An open-label, single group, single-dose clinical study to evaluate the usability of the pre-filled syringe (PFS) of SB11 in trial participants with Neovascular Age-Related Macular Degeneration (AMD), Macular Oedema Secondary to Retinal Vein Occlusion (RVO), or Myopic Choroidal Neovascularization (mCNV)

开始日期2025-06-13

申办/合作机构

Samsung Bioepis Co., Ltd.

NCT06176963

/ Completed临床2期

An Open-label, Single Group, Single-dose Clinical Study to Evaluate the Usability of the Pre-filled Syringe of SB11 in Subjects With Neovascular Age-Related Macular Degeneration or Macular Oedema Secondary to Retinal Vein Occlusion

This is a open label, multicenter, Phase II study to evaluate the usability of the pre-filled syringe (PFS) of SB11 (ranibizumab biosimilar). Healthcare Professionals (HCPs) followed the Instructions for Use (IFU) to prepare and administer SB11 PFS with intravitreal injection to subjects with nAMD or Macular Oedema Secondary to RVO.

开始日期2023-11-21

申办/合作机构

Samsung Bioepis Co., Ltd.

CTRI/2018/05/013650

/ Completed临床3期

A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB11 (proposed ranibizumab biosimilar) and LucentisÂ® in Subjects with Neovascular Age-related Macular Degeneration

开始日期2018-05-07

申办/合作机构

Samsung Bioepis Co., Ltd.

100 项与雷珠单抗生物类似药(Samsung Bioepis) 相关的临床结果

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100 项与雷珠单抗生物类似药(Samsung Bioepis) 相关的转化医学

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100 项与雷珠单抗生物类似药(Samsung Bioepis) 相关的专利（医药）

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项与雷珠单抗生物类似药(Samsung Bioepis) 相关的文献（医药）

2025-11-05·JOURNAL OF AGRICULTURAL AND FOOD CHEMISTRY

Synthesis and Preliminary Antifungal Evaluation of Acetylated Glucopyranoside Amidrazones against Pythium aphanidermatum , Rhizoctonia solani and Fusarium solani in Cucumber

Article

作者: Al Balushi, Zainab M. ; Devaraj, Premkumar S. ; Abdel-Jalil, Raid J. ; Al Maqbali, Anwaar S. ; Al-Sadi, Abdullah M.

Soilborne damping-off caused by Pythium aphanidermatum, Rhizoctonia solani, and Fusarium solani remains a major constraint to cucumber production and shows the need for new chemistries with tractable safety profiles. We synthesized and characterized eight acetylated glucopyranoside amidrazones (AM 1-AM 8) and conducted a preliminary antifungal screen. In dual-culture assays on PDA, halogenated analogues (AM 2:4Br; AM 6:3,5Cl₂; AM 7:3Cl) produced the largest inhibition zones against R. solani and F. solani, whereas P. aphanidermatum was less responsive. Scanning electron microscopy revealed wrinkled, shrunken, and fragmented hyphae at the treatment front, and bulk electrolyte leakage increased with concentration and time, which is consistent with the loss of membrane integrity as a contributing mode of action. In a greenhouse seedling screen, AM 2 and AM 7 increased survival to ∼60-67% in Fusarium- and Rhizoctonia-infested soil (vs 0% in inoculated controls), while responses to Pythium were lower; compound-only pots showed 70-90% survival, and AM 6 produced shorter, yellowish seedlings, indicating a potential phytotoxicity signal at the tested rate that warrants dose optimization. This first-round evaluation did not include commercial fungicide comparators or EC₅₀ determinations; therefore, we frame these amidrazones as lead scaffolds. We outline in the methods how potency benchmarking (poisoned-agar EC₅₀ vs reference fungicides) and crop-safety bracketing will be implemented to guide next-step structure optimization and mechanism studies. Together, these results nominate acetylated glucopyranoside amidrazones as promising starting points rather than definitive chemical controls.

2024-09-01·JOURNAL OF PROSTHETIC DENTISTRY

Cameo and intaglio surface stability and variability of additively, subtractively, and conventionally manufactured occlusal devices after long-term storage

Article

作者: Yilmaz, Burak ; Marques, Vinicius Rizzo ; Orgev, Ahmet ; Cakmak, Gulce ; Donmez, Mustafa Borga ; Kahveci, Cigdem ; Almogbel, Lolowh

STATEMENT OF PROBLEM:

Additive and subtractive manufacturing have become alternative technologies for fabricating occlusal devices. However, knowledge of the long-term stability of occlusal devices fabricated using these recent technologies is limited.

