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

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 trial participants with nAMD, Macular Oedema Secondary to RVO, or Myopic Choroidal Neovascularization (mCNV).

开始日期2026-03-30

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.

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

2026-04-01·KLINISCHE MONATSBLATTER FUR AUGENHEILKUNDE

Switching to the Biosimilar Ranibizumab-nuna for the Intravitreal Treatment of Retinal Diseases – a Real-World Study

Article

作者: Knecht-Bosch, Pascal ; Knecht-Bösch, Martina ; Said, Sadiq

Abstract:

Introduction Following the expiration of ranibizumabʼs (Lucentis) patent, the biosimilar ranibizumab-nuna (Byooviz) offers an alternative intravitreal medication with identical indications. However, real-world data on its efficacy remain limited. This study aimed to investigate the efficacy and safety of retinal disorders in patients who were switched from Lucentis to Byooviz.Methods This retrospective, single-center study assessed adult patients previously treated with intravitreal Lucentis and switched to Byooviz. We evaluated structural and functional outcomes based on Snellen visual acuity (VA), fundoscopy, and optical coherence tomography (OCT) parameters, and treatment safety. Disease activity was classified as active or inactive, with neovascular activity defined as retinal pigment epithelial detachments, intra- or subretinal fluid, subretinal hyperreflective material, or macular hemorrhage on OCT or fundoscopy.Results Between June 2021 and December 2024, we identified 31 patients, 21 (67.7%) of whom were female. Median (IQR, range) age was 82 (76.5 to 85.5, 49 to 91) years. The most common indication was neovascular age-related macular degeneration (61.3%), followed by macular edema (ME) due to retinal vein occlusion (22.6%), diabetic ME (9.7%), and secondary choroidal neovascularization (6.5%). Right and left eyes were nearly equally represented (48.4% vs. 51.6%). The median (IQR) injection numbers were 15 (10 to 40) for Lucentis and 8 (5 to 10.5) for Byooviz. After the switch, VA improved in 8 eyes (25.8%), was unchanged in 10 (32.3%), and worsened in 13 (41.9%). Disease activity decreased in 6 eyes (20%), increased in 3 (10%), and remained stable in 22 (70%). Treatment intervals shortened in 8 (25.8%) patients and extended in 14 (45.2%). No cases of endophthalmitis or other complications occurred.Discussion Switching from Lucentis to Byooviz was generally well tolerated, with anatomical disease stability maintained in most patients. Certain decline in VA is also be observed in real-world outcomes for Lucentis and may reflect underlying disease progression rather than reduced efficacy of the biosimilar. Overall, Byooviz seems to be a viable alternative for patients previously treated with Lucentis.

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 ; Donmez, Mustafa Borga ; Cakmak, Gulce ; 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.

