A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB15 (Proposed Aflibercept Biosimilar) and Eylea® in Subjects With Neovascular Age-related Macular Degeneration

This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy, safety, Pharmacokinetics (PK), and immunogenicity of SB15 compared to Eylea® in subjects with neovascular AMD.

开始日期2020-06-23

申办/合作机构

Samsung Bioepis Co., Ltd.

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项与阿柏西普生物类似药 (Samsung Bioepis) 相关的文献（医药）

2025-01-09·Journal of Physical Chemistry Letters

Evaluating the Synergistic Effects of Multi-Epitope Nanobodies on BA.2.86 Variant Immune Escape

Article

作者: Liu, Jinxin ; Zhang, Enhao ; Duan, Lili ; Xu, Xiaole ; Zhang, John Z. H. ; Luo, Song ; Liang, Houde

Addressing the frequent emergence of SARS-CoV-2 mutant strains requires therapeutic approaches with innovative neutralization mechanisms. The targeting of multivalent nanobodies can enhance potency and reduce the risk of viral escape, positioning them as promising drug candidates. Here, the synergistic mechanisms of the two types of nanobodies are investigated deeply. Our research revealed that the Fu2-1-Fu2-2 system exhibited significant synergy, whereas the Sb#15-Sb#68 system demonstrated antagonism, in which entropy was the dominant contributor to antagonism. Conformational analysis further demonstrated that the presence of a monomeric nanobody influenced the flexibility of residues near other epitopes, thereby affecting the overall synergy of the systems. Moreover, we identified that changes in the hydrogen bond network and the charge of residues played a critical role in the binding between nanobodies and spike. We hope this study will provide novel insights into the development of multivalent nanobody combinations.

2023-12-01·BMJ open ophthalmology

Biosimilar SB15 versus reference aflibercept in neovascular age-related macular degeneration: 1-year and switching results of a phase 3 clinical trial

Article

作者: Studnička, Jan ; Oh, Inkyung ; Csutak, Adrienne ; Yun, Cheolmin ; Ernest, Jan ; Vajas, Attila ; Sadda, SriniVas R ; Jang, Hyerin ; Choi, Wooree ; Enyedi, Lajos ; Tóth-Molnár, Edit ; Patel, Sunil ; Wylegala, Edward ; Veith, Miroslav ; Woo, Se Joon ; Astakhov, Sergei ; Sagong, Min ; Orski, Michal ; Bradvica, Mario

Background/aims:

To evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of SB15 versus reference aflibercept (AFL), and switching from AFL to SB15 in neovascular age-related macular degeneration (nAMD).

Design:

Prospective, double-masked, randomised, phase 3 trial.

Methods:

Participants with nAMD were randomised 1:1 to receive SB15 (N=224 participants) or AFL (N=225). At week 32, participants either continued on SB15 (SB15/SB15, N=219) or AFL (AFL/AFL, N=108), or switched from AFL to SB15 (AFL/SB15, N=111). This manuscript reports 1-year and switching results of secondary efficacy endpoints such as changes from baseline to week 56 in best-corrected visual acuity (BCVA), central subfield thickness (CST, from internal limiting membrane (ILM) to retinal pigment epithelium), and total retinal thickness (TRT, from ILM to Bruch’s membrane). Additional endpoints included safety, PK and immunogenicity.

Results:

Efficacy results were comparable between groups. The least squares mean (LSmean) change in BCVA from baseline to week 56 was 7.4 letters for SB15/SB15 and 7.0 letters for AFL/AFL (difference (95% CI)=0.4 (−2.5 to 3.2)). The LSmean changes from baseline to week 56 in CST and TRT were −119.2 µm and −132.4 µm for SB15/SB15 and −126.6 µm and −136.3 µm for AFL/AFL, respectively (CST: difference (95% CI)=7.4 µm (−6.11 to 20.96); TRT: difference (95% CI)=3.9 µm (−18.35 to 26.10)). Switched and non-switched participants showed similar LSmean changes in BCVA from baseline to week 56 (AFL/SB15, 7.9 letters vs AFL/AFL, 7.8 letters; difference (95% CI)=0.0 (−2.8 to 2.8)). Safety, PK and immunogenicity were comparable between groups.

