An Open-label, Single-arm, Single-dose Clinical Trial to Evaluate the Safety and Usability of SB15 Pre-filled Syringe (PFS) in Trial Participants With Neovascular Age-related Macular Degeneration (AMD), Macular Oedema Secondary to Retinal Vein Occlusion (RVO), or Diabetic Macular Oedema (DME)

This is an open label, multicenter, Phase II trial to evaluate the safety and usability of the pre-filled syringe (PFS) of SB15 (Aflibercept biosimilar). Healthcare Professionals (HCPs) followed the Instructions for Use (IFU) to prepare and administer SB15 PFS with intravitreal injection to trial participants with nAMD, Macular Oedema Secondary to RVO, or Diabetic Macular Oedema (DME).

开始日期2026-09-07

申办/合作机构

Samsung Bioepis Co., Ltd.

NCT04450329

/ Completed临床3期

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 ; 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.

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）

2026-10-01

·BioSpace

Samsung Bioepis and Teva Expand Strategic Partnership to Advance Up to Six Potential Biosimilar Candidates

The agreement covers SB41, a potential biosimilar candidate referencing Fasenra ® (benralizumab), and SB44, a potential biosimilar candidate referencing Ilaris ® (canakinumab) with an option for 4 additional assets The partnership will cover development and commercialization in the United States, Europe, and Canada, with an option to expand to other territories The partnership brings together Samsung Bioepis’ development, regulatory and manufacturing capabilities with Teva’s global commercial reach to advance the investigational biosimilar candidates and help bring additional important treatment options to patients worldwide INCHEON, Korea & TEL AVIV, Israel--(BUSINESS WIRE)-- #Fasenra --Samsung Bioepis Co., Ltd. and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the companies have entered into a global license, development, and commercialization agreement for up to six potential biosimilar candidates, with two confirmed investigational biosimilar candidates, SB41, a biosimilar candidate referencing Fasenra ®1 (benralizumab), and SB44, a biosimilar candidate referencing Ilaris ®2 (canakinumab). Under the terms of the agreement, Samsung Bioepis will be responsible for the development, regulatory registration, and manufacture of the biosimilars, while Teva will be responsible for commercialization in global markets, including the United States (U.S.), Europe, and Canada. The companies have agreed to an option for expanding the partnership to other territories. This agreement reinforces the long-standing and successful partnership between Samsung Bioepis and Teva, which has already resulted in the successful commercialization of EPYSQLI ® (eculizumab-aagh) in the U.S. The companies have also expanded that agreement further to include OPUVIZ ® (aflibercept) in Canada. The expanded collaboration reflects a shared approach to combining complementary capabilities for broadening access to biosimilar medicines across global markets. “We are thrilled to expand our successful partnership with Teva with these new biosimilar candidates. This agreement marks another milestone in our shared journey to improve patient access to life-changing medicines,” said Kyung-Ah Kim, President and Chief Executive Officer at Samsung Bioepis. “At Samsung Bioepis, we will continue to demonstrate our enduring commitment to biosimilars by further strengthening our pipeline and widening their availability for patients and healthcare systems across the world.” Richard Francis, President and CEO of Teva said, “Biosimilars are an increasingly important part of our Pivot to Growth strategy and our ambition to transform into a leading biopharmaceutical company. This global multi-product agreement is a significant step in scaling our biosimilars business, adding greater breadth to our pipeline and building on the strong foundation we have established with Samsung Bioepis in the U.S. By combining a strong and growing portfolio and our excellent global commercial capabilities, we are strengthening our leadership position in biosimilars and our ability to bring more treatment options to patients around the world.” 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 (KRX: 0126Z0), 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 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 . 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,” “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 the license, development and commercialization agreement with Samsung Bioepis; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute 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 sustain and focus our portfolio of generic medicines; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2026 and in our Annual Report on Form 10-K for the year ending December 31, 2025, including in the section captioned “Risk Factors” and “Cautionary Note Regarding 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 Fasenra is a trademark of AstraZeneca AB. 2 Ilaris is a trademark of Novartis AG. Contacts MEDIA CONTACT Samsung Bioepis Media Inquiries: Anna Nayun Kim, nayun86.kim@samsung.com Yoon Kim, yoon1.kim@samsung.com Teva Media Inquiries: TevaCommunicationsNorthAmerica@tevapharm.com Teva Investor Relations Inquiries: TevaIR@Tevapharm.com