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

2026-09-10

·bilibili

渤健（Biogen）主要药品全球销售收入分析（2000年至2025年）

渤健主要药品全球销售收入分析渤健（Biogen Inc.）介绍及公司主要历史变迁渤健（Biogen Inc.）是主要从事创新药开发、生产、销售的领先的生物技术公司。Biogen Inc.由Charles Weissmann，Heinz Schaller，Kenneth Murray与诺贝尔奖获得者Walter Gilbert和Phillip Sharp携手在1978年成立的全球首批生物科技公司之一，主要从事神经系统领域疾病的药物开发。 1985年以后，公司对外授权的产品开始陆续获批上市，包括乙肝疫苗、乙肝诊断试剂、α干扰素和γ干扰素，1991 年四款产品总销售额达 6 亿美元，公司营收超过 6000 万美元，实现扭亏为盈。1996 年公司首款重磅产品 Avonex（干扰素β-1a）获批上市。1986年，艾弗·罗伊斯顿（Ivor Royston）与霍华·宾道夫（Howard Birndorf），在加州圣地亚哥，成立 Idec Pharmaceuticals Corporation。1991年，Idec公司于美国上市。Idec自成立以来，一直专注于CD20抗体产品的研发，1995年与基因泰克签署了Rituxan的合作研发协议。1997年，Idec与基因泰克合作的Rituxan获批上市，基因泰克和Idec共同负责美国的商业化，Zenyaku Kogyo Co. Ltd负责日本的商业化，罗氏负责美国和日本以外地区的商业化。2003年， Biogen 与 Idec Pharmaceuticals Corporation在11月合并，合并后的公司为：Biogen Idec Inc。2015年3月，为了强化和统一全球品牌，公司将名称改为Biogen Inc.。渤健在神经领域的重要合作：2013年4月，自Elan处收购了TYSABRI的商业化权利。2017年1月，与Forward Pharma A/S达成协议，获得Forward的所有知识产权的授权（包括TECFIDERA），渤健向Forward支付12.5亿美元。2017年10月，与卫材签署协议，共同开发和商业化Aducanumab，用于阿尔茨海默症。此外，还将共同开发靶向淀粉样蛋白单抗BAN2401和BACE抑制剂E2609。2019年3月，渤建公司终止了阿尔茨海默氏病药物Aducanumab的 III 期试验。然而，在2019年10月，他们撤销了计划，并表示将寻求美国FDA批准Aducanumab。渤健表示，对更大范围的患者群进行的新分析显示出令人鼓舞的结果。2018年5月，与Neurimmune的修订合作和许可协议，向Neurimmune SubOne AG 支付了5000万美元，将先前商定的特许权费降低5%，包括aducanumab（治疗AD的抗淀粉样蛋白β抗体候选药物）。2020 年 7 月 8 日，渤健和卫材宣布，两家公司已共同成功提交 Aducanumab 的 FDA 监管和营销批准。2021 年 6 月 7 日，美国监管机构批准了渤健的Aducanumab 药物治疗阿尔茨海默病，以 Aduhelm 的品牌出售。2022年3月14日，渤健修改了与卫材就Aduhelm的合作协议，拥有其商业化决定权，只获得基于净收益一定比例的特许权费。2023年7月6日，渤健和卫材合作开发的Leqembi获FDA批准。2012年1月，6月和12月，与Isis Pharmaceuticals, Inc.（后改名为Ionis）签署协议，共同开发和商业化Isis的脊髓性肌萎缩症、杜氏肌营养不良管线等。 2013年9月，与Isis Pharmaceuticals, Inc.签署了6年协议，发现和开发神经系统紊乱疾病的药物。 2017年12月，与Ionis Pharmaceuticals签署协议，开发反义寡核苷酸药物治疗进行性脊髓性肌萎缩症。 2018年6月，与Ionis Pharmaceuticals, Inc. 达成为期10年的独家协议，以开发用于广泛神经系统疾病的新型反义寡核苷酸候选药物。（与Ionis合作主要涉及Spinraza和Qalsody相关项目）。2020年12月，与Sage Therapeutics， Inc. 达成了全球合作和许可协议，共同开发和商业化用于治疗重度抑郁症、产后抑郁症和其他精神疾病的zuranolone （Sage -217）和用于治疗原发性震颤和其他神经系统疾病的Sage -324。2023年7月28日，渤健同意以每股 172.50 美元现金收购 Reata Pharmaceuticals（一家专注于开发调节细胞代谢和炎症的治疗药物的生物制药公司），2023年9月26日，完成了收购。获得了SKYCLARYS (omaveloxolone)，美国和欧盟批准的用于治疗16岁及以上成人和青少年共济失调的药物，以及其他临床和临床前管线。渤健在CD20抗体相关领域的合作：2010年10月，渤健修改了与基因泰克的开发ocrelizumab的协议，并同意共同开发GA101（Gazyva），基因泰克负责ocrelizumab的开发和商业化，渤健将收取13.5%至24%的特许权费。同时，渤健将负责35%的GA101的开发和商业化费用，将收取净收益的35%至39%。2022年1月，渤健行使了与基因泰克的选择权，参与了LUNSUMIO（mosunetuzumab）的联合开发和商业化，用于B细胞非霍奇金病的晚期双特异性抗体。渤健在仿制药领域的合作：2011年12月，与Samsung Biologics Co., Ltd.签署协议，开发生产和商业化生物仿制药。2013年12月，与Samsung Biologics达成协议，获得在欧洲抗TNF生物仿制药的权利。Samsung Bioepis是渤健与Samsung Biologics的合资企业。在2022年1月，渤健达成协议，将其在Samsung Bioepis的49.9%的股权出售给Samsung Biologics。渤健将获得10亿美元现金，以及未来的13亿美元。2021年4月，签署了商业化和许可协议，以开发，生产和商业化BAT1806，这是一种3期临床阶段抗白细胞介素6 （IL-6）受体单克隆抗体，ACTEMRA生物仿制药。向百奥泰（Bio-Thera Solutions）公司预付了3000万美元。其他重要交易：2016年12月20日，渤健董事会宣布批准将血友病业务分拆成立独立上市公司Bioverativ，预计2017年2月1日完成交割。2018年1月21日，赛诺菲以每股105美元现金，斥资116亿美元，收购Bioverativ。2023年7月28日，渤健同意以每股 172.50 美元现金收购 Reata Pharmaceuticals（一家专注于开发调节细胞代谢和炎症的治疗药物的生物制药公司），2023年9月26日，完成了收购。获得了SKYCLARYS (omaveloxolone)，美国和欧盟批准的用于治疗16岁及以上成人和青少年共济失调的药物，以及其他临床和临床前管线。2024年7月2日，渤健完成了对HI-Bio的收购，HI-Bio是私人持有的临床阶段生物技术公司，专注于严重免疫介导性疾病患者的靶向治疗。