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.

100 项与阿柏西普生物类似药 (Samsung Bioepis) 相关的临床结果

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100 项与阿柏西普生物类似药 (Samsung Bioepis) 相关的转化医学

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100 项与阿柏西普生物类似药 (Samsung Bioepis) 相关的专利（医药）

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

2026-04-01·DRUGS & AGING

Anti-Vascular Endothelial Growth Factor Biosimilars for Use in the Aging Eye

Review

作者: Kuppermann, Baruch D ; Sharma, Ashish ; Sheth, Jay U

Anti-vascular endothelial growth factor (anti-VEGF) therapies have revolutionized the treatment of neovascular age-related macular degeneration (nAMD), a leading cause of vision loss, in addition to other retinal vascular diseases such as diabetic macular edema (DME), retinal vein occlusions (RVO). Biosimilars, which are nearly identical versions of original biologic drugs, offer a promising alternative to these costly treatments. Several biosimilars for anti-VEGF drugs including bevacizumab, ranibizumab, and aflibercept are in various stages of development and approval (e.g. Afilivu, Yesafili, Enzeevu, Ahzantive, AVT-06, ABP 938, and ALT L9). These biosimilars have shown comparable results in improving visual acuity and reducing retinal fluid in patients with nAMD but their adoption in clinical practice faces challenges, including regulatory hurdles, physician and patient acceptance, and the need for extensive post-marketing surveillance to monitor long-term safety and efficacy. However, as more data becomes available and biosimilars gain approval, they are expected to become an integral component in the management of nAMD. This review explores the current landscape of anti-VEGF biosimilars, their clinical efficacy, safety profiles, and the economic implications for treating the aging eye. It also addresses the challenges and future directions in the integration of biosimilars into routine ophthalmic practice.

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 ; Tóth-Molnár, Edit ; Enyedi, Lajos ; Patel, Sunil ; Wylegala, Edward ; Veith, Miroslav ; Astakhov, Sergei ; Woo, Se Joon ; 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.

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

2026-07-24

·BioSpace

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

Samsung Bioepis reports revenue of 847.1 billion KRW and an operating profit of 230.6 billion KRW in the first half of 2026, recording 6% year-over-year growth Expanding direct commercialization in Europe to five products with the launch of OPUVIZ™ 40 mg/mL vial, a biosimilar to Eylea 1 (aflibercept) First to announce preliminary results from Phase 1, 3 clinical studies for SB27, a biosimilar candidate referencing Keytruda 2 (pembrolizumab) Samsung Epis Holdings continuing to secure next-generation growth engines through establishment of a global R&D hub in China INCHEON, Korea--(BUSINESS WIRE)-- #biosimilars --Samsung Epis Holdings (KRX: 0126Z0), an investment company dedicated to innovations in biopharmaceuticals and biotechnology, today announced its financial results for the second quarter and first half of fiscal year 2026. “We delivered solid first-half 2026 results, achieving 6% growth year-over-year. This performance demonstrates the resilience of our biosimilar portfolio in the global market," said Kyung-Ah Kim, President and Chief Executive Officer (CEO) of Samsung Epis Holdings. “We remain confident in our growth trajectory; increasing product demand in Europe and the US is expected to be reflected sequentially in the second-half results, which would result in steady business performance for the fiscal year.” Second Quarter and First Half 2026 Results – Samsung Bioepis Samsung Bioepis, a 100% owned subsidiary of Samsung Epis Holdings, recorded revenue of 847.1 billion KRW and an operating profit of 230.6 billion KRW in the first half of 2026. This represents an increase of 45.5 billion KRW (+6%) in revenue and 12.8 billion KRW (+6%) in operating profit compared to the same period last year. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); For the second quarter, the company recorded revenue of 392.2 billion KRW and an operating profit of 86.6 billion KRW; revenue and operating profit decreased by 8.8 billion KRW (-2%) and by 3.2 billion KRW (-4%) respectively compared to the same period last year. [Samsung Bioepis Earnings, KRW billion] H1’25 H1’26 YoY Change Q2’25 Q2’26 YoY Change Revenue 801.6 847.1 45.5 (+6%) 401.0 392.2 -8.8 (-2%) Operating Profit 217.8 230.6 12.8 (+6%) 89.8 86.6 -3.2 (-4%) Business Updates Samsung Bioepis has expanded direct commercialization in Europe to five products with the launch of OPUVIZ (aflibercept) 40 mg/mL vial in May 2026. In the US, the company has expanded its market presence with the introduction of OSPOMYV ® (denosumab-dssb). Furthermore, the company is expanding its commercial footprint in international markets, including Japan where it launched its first biosimilar product in May 2026 through partnership with NIPRO Corporation. The company also announced the expansion of its global development and commercialization agreement with Organon to commercialize PYZCHIVA ® (ustekinumab), a biosimilar referencing Stelara 3 (ustekinumab), in Canada. In June 2026, the company announced preliminary results from Phase 1 and Phase 3 clinical studies for SB27, a biosimilar candidate referencing Keytruda (pembrolizumab). Phase 1 study demonstrated pharmacokinetic (PK) equivalence between SB27 and Keytruda while Phase 3 study demonstrated equivalent objective response rate (ORR) at Week 24. Both studies are expected to be completed within 2026. SBE303, the company's first novel antibody-drug conjugate (ADC) candidate, entered the global Phase 1 clinical study in March. SBE303 is engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumor cells, including urothelial cancer, lung cancer, and breast cancer. Nonclinical characterization of SBE303 was presented at the 2026 American Association for Cancer Research (AACR) Annual Meeting in April, highlighting its anti-tumor efficacy, safety, tolerability pro a promising ability to work in combination with existing immuno-oncology therapies. Second Quarter and First Half 2026 Results – Samsung Epis Holdings Samsung Epis Holdings recorded consolidated revenue of 845.8 billion KRW and an operating profit of 149.3 billion KRW in the first half of 2026, reflecting non-cash accounting adjustments. For the second quarter, the company achieved revenue of 391.9 billion KRW and an operating profit of 58.8 billion KRW. Samsung Epis Holdings is stabilizing its business under the holding company structure based on the solid performance of its core subsidiary, Samsung Bioepis, and established its first overseas R&D base in China to strengthen its novel therapeutic development capabilities. Disclaimer This document contains ‘forward-looking statements’ regarding future expectations, projections, plans, and anticipation. ‘Forward-looking statements’ are matters that pertain to the Company’s future business and financial performance, and are subject to uncertainties such as trends in domestic and international financial markets, including but not limited to fluctuations in exchange rates and/or interest rates. ‘Forward-looking statements,’ by their nature, addresses matters that may be uncertain; actual results may be materially different from those expressed in this document. About Samsung Epis Holdings Co., Ltd. As an investment holdings company dedicated to biopharmaceuticals and biotechnology, Samsung Epis Holdings aims to maximize corporate and shareholder value through proactive R&D and investment and optimize business strategies for its subsidiaries, Samsung Bioepis and Epis NexLab. Samsung Epis Holdings continues to embrace future challenges and drive innovation by identifying new growth drivers and strengthening global collaboration platforms, thereby laying a solid foundation for the continued growth of its subsidiaries. For more information about Samsung Epis Holdings, please visit: . About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. As a wholly owned subsidiary of Samsung Epis Holdings, Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit and follow us on LinkedIn and X . 1 Eylea is a trademark of Bayer AG 2 Keytruda is a trademark of Merck Sharp & Dohme. 3 Stelara is a trademark of Johnson & Johnson Corporation. Contacts Media Contact Anna Nayun Kim, nayun86.kim@samsung.com Yoon Kim, yoon1.kim@samsung.com