2026-09-02

·IPO先锋领航员

深度解读：嘉因生物-招股说明书

一、公司定位与核心概览嘉因生物（Exegenesis Bio）是一家成立于2019年的生物制药公司，专注于神经系统及眼科疾病的基因疗法开发，同时布局寡核苷酸类药物。公司总部位于中国，运营实体分布于杭州与广州，并以开曼群岛注册的控股主体申请于香港联交所主板上市，适用《上市规则》第18A章生物科技章节。其核心看点在于拥有两款处于临床中后期阶段的核心产品——EXG102-031（用于治疗湿性年龄相关性黄斑变性，wAMD）与EXG001-307（用于治疗1型脊髓性肌萎缩症，SMA 1型），以及一款关键产品EXG202（用于治疗眼底新生血管疾病）。公司尚未实现商业化产品的销售，处于典型的研发驱动型亏损阶段，其未来发展高度依赖核心管线的临床推进与监管审批。二、主营业务与产品管线分析嘉因生物的业务模式完全围绕内部研发的基因治疗产品展开，辅以寡核苷酸技术平台的早期探索。截至招股书披露日，公司共拥有九款候选产品，其中两款被认定为核心产品，一款为关键产品。 EXG102-031是公司眼科基因疗法的旗舰产品，其最大的差异化优势在于全球首个且唯一靶向所有关键血管生成通路（VEGF-A/B、VEGF-C/D、PlGF及Ang2）的眼科基因疗法。该药物通过视网膜下注射（SubR）实现单次给药，旨在为wAMD患者提供持久的抗新生血管及抗渗漏效果，从而大幅减少现有疗法中频繁玻璃体腔内注射的治疗负担。临床进展方面，该产品于2023年先后获得美国FDA及中国国家药监局的IND批准。在中国，所有受试者已于2026年5月完成IIa期试验为期52周的随访，IIb/III期试验预计于2026年下半年启动；在美国，I期临床试验已完成，临床数据库于2026年3月锁定。若后续临床数据能够验证其多通路抑制的持久疗效与安全性，EXG102-031有望重塑wAMD的治疗范式。 EXG001-307则聚焦于罕见病领域，针对SMA 1型这一婴幼儿最常见的致死性遗传病之一。与已获批的AAV9基因疗法Zolgensma相比，EXG001-307采用了神经元偏好性启动子，旨在实现SMN基因在中枢神经系统内的靶向表达，同时减少在肝脏和心脏等外周组织中的表达，从而降低全身性暴露风险并提高整体安全性。该设计直接回应了现有SMA基因疗法在外周组织过度表达导致的潜在毒性问题。临床开发上，EXG001-307已完成中国I/II期临床试验，公司计划于2026年下半年就关键性III期试验设计与监管机构展开讨论。值得注意的是，中国目前尚无获批的SMA基因疗法，若该产品能率先突围，将占据显著的先发优势。 EXG202作为关键产品，同样针对眼底新生血管疾病（包括wAMD、糖尿病黄斑水肿DME及视网膜静脉阻塞RVO），但采用玻璃体内注射（IVT）途径。其技术亮点在于通过AAVarta平台工程化改造的衣壳，增强了穿越内界膜（ILM）的能力，从而实现更广泛深入的视网膜转导。该产品于2025年7月获FDA IND批准，计划利用中国I期数据直接进入美国II期；在中国，IIa期于2026年3月启动。EXG202与EXG102-031形成了给药途径与临床策略的互补，共同覆盖了眼科基因疗法的主要技术路径。其余管线如EXG110（法布里病）已进入I/II期，而针对阿尔茨海默病、雷特综合征、慢性疼痛及杜氏肌营养不良症的产品仍处于IND准备或临床前阶段，短期内难以贡献价值。三、行业赛道与竞争格局嘉因生物所处的基因疗法赛道正处于高速成长期，但竞争格局日趋复杂。根据弗若斯特沙利文的资料，全球基因疗法市场规模预计将从2025年的约36亿美元增长至2030年的125亿美元，复合年增长率达28.3%；中国市场预计将从2025年的接近零起步，于2030年达到32亿元人民币，复合年增长率高达143.8%。这一增长主要由罕见病疗效验证、AI驱动的载体设计进步、生产成本优化及政策支持所驱动。在眼底新生血管疾病领域，全球已获批药物包括兰尼单抗（Lucentis）、阿柏西普（Eylea）、布罗鲁珠单抗（Beovu）及法瑞西单抗（Vabysmo），这些药物多为抗VEGF抗体或融合蛋白，需通过反复玻璃体腔内注射维持疗效，患者依从性负担沉重。基因疗法作为潜在的一次性治疗方案，正成为研发热点。全球临床阶段的竞争者包括艾伯维的ABBV-RGX-314、4D Molecular Therapeutics的4D-150、Adverum的Ixoberogene Soroparvovec以及中国的康弘药业KH631/KH658等。