HI-Bio的主要产品felzartamab是一种抗CD38抗体，目前正在对AMR（抗体介导的排斥反应）、PMN（原发性膜性肾病）和IgAN（免疫球蛋白A肾病）这三个主要适应症进行评估。渤健2025年主要动态财务业绩方面：2025年渤健实现营业收入98.91亿美元，相比去年增长2%。药品销售收入略有下降，抗CD20业务收入以及其他业务收入略有增长。2025年美国销售收入35.48亿美元，占全部业务收入的36%。 2.渤健2025年营业收入组成渤健主要产品化合物或疗法专利最早到期时间以及市场独占期情况如下表所示： 3.渤健主要产品专利及市场独占期情况渤健于2025年官方网站披露的产品审批进度情况总结如下表，包括阿尔茨海默症药物lecanemab以及产后抑郁药物ZURZUVAE的成功获批。Lecanemab来自于与卫材的合作，ZURZUVAE来自于与Sage Therapeutics， Inc.的合作。脊髓性肌萎缩症药物Spinraza在欧盟的申请收到完整恢复函，将进一步更新信息。 4.渤健2025年国际审批情况渤健在2025年披露的合作授权方面的交易包括：与Stoke Therapeutics关于Zorevunersen（用于Dravet综合征）的授权、City Therapeutics关于RNAi触发分子用于神经系统疾病的合作、与Vanqua Bio关于C5aR1拮抗剂（用于免疫疾病）的授权以及与Dayra Therapeutics关于免疫疾病口服大环肽的合作。这些都是渤健liscence-in的项目。 5.渤健2025年合作授权情况渤健在2025年披露的收并购交易包括对Alcyone Therapeutics的收购，包括鞘内递送反义寡核苷酸的植入式皮下导管装置等，主要拟用于配合渤健的SPINRAZA给药。具体情况如下表： 6.渤健2025年收并购情况渤健在2025年披露的临床进展包括felzartamab用于肾移植受者、免疫介导疾病及膜性肾病、dapirolizumab pegol（与UCB合作项目）用于红斑狼疮、omaveloxolone用于Friedreich共济失调、BIIB080（与Ionis合作项目）以及lecanemab用于阿尔茨海默症、salanersen（Ionis合作项目）以及SPINRAZA用于脊髓性肌萎缩症、zorevunersen用于Dravet综合征（来自于与Stoke的合作）、QALSODY用于肌萎缩侧索硬化症的临床试验。渤健总体营业收入情况渤健于2000年至2025年期间的主要收入情况如下图。2000年至2002年的总营业收入数据为Idec Pharmaceuticals Corporation的收入，2003年Idec和Biogen合并后，收入数据为渤健整体的销售收入。渤健的总营业收入包括药物产品收入、联营业务收入（抗CD20项目收入）、阿尔茨海默症药品收入以及合同生产、特许权费及其他收入等。2003年，Biogen和Idec合并以前，Idec的主要收入为与基因泰克就抗CD20产品的合作收入，早期主要是Rituxan，后面随着Gazyva、Lunsumio以及Ocrevus的获批，抗CD20产品的合作收入包含了这几个品种。2003年合并之后，随着Avonex、Zevalin、Amevive等产品逐步获批，渤健开始有了药品销售收入，并且很快超越了抗CD20产品的合作收入。合同生产、特许权费以及其他销售收入在渤健的总营业收入中占比不大。2025年，渤健的产品销售收入在总营业收入的占比为71.98%。CD20产品合作收入占比为18.81%。另外，由于2023年Leqembi的获批，渤健和卫材共同分享收益，渤健可获得50%的收益，在2024年开始单独记录了此阿尔茨海默症合作药品收入（约6000万美元），2025年此品种分得的收益显著增长，为1.78亿美元。 7.渤健总营业收入情况渤健药品分类销售收入情况根据渤健每年披露的各药品分类销售收入数据如下图，渤健年报上没有披露的品种的销售收入统一归入其他类。渤健大多数年份基本上100%的品种都披露了销售收入。2003年合并后的销售收入主要以神经系统药物为主，2025年神经系统类药物占渤健药物销售收入的82.42%。2011年12月与Samsung Biologics签署协议开发生物仿制药后，2016年推出了Enbrel、Remicade的仿制药，2017年推出了Humira的仿制药。2021年和Samsung Biopies推出了Lucentis 。2023年和百奥泰推出了Actemra的生物仿制药，生物仿制药类销售收入逐年增加。血液病类药物方面，2014年推出了血友病药物Elocate和Alprolix，2016年，将血液病药物单独分拆成Bioverativ公司，此公司后续又被赛诺菲收购。2023年从Reata Pharmaceuticals收购的SKYCLARYS为渤健添加了罕见病类药物产品。 8.渤健各药品分类销售收入情况渤健披露的各药品销售收入情况根据每年渤健年报披露的主要药品销售收入情况见下图。可见，在研究期间前期，Avonex（干扰素β-1a）为主要品种，销售收入逐年增长直至2015年开始下降。2004年推出TYSABRI（那他珠单抗），销售收入逐年增长直至2022年开始略有下降，但直到2025年，仍为渤健的第一大品种。2013年推出的TECFIDERA（富马酸二甲酯），销售收入迅速增长直至2020年开始销售收入快速下降。这几款药都是用于多发性硬化症的产品。在2022年以后销售收入均进入了下降区间。2016年推出的SPINRAZA（诺西那生钠），用于脊髓性肌萎缩症，也是2020年开始销售收入逐步下滑。2019年推出的VUMERIRY（控释型富马酸单甲酯），销售收入自推出以来逐渐上涨。但此品种销售收入的增长尚不能挽回其他品种销售收入下滑的总体趋势。因此，渤健的药品销售收入在2019年达到峰值后，2020年开始进入逐渐下降的趋势。虽然渤健正积极拓展其他领域，2023年新推出了罕见病药物SKYCLARYS（omaveloxolone）、抑郁症药物ZURZUVAE（zuranolone）、肌萎缩侧索硬化症药物QALSODY（托夫生），以及几款生物仿制药，但仍未能挽回药品销售收入的下滑趋势。 9.渤健各药品销售收入情况渤健2025年药品销售收入情况根据2025年披露的各药品销售收入数据，将各药品分类，未披露销售收入数据的药品全部归入其他类。渤健2026年药品销售收入共71.194亿美元，其中神经系统类药物销售收入58.68亿美元，占药品销售收入的83%。生物仿制药销售收入7.29亿美元，占药品销售收入的10%。 11.渤健2025年分类销售收入情况渤健2025年各品种销售收入如表。前五大品种都是神经系统药物，SPINRAZA为脊髓性肌萎缩症药物，其他四个品种均为多发性硬化症药物。TYSABRI为第一大品种，2025年实现销售收入16.65亿美元，占药品销售总收入的23.39%。TYSABRI的销售收入已于2021年达峰，销售收入处于下降阶段。SPINRAZA在2025年实现销售收入15.47亿美元，占药品销售总收入的21.73%，此品种销售收入也是在2019年达峰，销售收入处于下降阶段。VUMERIRY为2019年新获批品种，销售收入处于增长阶段。SPINRAZA和QALSODY都是反义寡核苷酸药物。QALSODY为2023年获批用于肌萎缩侧索硬化症药物。ZURZUVAE也为2023年获批神经系统药物，为抗抑郁症药物。