Conclusions:

Efficacy, safety, PK and immunogenicity were comparable between SB15 and AFL and between switched and non-switched participants.

2023-07-01·JAMA ophthalmology

Efficacy and Safety of the Aflibercept Biosimilar SB15 in Neovascular Age-Related Macular Degeneration

Article

作者: Kim, Taehyung ; Oh, Inkyung ; Sadda, SriniVas R. ; Csutak, Adrienne ; Yun, Cheolmin ; Ernest, Jan ; Vajas, Attila ; Jang, Hyerin ; Enyedi, Lajos ; Tóth-Molnár, Edit ; Patel, Sunil ; Wylegala, Edward ; Veith, Miroslav ; Woo, Se Joon ; Astakhov, Sergei ; Studnicka, Jan ; Sagong, Min ; Orski, Michal ; Bradvica, Mario

Importance:

Aflibercept biosimilars can expand available treatment options in retinal diseases and have the potential to improve patient access to safe and effective therapy.

Objective:

To establish equivalence in efficacy and similarity in safety, pharmacokinetics, and immunogenicity of SB15 and reference aflibercept (AFL) in neovascular age-related macular degeneration (nAMD).

Design, Setting, and Participants:

This was a randomized double-masked parallel group phase 3 trial conducted at 56 centers in 10 countries from June 2020 to March 2022, including follow-up through 56 weeks. Of 549 screened participants, 449 participants 50 years and older with treatment-naive nAMD were included and randomly assigned to SB15 (n = 224) or AFL (n = 225). Key exclusion criteria included considerable scarring, fibrosis, atrophy, and hemorrhage. This report includes results up to the end of the parallel group period at week 32. Of the 449 randomized participants, 438 (97.6%) completed week 32 follow-up.

Intervention:

Participants were randomized 1:1 to receive 2 mg of SB15 or AFL every 4 weeks for the first 12 weeks (3 injections), followed by dosing every 8 weeks up to week 48, with final assessments at week 56.

Main Outcomes and Measures:

The primary end point was the change in best-corrected visual acuity (BCVA) from baseline to week 8 with predefined equivalence margins of −3 letters to 3 letters. Other key end points were changes in BCVA and central subfield thickness up to week 32, safety, pharmacokinetics, and immunogenicity.

Results:

The mean (SD) age among the 449 included participants was 74.0 (8.1) years, and 250 participants (55.7%) were female. Baseline demographic characteristics and most disease characteristics were comparable between treatment groups. The least squares mean change in BCVA from baseline to week 8 in the SB15 group was equivalent to that in the AFL group (6.7 letters vs 6.6 letters, respectively; difference, 0.1 letters; 95% CI, −1.3 to 1.4). Comparable efficacy between treatment groups was maintained up to week 32 (least squares mean change from baseline in BCVA: SB15, 7.6 letters vs AFL, 6.5 letters; least squares mean change from baseline in central subfield thickness: SB15, −110.4 μm vs AFL, −115.7 μm). No clinically relevant differences were observed in the incidence of treatment-emergent adverse events (TEAEs) (SB15, 107/224 [47.8%] vs AFL, 98/224 [43.8%]) and ocular TEAEs in the study eye (SB15, 41/224 [18.3%] vs AFL, 28/224 [12.5%]). The serum concentration profiles and cumulative incidences of overall antidrug antibody positive participants were comparable.

Conclusions and Relevance:

In this phase 3 randomized clinical trial, SB15 and AFL showed equivalent efficacy and comparable safety, pharmacokinetics, and immunogenicity in participants with nAMD.

Trial Registration:

ClinicalTrials.gov Identifier: NCT04450329

项与阿柏西普生物类似药 (Samsung Bioepis) 相关的新闻（医药）

2026-01-31

·小白学药

医药圈大动作! 德国CDMO砸4.8亿欧元建厂; 三星生物类似药进军欧洲, 韩国药企杀疯了！

点击关注小白学药三星生物类似药抢滩欧洲；德国 4.8 亿欧元 CDMO 工厂重塑产业链近期全球医药行业动作频频：一边是韩国生物药企突破专利壁垒，加速布局欧洲生物类似药市场；另一边是德国 CDMO 巨头砸下重金新建工厂，加码注射剂生产产能。两大事件分别聚焦终端产品竞争与上游产业链支撑，折射出全球医药行业 “创新 + 产能” 双轮驱动的发展逻辑。一、三星生物：和解破局，Eylea 生物类似药进军欧洲困扰三星生物（Samsung Bioepis）一年多的专利纠纷终于落幕，其一款针对重磅眼药 Eylea 的生物类似药，正式获得欧洲市场商业化 “通行证”，全球生物类似药竞争再添新变量。1. 和解落地，欧洲上市时间表明确三星生物与原研药企业 Regeneron、Bayer 达成和解协议，扫清了 SB15（Eylea 生物类似药）在欧洲的上市障碍。根据规划： 2026 年 1 月已启动英国市场销售； 4 月将拓展至欧洲其他地区； 5 月起进军更多 “和解协议覆盖国家”（不含韩国、美国、加拿大）。这款生物类似药在欧洲以 “Opuviz” 为品牌名，早在 2024 年 11 月就获欧盟委员会批准，2025 年 4 月拿下英国药监机构认证，此次和解终于让 “获批即上市” 成为现实。2. 韩国本土价格战白热化，低价成竞争核心就在欧洲市场即将发力的同时，三星生物这款名为 “Afilivu” 的生物类似药，在韩国本土已陷入激烈的价格竞争。原研药 Bayer Eylea 每瓶报销价约 49.6 万韩元；三星生物与 Celltrion 的产品定价约 33 万韩元，而三进制药（Sam Chun Dang）的 Vgenfli 直接压至 19.8 万韩元，价格仅为原研的 40%。低价策略拉动市场需求，Afilivu 自 2025 年 12 月恢复销售以来，累计销售额已达 1.6 亿韩元。此外，三进制药已启动全球布局，产品已出口至加拿大、欧洲、英国等市场，计划 2026 年进军日美。医药产业链大动作！德国 CDMO 巨头建厂，三星生物类似药进军欧洲，韩国药企杀疯了！欢迎关注小白学药视频号3. 行业趋势转向：高剂量成新赛道随着 2 毫克规格生物类似药竞争加剧，行业目光开始聚焦高剂量领域。原研企业 Regeneron 正推广 8 毫克规格的 Eylea HD（长效剂型），而韩国药企 Alteogen 也已布局 —— 其获批的生物类似药 Eyluxvi，已提交高浓度制剂相关的国际专利申请，同时推进韩国市场审批，商业化重心聚焦欧洲、拉美、中东等地区。二、Vetter Pharma：4.8 亿欧元加码 CDMO，传统工业基地转型医药重镇另一边，德国 CDMO 巨头 Vetter Pharma 宣布重大投资计划，拟在萨尔州萨尔路易市新建一座现代化生产基地，总初始投资达 4.8 亿欧元，助力当地从传统工业向医药产业转型。1. 项目核心信息：规模与时间表清晰投资与产能：初始投资 4.8 亿欧元，欧盟批准提供 4700 万欧元国家补贴（占初始投资 10%）；工厂占地约 40 公顷，计划 2026 年第二季度开工，2031 年正式投产，聚焦注射剂药物的合同开发与生产（CDMO）；就业贡献：长期将创造多达 2000 个就业岗位，成为萨尔州重要的医药产业雇主。