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 ; Baek, Ki-Hyun ; Mordaka, Robert ; 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）

2026-07-24

·BioSpace

Samsung Epis Holdings Reports Second Quarter and Half-Year 2026 Financial Results

Samsung Bioepis reports revenue of 847.1 billion KRW and an operating profit of 230.6 billion KRW in the first half of 2026, recording 6% year-over-year growth Expanding direct commercialization in Europe to five products with the launch of OPUVIZ™ 40 mg/mL vial, a biosimilar to Eylea 1 (aflibercept) First to announce preliminary results from Phase 1, 3 clinical studies for SB27, a biosimilar candidate referencing Keytruda 2 (pembrolizumab) Samsung Epis Holdings continuing to secure next-generation growth engines through establishment of a global R&D hub in China INCHEON, Korea--(BUSINESS WIRE)-- #biosimilars --Samsung Epis Holdings (KRX: 0126Z0), an investment company dedicated to innovations in biopharmaceuticals and biotechnology, today announced its financial results for the second quarter and first half of fiscal year 2026. “We delivered solid first-half 2026 results, achieving 6% growth year-over-year. This performance demonstrates the resilience of our biosimilar portfolio in the global market," said Kyung-Ah Kim, President and Chief Executive Officer (CEO) of Samsung Epis Holdings. “We remain confident in our growth trajectory; increasing product demand in Europe and the US is expected to be reflected sequentially in the second-half results, which would result in steady business performance for the fiscal year.” Second Quarter and First Half 2026 Results – Samsung Bioepis Samsung Bioepis, a 100% owned subsidiary of Samsung Epis Holdings, recorded revenue of 847.1 billion KRW and an operating profit of 230.6 billion KRW in the first half of 2026. This represents an increase of 45.5 billion KRW (+6%) in revenue and 12.8 billion KRW (+6%) in operating profit compared to the same period last year. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); For the second quarter, the company recorded revenue of 392.2 billion KRW and an operating profit of 86.6 billion KRW; revenue and operating profit decreased by 8.8 billion KRW (-2%) and by 3.2 billion KRW (-4%) respectively compared to the same period last year. [Samsung Bioepis Earnings, KRW billion] H1’25 H1’26 YoY Change Q2’25 Q2’26 YoY Change Revenue 801.6 847.1 45.5 (+6%) 401.0 392.2 -8.8 (-2%) Operating Profit 217.8 230.6 12.8 (+6%) 89.8 86.6 -3.2 (-4%) Business Updates Samsung Bioepis has expanded direct commercialization in Europe to five products with the launch of OPUVIZ (aflibercept) 40 mg/mL vial in May 2026. In the US, the company has expanded its market presence with the introduction of OSPOMYV ® (denosumab-dssb). Furthermore, the company is expanding its commercial footprint in international markets, including Japan where it launched its first biosimilar product in May 2026 through partnership with NIPRO Corporation. The company also announced the expansion of its global development and commercialization agreement with Organon to commercialize PYZCHIVA ® (ustekinumab), a biosimilar referencing Stelara 3 (ustekinumab), in Canada. In June 2026, the company announced preliminary results from Phase 1 and Phase 3 clinical studies for SB27, a biosimilar candidate referencing Keytruda (pembrolizumab). Phase 1 study demonstrated pharmacokinetic (PK) equivalence between SB27 and Keytruda while Phase 3 study demonstrated equivalent objective response rate (ORR) at Week 24. Both studies are expected to be completed within 2026. SBE303, the company's first novel antibody-drug conjugate (ADC) candidate, entered the global Phase 1 clinical study in March. SBE303 is engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumor cells, including urothelial cancer, lung cancer, and breast cancer. Nonclinical characterization of SBE303 was presented at the 2026 American Association for Cancer Research (AACR) Annual Meeting in April, highlighting its anti-tumor efficacy, safety, tolerability pro a promising ability to work in combination with existing immuno-oncology therapies. Second Quarter and First Half 2026 Results – Samsung Epis Holdings Samsung Epis Holdings recorded consolidated revenue of 845.8 billion KRW and an operating profit of 149.3 billion KRW in the first half of 2026, reflecting non-cash accounting adjustments. For the second quarter, the company achieved revenue of 391.9 billion KRW and an operating profit of 58.8 billion KRW. Samsung Epis Holdings is stabilizing its business under the holding company structure based on the solid performance of its core subsidiary, Samsung Bioepis, and established its first overseas R&D base in China to strengthen its novel therapeutic development capabilities. 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. As a wholly owned subsidiary of Samsung Epis Holdings, 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 . 1 Eylea is a trademark of Bayer AG 2 Keytruda is a trademark of Merck Sharp & Dohme. 3 Stelara is a trademark of Johnson & Johnson Corporation. Contacts Media Contact Anna Nayun Kim, nayun86.kim@samsung.com Yoon Kim, yoon1.kim@samsung.com