2026-07-23

·臻视特咨询

全球眼科战略情报周报（7月6-12日）

发布日期：2026年7月12日 Produced by: ZhenSight LLC | Ophthalmology innovation, BD & market strategy 1. 执行摘要 2026年7月6日至7月12日这一周，眼科领域最值得关注的变化不是新批准，而是多个赛道同时出现监管去风险、平台合作和资本配置前移。最清楚的主线来自遗传性retina、角膜再生、老视矫正IOL、wet AMD递送路径，以及近视管理证据的继续外溢。 7月6日，Opus Genetics宣布FDA已就OPGx-LCA5的III期注册设计达成一致，并给出基于6个月疗效数据推进BLA的潜在路径。[1][2] 7月7日，Emmecell的EO2002获得RMAT认定；7月8日，OKYO Pharma表示FDA反馈支持urcosimod用于神经病理性角膜痛的III期路径。[3][4] 这些事件共同说明，当前眼科创新的价值正在更多由“监管路线是否清晰”来决定，而不只是由机制是否新颖来决定。在手术与器械策略上，Alcon与RxSight宣布合作开发可调节的老视矫正人工晶状体，RxSight将获得6000万美元首付款及后续里程碑付款。[5] 与此同时，Cascade Prodrug与Uneedle扩大合作，推进CPD100在wet AMD中的suprachoroidal递送，说明给药路径创新仍然是眼科竞争中的独立变量，即便项目尚未进入人体疗效验证阶段。[6] 本周中国本土眼科创新headline相对上周偏少，但中国仍通过近视和筛查研究保持战略存在感。一项中国学校筛查研究提示，风险预测可显著减少不必要的预防性干预；CHAMP-UK则进一步证明0.01%阿托品的价值不只局限于东亚人群。[10][11] 7月9日，Bausch + Lomb公布BL1107青光眼II期未达视觉功能主要终点，并停止该滴眼液适应症；公司同时把项目重心转向GA持续释放植入物，计划2028年启动临床。[15] 这一事件强化了本期判断：管线价值不仅取决于机制，还取决于终点能否证明患者获益，以及失败后能否迅速重组资产与开发路径。中国监管侧也出现了研发工具层面的重要变化。7月7日，CDE就推进新方法研究和应用试点计划“先锋计划”公开征求意见，拟推动类器官、器官芯片等NAMs进入药物研发和非临床评价。对眼科而言，这为视网膜、角膜及眼表人源模型用于药效、毒性和递送评价提供了潜在监管协作路径，但现阶段仍是征求意见和试点设计，不等同于相关数据已可替代既有注册要求。[16] 2. 疾病领域情报 2.1 视网膜疾病覆盖子领域：wet AMD、dry AMD、geographic atrophy、diabetic retinopathy、diabetic macular edema、retinal vein occlusion、inherited retinal diseases等高影响力视网膜疾病。科学进展本报告期内未见达到纳入阈值的重大基础科学、临床前或临床研究论文。论文主要结论：本周无符合时间窗和重要性标准的论文，因此不以历史文献补位。对眼科创新的意义：维持时间边界比填满栏目更重要；相关领域继续跟踪，待出现当周高质量证据后再作分析。研发进展 7月6日，Opus Genetics宣布FDA已就OPGx-LCA5用于LCA5相关遗传性视网膜病的III期注册设计达成一致，并给出基于6个月疗效数据推进BLA申报的潜在路径。[1][2] 7月9日，Atsena选择ATSN-401作为Stargardt病基因治疗的主导候选项目并推进至IND enabling阶段，说明full-length ABCA4递送仍是遗传性黄斑病的重要攻关方向。[8] 市场动态本周retina市场层面更值得注意的是生物类似药和证据巩固。7月9日，Teva Canada与Samsung Bioepis签署Opuviz在加拿大的商业化协议；Biocon同期强调支持Yesafili用于DME的同行评审数据，进一步强化aflibercept biosimilar竞争正在从获批延伸到市场执行与临床信心建设。[7][9] 2.2 青光眼覆盖子领域：primary open-angle glaucoma、normal-tension glaucoma、angle-closure glaucoma、ocular hypertension及glaucoma neuroprotection。科学进展本报告期内未见达到纳入阈值的重大基础科学、临床前或临床研究论文。论文主要结论：本周无符合时间窗和重要性标准的论文，因此不以历史文献补位。对眼科创新的意义：维持时间边界比填满栏目更重要；相关领域继续跟踪，待出现当周高质量证据后再作分析。