PURPOSE:

The purpose of this in vitro study was to evaluate the cameo and intaglio surface stability and variability of additively, subtractively, and conventionally manufactured occlusal devices after 18 months of storage.

MATERIAL AND METHODS:

A standard tessellation language (STL) file of a dentate maxillary typodont was used to design a master occlusal device. The STL file of this design was used to fabricate occlusal devices additively either with a digital light processing (AM-1) or a continuous liquid interface production (AM-2) printer, subtractively with 2 different 5-axis milling units (SM-1 and SM-2), and conventionally (TM-HP) (n=10). STL files of each device's cameo and intaglio surfaces were generated using a laboratory scanner after fabrication and after 18 months of storage in a moist environment. These generated files were imported into an analysis software program (Geomagic Control X) to analyze the dimensional stability of tested devices by using the root mean square method. The average deviation values defined the variability of measured changes over time. Cameo and intaglio surface deviations were analyzed using the Kruskal-Wallis and Dunn tests, while the variability of measured deviations was analyzed with 1-way analysis of variance and the Tukey HSD tests (α=.05).

RESULTS:

Significant differences were observed among tested devices when the intaglio surface deviations and the cameo surface variability were considered (P<.001). SM-2 had significantly higher intaglio surface deviations than AM-1, SM-1, and AM-2 (P≤.036). Among the test groups, AM-1 had the greatest cameo surface variability (P≤.004).

CONCLUSIONS:

SM-2 resulted in lower intaglio surface stability than the additive and the other subtractive manufacturing technologies, while AM-1 led to the highest cameo surface variability among the test groups.

2024-08-01·ADVANCES IN THERAPY

Usability of the SB11 Pre-filled Syringe (PFS) in Patients with Retinal Diseases

Article

作者: Lee, Jiwon ; Wylęgała, Edward ; Lee, Yujin ; Orski, Michał ; Zalewski, Dominik ; Oleksy, Piotr ; Kim, Sunji

INTRODUCTION:

SB11 (Byooviz™; Samsung Bioepis Co., Ltd.) is a ranibizumab (Lucentis^®; Genentech, Inc.) biosimilar targeting vascular endothelial growth factor A for the treatment of retinal diseases. The pre-filled syringe (PFS) presentation of SB11 offers an alternative administration method to the vial, with the potential for enhanced safety and efficient syringe preparation. The objective of this study was to assess the ability of healthcare professionals (HCPs) to follow the instructions for use to prepare and administer SB11 PFS intravitreal (IVT) injections to patients with neovascular age-related macular degeneration (nAMD) or macular edema secondary to retinal vein occlusion (RVO).

METHODS:

This study was an open-label, single-arm, single-dose clinical study to evaluate the usability of the SB11 PFS in patients with nAMD or macular edema secondary to RVO. Four HCPs prepared and administered 0.5 mg SB11 PFS IVT injections to 34 patients. Product use task completion (12 tasks in total) was assessed by independent observers. Safety was assessed up to 7 days after injection of the investigational product.

RESULTS:

A total of 34 patients were enrolled and completed the study. All 12 tasks were successfully completed in 34 (100%) patients without a use-related failure. Most patients (32 patients, 94.1%) experienced no adverse events (AEs), whereas 2 (5.9%) patients experienced three treatment-emergent AEs (TEAEs) which were mild to moderate in severity. There were no severe or serious TEAEs reported during the study.

CONCLUSIONS:

This study showed that HCPs were able to successfully prepare and administer the SB11 PFS via IVT injection. No unexpected safety issues were identified. The SB11 PFS is a promising alternative for therapeutic administration of SB11 in patients with retinal disease.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier NCT06176963; EudraCT number 2021-003566-12.