2026-05-29

·BioSpace

Samsung Bioepis Launches OPUVIZ™ (Aflibercept) 40 mg/mL Vial Across Europe, to Treat Ophthalmic Conditions

OPUVIZ™ 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea (aflibercept), will be rolled out across Europe, starting today Launch strengthens Samsung Bioepis ophthalmology portfolio in Europe, after the company began direct commercialization of BYOOVIZ ™ (ranibizumab) 10 mg/mL solution for injection in a vial in January 2026 Marks fifth biosimilar product to be directly commercialized by Samsung Bioepis in Europe OPUVIZ 40 mg/mL solution for injection in pre-filled syringe has obtained positive opinion from the Committee for Medicinal Products for Human use (CHMP) in November 2025, and is expected to be available in the market in the third quarter of this year INCHEON, Korea--(BUSINESS WIRE)-- #Europe --Samsung Bioepis Co., Ltd. today announced the launch of OPUVIZ ™ 40 mg/mL solution for injection in a vial , a biosimilar referencing Eylea 1 (aflibercept), across Europe, starting today. OPUVIZ marks the fifth biosimilar product to be directly commercialized by Samsung Bioepis. It builds on other key biosimilar milestones in Europe this year, including the initiation of direct commercialization of BYOOVIZ™ (ranibizumab) 10 mg/mL solution for injection in a vial, as well as the launch of XBRYK™ (denosumab) 120 mg solution for injection in a vial in January. “We are pleased to launch OPUVIZ in Europe, marking a significant milestone in expanding patient access to ophthalmology treatments,” said Antonio Rito, Vice President and Head of Europe, at Samsung Bioepis. “Leveraging our direct commercialization capabilities, we will work closely with healthcare professionals and payers to facilitate access to this important medicine, so that patients can benefit from quality-assured, safe and effective biosimilar alternatives.” In January 2026, Samsung Bioepis announced that the company signed a settlement and license agreement with Regeneron and Bayer concerning the commercialization of its biosimilar to Eylea 2 mg (aflibercept 40 mg/mL solution) in Europe and the Rest of the World (RoW). 2 Samsung Bioepis’s aflibercept biosimilar is also available in the Republic of Korea under the brand name AFILIVU™. About OPUVIZ OPUVIZ contains the active ingredient (aflibercept), a vascular endothelial growth factor (VEGF) inhibitor, acting as a recombinant fusion protein designed to block abnormal blood vessel growth and leakage in the eye. OPUVIZ was first approved as 40 mg/mL solution for injection in a vial by the European Commission (EC) in November 2024 and by the Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025 for adults for the treatment of neovascular (wet) age related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO), visual impairment due to diabetic macular oedema (DME), and visual impairment due to myopic choroidal neovascularisation (myopic CNV). 3,4 OPUVIZ 40 mg/mL solution for injection in pre-filled syringe has later obtained positive opinion from the CHMP in November 2025 for the same indications as the vial presentation. OPUVIZ SELECT IMPORTANT SAFETY INFORMATION The safety of OPUVIZ has been evaluated and, on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine, Eylea. For the complete list of side effects and restrictions of OPUVIZ, see the package leaflet. The most common side effects with OPUVIZ are conjunctival haemorrhage, retinal haemorrhage, reduced vision and eye pain. Other common side effects are vitreous detachment, cataract, vitreous floaters and increased intraocular pressure. Serious injection-related side effects are blindness, endophthalmitis, cataracts, increased intraocular pressure, vitreous haemorrhage and vitreous or retinal detachment. OPUVIZ must not be used in patients who have or are thought to have ocular or periocular infections, or in patients who have severe inflammation inside the eye. BYOOVIZ SELECT IMPORTANT SAFETY INFORMATION The safety of BYOOVIZ has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Lucentis. The most common side effects with ranibizumab are increased intraocular pressure, headache, vitritis, vitreous detachment, retinal haemorrhage, visual disturbance, eye pain, vitreous floaters, conjunctival haemorrhage, eye irritation, sensation of a foreign body in the eye, increased lacrimation, blepharitis, dry eye, ocular hyperaemia, eye pruritis, arthralgia and nasopharyngitis. Rarely, endophthalmitis, blindness, serious damage to the retina and cataract can occur. BYOOVIZ must not be used in patients who may have an infection of the eye or of the area around the eye, or who have severe inflammation within the eye. For the full list of side effects and restrictions of BYOOVIZ, see the package leaflet. XBRYK SELECT IMPORTANT SAFETY INFORMATION The safety of denosumab in XBRYK has been evaluated and on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine, Xgeva. For the complete list of side effects and restrictions with XBRYK, see the package leaflet. The most common side effects with XBRYK include hypocalcaemia, pain in the muscles and bones, dyspnoea and diarrhoea. Other common side effects are development of another form of cancer in patients with advanced cancer, hypophosphataemia, excessive sweating, tooth loss and osteonecrosis in the jaw. Hypocalcaemia mostly occurs within the first 2 weeks of starting treatment and can be severe; however, it can be managed with calcium and vitamin D supplementation. XBRYK must not be used in patients with wounds from dental or mouth surgery that have not yet healed, or in people with severe, untreated hypocalcaemia. DISCLAIMER This press release is intended solely for the purpose of sharing the availability of OPUVIZ in Europe. This document should not be construed as medical advice or as an endorsement of any product or treatment. Regulatory approval status and prescribing information may vary by country; please refer to local product information for any medicinal products mentioned herein. Information in this press release may include data on investigational compounds or unapproved indications. Such information is shared for scientific discussion purposes only and does not represent an assertion of safety or efficacy for any unapproved use. This press release may contain forward-looking statements, including statements regarding clinical development programs, regulatory submissions, potential approvals, and future therapeutic potential. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. Forward-looking statements are not guarantees of future performance. Samsung Bioepis undertakes no obligation to update any forward-looking statements contained in this press release. 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 . 1 Eylea is a trademark of Regeneron Pharmaceuticals. 2 Samsung Bioepis. “Samsung Bioepis Reaches Settlement Agreement for Eylea (Aflibercept) Biosimilar in Europe and the Rest of the World.” News Release, January 30, 2026. Available at: 3 OPUVIZ EMA Summary of Product Characteristics (SmPC). Available at: (Accessed May 2026) 4 OPUVIZ MHRA Summary of Product Characteristics (SmPC). Available at: (Accessed May 2026) Contacts MEDIA CONTACT Anna Nayun Kim, nayun86.kim@samsung.com Yoon Kim, yoon1.kim@samsung.com