新获批品种的销售收入尚未放量，因此渤健药品销售收入还是处于缓慢下降状态。但下降速度已大幅减缓。 10.渤健2025年销售收入情况披露的神经系统类产品销售收入情况根据每年渤健披露的神经系统类产品销售收入情况整理的各单品销售收入变迁情况见下图。 12.渤健神经系统类药物品种销售收入情况 13.渤健神经系统类药物单品详细情况根据每年渤健披露的各品种销售收入情况整理，渤健于2000年至2025年的财报上披露有销售数据的神经系统类药物有11个品种，2025年销售收入约为约58.677亿美元，占渤健总药品销售收入的83%。渤健神经系统类品种包括：TYSABRI（那他珠单抗）、SPINRAZA（诺西那生钠）、VUMERIRY（控释型富马酸单甲酯）、AVONEX（干扰素β-1a）、TECFIDERA（富马酸二甲酯）、PLEGRIDY（聚乙二醇干扰素β-1a）、ZURZUVAE（zuranolone）、QALSODY（托夫生）、FAMPYRA（氨吡啶）、ADUHELM（aducanumab）以及ZINBRYTA（daclizumab）。以上药物中，用于多发性硬化症的药物包括： TYSABRI、 VUMERIRY、 AVONEX、 TECFIDERA、 PLEGRIDY、 FAMPYRA以及ZINBRYTA。其中，TYSABRI和ZINBRYTA为单抗类药物，TYSABRI为抑制淋巴细胞与内皮细胞黏附的单抗，结合除中性粒细胞以外的白细胞表面表达的α4β1和α4β7整联蛋白的α4亚基，可阻止白细胞进入中枢神经系统，减少自身免疫疾病的发作，此药物2004年获批，2021年达峰值销售额20.63亿美元。ZINBRYTA为IL-2受体亚基CD25单抗，调节IL-2信号通路，2016年获批，2017年销售收入最高，为5300万美元。富马酸甲酯类药物包括TECFIDERA以及VUMERIRY。富马酸甲酯类可激活Nrf2通路，Nrf2通路参与氧化应激的细胞应答。TECFIDERA于2013年获批，2019年达峰值销售额44.327亿美元。VUMERIRY为富马酸单甲酯控释剂型，2019年获批，销售收入仍处于增长阶段，2025年实现销售收入7.468亿美元。干扰素类药品包括AVONEX和PLEGRIDY。干扰素是内源性蛋白，具有免疫调节、抗病毒及抗增生作用。AVONEX为干扰素β-1a，1996年获批，2014年达峰值销售额30.13亿美元。PLEGRIDY为聚乙二醇化的干扰素β-1a，能延长干扰素的作用时间，2014年获批，2017年达峰值销售额4.94亿美元。FAMPYRA为广谱钾通道阻滞剂，抑制钾通道提高脱髓鞘化轴突动作电位的传导，2011年获批，2021年实现峰值销售额1.05亿美元。神经系统药物中，反义寡核苷酸类药物包括SPINRAZA以及QALSODY。SPINRAZA为用于治疗脊髓性肌萎缩症的反义寡核苷酸，用于治疗因染色体5q基因突变导致的SMN蛋白缺失。2016年获批，2019年达峰值销售额20.97亿美元。QALSODY用于肌萎缩侧索硬化症，以反义寡核苷酸技术靶向SOD1基因的疗法，2023年获批，2025年实现销售收入约8690万美元。ZURZUVAE用于抑郁症，为神经活性类固醇，可增强神经递质γ-氨基丁酸（GABA）的活性，2023年获批，2025年实现销售收入1.951亿美元。ADUHELM为用于阿尔茨海默症的单抗类药物，靶向聚集态β-淀粉样蛋白，减少大脑中淀粉样板块的沉积。2021年获批。综合来看，神经系统类药物，主要品种TYSABRI、SPINRAZA、TECFIDERA、AVONEX、PLEGRIDY以及FAMPYRA的销售收入均处于下降区间。仅VEMERIRY的销售收入处于迅速上升阶段，另外，ZURZUVAE、QALSODY和ADUHELM为近年来新推出的品种。ZURZUVAE和QALSODY的销售收入还有一定的增长空间。ADUHELM自2022年与卫材修改合作协议后，渤健仅收取特许权费。总体来看，神经系统类药物新品种销售收入的增长不能支撑成熟品种销售收入的下跌，神经系统类药物总体销售收入呈现连续下跌趋势。披露的其他药品销售收入情况根据每年渤健披露的各品种销售收入情况整理的其他类药物各单品销售收入变迁情况见下图。 14.渤健其他药品销售收入情况 15.渤健其他药物单品详细情况根据每年渤健披露的各品种销售收入情况整理，渤健生物仿制药类药物有5个品种，2025年销售收入约7.291亿美元，占渤健总药品销售收入的10%。罕见病类品种1个，2025年销售收入约5.205亿美元，占2025年总药品销售收入的7%。免疫类品种2个，血液病类品种2个，肿瘤类品种1个。这三个品类均未披露2025年销售收入。渤健的仿制药类品种包括：BENEPALI（依那西普）、IMRALDI（阿达木单抗）、FLIXABI（英夫利昔单抗）、BYOOVIZ（雷珠单抗）以及TOFIDENCE（托珠单抗）。前四个为渤健和Samsung Biologics合作的项目。BENEPALI为Enbrel的生物仿制药，用于关节炎、银屑病、强直性脊柱炎等，2016年获批，2021年达峰值销售额4.98亿美元。IMRALDI为Humira的生物仿制药，用于关节炎、银屑病、强制性脊柱炎等，2017年获批，2021年达峰值销售额2.33亿美元。FLIXABI为Remicade的生物仿制药，用于风湿性关节炎等，2016年获批，2021年达峰值销售额约9900万美元。以上三种均为人肿瘤坏死因子拮抗剂。BYOOVIZ为Lucentis的生物仿制药，用于黄斑变性、视网膜静脉阻塞、视网膜病变等眼科疾病，为血管内皮生长因子抑制剂，抑制新生血管生成，降低血管的通透性。2021年获批，2024年实现最高销售收入3660万美元。TOFIDENCE为Actemra的生物仿制药，为渤健和百奥泰的合作项目，靶向IL-6受体，抑制其介导的信号传导，用于风湿性关节炎，2023年获批，2024年实现销售收入约110万美元，2025年销售收入下降至70万美元。总体来看，渤健的生物仿制药类品种上市后销售收入很快就进入下降趋势，这和仿制药类的激烈市场竞争有关。渤健的整体生物仿制药类销售收入在2021年达到高峰，之后缓慢下降。新品种的推出使得仿制药销售收入有略微的回升。渤健罕见病类品种为SKYCLARYS（omaveloxolone），为自Reata Pharmaceuticals收购的品种，用于弗里德赖希共济失调症，属于Nrf2激动剂，可通过恢复线粒体功能，降低氧化应激，抑制促炎信号而减轻炎症反应。2023年获批，2024年实现销售收入约3.83亿美元，2025年销售收入增长至5.205亿美元，未来还有很大的增长潜力。渤健免疫类品种包括：FUMADERM（富马酸二甲酯、富马酸氢乙酯、钙盐、镁盐、锌盐）以及AMEVIVE（阿法塞特）。FUMADERM也为富马酸甲酯类药物，可激活Nrf2通路。用于中度至重度寻常型银屑病。1994年获批，2014年实现最高销售额约6300万美元。AMEVIVE为免疫抑制剂二聚物融合蛋白，为人类白细胞功能相关抗原-3与CD2结合的细胞外部分与人类IgG1的Fc部分结合而成，抑制LFA-3与CD2相互作用，影响淋巴细胞活化，用于银屑病。2003年获批，2005年最高销售额为4800万美元。免疫类品种均为老品种，销售收入近年来未进行披露。渤健血液病类品种包括：ELOCTATE（重组抗血友病因子Fc融合蛋白）和ALPROLIX（艾诺凝血素α），用于血友病控制出血。