项与雷珠单抗生物类似药(Samsung Bioepis) 相关的新闻（医药）

2026-01-27

·Rimonci

模仿者还是破局者？—— 视网膜生物类似药的崛起

眼科领域正悄然掀起一场变革，生物类似药进军视网膜疾病治疗领域，有望重新定义临床诊疗的经济学格局。视网膜药物市场的产业变革从原研药垄断逐步转向“原研药+生物类似药”的多元竞争。作为获批生物制剂的高度相似仿制品，生物类似药为各类常见且治疗成本高昂的致盲性视网膜疾病，提供了全新治疗选择。就像厨师在厨房里斟酌不同品牌的刀具一样，视网膜专科医生如今在治疗方案的选择上有了更多余地，每一种选择都可能对患者护理、诊疗经济学及更广泛的医疗体系产生影响。 “生物类似药是治疗药物生命周期中不可避免的演进产物，” 美国 NJRetina 视网膜专科医生 Paul Hahn 医学博士解释道，“我认为与参比药物相比，它们在疗效上不太可能展现出显著优势，但潜在的成本节约可能是推动其应用的重要因素。” Part.01 不断变化的市场格局视网膜疾病治疗领域的生物类似药发展始于2021年，彼时美国 FDA 批准了由韩国仁川三星生物制剂公司研发的 Byooviz（雷珠单抗 - nuna）。此后多款雷珠单抗生物类似药相继上市，其中包括中国齐鲁制药的安卓明®（雷珠单抗眼内注射液），作为国内首款获批的雷珠单抗生物类似药，该药物不仅通过国际多中心 III 期临床试验验证了与原研药的等效性，还成功登陆欧盟市场（商品名：Rimmyrah）；另有瑞士巴塞尔 Sandoz 公司的 Cimerli（雷珠单抗-eqrn），这款药物已获得 FDA 的可互换性认定。如今，阿柏西普生物类似药正成为焦点。2023年底，齐鲁制药的卓初明®（阿柏西普眼内注射液）获批上市，成为中国首个获批的阿柏西普生物类似药。2025年11月，博安生物研发的博优景®获中国国家药监局批准，用于治疗新生血管性年龄相关性黄斑变性和糖尿病性黄斑水肿，成为中国第二款同类产品。还需关注的是，印度班加罗尔的 Biocon 生物制剂公司近期与美国纽约的 Regeneron 公司达成和解，为其研发的 Yesafili（阿柏西普-jbvf）——Eylea 的可互换生物类似药 —— 铺平了道路，计划于2026年底前或根据特定条款提前在美国上市。 “此次和解为 Biocon 生物制剂公司成为首批向美国患者和医疗服务提供者提供可靠、高质量阿柏西普生物类似药的企业之一扫清了障碍，”Biocon 公司首席执行官 Shreehas Tambe 在新闻稿中表示。这是在一个庞大市场中迈出的大胆步伐。Eylea 在2023年的销售额约为94亿美元，预计到2028年市场规模将增长至127.3亿美元，使其成为生物类似药竞争的热门目标[1]。 Part.02 解读生物类似药与小分子药物的完全拷贝品，仿制药不同，生物类似药是另一类特殊药物。它们是由活细胞培育而成的大型复杂蛋白质，因此无法制造出与原研生物制剂完全一致的复制品。但尽管无法做到完全相同，它们与参比药物在结构、纯度和效价上极为相似，疗效也与参比药物相当。 “根据定义，生物类似药的分子和蛋白质特征必须与参比产品相似，”Bressler 等人在《Survey of Ophthalmology》（眼科学综述）上发表的一篇综述中解释道，“生物制剂本身就具有一定的内在微观异质性。” 也就是说，生产过程中必然存在微小差异。这些差异源于生产药物所用活细胞的自然变异，以及生产过程中的细微变化[2]。这种内在变异性意味着，即使是同一参比产品的不同批次，也并非绝对一致。正如 Bressler 等人所指出的：“2018年生产的参比药物雷珠单抗（Lucentis）批次，与2022年生产的同产品批次可能并非完全相同[2]。” 要获得 FDA 批准，生物类似药必须经过严格测试以证明其临床等效性，但其研发过程比原研生物制剂更快、成本更低[2]。 “坦率地说，开发生物类似药成本更低，因为无需经历原研药的全新研发流程，” 美国俄亥俄州视网膜中心首席执行官 Suber Huang 博士解释道，“例如，对于安维汀（Avastin），要开发生物类似药就必须经历完整的新流程，因为原研药安维汀（贝伐珠单抗）最初获批的适应症是恶性肿瘤，并非眼科领域的参比药物。” Part.03 成本考量推动生物类似药研发的最大动力之一是实实在在的成本节约。首款雷珠单抗生物类似药上市时，价格较参比药物降低了40%，平均销售价格差异约为31.3%。考虑到新生血管性年龄相关性黄斑变性或糖尿病性黄斑水肿等疾病患者，仅在治疗第一年就可能平均接受9次注射，这一成本节约潜力显著[2]。加拿大的一项估算显示，2023年改用雷珠单抗生物类似药可能节省7000万至2.01亿加元。其他市场情况类似，尤其是随着更多生物类似药进入市场并展开价格竞争，也有望实现大幅成本节约[2]。当然，成本节约只有在生物类似药得到应用的情况下才能实现，这就涉及到药物的使用率问题。“当有更便宜的选择时…… 如果疗效和安全性相当，患者、保险、社会乃至整个医疗体系通常都会倾向于选择这些药物，”Huang 博士表示。 Part.04 临床应用经验与推广挑战尽管生物类似药具有降低成本和扩大医疗可及性的潜力，但在眼科领域的推广起步较为缓慢。