研发进展 7月9日，Bausch + Lomb公布BL1107青光眼II期结果。159例随机、双盲、三组研究未达到第28天视野平均缺损较基线变化的主要终点，低照度BCVA应答等视觉功能次要终点也未达成；但第28天眼压下降终点达到，提示存在眼部靶点参与。公司据此停止BL1107滴眼液在青光眼视觉改善中的开发。[15] 市场动态该失败对青光眼神经保护构成短期挫折，也说明眼压变化不能替代视觉功能获益。Bausch + Lomb将资源转向与Ripple Therapeutics合作的BL1107无聚合物持续释放植入物，重点开发GA，并计划2028年启动临床试验。[15] 2.3 眼表与角膜疾病覆盖子领域：dry eye disease、meibomian gland dysfunction、neurotrophic keratitis、corneal injury、corneal transplantation及相关眼表疾病。科学进展本报告期内未见达到纳入阈值的重大基础科学、临床前或临床研究论文。论文主要结论：本周无符合时间窗和重要性标准的论文，因此不以历史文献补位。对眼科创新的意义：维持时间边界比填满栏目更重要；相关领域继续跟踪，待出现当周高质量证据后再作分析。研发进展眼表与角膜是本周监管去风险最明确的章节。7月7日，Emmecell基于其磁性细胞递送平台开发的EO2002用于角膜内皮疾病获得FDA RMAT认定；该平台通过磁场辅助细胞在角膜内皮定位，目标是以微创细胞治疗替代供体依赖型移植。[3] 7月8日，OKYO Pharma表示FDA反馈支持urcosimod用于神经病理性角膜痛的III期NEPTUNE设计，并可能在成功情况下支持单项关键试验注册路径。[4] 市场动态本周眼表与角膜并无独立商业化事件，其战略含义反而更直接：只要能提供替代移植或填补无药可用空白的方案，前节创新仍能获得明显的监管加速关注。[3][4] 2.4 白内障、老视与屈光障碍覆盖子领域：cataract、presbyopia、refractive error、premium IOL及术后视觉质量相关路径。科学进展本报告期内未见达到纳入阈值的重大基础科学、临床前或临床研究论文。论文主要结论：本周无符合时间窗和重要性标准的论文，因此不以历史文献补位。对眼科创新的意义：维持时间边界比填满栏目更重要；相关领域继续跟踪，待出现当周高质量证据后再作分析。研发进展本周白内障与老视并无关键临床读出，但平台级动作非常明显。7月10日，Azalea Vision获得最高750万欧元EIC资金，用于推进可主动调节屈光度的智能隐形眼镜平台；该项目面向老视等动态屈光矫正需求，与可调节IOL形成非手术和手术路径之间的潜在竞争与互补。[13] 市场动态 7月7日，Alcon与RxSight宣布合作开发可调节的老视矫正人工晶状体，由Alcon负责全球商业化，RxSight获得6000万美元首付款及后续里程碑付款。[5] 7月9日，Bausch + Lomb推出面向白内障术前教育和流程支持的AI平台Orphia，说明白内障竞争开始把患者教育和数字化流程也纳入核心能力，而不只是晶体本身。[14] 2.5 近视与儿童视觉障碍覆盖子领域：myopia prevention、myopia control、pathologic myopia、amblyopia及儿童视觉发育相关障碍。科学进展 2026年7月9日发表于BMJ的CHAMP-UK研究显示，0.01%阿托品可在儿童中减缓近视进展和眼轴增长。[11] 论文主要结论：CHAMP-UK显示，每日0.01%阿托品在2年内可较安慰剂额外减少0.33D近视进展，并减少0.14 mm眼轴增长。[11] 对眼科创新的意义：这一结果的重要性在于，它进一步说明低浓度阿托品并不只是东亚特定场景下的近视控制策略，而可成为更广泛儿科近视管理中的标准选项，这对中国近视防控体系同样有直接参考价值。[11] 研发进展 7月6日，Eyewire报道一项中国学校筛查研究显示，基于纵向视力筛查数据建立的预测模型可在发病前识别高风险儿童，并在10%风险阈值下减少近一半不必要的预防性干预。[10] 市场动态本周近视领域没有改变竞争排序的商业化事件，但研究层面的信息非常清楚：近视管理正在同时走向更可泛化的药物证据和更精细化的风险分层。[10][11] 2.6 葡萄膜炎与眼部炎症覆盖子领域：non-infectious uveitis、uveitic macular edema、scleritis、episcleritis及其他炎症性眼病。科学进展本报告期内未见达到纳入阈值的重大基础科学、临床前或临床研究论文。论文主要结论：本周无符合时间窗和重要性标准的论文，因此不以历史文献补位。