ELOCTATE为抗血友病因子融合蛋白，2014年获批，2016年最高销售额为5.13亿美元。ALPROLIX为重组凝血因子IX融合蛋白，2014年获批，2016年最高销售额为3.34亿美元。渤健的血友病业务于2017年分拆出来，成立独立上市公司Bioverativ。此上市公司于2018年被赛诺菲收购。渤健肿瘤类品种包括ZEVALIN（替伊莫单抗），用于非霍奇金淋巴瘤，为放射性同位素偶联物，为单克隆抗体ibritumomab和连接物螯合剂tiuxetan经硫脲共价键结合而成。螯合剂对111In和90Yb具有高亲和力。与In和Yb结合的螯合剂与抗体的裸露赖氨酸和精氨酸结合，放射性射线可杀伤癌细胞。此药物2002年获批，2004年最高销售额为2300万美元。总体来看，其他药物品类，生物仿制药销售收入处于略微下降阶段。罕见病类品种为2023年新推出品种，销售收入有很大增长潜力。渤健2025年各单品销售收入增长情况渤健2025年各药品销售收入增长情况如表。渤健2025年总药品销售收入相比2024年降低了9410万美元（降低1.30%）。其中大多数老品种，包括TYSABRI、SPINRAZA、AVONEX、TECFIDERA、BENEPALI、PLEGRIDY、IMRALDI、FLIXABI 、FAMPYRA的销售收入均处于下降趋势。近年来新推出的品种，VUMERIRY、SKYCLARYS、ZURZUVAE以及QALSODY等增长较好。新推出的生物仿制药类品种BYOOVIZ和TOFIDENCE在2025年销售收入略有下降。 16.渤健各药品2025年销售收入增长情况渤健主要以神经系统药物为主，而神经系统药物里主要以治疗多发性硬化症药物为主。但由于近年来，多发性硬化症类品种销售收入降低较为明显，渤健通过大量的并购，试图寻找其他的能带动其药品销售收入增长的新品。近年来通过收购获得的罕见病药物SKYCLARYS、抑郁症药物ZURZUVAE，为挽回渤健药品销售收入下降的趋势起到了显著作用。SKYCLARYS的收购为渤健2024年的销售收入带来了3.266亿美元的增长，2025年销售收入增长了1.38亿美元。与Samsung Biologics等在生物仿制药方面的尝试也为拉动销售收入增长贡献了一定的力量。2023年推出的QALSODY未来有一定的销售收入增长趋势。VUMERIRY在2025年销售收入增长了1.19亿美元，相比2024年增长了18.92%。ZURZUVAE2025年销售收入有明显的放量，相比2024年增长了1.23亿美元，增长了170.22%。总体来看，渤健近年来的新品尝试一定程度上缓解了神经系统药物销售收入的下降，但2025年还没有能彻底扭转局面。渤健CD20合作项目收入情况1995年3月，渤健与基因泰克签署合作协议，开发CD20抗体类产品。1997年，首个合作产品RITUXAN获批，渤健与基因泰克约定，其与基因泰克共同负责美国的商业化，渤健将分享美国的销售收入，分享比例在30%~40%之间，比例随着是否达成某些条件进行调整。美国以外部分区域，渤健有权获得特许权费。后续的获批产品GAZYVA和LUNSUMIO，渤健和基因泰克的合作模式均类似，渤健均分享美国收益的30%~40%，美国以外部分区域获得特许权费。2017年获批的OCREVUS也是双方合作项目，但渤健只是获得特许权费，美国的特许权费比例为13.5%至24%，美国以外区域为3%。渤健的CD20合作项目收入主要为收益分成和特许权费收入。渤健和基因泰克的合作是在Biogen和Idec合并之前就开始的，开始主要为Idec与基因泰克进行的合作。在尚未有药品上市之前，Idec的销售收入主要以CD20的合作收入为主。2003年，Biogen和Idec合并后，渤健陆续有药物获批上市，之后CD20的合作收入在渤健总营业收入中的占比迅速减少。但后续，由于渤健药品销售收入的快速下降，CD20的合作收入占比略有提升。2025年，CD20合作收入占渤健总营业收入的比例达18.81%。 17.渤健CD20合作业务收入组成渤健与基因泰克的CD20合作项目涵盖的药物单品如下。最先获批的为1997年的Rituxan（利妥昔单抗，美罗华），主要用于淋巴瘤，为人鼠嵌合CD20单抗。随后2013年，Gazyva（奥妥珠单抗，佳罗华）获批，用于滤泡性淋巴瘤。2017年，Ocrevus（奥瑞利珠单抗，罗可适）获批，与Rituxan和Gazyva不同，Ocrevus的合作中，渤健主要收取特许权费。而Rituxan和Gazyva以及后来获批的Lunsumio，渤健参与程度更高，收取更高比例的销售收益分成。Ocrevus主要用于多发性硬化症，2022年Lunsumio（莫妥珠单抗，皓罗华）获批，可结合T细胞CD3受体以及淋巴细胞表达的CD20受体，为双特异性抗体，用于滤泡性淋巴瘤。 18.渤健CD20合作项目各药物单品详细情况2024年以来，渤健还列出了和卫材的阿尔茨海默症的合作收入，此合作主要基于2023年获批的Leqembi（仑卡奈单抗，乐意保），为淀粉样蛋白单抗，2024年1月已在中国获批。渤健和卫材各自享有项目50%的收益。总结渤健于自1978年成立，Idec于1986年成立，2003年两者合并后，成为今天的渤健。渤健自成立以来，一直主要致力于神经系统疾病的研究。陆续推出多款多发性硬化症品种。在研究初始阶段，2000年至2002年，这里的数据为Idec的公司数据。此时Idec还没有药品获批上市，主要收入为与基因泰克的CD20产品合作收入。2003年，Biogen和Idec合并后，陆续推出了Avonex、Zevalin、Amevive等几款药品，渤健则主要以药品销售收入为主。渤健和基因泰克的CD20合作收入也在快速增长。随着合作产品仿制药的推出，2019年合作收入达到峰值。同时，渤健的药品销售收入也在2019年达到峰值，2020年，渤健的药品销售收入以及CD20合作收入都进入了下降区间。但CD20合作收入由于后续Lunsumio的推出以及Ocrevus分享的收益增加，合作收入近年来有所增长。在药品销售收入方面，虽然渤健后续也大量推出了SKYCLARYS、ZURZUVAE、QALSODY和ADUHELM等新品种，但由于新品种销售收入的放量还需要一段时间，因此，渤健到目前仍未挽回产品销售收入的下降趋势。2025年，渤健的药品销售收入相比2024年下降1.30%，但总营业收入由于CD20合作收入相比2024年有所增长，另外阿尔茨海默症药品收入在2025年也有所增长，因此2025年渤健的总营业收入相比2024年增长了2%。总体来看，渤健总营业收入于2019年达到峰值143.78亿美元后，由于多款神经产品面临的市场竞争等原因，导致总体销售收入近年来一直处于下降态势，2024年总营业收入已降至96.76亿美元。但渤健已在积极自其他公司收购创新品种，力图以推出新品挽回销售收入的下降。虽然药品销售收入还在下降，但由于药品销售收入下降放缓，CD20合作收入还有阿尔茨海默症药品Leqembi的推出，使得渤健的总营业收入在2025年略有增长。未来还是需要观察新品推出的效果，有望使得渤健改变药品销售收入持续下降的趋势。渤健主要药品全球销售收入数据整理（2000年至2025年）详见： UP主的推荐渤健(Biogen)主要药品全球销售收入数据整理(2000年至2025年) ¥2.85起去看看关注公众号（乙酰水杨酸投研），加入知识星球（阿司匹林投研），可下载本文的可编辑图表excel文件