2023年，其使用率仅为3%，2024年也仅小幅上升至约10%[3]。那么，犹豫的背后原因是什么？根据 Hahn 医生的说法，并非视网膜专科医生怀疑生物类似药的疗效。“我认为当生物类似药首次成为视网膜治疗方案的考量选项时，人们对此存在诸多犹豫，” 他解释道，“这种犹豫本质上是思维模式的差异：一方面，生物类似药的疗效和原研参比药物相当，并非‘更有效’，其核心优势是成本更低；另一方面，多数眼科医生的职业习惯是聚焦‘为患者选择疗效最优的治疗方案’，这种思维惯性让医生对以成本为核心优势的生物类似药产生了选择上的迟疑[3]。” 但这种思维模式的转变正在缓慢发生，对于那些已经率先采用生物类似药的医生来说，结果令人鼓舞。“我们已将雷珠单抗生物类似药纳入临床治疗，应用于新患者和现有治疗患者，整合过程总体顺利，”Hahn 博士表示，“一旦医生们对其安全性和疗效特征感到放心，患者通常会遵循医生的建议，不会有太多顾虑。” Part.05 阶梯治疗的难题谈到生物类似药，美国的视网膜专科医生并不担心药物本身，但他们对保险公司可能利用生物类似药推行限制性阶梯治疗方案表示担忧。 “我认为最大的问题之一是强制阶梯治疗，”Huang 博士说，“当保险公司强制规定必须按特定顺序尝试药物时，我认为这与医学实践的本质相悖。” Hahn 医生也表达了同样的担忧。“如今市场上有多种生物类似药，还有一种虽未获批眼科适应症但成本更低的选择，视网膜专科医生现在背负着多重‘阶梯’，必须在每个阶梯的治疗失败后，才能更换为另一种治疗方案，”他解释道。这些阶梯并非仅存在于理论中。根据凯撒家庭基金会的数据，98%的联邦医疗保险优势计划（Medicare Advantage）目前对B部分药物采用阶梯治疗，影响着超过40%的联邦医疗保险受益人。在实际临床中，这通常意味着首先使用复方贝伐珠单抗进行治疗，只有在该方案“失败”后，才能使用 FDA 批准的原研药[4]。眼科界并未对此坐视不管。正如 Hahn 医生所指出的，美国视网膜专家学会（ASRS）等组织“积极维护医生在治疗选择中的判断权和选择权”。美国眼科学会（AAO）也对此表示反对，称“药物治疗的选择应由患者和医生在充分讨论每种治疗的风险和益处后共同决定，而非由保险公司决定[5]。” Part.06 患者沟通与接受度在与患者沟通生物类似药时，视网膜专科医生发现，清晰、简洁的解释往往能达到良好效果。 “患者通常理解仿制药的作用并愿意接受使用。我向他们解释，生物类似药相当于注射类疗法的仿制药，患者通常不会有顾虑，”Hahn 医生说，“对于那些确实有顾虑的患者，我会解释我们有多种选择，如果未达到预期效果，我们随时可以更换其他治疗方案。” 尽管随着生物类似药的普及，患者教育仍然很重要，但目前仍存在一定的知识缺口需要弥补。一份行业报告发现，50%的受访者表示对生物制剂和生物类似药“了解甚少”。不过，在眼科领域，注射治疗由医生实施，患者的认知可能不如医生对产品的信心重要。即便如此，清晰的沟通总归是有益的[6]。 Part.07 视网膜疾病治疗中生物类似药的未来随着更多生物类似药加入治疗工具箱，以及临床医生对其使用越来越熟悉，视网膜疾病治疗的格局必然会发生变化。但变化会有多大？这取决于你询问的对象。 Hahn 医生并不认为生物类似药是变革者，而更倾向于将其视为有益的补充。“与目前正在研发的视网膜疾病创新治疗方法相比，我认为生物类似药不会从根本上改变我们治疗视网膜疾病的方式，”他说，“治疗工具箱中更多治疗选择的出现总体上是有价值的，尤其是在社会和患者个体层面，治疗成本的重要性日益凸显的情况下。” 与此同时，Huang 博士就药物研发的优先级提出了一个发人深省的问题。“生物医学研究投入的大量时间和资金…… 这些资源最终被用于研发一种实际上并不比我们已有的药物更好的产品，”他指出，“如果永远无法实现改进，那么我们所做工作中非常有价值的一部分。即努力研发更好的产品，就会丢失。” 尽管如此，问题的另一面：“如果生物类似药成本更低，更多人就能负担得起。如果更多人能够获得治疗。而且疗效同样良好。那么你就以另一种但同样有意义的方式改善了医疗服务，” Huang 博士补充道。 Part.08 新工具在眼科生物类似药的新时代，或许 Huang 博士用一个烹饪比喻说得最为贴切：“如果两把刀由不同制造商生产，它们仍然是刀，用来准备晚餐的效果是一样的。” 换句话说，生物类似药并没有重塑视网膜疾病的治疗方案，但它们为视网膜专科医生提供了更多可用工具。这些工具功能相似，但价格不同。就像切洋葱不一定需要正光（Masamoto Sohonten）刀具一样，有效治疗患者也不一定总是需要原研生物制剂。关键在于？确保这些额外的选择赋予医生权力，而不是束缚他们的手脚。“作为一个社会，我们必须确保这些额外的治疗方式为医生提供更多选择，而不是限制选择，”Hahn 医生警告说。通过完善的教育、周密的推广，以及对安全性和疗效的密切关注，生物类似药有望在扩大医疗可及性的同时，减轻视网膜疾病治疗的经济负担。从这个意义上说，它们不仅仅是另一套工具，更是为更多患者创造更好治疗结果的机会。 Part.09 迎接生物类似药时代对于希望将生物类似药纳入临床诊疗的视网膜专科医生来说，适当的准备有助于实现平稳过渡。以下是一些关键点： 👉 做好功课：深入了解临床试验数据和真实世界证据，扎实掌握每种生物类似药的安全性和疗效。 