对眼科创新的意义：维持时间边界比填满栏目更重要；相关领域继续跟踪，待出现当周高质量证据后再作分析。研发进展本周未见达到纳入阈值的葡萄膜炎与眼部炎症临床、监管或融资事件。市场动态本报告期内未见本章重要的商业化或合作事件。 2.7 神经眼科覆盖子领域：optic neuropathies、LHON、optic neuritis、NAION、papilledema/IIH及相关神经视觉障碍。科学进展本报告期内未见达到纳入阈值的重大基础科学、临床前或临床研究论文。论文主要结论：本周无符合时间窗和重要性标准的论文，因此不以历史文献补位。对眼科创新的意义：维持时间边界比填满栏目更重要；相关领域继续跟踪，待出现当周高质量证据后再作分析。研发进展本周未见重要的神经眼科临床、监管或融资节点。市场动态本报告期内未见本章重要的商业化或交易事件。 2.8 眼整形、眼眶与甲状腺眼病覆盖子领域：thyroid eye disease、orbital inflammatory disease、lacrimal disorders、eyelid disorders及相关眼眶疾病。科学进展本报告期内未见达到纳入阈值的重大基础科学、临床前或临床研究论文。论文主要结论：本周无符合时间窗和重要性标准的论文，因此不以历史文献补位。对眼科创新的意义：维持时间边界比填满栏目更重要；相关领域继续跟踪，待出现当周高质量证据后再作分析。研发进展 7月6日至7月12日窗口内，未见达到纳入阈值的TED新增临床或监管节点。作为竞争基线，Viridian的Lumvoa于6月26日获FDA批准，标签覆盖活跃期和慢性TED；Genentech的Enspryng用于TED的sBLA于6月29日获优先审查，PDUFA日期为2026年10月15日。两项均属于上一报告期，不列作本周新事件。市场动态本周未出现新的TED商业事件，但6月下旬形成的市场基线已把竞争重点推向适应症覆盖、给药便利性、起效速度和商业执行。 2.9 眼肿瘤覆盖子领域：uveal melanoma、retinoblastoma、conjunctival/ocular surface tumors及相关眼肿瘤领域。科学进展本报告期内未见达到纳入阈值的重大基础科学、临床前或临床研究论文。论文主要结论：本周无符合时间窗和重要性标准的论文，因此不以历史文献补位。对眼科创新的意义：维持时间边界比填满栏目更重要；相关领域继续跟踪，待出现当周高质量证据后再作分析。研发进展本周未见达到纳入阈值的眼肿瘤临床、监管或融资事件。市场动态本报告期内未见眼肿瘤领域的重要商业化或交易事件。 2.10 感染性眼病覆盖子领域：endophthalmitis、keratitis、viral retinitis、CMV retinitis及其他威胁视力的眼感染。科学进展本报告期内未见达到纳入阈值的重大基础科学、临床前或临床研究论文。论文主要结论：本周无符合时间窗和重要性标准的论文，因此不以历史文献补位。对眼科创新的意义：维持时间边界比填满栏目更重要；相关领域继续跟踪，待出现当周高质量证据后再作分析。研发进展 7月8日，Tarsus收购iRenix Medical及其眼科抗菌消毒项目IRX-101。IRX-101为稳定的二氧化氯水溶液；154例Phase 2b/3 RELIEF试验中，相较聚维酮碘，术后疼痛评分相对降低约50%，角膜荧光素染色相对降低约25%，两个共同主要终点均达到统计学显著性。FDA已就III期方案提供反馈，公司计划2027年上半年启动III期。[12] 市场动态交易首付款约7500万美元，其中现金与Tarsus股票各3750万美元，另设最高4.9亿美元审批和商业里程碑。高度后置的支付结构说明，围绕高频retina注射流程的抗感染与耐受性工具正在获得独立战略价值，但收购方仍把大部分经济对价绑定于后续去风险。[12] 2.11 罕见眼病覆盖子领域：rare retinal diseases、rare corneal diseases、rare neuro-ophthalmic diseases及其他低患病率眼病。科学进展本报告期内未见达到纳入阈值的重大基础科学、临床前或临床研究论文。论文主要结论：本周无符合时间窗和重要性标准的论文，因此不以历史文献补位。对眼科创新的意义：维持时间边界比填满栏目更重要；相关领域继续跟踪，待出现当周高质量证据后再作分析。研发进展本周罕见眼病的主线不是人体疗效读出，而是开发路径清晰化。Opus拿到了OPGx-LCA5的注册设计一致性，Atsena则把ATSN-401推进到IND enabling阶段。[1][8] 市场动态本周未见独立的罕见眼病商业化事件，其战略重要性超过上述开发路径更新。 3. 