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.

100 项与地舒单抗生物类似药 (Samsung Bioepis) 相关的临床结果

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100 项与地舒单抗生物类似药 (Samsung Bioepis) 相关的转化医学

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100 项与地舒单抗生物类似药 (Samsung Bioepis) 相关的专利（医药）

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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）

2026-02-05

·PRNewswire

CVS Health Helps Customers Accelerate Biosimilar Adoption Through Formulary Changes - Supporting Affordable Options for Osteoporosis Care

WOONSOCKET, R.I., Feb. 5, 2026 /PRNewswire/ -- CVS Health® (NYSE: CVS) today announced new steps to further help customers expand adoption of lower-cost biosimilar medications. Effective April 1, 2026, CVS Caremark will begin offering osteoporosis biosimilars Ospomyv and Stoboclo, as well as generic teriparatide, Bonsity, and Tymlos on major national commercial template formularies. These medications will replace Prolia and Forteo, giving customers and their members more affordable options with strong clinical and supply confidence. This preferred biosimilar approach is over 50% lower in costs per prescription than the original brand. What is a drug formulary? A drug formulary is a continually updated list of preferred medications and related products supported by current evidence-based medicine, judgment of physicians, pharmacists and other experts. How does CVS Caremark help customers use a formulary to drive savings? CVS Caremark helps customers use a formulary to help manage costs while making sure that their members have access to clinically appropriate medications. In much the same way that generic drugs are used as alternatives to branded drugs, biosimilars offer quality, safe, and effective treatment options that have no clinically meaningful difference from their reference products. How is CVS Caremark helping to improve the use of biosimilars? This formulary change builds on steps Caremark previously took to exclude reference brand Humira from its template formulary and include lower list price biosimilars. "Caremark was the first pharmacy benefit manager to exclude reference brand Humira from our commercial template formulary in favor of biosimilars priced dramatically less than the branded product," said Ed DeVaney, President, CVS Caremark. "The results of our industry leadership in this category illustrate the value we can deliver when we can leverage our tools to drive competition. To date, our biosimilar formulary strategy has helped customers and their members realize $1.5 billion in gross savings." CVS Caremark has proven experience in supporting biosimilar adoption, helping 96% of Caremark's client members using Humira to transition to a biosimilar. How is CVS Specialty making care simpler? Like Humira and its biosimilars, Prolia is a specialty drug dispensed by CVS Specialty. As is done for all CVS Specialty patients who experience changes to their plan formulary, CVS Specialty proactively reaches out to both the prescriber and the patient to inform them about the formulary change, describe the process for providers to submit a new prescription for a covered alternative and keep the patient updated about the process. "When a CVS Specialty patient's plan formulary changes, our advanced technology capabilities allow us to streamline the process for the doctor by communicating with them in their electronic health record workflow and sending a new prescription that can be approved with a single click," said Lucille Accetta, RPh, MPH, MBA, Senior Vice President & Head of CVS Specialty Operations, CVS Health. "We also work to deliver a frictionless experience for the patient by proactively communicating with them digitally or over the phone – based on their preferences – to inform them of the changes, answer their questions and educate them about the new medication." What are biosimilars and what do these biosimilars treat? Biosimilars are often injectable medications that treat complex chronic conditions and require special handling such as temperature control. These factors make drug shortages and supply chain issues particularly challenging for biosimilars and underscore the importance of a reliable supply of medication for the patient. The Prolia biosimilar options now included on Caremark's template formulary are Ospomyv, brought to market by Cordavis Limited, and Stoboclo, manufactured by Celltrion, Inc. Ospomyv and Stoboclo are FDA-approved for the treatment of osteoporosis in high-risk individuals, as well as increasing bone density in men and women undergoing certain cancer treatments. Treating osteoporosis is crucial to prevent painful and debilitating fractures, which can lead to loss of independence, disability, and even death, particularly in older adults. These effective alternatives for osteoporosis offer patients affordable options with the same clinical benefits—increasing access to lifechanging medications. About CVS Health CVS Health® is a leading health solutions company building a world of health around every consumer, wherever they are. As of September 30, 2025, the Company had approximately 9,000 retail pharmacy locations, more than 1,000 walk-in and primary care medical clinics and a leading pharmacy benefits manager with approximately 87 million plan members. The Company also serves an estimated more than 37 million people through traditional, voluntary and consumer-directed health insurance products and related services, including highly rated Medicare Advantage offerings and a leading standalone Medicare Part D prescription drug plan. The Company's integrated model uses personalized, technology driven services to connect people to simply better health, increasing access to quality care, delivering better outcomes, and lowering overall costs. Media Contact: David Whitrap [email protected] SOURCE CVS Health 21% more press release views with Request a Demo