👉 关注细节：熟悉“可互换性”等监管术语，更重要的是，了解这些标签对你日常临床决策的实际意义（及其局限性）。 👉 准备简洁说明：用清晰、直白的方式向患者解释生物类似药，有助于缓解他们的顾虑。 👉 关注医保动态：随着生物类似药的普及，做好应对保险覆盖政策变化的准备。 👉 跟踪结果：监测患者疗效，以建立自己对这些药物的信心。归根结底，信任是关键。“患者信任他们的医生，”Hahn 医生提醒道，“如果你对提供给患者的治疗方案感到放心，患者通常也会感到放心。” 参考文献（上下滑动可查看） [1] Eylea (Aflibercept) Market Research Report 2025: Strategic Partnerships and Biosimilars Enhance Accessibility, Diabetes-Related Retinal Issues and Myopia Surge Boost – Long-term Forecasts to 2033. Research and Markets. February 12, 2025. Available at: https://www.globenewswire.com/news-release/2025/02/12/3024804/28124/en/Eylea-Aflibercept-Market-Research-Report-2025-Strategic-Partnerships-and-Biosimilars-Enhance-Accessibility-Diabetes-Related-Retinal-Issues-and-Myopia-Surge-Boost-Long-term-Forecast.html. Accessed on June 2, 2025. [2] Bressler NM, Kaiser PK, Do DV, et al. Biosimilars of anti-vascular endothelial growth factor for ophthalmic diseases: A review. Surv Ophthalmol. 2024;69(4):521-538. [3] Jeremias S. Retina Specialists’ Evolving View on Biosimilars in AMD Treatment. The Center for Biosimilars. March 16, 2025. Available at: https://www.centerforbiosimilars.com/view/retina-specialists-evolving-view-on-biosimilars-in-amd-treatment. Accessed on June 2, 2025. [4] Freed M, Biniek JF, Damico A, et al. Medicare Advantage in 2024: Enrollment Update and Key Trends. August 8, 2024. Available at: https://www.kff.org/medicare/issue-brief/medicare-advantage-in-2024-enrollment-update-and-key-trends/. Accessed on June 2, 2025. [5] Congress’ Physicians Prep Strong Message Opposing Step Therapy in Medicare. AAO. June 27, 2019. Available at: https://www.aao.org/advocacy/eye-on-advocacy-article/congress-physicians-prep-strong-message-opposing. Accessed on June 2, 2025. [6] National Survey on Innovator Biologics and Biosimilars. Biologics Prescribers Collaborative. August 8, 2023. Available at: https://biologicsprescribers.org/wp-content/uploads/2023/08/BPC_Patient-Choice_National-Survey-Report_August-2023.pdf. Accessed on June 2, 2025. 视网膜研究最新亮点 | 2025年美国视网膜专家学会（ASRS）年会报告精选 30种药物与视网膜脱离相关联：来自FDA不良事件报告系统 ESCRS临床趋势调查：老视睿盟希国际视觉科学基金，以 For better vision and insight 为愿景，致力于全球范围内挖掘并投资视觉科学领域的创新科技公司我们专注于细分领域跨境投资、并购、商务合作和技术转移长按以下二维码关注