平台技术本周平台技术层面的重点主要集中在六个方向：遗传性retina基因递送工程、角膜磁性细胞递送、wet AMD的suprachoroidal递送、GA持续释放植入物、可调节老视矫正IOL，以及数字化/智能硬件工作流工具。[1][3][5][6][13][14][15] Atsena的ATSN-401与Opus的OPGx-LCA5共同说明，retina平台价值越来越取决于capsid、递送方式、试验结构和注册可行性，而不只是靶基因本身。[1][8] Emmecell的RMAT节点则从另一个角度证明，若递送平台本身能够替代供体依赖型移植，其平台属性就会成为估值的一部分。[3] 在器械和手术平台上，Alcon与RxSight试图把术后可调节能力带入老视矫正IOL赛道。[5] Cascade与Uneedle则代表另一种思路：通过suprachoroidal路径把缺氧靶向分子带入wet AMD场景，试图从组织靶向和给药路径上重构治疗负担，而不是继续沿着传统VEGF注射逻辑内卷。[6] 与此同时，Azalea Vision的智能隐形眼镜和Bausch + Lomb的Orphia平台都说明，眼科平台竞争正在超出药物和植入物本身，开始进入可穿戴、生物标志物、患者教育和流程支持的综合层面。[13][14] BL1107的重定向展示了另一类平台价值：同一小分子从青光眼滴眼液切换到GA持续释放植入物，依赖Ripple无需聚合物的控制释放技术。这里的价值不在于掩盖青光眼失败，而在于保留药物暴露与递送工程的可复用部分，并重新匹配更适合的疾病和给药场景。[15] CDE“先锋计划”把平台技术进一步延伸到证据生成基础设施。征求意见材料拟允许药物研发企业或NAMs开发机构申请，将NAMs用于非临床评价支持性数据，或开展方法学联合验证。对眼科创新者，优先价值可能来自视网膜类器官、角膜/眼表模型、眼部屏障与递送芯片，以及CGT相关效力和毒性评价；但能否进入具体申报场景，仍取决于模型适用范围、重复性、对照体系和验证标准。[16] 4. 监管与政策情报本周监管章节的重心不在宏观政策，而在单项目的路线去风险。Opus就OPGx-LCA5拿到的FDA一致性意见非常关键，因为它不仅确认了III期设计，也表明“6个月疗效数据即可进入BLA讨论”，这对超罕见遗传性retina项目尤其重要。[1][2] 前节方面，Emmecell获得RMAT、OKYO获得支持III期路径的Type D反馈，说明只要项目能明确对应未满足需求并给出较清晰的开发逻辑，FDA仍愿意在角膜和神经病理性疼痛等细分领域提供更高频的监管互动。[3][4] BL1107则提供了相反方向的监管与开发教训：眼压下降证明靶点参与，但无法替代预设的视觉功能终点。对于青光眼神经保护项目，未来开发必须更早验证终点敏感性、治疗时长和患者分层，不能把替代指标改善直接外推为视功能获益。[15] 7月7日，CDE公开征求“先锋计划”申报指南、申请表和实施框架意见，征求期为1个月。拟议试点招募期为5年、不设名额限制，并计划对入选项目采取早期介入、及时沟通、全程跟踪的工作方式。其监管意义不是立即削减动物试验，而是建立NAMs数据进入注册沟通和方法学验证的制度化入口；企业应避免把征求意见稿解读成普遍豁免。[16] 值得注意的是，7月6日至7月12日这一窗口内，并没有达到同等战略权重的中国眼科新监管headline。也就是说，本周真正改变市场判断的，不是新的批件，而是项目把注册路径讲清楚的能力。 5. 融资、战略合作与资本流向情报与近期相比，这并不是单笔超大融资的一周，但资本流向的指向性很强：资金和交易都更愿意支持那些能降低采用不确定性、改善流程负担或强化高端术式差异化的平台。最典型的是Alcon与RxSight。6000万美元首付款加最多1.4亿美元里程碑付款，说明premium cataract赛道仍愿意为“术后可调节”这种真正改变患者结果管理方式的能力付钱。[5] Tarsus收购iRenix及IRX-101也是类似逻辑。首付款约7500万美元，其中现金和股票各半，审批及商业里程碑最高4.9亿美元；交易买的不是核心retina疗效，而是反复玻璃体腔注射场景中的疼痛与角膜毒性优化能力。大部分对价后置，体现资本按后续临床和商业去风险分阶段支付。[12] Azalea Vision获得最高750万欧元EIC资金，则进一步说明只要工程验证和临床路径逐渐清晰，智能视力硬件仍然能获得资本支持。[13] 6. 本周值得关注的变化 1. 遗传性retina基因治疗正在越来越按“能否进入注册阶段”来估值，而不只是按机制故事来估值，OPGx-LCA5就是最直接的例子。[1][2] 2. 角膜和眼表创新仍能获得显著监管加速，但前提是项目明确对应移植替代或无药可用的空白需求，EO2002和urcosimod都体现了这一点。[3][4] 3. 