上市批准

2026-01-26

·BioSpace

Samsung Epis Holdings Reports Fourth Quarter and Fiscal Year 2025 Financial Results

In its first financial results announcement after the spin-off, Samsung Bioepis recorded FY2025 revenue of KRW 1.672 trillion, highest annual revenue in its 14-year history Excluding milestone revenue, annual sales revenue grew 28% year-over-year (YoY), recording KRW 1.626 trillion, with 101% YoY growth in operating profit to KRW 330.8 billion INCHEON, Korea--(BUSINESS WIRE)-- #ADCs --Samsung Epis Holdings (KRX: 0126Z0), an investment company dedicated to innovations in biopharmaceuticals and biotechnology, today announced financial results for the fourth quarter and fiscal year 2025. “We are very pleased to report strong year-to-date sales growth in our first financial results following the spin-off. Our organic growth has been driven by solid performance across our biosimilars portfolio," said Kyung-Ah Kim, President and Chief Executive Officer (CEO) of Samsung Epis Holdings. “We are continuing to make meaningful progress in our regulatory and commercial milestones with our existing biosimilars portfolio, while strategically investing in our future pipeline with a disciplined, long-term approach. We aim to drive sustainable growth and create long-term value for our shareholders, so that we can remain committed to improving patient access worldwide.” Samsung Bioepis Fourth Quarter & Fiscal Year 2025 Results In the fourth quarter of 2025, Samsung Bioepis achieved a consolidated revenue of KRW 429.4 billion with an operating profit of KRW 29.2 billion. Revenue and operating profit based on product sales (excluding milestone revenue) in the fourth quarter increased by 23% and 14% year-over-year (YoY), respectively. Full-year 2025 (FY2025) revenue reached KRW 1.672 trillion (+9%) while operating profit stood at KRW 375.9 billion (-14%). Excluding milestone revenue, sales revenue and operating profit stood at KRW 1.626 trillion (+28%) and KRW 330.8 billion (+101%), respectively. [Consolidated Earnings, KRW billion] Q4’23 Q4’24 Q4’25 YoY Change FY23 FY24 FY25 YoY Change Revenue 288.9 397.4 429.4 +32.0 1 (+8%) 1,020.3 1,537.7 1,672.0 +134.3 1 (+9%) Excluding Milestone Revenue 288.9 347.0 425.2 +78.2 (+23%) 1,008.3 1,266.8 1,626.9 +360.1 (+28%) Operating Profit 78.2 72.3 29.2 -43.1 (-60%) 205.4 435.4 375.9 -59.5 (-14%) Excluding Milestone Revenue 78.2 21.9 25.0 +3.1 (+14%) 193.4 164.5 330.8 +166.3 (+101%) The growth was driven by Samsung Bioepis’ continued global expansion through product launches, regulatory approvals, and new partnerships. EPYSQLI™ (SB12), a biosimilar to Soliris 2 (eculizumab), indicated for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH), atypical Hemolytic Uremic Syndrome (aHUS), and generalized Myasthenia Gravis (gMG), was launched in the United States (US) in April 2025 through its commercialization partner Teva Pharmaceuticals, improving access for patients with rare diseases. OBODENCE™ / OSPOMYV™ 3 (SB16), a biosimilar to Prolia 4 (denosumab), and XBRYK™ (SB16), a biosimilar to Xgeva 3 (denosumab), were approved by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) in February 2025. In Europe, OBODENCE was launched in December 2025, consequently followed by the launch of XBRYK in January 2026. As of January 2026, four products are directly commercialized by Samsung Bioepis in Europe, namely EPYSQLI (eculizumab), OBODENCE (denosumab), XBRYK (denosumab), and BYOOVIZ™ (ranibizumab). 5 PYZCHIVA™ (SB17), a biosimilar to Stelara 6 (ustekinumab), was launched in the US in partnership with Sandoz in February 2025. PYZCHIVA has also been available as private label brands since the second and third quarter of 2025. In Japan, SB17 was approved as Ustekinumab BS Subcutaneous Injection 45mg Syringes 「NIPRO」 by Pharmaceuticals and Medical Devices Agency (PMDA) in December 2025. It is the first product to gain marketing approval in Japan under the partnership with NIPRO CORPORATION entered in June 2025. Samsung Bioepis entered into a partnership agreement with Harrow for commercialization of BYOOVIZ (SB11), a biosimilar referencing Lucentis 7 (ranibizumab) and OPUVIZ™ (SB15), a biosimilar referencing Eylea 8 (aflibercept), in the US. Fiscal Year 2026 Outlook Samsung Epis Holdings is actively supporting its subsidiaries' core businesses under the holding company structure, with a goal of increasing global biosimilar sales by more than 10% compared YoY. Samsung Bioepis plans to secure 20 biosimilars in its portfolio by 2030, including dupilumab, guselkumab, ixekizumab, trastuzumab deruxtecan, vedolizumab, and ocrelizumab. Beyond biosimilars, the company has also embarked on its novel therapeutic development. It plans to have one novel therapeutic candidate enter into clinical study every year, starting with SBE303. SBE303 is Samsung Bioepis’ first novel antibody-drug conjugate (ADC) engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumor cells, including bladder cancer, urothelial cancer, lung cancer, and breast cancer. 9 The Phase 1 first-in-human clinical trial, aiming to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of SBE303 in participants with advanced refractory solid tumors, is set to begin this year. Epis NexLab, the new subsidiary under Samsung Epis Holdings, has launched a project to develop a peptide-based drug delivery platform. 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: . 1 The year-over-year (YoY) change in operating profit is reflective of the ‘milestone payment’ – a payment system that pays out upon completion of specific milestones within a project’s development. 2 Soliris is a trademark of Alexion Pharmaceuticals, Inc. 3 SB16 was approved under different names in Europe and the US; OBODENCE in Europe and OSPOMYV in the US 4 Prolia and Xgeva are trademarks of Amgen Inc. 5 In Europe, Samsung Bioepis has assumed full responsibility for commercialization of BYOOVIZ upon the transfer of commercial rights from Biogen back to Samsung Bioepis, effective as of January 2026. 6 Stelara is a trademark of Johnson & Johnson Corporation. 7 Lucentis is a trademark of Genentech Inc. 8 Eylea is a trademark of Regeneron Pharmaceuticals, Inc 9 Li K, Zhou Y, Zang M, Jin X, Li X. Therapeutic prospects of nectin-4 in cancer: applications and value. Front Oncol. 2024 Mar 28;14:1354543. doi: 10.3389/fonc.2024.1354543. PMID: 38606099; PMCID: PMC11007101. Contacts Media Contact Yoon Kim, yoon1.kim@samsung.com Anna Nayun Kim, nayun86.kim@samsung.com