2026-07-28

·BioSpace

Samsung Bioepis and Harrow Present Interim Data from a Large-Scale Post-Marketing Surveillance Study on SB11 (BYOOVIZ® / AMELIVU®), a Biosimilar to Lucentis (ranibizumab), at ASRS 2026

A real-world PMS study based on a large population demonstrates comparable safety pro SB11 (BYOOVIZ ® / AMELIVU ® ) to reference ranibizumab In treatment-naïve patients, SB11 provided functional and anatomical improvements, while BCVA and CST were well maintained in patients who were switched from other anti-VEGF treatments to SB11, adding clinical confidence in using SB11 INCHEON, Korea and NASHVILLE, Tenn., July 20, 2026 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, presented interim data from a post-marketing surveillance (PMS) study on SB11 (US brand name: BYOOVIZ ® , Korea brand name: AMELIVU ® ), a biosimilar referencing Lucentis 1 , at the 44 th Annual Meeting of the American Society of Retina Specialists (ASRS), held in Montréal, Canada, July 15–18, 2026. “The interim results from this large-scale post-marketing surveillance study reinforce the comparable safety pro SB11 to reference ranibizumab. Importantly, the study demonstrated clinically meaningful efficacy improvement in treatment-naïve patients while maintaining efficacy in those switched from other anti-VEGF therapies,” said Donghoon Shin, Executive Vice President and Head of Clinical Sciences Division, Samsung Bioepis. "At Samsung Bioepis, we are committed to generating robust real-world evidence that can support retinal specialists in making informed treatment decisions for their patients." "We believe this post-marketing surveillance data further strengthens the clinical foundation supporting BYOOVIZ, reinforcing the confidence retina specialists can have in this biosimilar option — both in treatment-naïve patients and those transitioning from other anti-VEGF therapies," said Mark L. Baum, Chief Executive Officer of Harrow. "We're grateful for our collaboration with Samsung Bioepis in generating this evidence, and we remain committed to giving physicians the data they need to prescribe with confidence." This open-label, prospective, multicenter, observational, Phase 4 PMS study, initiated in May 2022 and completed in May 2026, was designed to evaluate real-world safety and efficacy data for SB11 by evaluating a large patient population from a PMS study conducted in Republic of Korea. The interim report includes data from 298 patients (182 treatment-naïve, 116 switched) out of 305 patients who had been enrolled in the study as of the interim data cutoff. To reflect real-world practice, treatment interval was determined at the investigator’s discretion, and the study followed up with patients up to 24 weeks after the first dose. Efficacy was assessed by best-corrected visual acuity (BCVA) and central subfield thickness (CST), with subgroup analyses by treatment status (naïve/switched). Safety was evaluated by the incidence of adverse events. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); The mean (standard deviation; SD) BCVA improved by -0.10 (0.29) in the treatment-naïve patients and -0.03 (0.24) in switched patients (P= 0.0239). Mean (SD) CST improved by -95 (125) µm in the treatment-naïve patients and -53 (108) µm in switched patients (P= 0.0168). Across different indications, there was no statistically significant difference in BCVA (P=0.6312) and CST (P=0.1686) outcome. In contrast, disease duration was significantly associated with BCVA (P= 0.0003) and CST (P=0.001) outcomes, suggesting that earlier treatment may lead to a better visual prognosis. No new safety concerns were identified. Title: Efficacy and Safety of SB11 in Treatment-Naïve and Switched Patients with Retinal Diseases: Interim Results from a Post-Marketing Surveillance Study Authors: Hyun Seung Yang, Se Joon Woo, Christopher Seungkyu Lee, Hyung-Il Kim, Kyu-Seop Kim, Kwan Hyuk Cho, Kwang Soo Kim, Inkyung Oh, Mercy Yeeun Kim, Juntae Kim, Daniel Duck-Jin Hwang Presentation Type: paper on demand (Category: POD 1: AMD – Neovascular) About BYOOVIZ BYOOVIZ (ranibizumab-nuna) injection, for intravitreal use is a biosimilar to LUCENTIS (ranibizumab injection) INDICATIONS AND USAGE BYOOVIZ, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Myopic Choroidal Neovascularization (mCNV) IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Ocular or periocular infections Hypersensitivity WARNINGS AND PRECAUTIONS Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection Increases in intraocular pressure (IOP) have been noted both pre- and post intravitreal injection There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors ADVERSE REACTIONS The most common adverse reactions (reported more frequently in ranibizumab treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP Please see full Prescribing information 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 Harrow Harrow, Inc. (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America, offering a comprehensive portfolio of products that address conditions affecting both the front and back of the eye, such as dry eye disease, wet (or neovascular) age-related macular degeneration, cataracts, refractive errors, glaucoma and a range of other ocular surface conditions and diseases of the retina. Harrow was founded with a commitment to deliver safe, effective, accessible, and affordable medications that enhance patient compliance and improve clinical outcomes. For more information about Harrow, please visit harrow.com and connect with us on LinkedIn . Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, risks related to: liquidity or results of operations; our ability to successfully implement our business plan, develop and commercialize our products, product candidates and proprietary formulations in a timely manner or at all, identify and acquire additional products, manage our pharmacy operations, service our debt, obtain financing necessary to operate our business, recruit and retain qualified personnel, manage any growth we may experience and successfully realize the benefits of our previous acquisitions and any other acquisitions and collaborative arrangements we may pursue; competition from pharmaceutical companies, outsourcing facilities and pharmacies; general economic and business conditions, including inflation and supply chain challenges; regulatory and legal risks and uncertainties related to our pharmacy operations and the pharmacy and pharmaceutical business in general, including the ongoing communications with the U.S. Food and Drug Administration relating to compliance and quality plans at our outsourcing facility in New Jersey; physician interest in and market acceptance of our current and any future formulations and compounding pharmacies generally. These and additional risks and uncertainties are more fully described in Harrow’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2025, and other filings with the SEC. Such documents may be read free of charge on the SEC's web site at sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. MEDIA CONTACT – Samsung Bioepis Anna Nayun Kim, nayun86.kim@samsung.com Yoon Kim, yoon1.kim@samsung.com MEDIA CONTACT – Harrow Mike Biega Vice President of Investor Relations and Communications mbiega@harrowinc.com 617-913-8890 1 Lucentis is a trademark of Genentech.