高端白内障竞争开始同时比拼植入物和患者管理系统，Alcon / RxSight与Orphia代表的是同一条价值链上的两端。[5][14] 4. wet AMD领域仍然存在给药路径层面的新空间，Cascade与Uneedle说明suprachoroidal路线依然被视为可独立成章的竞争变量。[6] 5. retina商业竞争继续向biosimilar执行和证据巩固扩散，Opuviz加拿大协议和Yesafili的DME数据都说明这一点。[7][9] 6. 近视管理正在同时走向更可泛化的药物证据和更精细化的风险分层，CHAMP-UK与中国筛查研究构成了很强的互证关系。[10][11] 7. 资本仍在支持降低流程负担和建设智能硬件基础设施的项目，而不只是核心疗效分子，Tarsus和Azalea就是代表。[12][13] 8. BL1107在青光眼中的失败说明，神经保护项目必须以视功能获益而非单一眼压变化建立价值；转向GA植入物则显示成熟公司会快速保留可复用技术并重新配置适应症。[15] 9. CDE“先锋计划”拟为类器官、器官芯片等NAMs建立试点和验证入口。眼科企业的近期任务不是宣称替代动物试验，而是选择适用场景、建立可重复验证体系，并尽早参与监管沟通。[16] 7. 总体观察本周最重要的整体变化是：眼科行业的价值判断正在继续从“谁讲出了更大的科学故事”转向“谁把采用路径讲得更清楚”。能够拿到清晰注册设计的遗传性retina项目、能够替代供体依赖手术的角膜项目、能够提升术后个体化结果的IOL平台、以及能够降低患者教育或流程负担的数字工具，都比单纯的新机制更容易获得战略注意力。BL1107又补上了失败管理这一维度：预设视功能终点未达成就应及时停止原路径，同时把可复用的药物和递送能力转向更匹配的GA场景。中国本周企业层面headline虽然偏少，但近视筛查研究和CDE“先锋计划”分别从临床管理和研发工具两端增强了中国的战略存在。下一阶段眼科竞争的关键，不只是科学差异化，而是科学差异化能否被装进一个可验证、可执行、可注册、可商业化，并能在证据不成立时迅速纠偏的系统。 8. 关键来源 [1] Opus Genetics（2026年7月6日）：FDA就OPGx-LCA5用于LCA5相关遗传性视网膜病的III期注册设计达成一致 [2] Ophthalmology Times（2026年7月8日）：报道OPGx-LCA5的III期注册路径及潜在BLA申报逻辑 [3] Emmecell（2026年7月7日）：EO2002用于角膜内皮疾病获得FDA RMAT认定 [4] Eyewire News（2026年7月8日）：OKYO Pharma获得FDA反馈，支持urcosimod用于神经病理性角膜痛的III期路径 [5] Alcon / RxSight（2026年7月7日）：合作开发可调节的老视矫正人工晶状体，包含6000万美元首付款及最多1.4亿美元里程碑付款 [6] Cascade Prodrug / Uneedle（2026年7月8日）：扩大合作，推进CPD100用于wet AMD的suprachoroidal递送 [7] Eyewire News（2026年7月9日）：Teva Canada与Samsung Bioepis签署Opuviz在加拿大的商业化协议 [8] Eyewire News（2026年7月9日）：Atsena选择ATSN-401作为Stargardt病基因治疗的临床主导候选项目 [9] Eyewire News（2026年7月9日）：Biocon公布支持Yesafili用于DME的INSIGHT III期同行评审数据 [10] Eyewire News（2026年7月6日）：中国学校筛查研究显示预测模型可识别最可能发生近视的儿童 [11] Eyewire News / BMJ（2026年7月10日）：CHAMP-UK显示0.01%阿托品可在2年内减缓近视进展和眼轴增长 [12] Tarsus Pharmaceuticals（2026年7月8日）：收购iRenix Medical及眼科抗菌消毒项目IRX-101，披露RELIEF结果和交易结构 [13] Eyewire News（2026年7月10日）：Azalea Vision获得最高750万欧元EIC资金，用于推进智能隐形眼镜平台 [14] Eyewire News（2026年7月9日）：Bausch + Lomb推出AI驱动的白内障患者教育与流程平台Orphia [15] Bausch + Lomb（2026年7月9日）：BL1107青光眼II期未达主要终点，停止滴眼液开发并转向GA持续释放植入物 [16] 国家药监局药审中心（2026年7月7日）：公开征求NAMs研究和应用试点计划“先锋计划”的申报指南、申请表及实施框架意见