上市批准临床1期

2026-01-18

·每日热点网

Samsung Epis Holdings亮相第44届

Samsung Epis Holdings亮相第44届J.P. Morgan医疗健康大会，发布业务最新进展• Samsung Bioepis计划到2030年将产品线与研发管线扩展至20款生物类似药• 新增管线将纳入dupilumab、guselkumab、ixekizumab、fam-trastuzumab deruxtecan-nxki、vedolizumab和ocrelizumab，此外pembrolizumab目前正处于Ⅰ期和Ⅲ期临床研究阶段• Samsung Bioepis研发的新型抗体药物偶联物(ADC) SBE303已获得美国食品药品管理局(FDA)的新药临床试验申请(IND)批准，该药物靶向Nectin-4，将于今年启动Ⅰ期首次人体临床试验• Samsung Bioepis计划每年新增一款新型候选治疗药物进入临床研究阶段韩国仁川--(美国商业资讯)-- Samsung Epis Holdings (KRX: 0126Z0)今日于第44届J.P. Morgan医疗健康大会上分享了公司发展动态与业务更新。本新闻稿包含多媒体。此处查看新闻稿全文： https://www.businesswire.com/news/home/20260114500371/zh-CN/Samsung Epis Holdings总裁兼首席执行官Kyung-Ah Kim表示：“2026年对我们而言是具有里程碑意义的一年，公司发展将迈入全新篇章。今天，我们宣布在生物类似药管线中新增6款候选药物，包括vedolizumab和dupilumab。我们正稳步推进在2030年前实现产品管线包含20款生物类似药的目标。此外，Samsung Bioepis自主研发的首款新型候选治疗药物已获得新药临床试验申请(IND)批准，我们计划于今年推进相关临床项目。在生物类似药之外，我们将进一步拓宽产品组合，持续投入抗体药物偶联物(ADC)的研发，依托创新研发平台为存在未满足医疗需求的患者拓展切实可行的治疗选择。”Samsung Bioepis生物类似药业务最新进展Samsung Bioepis目前拥有11款生物类似药，对应10种独特生物分子，已在全球40多个国家获批上市。1公司的pembrolizumab生物类似药正处于Ⅰ期和Ⅲ期临床研究阶段，并计划在2030年前实现产品管线包含20款生物类似药。新增管线将纳入dupilumab、guselkumab、ixekizumab、fam-trastuzumab deruxtecan-nxki、vedolizumab和ocrelizumab。创新疗法业务最新进展2025年12月，SBE303的IND申请获得FDA批准。SBE303是Samsung Bioepis研发的首款新型ADC，靶向Nectin-4，该黏附蛋白特异性表达于尿路上皮癌、肺癌、乳腺癌等多种肿瘤细胞。2旨在评估SBE303用于晚期难治性实体瘤患者的安全性、耐受性、疗效、药代动力学及免疫原性的Ⅰ期首次人体临床试验将于今年正式启动。Samsung Bioepis计划每年新增一款新型候选治疗药物进入临床研究阶段。Epis NexLab是Samsung Epis Holdings旗下新设立的子公司，目前已启动肽类药物递送平台的研发项目。Samsung Bioepis生物类似药产品组合代号（商品名3）通用名参考产品状态4SB5（IMRALDI™、HADLIMA™、ADALLOCE™）AdalimumabHumira已上市SB4（BENEPALI™、BRENZYS™、ETOLOCE™）EtanerceptEnbrel已上市SB2（FLIXABI™、RENFLEXIS™、REMALOCE™）InfliximabRemicade已上市SB3（ONTRUZANT™、SAMFENET™）TrastuzumabHerceptin已上市SB8(AYBINTIO™)BevacizumabAvastin已上市SB11（BYOOVIZ™、AMELIVU™）RanibizumabLucentis已上市SB12(EPYSQLI™)EculizumabSoliris已上市SB15（OPUVIZ™、AFILIVU™）AfliberceptEylea已上市SB16（OBODENCE™、OSPOMYV™）DenosumabProlia已上市SB16(XBRYK™)DenosumabXgeva已上市SB17（PYZCHIVA™、EPYZTEK™）UstekinumabStelara已上市SB27PembrolizumabKeytrudaⅠ期和Ⅲ期临床Samsung Bioepis早期研发阶段生物类似药候选药物通用名参考产品DupilumabDupixentGuselkumabTremfyaIxekizumabTaltzVedolizumabEntyvioOcrelizumabOcrevusFam-trastuzumab deruxtecan-nxkiEnhertu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。如需了解更多关于Epis NexLab的信息，请访问：www.samsungepisholdings.com。1 “40多个国家”指Samsung Bioepis已有一款或多款产品实现商业化布局的国家。2 Li K、Zhou Y、Zang M、Jin X、Li X。nectin-4在癌症治疗中的前景：应用与价值(Therapeutic prospects of nectin-4 in cancer: applications and value)。《肿瘤前沿》。2024年3月28日；14:1354543。doi: 10.3389/fonc.2024.1354543。PMID: 38606099；PMCID: PMC11007101。3 不同国家和地区的商品名存在差异。4 “已上市”指药物已在一个或多个市场获批上市，不一定代表已在全球所有市场上市