嘉因生物的EXG102-031凭借多靶点覆盖（VEGF-A/B/C/D、Ang2、PlGF）及视网膜下注射的精准递送，在机制上具备差异化；而EXG202则通过改良衣壳尝试攻克玻璃体内注射的转导效率难题。然而，视网膜下注射的手术创伤性与玻璃体内注射的免疫原性风险，仍是公司需要面对的技术权衡。在SMA治疗领域，全球市场已被诺华的Zolgensma（一次性IV基因疗法）、渤健的Spinraza（反复鞘内注射ASO）及罗氏的Evrysdi（口服小分子）所占据，诺华于2025年还获批了鞘内给药的ITVISMA。中国已获批药物为Spinraza与Evrysdi。嘉因生物的EXG001-307所处的竞争环境极为激烈，不仅要面对已建立市场地位的现有疗法，还需与诺华的OAV101 IT（BLA阶段）等临床后期管线竞争。公司的核心赌注在于其神经元偏好性启动子带来的安全性与疗效平衡，以及静脉注射相较于鞘内注射的临床便利性。但SMA 1型患者群体相对有限且患病率较低，若定价与支付体系无法匹配，商业化前景仍将受限。四、核心技术平台嘉因生物的研发能力建立在AAVarta与SODA两大技术平台之上，分别对应“精准递送”与“基因调控”两大核心环节。 AAVarta平台是一个专有的AI辅助基因递送载体发现与优化平台。传统的野生型AAV衣壳在组织嗜性、转导效率及免疫原性方面存在显著局限，尤其在眼科应用中，内界膜成为基因药物进入视网膜深层的主要物理屏障。AAVarta平台通过高通量筛选与AI辅助进化，能够设计出具有组织特异性的新型衣壳。EXG202所采用的衣壳即通过该平台开发，经工程改造以增强ILM穿越能力，实现更深入广泛的视网膜转导。这一平台能力不仅支撑了现有眼科管线，也为未来针对其他组织器官的基因疗法开发提供了可扩展的技术基础。 SODA平台则专注于寡核苷酸类药物（包括ASO、siRNA及AOC）的基因沉默设计与优化。该平台系统性地将候选药物从合理设计推进至临床前验证，旨在解决寡核苷酸疗法中稳定性、脱靶效应及递送效率等关键问题。随着寡核苷酸药物从罕见病向慢性病（如阿尔茨海默病、慢性疼痛）拓展，SODA平台有望与AAVarta形成协同，覆盖更广泛的疾病领域。此外，公司在知识产权方面已进行初步布局，截至最后可行日期，在中国拥有六项已授权专利及一项澳门专利，另有数十项专利申请处于审查阶段。然而，相较于成熟的国际基因治疗巨头，其专利组合的广度与深度仍需时间验证。五、公司治理、核心团队与股东背景嘉因生物的控股权由三位创始人通过一致行动协议牢牢掌握。吴振华博士担任执行董事、董事长，叶国杰博士担任执行董事兼首席科学官，王立军女士为联合创始人。三人通过Landes Therapeutics Ltd及直接持股，于最后可行日期合计控制公司约31.16%的投票权。这种创始人主导的治理结构在18A公司中较为常见，有利于战略决策的高效执行，但也对投资者保护提出了更高要求。核心管理团队中，宋春娟博士亦为执行董事，三位独立非执行董事李安康博士、赵晖先生及吴优博士则提供了财务、法律及行业方面的监督视角。值得注意的是，公司研发团队主要分布于杭州（寡核苷酸）与广州（基因疗法临床开发），形成了双中心协作模式。在资本化路径上，嘉因生物经历了多轮私募融资，估值呈阶梯式上升。A-1轮与A-2轮融资于2020年完成，合计代价约人民币7900万元；B轮融资于2020年7月启动，总代价2250万美元，投后估值约9624万美元；B+轮于2020年12月启动，总代价3050万美元，投后估值跃升至2.5亿美元；B++轮于2021年5月完成，总代价7000万美元，投后估值约5.78亿美元。此轮融资引入了君联资本（LC Healthcare Fund II）、高瓴（NVMB III Holdings）、淡马锡（Elbrus Investments）、CPE（CJY Genetic Sciences）、清池资本（LBC Sunshine Healthcare Fund II）及LYFE Capital（Black Elk Peak）等知名机构，反映了资本市场对其早期管线价值的认可。此外，公司于2022年及2025年分别获得浙江省产业基金1亿元人民币及万联广生2000万元人民币的可换股贷款，年利率分别为8%及5%，转股价约每股人民币8.97元。这些债务融资在为研发输血的同时，也将在上市后转化为股权稀释压力。六、财务状况与运营分析作为一家处于商业化前阶段的生物科技公司，嘉因生物的财务报表呈现出典型的“高研发投入、零产品收入、持续亏损”特征。