生物类似药上市批准临床3期

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 项与雷珠单抗生物类似药(Samsung Bioepis) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	S01LA04	-

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
年龄相关性黄斑变性	韩国	Samsung Bioepis Co., Ltd.	2024-11-04
失明	韩国	Samsung Bioepis Co., Ltd.	2024-11-04
视力低下	韩国	Samsung Bioepis Co., Ltd.	2024-11-04
近视脉络膜新生血管	美国	Samsung Bioepis Co., Ltd.	2021-09-17
视网膜静脉阻塞相关黄斑水肿	美国	Samsung Bioepis Co., Ltd.	2021-09-17
脉络膜新生血管	欧盟	Samsung Bioepis Co., Ltd.	2021-08-18
脉络膜新生血管	冰岛	Samsung Bioepis Co., Ltd.	2021-08-18
脉络膜新生血管	列支敦士登	Samsung Bioepis Co., Ltd.	2021-08-18
脉络膜新生血管	挪威	Samsung Bioepis Co., Ltd.	2021-08-18
糖尿病性黄斑水肿	欧盟	Samsung Bioepis Co., Ltd.	2021-08-18
糖尿病性黄斑水肿	冰岛	Samsung Bioepis Co., Ltd.	2021-08-18
糖尿病性黄斑水肿	列支敦士登	Samsung Bioepis Co., Ltd.	2021-08-18
糖尿病性黄斑水肿	挪威	Samsung Bioepis Co., Ltd.	2021-08-18
黄斑水肿	欧盟	Samsung Bioepis Co., Ltd.	2021-08-18
黄斑水肿	冰岛	Samsung Bioepis Co., Ltd.	2021-08-18
黄斑水肿	列支敦士登	Samsung Bioepis Co., Ltd.	2021-08-18
黄斑水肿	挪威	Samsung Bioepis Co., Ltd.	2021-08-18
伴有糖尿病的增殖性视网膜病变	欧盟	Samsung Bioepis Co., Ltd.	2021-08-18
伴有糖尿病的增殖性视网膜病变	冰岛	Samsung Bioepis Co., Ltd.	2021-08-18
伴有糖尿病的增殖性视网膜病变	列支敦士登	Samsung Bioepis Co., Ltd.	2021-08-18

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
湿性黄斑变性	临床2期	波兰	Samsung Bioepis Co., Ltd.	2023-11-21
糖尿病性视网膜病变	临床申请批准	中国	Samsung Bioepis Co., Ltd.	2022-08-30

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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