临床结果临床3期

2026-07-20

·BioSpace

Harrow Highlights Growing Clinical Evidence Supporting IHEEZO® and BYOOVIZ® at ASRS 2026 Annual Meeting

NASHVILLE, Tenn., July 20, 2026 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, today announced the presentation of three studies supporting IHEEZO ® (chloroprocaine HCl ophthalmic gel 3%), a broadly labeled low viscosity ocular anesthetic gel, and BYOOVIZ ® (ranibizumab-nuna) i , an FDA-approved biosimilar referencing LUCENTIS ii (ranibizumab) at the American Society of Retina Specialists (ASRS) 2026 Annual Meeting. Collectively, the presentations expand the growing body of clinical and real-world evidence supporting Harrow's retina portfolio and reinforce Harrow’s commitment to generating quality evidence that strengthens physician confidence, improves patient experience, and supports long-term product adoption and innovation. “ASRS is one of the premier scientific meetings in retina, and we're excited to share data that continues to strengthen the foundation supporting our growing retina franchise,” said Mark L. Baum, Chief Executive Officer of Harrow. “We believe durable commercial success is built on strong clinical evidence, generated before FDA-approval, and then robust supportive data sets subsequently produced. These studies further expand the evidence supporting IHEEZO while adding to the growing body of real-world experience for BYOOVIZ, reflecting our long-term commitment to retina specialists and the patients they treat.” One presentation highlighted interim findings from an investigator-initiated, prospective, randomized study of 150 patients comparing IHEEZO versus subconjunctival lidocaine. While these preliminary data represent an early look at the data, investigators observed encouraging trends toward less post-procedure pain, a better post-injection patient experience, and fewer ocular symptoms through 24 hours following intravitreal injection among patients treated with IHEEZO. Harrow believes these early findings provide an encouraging signal supporting further investigation in a larger patient population. Importantly, Harrow continues to enroll QUELL, a prospective, randomized, multi-center clinical trial of approximately 236 subjects that is being conducted under an active Investigational New Drug (IND) application. QUELL is designed to generate robust clinical evidence evaluating post-injection pain, patient experience, procedural performance, and safety in a substantially larger patient population, with topline data expected in the fourth quarter of 2026. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Another real-world study retrospectively evaluated whether IHEEZO's proprietary low-viscosity gel formulation interferes with antisepsis when used with chlorhexidine before intravitreal injection. Across nearly 20,000 injections, investigators observed no evidence of an increased endophthalmitis risk compared with a legacy tetracaine/povidone-iodine preparation. Although retrospective and not intended to demonstrate statistical superiority, the findings provide further confidence that physicians can realize the patient-experience benefits of IHEEZO's low-viscosity gel formulation without introducing additional procedural risk associated with antisepsis. “These studies help build the scientific foundation supporting IHEEZO,” said Amir Shojaei, Chief Scientific Officer of Harrow. “The early interim randomized data suggest the potential to improve the patient experience, while the large real-world analysis provides reassuring evidence regarding procedural safety. We look forward to completing enrollment in QUELL, which we believe will provide the most comprehensive evaluation of IHEEZO in retina to date.” Finally, Samsung Bioepis presented interim findings from a large-scale, real-world post-marketing surveillance study of BYOOVIZ. Full results from this study are being announced jointly with Samsung Bioepis today. “Between the continued expansion of the clinical evidence supporting IHEEZO, the recent launch of BYOOVIZ, and the ongoing growth of our retina franchise, we believe Harrow is increasingly well-positioned as a trusted long-term partner to retina specialists,” Baum concluded. “We appreciated the opportunity to engage with physicians throughout ASRS and look forward to sharing additional updates later this year.” IHEEZO ® (chloroprocaine hydrochloride ophthalmic gel) 3%, for topical ophthalmic use INDICATIONS AND USAGE IHEEZO is an ester anesthetic indicated for ocular surface anesthesia. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS IHEEZO is contraindicated in patients with a history of hypersensitivity to any component of this preparation WARNINGS AND PRECATIONS Not for Injection or Intraocular Administration. Corneal Injury Due to Insensitivity. Corneal Opacification For Administration by Healthcare Provider: IHEEZO is not intended for patient self-administration ADVERSE REACTIONS Most common adverse reaction is mydriasis (approximately 25%) Please see full Prescribing information BYOOVIZ ® (ranibizumab-nuna) injection, for intravitreal use is a biosimilar to LUCENTIS (ranibizumab injection) INDICATIONS AND USAGE BYOOVIZ, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Myopic Choroidal Neovascularization (mCNV) IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Ocular or periocular infections Hypersensitivity WARNINGS AND PRECAUTIONS Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection Increases in intraocular pressure (IOP) have been noted both pre- and post intravitreal injection There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors ADVERSE REACTIONS The most common adverse reactions (reported more frequently in ranibizumab treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP Please see full Prescribing Information About Harrow Harrow, Inc. (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America, offering a comprehensive portfolio of products that address conditions affecting both the front and back of the eye, such as dry eye disease, wet (or neovascular) age-related macular degeneration, cataracts, refractive errors, glaucoma and a range of other ocular surface conditions and diseases of the retina. Harrow was founded with a commitment to deliver safe, effective, accessible, and affordable medications that enhance patient compliance and improve clinical outcomes. For more information about Harrow, please visit harrow.com and connect with us on LinkedIn . 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 . Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, risks related to: liquidity or results of operations; our ability to successfully implement our business plan, develop and commercialize our products, product candidates and proprietary formulations in a timely manner or at all, identify and acquire additional products, manage our pharmacy operations, service our debt, obtain financing necessary to operate our business, recruit and retain qualified personnel, manage any growth we may experience and successfully realize the benefits of our previous acquisitions and any other acquisitions and collaborative arrangements we may pursue; competition from pharmaceutical companies, outsourcing facilities and pharmacies; general economic and business conditions, including inflation and supply chain challenges; regulatory and legal risks and uncertainties related to our pharmacy operations and the pharmacy and pharmaceutical business in general, including the ongoing communications with the U.S. Food and Drug Administration relating to compliance and quality plans at our outsourcing facility in New Jersey; physician interest in and market acceptance of our current and any future formulations and compounding pharmacies generally. These and additional risks and uncertainties are more fully described in Harrow’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2025, and other filings with the SEC. Such documents may be read free of charge on the SEC's web site at sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Contacts: Mike Biega Vice President of Investor Relations and Communications mbiega@harrowinc.com 617-913-8890 i Byooviz is a trademark of Samsung Bioepis Co., Ltd. ii Lucentis is a trademark of Genentech, Inc.