2. 象征意义深远：从汽车工厂到医药基地这座新工厂的选址极具象征意义 —— 场地原为福特汽车的生产基地，数十年来一直是当地传统工业的核心。如今转型生产注射剂药物，标志着萨尔路易从 “汽车制造重镇” 向 “医药创新枢纽” 的跨越，成为德国区域经济结构转型的典型案例。3. 战略布局：锚定欧美，强化 CDMO 竞争力作为拥有 75 年历史的家族企业，Vetter Pharma 此次投资是其史上最大规模单笔投资之一，核心战略聚焦欧美市场：明确重申对德国商业环境的信心，将萨尔路易工厂打造成欧洲产能枢纽；依托自身在注射剂制造领域的技术积累，进一步扩大全球 CDMO 业务份额，为全球药企提供从研发到生产的一体化服务。德国萨尔州政府对该项目高度认可，州长 Anke Rehlinger 称其为 “区域未来的强烈信号”，认为这一投资将加速当地经济多元化，提升区域创新吸引力。三、结语：全球医药行业的 “竞争与支撑” 双重逻辑三星生物进军欧洲，反映出生物类似药市场 “专利破局 + 全球布局 + 赛道升级” 的竞争新态势，低价竞争与高剂量创新并行，成为药企突围的关键；而 Vetter Pharma 的重资建厂，则凸显了 CDMO 行业在医药产业链中的重要性 —— 随着创新药研发加速，对高标准、大规模注射剂生产产能的需求持续攀升。从终端产品的全球卡位，到上游产能的提前布局，两大事件共同印证了全球医药行业 “创新驱动 + 产能保障” 的核心逻辑。未来，生物类似药的市场争夺将更趋激烈，而 CDMO 企业的产能布局，也将深刻影响全球医药创新的落地效率。关注「小白学药」，我们将持续追踪行业热点！点击关注小白学药喜欢就点个感恩一路相伴推荐阅读破解耐药+全球突围! 信达三抗获FDA快车道, 亚洲43%创新管线领跑世界艾伯维ADC落地韩国改写卵巢癌治疗; 弼领生物 2 亿 B 轮加码纳米偶联下一代抗体药物浪潮来袭：ADC、双抗领衔，研发、生产、商业化全解析2026上半年10大核心临床trial干货：巨头卡位、Biotech翻身战全解析GSK联手韩国公司, 改写PD-1给药规则; 2026 Biotech复苏藏三大隐忧！艾伯维双抗命悬一线, 但故事没完! ADC赛道再添狠角色! 乐天生物, 2026 新基地剑指全球JPM26落幕，2026医药行业格局已定？并购回暖、巨头冲刺、赛道内卷, 谁将笑到最后？医药人必藏双平台:「小白学药」公众号+视频号2026 年全球生物制药领域核心会议指南：见证医学突破与行业风向HER2 阳性膀胱癌患者福音！RC48-ADC 免疫联合疗法，疗效提升 6.75 倍，安全性可控百亿布局! Ipsen联手先声药业押注ADC新赛道, 靶向LRRC15资产引关注2025创新药年终考: 融资超40亿美元, BD破千亿美金, ADC/双抗扛起大旗！不止双特异性抗体！新型表达载体技术，多链生物疗法加速落地从 License-out 到联合研发，抗体与 ADC 引领创新，全球药企竞逐大分子赛道1 月医药圈炸场：荣昌生物 56 亿 BD 交易、科伦 ADC 获突破性疗法，中国创新药的 “出海 + 内卷” 双节奏继ADC之后，下一个千亿赛道？AOC技术全景解析声明：本公众号所有推文不构成任何投资意见和建议，科普性质内容，非医疗建议。转载请注明出处：小白学药公众号。部分内容源于网络公开信息，仅用于交流学习传播知识，侵删。因水平有限，若出现错误，欢迎指出。