临床3期引进/卖出

2026-07-09

·BioSpace

Teva and Samsung Bioepis Enter Commercialization Agreement for OPUVIZ®, a Biosimilar Referencing Eylea® (aflibercept), in Canada

TORONTO, Canada and INCHEON, South Korea , July 9, 2026 /CNW/ - Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) (TASE: TEVA) and Samsung Bioepis Co., Ltd. today announced that the companies have entered into a license and commercialization agreement for OPUVIZ ® (aflibercept), a biosimilar referencing Eylea ®1 (aflibercept), in Canada. Under the agreement, Samsung Bioepis is responsible for registration and manufacture of the products, while Teva Canada (a subsidiary of Teva Pharmaceutical Industries Ltd.) is responsible for commercialization. "This agreement is an important step in strengthening our biosimilars portfolio in Canada," said Fabien Paquette, General Manager, Teva Canada. "It continues to build on our momentum in biosimilars, to expand our ophthalmology footprint, and reflects our commitment to bringing high-quality treatment options to Canadian patients and healthcare professionals through strategic partnerships." "This agreement represents an important step in advancing our growth strategy in North America and expanding access of ophthalmic biologic medicines in Canada," said Kwang Ryu, Vice President and Team Leader of Business Development at Samsung Bioepis. "Through our collaboration with Teva we are committed to expanding access to high-quality treatment options in Canada and helping more patients benefit from timely and sustainable care." OPUVIZ received Health Canada approval in October 2025 and is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment resulting from macular edema secondary to central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO), diabetic macular edema (DME), and myopic choroidal neovascularization (mCNV). Samsung Bioepis' aflibercept biosimilar is also available in Europe and in Republic of Korea. Teva Canada will provide further details on the anticipated Canadian market launch of OPUVIZ ® at the appropriate time. Please see Product Monograph for OPUVIZ (aflibercept) including important safety information HERE . DISCLAIMER This press release is intended solely for the purpose of sharing the availability of OPUVIZ in Canada. This document should not be construed as medical advice or as an endorsement of any product or treatment. Regulatory approval status and prescribing information may vary by country; please refer to local product information for any medicinal products mentioned herein. Information in this press release may include data on investigational compounds or unapproved indications. Such information is shared for scientific discussion purposes only and does not represent an assertion of safety or efficacy for any unapproved use. This press release may contain forward-looking statements, including statements regarding clinical development programs, regulatory submissions, potential approvals, and future therapeutic potential. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. Forward-looking statements are not guarantees of future performance. Samsung Bioepis undertakes no obligation to update any forward-looking statements contained in this press release. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva's commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars, and pharmacy brands worldwide, Teva is dedicated to addressing patients' needs, now and in the future. At Teva, We Are All In For Better Health . To learn more about how, visit . About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. As a wholly owned subsidiary of Samsung Epis Holdings, Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, endocrinology and neurology. For more information, please visit and follow us on LinkedIn and X . Teva Cautionary Note Regarding Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management's current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as "should," "expect," "anticipate," "estimate," "target," "may," "project," "intend," "plan," "believe" and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully execute our license, development and commercialization agreement with Samsung Bioepis Co., Ltd. for OPUVIZ (aflibercept), a biosimilar referencing Eylea ® ; our ability to successfully commercialize OPUVIZ (aflibercept) in Canada; our ability to successfully compete in the marketplace including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute on our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to execute on our organizational transformation and to achieve expected cost savings; and other factors discussed in this press release, in our Quarterly Report on Form 10-Q for the first quarter of 2026 and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned "Risk Factors" and Forward-Looking Statements." Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. 1 Eylea ® is a trademark of Regeneron Pharmaceuticals, Inc. SOURCE Teva Canada