临床结果

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,

后查看更多信息

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

评价

查看全部结果

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	製糧窪鬱夢廠鬱鏇淵鬱 = 獵鏇膚廠製壓觸蓋襯衊範憲簾獵遞築製鹽壓憲 (糧憲窪顧顧憲網鑰網窪, 獵鹽蓋醖襯鹹醖顧構遞 ~ 鹽觸餘鬱糧醖餘築築壓) 更多	-	2024-12-30
EURETINA2023	N/A	-	-	SB11	醖鬱淵憲膚簾夢獵壓選(糧壓膚築鏇醖繭餘夢網) = 鏇築醖獵觸觸廠鏇構範範顧築遞鹽夢齋艱繭糧 (襯願蓋蓋窪築蓋膚夢觸 )	-	2023-10-05
				rRBZ	醖鬱淵憲膚簾夢獵壓選(糧壓膚築鏇醖繭餘夢網) = 簾築鹽醖壓糧鏇膚鬱膚範顧築遞鹽夢齋艱繭糧 (襯願蓋蓋窪築蓋膚夢觸 )
APAO2023	临床3期	年龄相关性黄斑变性	705	SB11 (BYOOVIZ, Ranibizumab-Nuna)	壓構獵醖鏇窪鹹憲願築(餘鬱繭鑰夢簾艱選築襯) = 餘築簾築襯觸襯夢鬱製構構繭蓋蓋壓壓顧顧範 (構鹽壓齋顧齋鬱鏇憲繭, 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	製廠衊憲糧糧齋鑰廠願(蓋繭襯衊積築餘鬱顧壓) = IOI-related events occurred in 1 of 32 overall ADA-positive participants (3.1%) and 4 of 620 overall ADA-negative participants (0.6%) 鑰築願壓獵製壓蓋淵簾 (餘顧廠簾鹹遞鬱觸衊鹽 ) 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))	簾構鬱構簾顧醖構壓觸(網齋夢醖糧簾獵膚醖簾) = 積選鏇遞襯範網顧製艱遞選獵範構鏇鹽鹹夢夢 (衊網鑰築遞積選遞網觸, 0.51) 更多	-	2021-05-21
				ranibizumab+Lucentis (Lucentis (Ranibizumab))	簾構鬱構簾顧醖構壓觸(網齋夢醖糧簾獵膚醖簾) = 網醖壓窪壓餘鑰鏇願鏇遞選獵範構鏇鹽鹹夢夢 (衊網鑰築遞積選遞網觸, 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	餘鬱鑰餘顧艱鏇艱網簾(範艱餘餘積夢糧窪艱壓) = 願膚壓糧膚構鑰糧範衊鏇膚艱蓋鏇壓夢範選範 (餘艱範膚鹹鹽製選鹽窪 ) 更多	相似	2021-01-01
				Ranibizumab	餘鬱鑰餘顧艱鏇艱網簾(範艱餘餘積夢糧窪艱壓) = 繭簾積鹹積鹹簾遞齋鬱鏇膚艱蓋鏇壓夢範選範 (餘艱範膚鹹鹽製選鹽窪 ) 更多
AAO2020	临床3期	-	705	SB11	鹽醖簾簾鑰憲鹹積範衊(餘憲艱壓鬱鏇製構選夢) = 蓋膚鹹夢鏇鏇襯鑰齋鑰壓餘窪構襯選齋齋糧範 (鹹鏇選繭糧構構齋願淵, 0.76)	积极	2020-11-13
				Ranibizumab	鹽醖簾簾鑰憲鹹積範衊(餘憲艱壓鬱鏇製構選夢) = 鏇壓獵壓鑰憲齋齋艱願壓餘窪構襯選齋齋糧範 (鹹鏇選繭糧構構齋願淵, 0.74)