临床3期生物类似药抗体药物偶联物临床1期临床2期

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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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
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)	廠憲範蓋夢鹽顧鬱簾顧(鬱網廠衊獵夢襯膚觸糧) = 蓋壓願鹹簾簾鏇範衊遞鏇齋鏇獵齋窪製窪鏇廠 (糧鹹膚廠範餘窪壓築鏇, 0.250) 更多	-	2025-01-09
				Prolia (Prolia)	廠憲範蓋夢鹽顧鬱簾顧(鬱網廠衊獵夢襯膚觸糧) = 積壓餘壓衊淵艱壓鑰壓鏇齋鏇獵齋窪製窪鏇廠 (糧鹹膚廠範餘窪壓築鏇, 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	構製淵壓廠鹽窪夢築範(襯製鏇願鑰窪簾鹽構衊) = 鹽鹽膚壓鬱構鬱醖糧齋衊顧齋艱簾窪餘獵繭憲 (衊糧製簾顧淵齋膚簾壓 )	相似	2024-09-07
				Prolia	構製淵壓廠鹽窪夢築範(襯製鏇願鑰窪簾鹽構衊) = 糧醖遞鹹築鹽鹹築願鏇衊顧齋艱簾窪餘獵繭憲 (衊糧製簾顧淵齋膚簾壓 )
NCT04664959 (EULAR 12024 \| EULAR 22024) 人工标引	临床3期	绝经期后骨质疏松	457	SB16+SB16	壓衊範獵築鹽廠壓衊鏇(鹹願製簾壓鏇廠範蓋鏇) = 觸憲廠膚醖齋齋糧願壓顧鹽艱廠憲餘範襯鹹鹽 (範獵窪醖淵窪遞淵繭齋 )	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	選膚衊廠鏇製顧願廠顧(繭繭鹽夢襯鏇積構膚壓) = 築鏇選選選衊餘觸構衊獵選窪鬱夢膚衊襯願構 (夢繭獵齋範夢選築鹽構 ) 更多	积极	2023-11-04
				Denosumab	選膚衊廠鏇製顧願廠顧(繭繭鹽夢襯鏇積構膚壓) = 簾製淵鹹鬱積顧餘糧淵獵選窪鬱夢膚衊襯願構 (夢繭獵齋範夢選築鹽構 ) 更多