生物类似药专利到期上市批准

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 项与阿柏西普生物类似药 (Samsung Bioepis) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XX44 S01LA05	-

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
糖尿病性视网膜病变	美国	Samsung Bioepis Co., Ltd.	2024-05-20
糖尿病性黄斑水肿	韩国	Samsung Bioepis Co., Ltd.	2024-02-23
近视脉络膜新生血管	韩国	Samsung Bioepis Co., Ltd.	2024-02-23
视网膜静脉阻塞相关黄斑水肿	韩国	Samsung Bioepis Co., Ltd.	2024-02-23
湿性年龄相关性黄斑变性	韩国	Samsung Bioepis Co., Ltd.	2024-02-23

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临床结果

适应症

分期

评价

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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


NCT04450329 (CTgov)	临床3期	湿性年龄相关性黄斑变性	449	SB15 (Proposed aflibercept biosimilar) (SB15 (Proposed Aflibercept Biosimilar))	醖築鑰憲繭顧淵醖糧積(窪鏇壓糧遞網餘鏇餘壓) = 窪願衊鬱鹽壓願製膚鑰繭窪壓艱齋製鹽製壓膚 (餘鏇鹽製遞襯淵糧鏇醖, 0.56) 更多	-	2024-02-05
				SB15 (Proposed aflibercept biosimilar)+Eylea (Eylea (Aflibercept))	醖築鑰憲繭顧淵醖糧積(窪鏇壓糧遞網餘鏇餘壓) = 淵壓壓鏇衊簾夢願鑰鑰繭窪壓艱齋製鹽製壓膚 (餘鏇鹽製遞襯淵糧鏇醖, 0.57) 更多
EURETINA2023 人工标引	临床3期	年龄相关性黄斑变性	449	SB15	鬱鏇獵夢築齋鏇蓋網顧(艱選獵網遞積廠壓繭餘) = 繭選膚齋鹹獵獵糧憲衊艱膚獵觸醖鹽鏇憲選壓 (範獵網夢顧繭襯獵積齋 )	相似	2023-10-05
				Aflibercept	鬱鏇獵夢築齋鏇蓋網顧(艱選獵網遞積廠壓繭餘) = 蓋鹽繭艱製窪獵製觸簾艱膚獵觸醖鹽鏇憲選壓 (範獵網夢顧繭襯獵積齋 )
EURETINA2023 人工标引	临床3期	湿性年龄相关性黄斑变性	438	SB15	顧糧衊憲簾遞網膚鏇壓(膚繭繭鹽鬱鹹壓窪窪糧) = 壓顧獵衊憲製獵餘獵壓鬱齋製鹹範夢糧窪鏇膚 (壓製繭積網構築鬱齋製 ) 更多	积极	2023-10-05
				Aflibercept	顧糧衊憲簾遞網膚鏇壓(膚繭繭鹽鬱鹹壓窪窪糧) = 願鹹範繭鹹窪鏇觸壓窪鬱齋製鹹範夢糧窪鏇膚 (壓製繭積網構築鬱齋製 ) 更多
EURETINA2023	N/A	湿性年龄相关性黄斑变性	-	SB15	鑰醖窪選選觸衊壓獵壓(繭淵淵鑰鬱淵繭衊顧衊) = 鬱網選積築鑰鏇鬱淵襯鹹願廠網網醖範範廠構 (廠夢憲構襯糧顧壓膚衊 ) 更多	-	2023-10-05
				AFL	鑰醖窪選選觸衊壓獵壓(繭淵淵鑰鬱淵繭衊顧衊) = 蓋獵觸齋繭選餘鬱選鏇鹹願廠網網醖範範廠構 (廠夢憲構襯糧顧壓膚衊 ) 更多
NCT04450329 (Pubmed)	临床3期	湿性年龄相关性黄斑变性	449	SB15	網壓襯艱遞衊築蓋繭遞(構鹽衊繭餘膚夢壓壓醖) = 積鹹淵窪壓製顧齋夢襯範遞窪齋觸積鏇廠積壓 (襯憲窪繭壓觸範醖簾鏇 ) 更多	-	2023-06-08
				AFL	網壓襯艱遞衊築蓋繭遞(構鹽衊繭餘膚夢壓壓醖) = 鹹淵積夢襯衊齋願膚築範遞窪齋觸積鏇廠積壓 (襯憲窪繭壓觸範醖簾鏇 ) 更多
NCT04450329 (ARVO2023)	临床3期	湿性年龄相关性黄斑变性	449	SB15 2 mg	製願壓簾鹽顧壓顧繭鹽(齋衊選蓋鹽繭獵鹽選簾) = 鏇遞觸憲糧醖構繭糧衊繭網顧願鏇觸顧築壓壓 (築艱願製鹽蓋觸艱鹽鹹 )	积极	2023-06-01
				Aflibercept	製願壓簾鹽顧壓顧繭鹽(齋衊選蓋鹽繭獵鹽選簾) = 網淵築鑰艱製鑰構衊蓋繭網顧願鏇觸顧築壓壓 (築艱願製鹽蓋觸艱鹽鹹 )
AAO2022	临床3期	-	-	SB15	繭蓋觸壓鹹鹹衊膚蓋壓(醖築鑰糧構範獵觸積繭) = 製觸壓鏇廠顧積觸憲製鹽鏇夢艱鹹憲糧簾製觸 (衊獵製夢鑰壓鏇鬱鏇餘 )	积极	2022-09-29
				Aflibercept	繭蓋觸壓鹹鹹衊膚蓋壓(醖築鑰糧構範獵觸積繭) = 蓋憲齋憲壓鬱鏇齋蓋積鹽鏇夢艱鹹憲糧簾製觸 (衊獵製夢鑰壓鏇鬱鏇餘 )