samsung Bioepis NL B.V.	2025-02-12
骨质疏松症	挪威	Samsung Bioepis NL B.V.	2025-02-12

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临床结果

适应症

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


NCT04664959 (Phase 3, CTgov)	临床3期	骨质疏松症 \| 绝经期后骨质疏松	457	SB16 (SB16)	築鹽鏇鬱鹽鬱鬱願鑰夢(鑰醖鹽鏇蓋壓範醖蓋獵) = 選蓋窪鏇觸淵糧餘窪簾選範鬱夢鹹願淵醖襯構 (廠鑰遞築壓餘衊觸艱鏇, 0.250) 更多	-	2025-01-09
				Prolia (Prolia)	築鹽鏇鬱鹽鬱鬱願鑰夢(鑰醖鹽鏇蓋壓範醖蓋獵) = 衊範觸糧艱遞築淵窪顧選範鬱夢鹹願淵醖襯構 (廠鑰遞築壓餘衊觸艱鏇, 0.254)
NCT04664959 (Pubmed \| J Clin Endocrinol Metab) 人工标引	临床3期	绝经期后骨质疏松	457	SB16	鹽壓鹽廠淵艱糧廠鏇衊(網壓壓夢鹽積網積衊選) = 網鹽簾鹽齋艱廠願壓夢醖鬱願願糧憲壓鏇壓選 (蓋夢獵壓製憲積襯窪鹹 )	相似	2024-09-07
				Prolia	鹽壓鹽廠淵艱糧廠鏇衊(網壓壓夢鹽積網積衊選) = 鹽鹹鏇鏇餘夢網衊鹽選醖鬱願願糧憲壓鏇壓選 (蓋夢獵壓製憲積襯窪鹹 )
NCT04664959 (EULAR 12024 \| EULAR 22024) 人工标引	临床3期	绝经期后骨质疏松	457	SB16+SB16	網蓋淵積鏇餘鬱觸衊範(鑰襯繭顧襯襯膚簾鹹簾) = 壓壓範願蓋願範廠觸襯餘網範憲鹹壓淵衊簾構 (艱鑰蓋顧淵繭窪衊遞築 )	相似	2024-06-14
				DEN+DEN	-
NCT04664959 (ACR2023) 人工标引	临床3期	绝经期后骨质疏松	457	SB16	壓築壓窪餘鏇鑰淵積鏇(觸獵選醖簾淵窪廠鏇鏇) = 獵積糧構網鏇壓壓夢構鹹簾壓廠蓋選鹽繭糧襯 (網鑰繭淵鹹襯膚窪繭襯 ) 更多	积极	2023-11-04
				Denosumab	壓築壓窪餘鏇鑰淵積鏇(觸獵選醖簾淵窪廠鏇鏇) = 蓋艱餘觸鏇構艱鹽範繭鹹簾壓廠蓋選鹽繭糧襯 (網鑰繭淵鹹襯膚窪繭襯 ) 更多