引进/卖出上市批准

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))	積鑰製窪願壓築獵鑰鹽(膚鏇憲鹽獵繭願淵簾衊) = 衊衊淵鏇齋衊鏇鹽範製齋醖齋醖蓋衊襯襯憲遞 (夢糧憲糧遞鑰願鬱顧艱, 0.56) 更多	-	2024-02-05
				SB15 (Proposed aflibercept biosimilar)+Eylea (Eylea (Aflibercept))	積鑰製窪願壓築獵鑰鹽(膚鏇憲鹽獵繭願淵簾衊) = 夢選餘膚餘範鏇構糧鹹齋醖齋醖蓋衊襯襯憲遞 (夢糧憲糧遞鑰願鬱顧艱, 0.57) 更多
EURETINA2023 人工标引	临床3期	湿性年龄相关性黄斑变性	438	SB15	鹹構餘襯餘膚網淵觸糧(範鏇蓋鑰淵廠簾餘繭網) = 繭艱遞淵淵積壓簾衊獵構積襯積鏇製選網餘餘 (網糧淵築艱襯製積製糧 ) 更多	积极	2023-10-05
				Aflibercept	鹹構餘襯餘膚網淵觸糧(範鏇蓋鑰淵廠簾餘繭網) = 窪壓鏇獵鏇憲觸獵築齋構積襯積鏇製選網餘餘 (網糧淵築艱襯製積製糧 ) 更多
EURETINA2023 人工标引	临床3期	年龄相关性黄斑变性	449	SB15	鏇鹽遞獵蓋壓選壓齋蓋(願壓鹹構糧齋願艱製顧) = 壓範鑰夢鑰壓醖壓廠範觸獵餘鬱觸夢選選艱願 (簾醖廠鹹簾壓鬱繭艱壓 )	相似	2023-10-05
				Aflibercept	鏇鹽遞獵蓋壓選壓齋蓋(願壓鹹構糧齋願艱製顧) = 廠鏇齋築壓壓積齋艱衊觸獵餘鬱觸夢選選艱願 (簾醖廠鹹簾壓鬱繭艱壓 )
EURETINA2023	N/A	湿性年龄相关性黄斑变性	-	SB15	選積觸糧淵衊糧鬱築選(製蓋廠積構顧顧淵鹹築) = 糧獵顧顧網獵鬱範淵餘蓋選淵選鹹廠窪壓製夢 (窪鏇廠願構齋願蓋積願 ) 更多	-	2023-10-05
				AFL	選積觸糧淵衊糧鬱築選(製蓋廠積構顧顧淵鹹築) = 夢夢獵襯鏇選淵製衊壓蓋選淵選鹹廠窪壓製夢 (窪鏇廠願構齋願蓋積願 ) 更多
NCT04450329 (Pubmed)	临床3期	湿性年龄相关性黄斑变性	449	SB15	築簾壓壓醖膚窪齋範顧(網選艱窪製築選鹹繭範) = 顧壓遞齋鏇簾遞網繭鬱壓網鬱獵糧廠獵鏇鏇壓 (願壓鑰範觸窪鬱鹽鏇簾 ) 更多	-	2023-06-08
				AFL	築簾壓壓醖膚窪齋範顧(網選艱窪製築選鹹繭範) = 夢淵齋衊艱衊醖淵蓋淵壓網鬱獵糧廠獵鏇鏇壓 (願壓鑰範觸窪鬱鹽鏇簾 ) 更多
NCT04450329 (ARVO2023)	临床3期	湿性年龄相关性黄斑变性	449	SB15 2 mg	鏇齋鹹糧願蓋餘範憲製(廠鏇鏇簾獵糧壓憲築遞) = 簾範鬱願範鹽簾遞艱鹹襯範醖餘憲淵膚築襯願 (簾網鏇衊糧範餘壓壓窪 )	积极	2023-06-01
				Aflibercept	鏇齋鹹糧願蓋餘範憲製(廠鏇鏇簾獵糧壓憲築遞) = 鹽鏇蓋積憲遞襯製簾憲襯範醖餘憲淵膚築襯願 (簾網鏇衊糧範餘壓壓窪 )
AAO2022	临床3期	-	-	SB15	製廠齋築膚獵憲膚網鹹(艱糧鹹憲繭顧鏇襯糧範) = 鹽糧積壓積鏇餘願積願壓選願鏇簾鹹鹹廠積築 (艱鬱鬱蓋齋鹽簾選顧願 )	积极	2022-09-29
				Aflibercept	製廠齋築膚獵憲膚網鹹(艱糧鹹憲繭顧鏇襯糧範) = 齋衊鹹簾窪鏇夢淵糧獵壓選願鏇簾鹹鹹廠積築 (艱鬱鬱蓋齋鹽簾選顧願 )