NCT06176963 (SB11 Pre-filled Syringe, CTgov)	临床2期	视网膜静脉阻塞相关黄斑水肿 \| 视网膜静脉阻塞 \| 黄斑水肿 ... 更多	34	SB11 PFS	膚鏇簾顧憲網襯獵廠遞 = 糧繭觸齋壓簾獵淵築蓋鏇觸獵艱鏇構遞觸繭糧 (艱齋糧鹹積鏇夢繭壓襯, 觸鹹醖鹹鏇醖淵壓範鹹 ~ 憲窪顧鹹膚網鹽顧壓夢) 更多	-	2024-12-30
EURETINA2023	N/A	-	-	SB11	窪顧糧襯範鬱鏇鬱糧衊(夢獵遞憲鹽齋遞衊窪蓋) = 夢製製獵構鏇淵簾願衊餘製鑰鹽廠醖齋遞糧選 (襯餘網顧淵壓願願襯願 )	-	2023-10-05
				rRBZ	窪顧糧襯範鬱鏇鬱糧衊(夢獵遞憲鹽齋遞衊窪蓋) = 憲淵淵淵獵壓製糧觸醖餘製鑰鹽廠醖齋遞糧選 (襯餘網顧淵壓願願襯願 )
APAO2023	临床3期	年龄相关性黄斑变性	705	SB11 (BYOOVIZ, Ranibizumab-Nuna)	鹹膚廠壓廠糧簾選顧選(遞鏇衊選鏇糧製製鑰願) = 壓衊鬱觸醖鏇窪繭廠醖願衊蓋鏇範蓋鬱壓膚願 (窪鑰齋襯鹹築衊繭範淵, 0.76) 更多	积极	2023-02-23
NCT03150589 (Pubmed)	临床3期	年龄相关性黄斑变性 \| 湿性年龄相关性黄斑变性	705	SB11	積艱構艱網淵艱製夢夢(淵鏇製網艱鏇鏇選齋齋) = IOI-related events occurred in 1 of 32 overall ADA-positive participants (3.1%) and 4 of 620 overall ADA-negative participants (0.6%) 壓簾夢衊壓繭鑰願構築 (簾憲廠窪窪獵構艱顧鏇 ) 更多	-	2022-12-15
				RBZ
NCT03150589 (CTgov)	临床3期	湿性年龄相关性黄斑变性	705	SB11 (Proposed ranibizumab biosimilar) (SB11 (Proposed Ranibizumab Biosimilar))	選壓夢願鹹夢齋鹽夢醖(顧構膚鑰鹹夢壓繭鹽願) = 選糧繭淵壓遞蓋淵衊構憲繭餘夢艱選選獵鑰齋 (鏇齋蓋齋鏇鹹齋齋製衊, 0.51) 更多	-	2021-05-21
				ranibizumab+Lucentis (Lucentis (Ranibizumab))	選壓夢願鹹夢齋鹽夢醖(顧構膚鑰鹹夢壓繭鹽願) = 願艱齋夢憲衊鹽淵壓鬱憲繭餘夢艱選選獵鑰齋 (鏇齋蓋齋鏇鹹齋齋製衊, 0.51) 更多
NCT03150589 (Pubmed \| JAMA Ophthalmol) 人工标引	临床3期	湿性年龄相关性黄斑变性	705	SB11	構觸觸願壓廠範醖鬱築(繭鏇鬱顧鏇範膚醖獵餘) = 夢餘齋繭窪鑰願範齋鬱餘艱廠窪願蓋鹽蓋餘鏇 (膚糧鬱願鏇鬱選蓋膚製 ) 更多	相似	2021-01-01
				Ranibizumab	構觸觸願壓廠範醖鬱築(繭鏇鬱顧鏇範膚醖獵餘) = 積顧選齋膚蓋膚窪艱蓋餘艱廠窪願蓋鹽蓋餘鏇 (膚糧鬱願鏇鬱選蓋膚製 ) 更多
AAO2020	临床3期	-	705	SB11	觸鏇鏇製遞願鹽觸顧遞(襯淵鑰鏇網窪蓋製膚衊) = 選廠襯製願鬱繭齋鬱繭選襯鏇鹽鏇餘範膚壓獵 (鏇獵積夢餘襯膚選鏇廠, 0.76)	积极	2020-11-13
				Ranibizumab	觸鏇鏇製遞願鹽觸顧遞(襯淵鑰鏇網窪蓋製膚衊) = 膚膚遞膚鑰淵齋願繭鹹選襯鏇鹽鏇餘範膚壓獵 (鏇獵積夢餘襯膚選鏇廠, 0.74)