引进/卖出上市批准

2026-05-13

·每日热点网

注意-更正并替换：Samsung

注意-更正并替换：Samsung Epis Holdings公布2026年第一季度财务业绩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Cordavis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。如需了解更多关于Samsung Epis Holdings的信息，请访问： www.samsungepisholdings.com 。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。如需了解更多信息，请访问 www.samsungbioepis.com ，并在 LinkedIn 和 X 上关注我们。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。

100 项与地舒单抗生物类似药 (Samsung Bioepis) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	M05BX04	-

研发状态

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适应症	国家/地区	公司	日期
骨病	加拿大	Samsung Bioepis Co., Ltd.	2026-04-13
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

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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 (WCO_IOF_ESCEO2026)	临床3期	绝经期后骨质疏松	456	SB16	築鹹艱襯憲網網鏇襯餘(淵鹽範簾憲廠獵構繭範): Difference = 0.07 (90.0% CI, -0.82 ~ 0.96) 更多	积极	2026-04-16
				DENOSUMAB
NCT04664959 (Phase 3, CTgov)	临床3期	骨质疏松症 \| 绝经期后骨质疏松	457	SB16 (SB16)	築製蓋廠築廠獵鑰壓鬱(製窪襯齋壓衊糧廠鏇選) = 鏇鏇夢壓憲顧鑰願構鏇壓糧製醖繭蓋糧艱壓衊 (醖衊築齋繭鹹餘壓選衊, 0.250) 更多	-	2025-01-09
				Prolia (Prolia)	築製蓋廠築廠獵鑰壓鬱(製窪襯齋壓衊糧廠鏇選) = 繭顧鏇餘顧衊鹹艱廠糧壓糧製醖繭蓋糧艱壓衊 (醖衊築齋繭鹹餘壓選衊, 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	顧膚範鑰壓積廠醖簾觸(簾簾鹽鹹鏇餘壓糧廠觸) = 窪遞簾鬱醖鬱餘糧觸積網廠廠網夢鹽顧鑰鹹製 (築築鬱窪鏇夢壓鑰蓋簾 )	相似	2024-09-07
				Prolia	顧膚範鑰壓積廠醖簾觸(簾簾鹽鹹鏇餘壓糧廠觸) = 鹹鏇襯積製衊遞遞製淵網廠廠網夢鹽顧鑰鹹製 (築築鬱窪鏇夢壓鑰蓋簾 )
NCT04664959 (EULAR 12024 \| EULAR 22024) 人工标引	临床3期	绝经期后骨质疏松	457	SB16+SB16	簾壓夢襯醖蓋簾鬱襯蓋(齋構齋齋艱願積襯夢蓋) = 範選膚願窪築鑰鹽淵膚齋鹹築鑰繭衊餘觸積糧 (鹹鹹蓋顧鏇獵範淵憲範 )	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	顧選鑰鬱醖範膚壓簾齋(齋範壓醖鹽範廠簾夢憲) = 範糧衊構網夢襯簾艱鏇願築窪醖遞淵糧憲襯鏇 (觸窪襯觸築鏇淵淵齋願 ) 更多	积极	2023-11-04
				Denosumab	顧選鑰鬱醖範膚壓簾齋(齋範壓醖鹽範廠簾夢憲) = 繭繭襯鹹憲鹹製糧簾鬱願築窪醖遞淵糧憲襯鏇 (觸窪襯觸築鏇淵淵齋願 ) 更多