在收入端，公司于2024年未产生任何收益，2025年录得收益129.9万元人民币，主要来源于向一名海外跨国制药客户提供附带专有载体的rAAV研发服务；2026年上半年收益仅为1万元，显示该业务不具备持续性，公司收入结构极度脆弱。研发开支是公司的最大成本项。2024年研发开支为1.45亿元人民币，2025年为1.04亿元，2026年上半年为5337万元。其中，核心产品EXG102-031与EXG001-307合计占研发支出的半壁江山。2025年研发总支出同比下降，主要因股份支付、薪酬福利及折旧减少，但EXG102-031的试验及测试开支因患者就诊次数增加而上升。EXG001-307的研发开支下降则反映了临床阶段 transitions——2024年约80%的主要研究访视已完成，2025年仅余下20%及后续跟进。在盈利表现上，公司亏损幅度急剧扩大。2024年年度亏损为2.198亿元人民币，2025年亏损扩大至8.269亿元人民币，2026年上半年亏损达3.812亿元人民币。这一恶化并非源于经营基本面的断崖式下跌，而是由于按公允价值计入损益的金融负债及可换股贷款票据的公允价值变动——2025年该科目产生亏损7.068亿元，2026年上半年产生亏损3.045亿元。这些会计上的非现金亏损反映了公司估值上升导致的优先股及可转债账面价值增加，是18A公司常见的财务现象，但客观上加剧了报表层面的亏损规模。现金流状况值得警惕。2024年及2025年经营活动所用现金净额分别为6757万元及7182万元。截至2026年6月30日，现金及现金等价物为1.382亿元人民币，较2024年末的2.786亿元显著下降。公司披露，在不考虑IPO募资的情况下，按2025年平均现金消耗率的1.8倍计算，现有资金可维持约21个月的财务可行性；若计入IPO募资，则可维持约102个月。这一测算高度依赖IPO的成功实施及募资规模，若市场窗口收紧或发行定价不及预期，公司的资金链将面临严峻考验。资产负债表方面，公司于各报告期末均录得流动负债净额及负债净额。截至2026年6月30日，流动负债净额为26.96亿元人民币，负债净额为26.49亿元人民币。这主要由优先股作为金融负债的会计处理所致，IPO后优先股自动转换为普通股，该等负债净额将得以消除。但在此之前，高企的负债率仍对公司的融资能力与债权人信心构成压力。七、供应链与客户结构嘉因生物目前无商业化生产与销售，其供应链主要围绕研发活动构建。供应商主要包括提供第三方合约服务的CRO、设备供应商、实验室及生产设施租赁方。报告期内，公司向五大供应商的采购额占总采购额的比例分别为2024年的61.0%、2025年的45.7%及2026年上半年的51.0%，集中度较高。其中，杭州行诚生物科技有限公司作为关联方（吴博士、叶博士及王女士间接持股），在2023年曾受让公司终止运营的质粒生产线及设备，交易对价合计约7290万元人民币，截至2026年6月末仍有部分余款未结清。这一关联交易不仅反映了公司早期生产策略的调整，也提示了与创始人关联实体之间的持续资金往来风险。客户层面，公司目前仅依赖单一海外客户的研发服务收入，且金额微小。这种收入结构意味着公司在未来数年内仍将完全依赖外部融资与潜在的管线授权交易来支撑运营，直至核心产品获批上市。八、风险因素与潜在挑战嘉因生物面临的风险是多维度且相互交织的。首先是临床开发与监管风险。所有候选产品均处于临床前或临床阶段，失败概率 inherent。AAV基因疗法虽被视为前景广阔，但其固有风险不容忽视——高剂量载体可能引发肝毒性、血栓性微血管病（TMA）、心脏毒性甚至死亡。历史上AAV疗法的严重不良事件已导致多家公司的临床暂停。此外，公司部分产品采用视网膜下注射或鞘内注射等侵入性给药途径，操作相关的感染、出血、视网膜损伤等并发症可能直接影响临床入组与监管审批。其次是资金与流动性风险。尽管IPO被寄予厚望，但公司现金储备消耗迅速，且经营现金流出呈持续状态。若IPO延迟或募资不足，公司可能需要在不利条款下进行稀释性融资或削减研发项目。可换股贷款虽提供了短期缓冲，但转股后将进一步摊薄现有股东权益。第三是商业化与市场竞争风险。即便产品获批，基因疗法的高昂生产成本与定价压力将直接考验公司的盈利能力。以SMA为例，Zolgensma的定价超过200万美元，而中国市场对高价创新药的支付能力仍受医保目录谈判的严格约束。在眼科领域，已有众多抗VEGF药物占据市场，医生与患者对基因疗法这一新型治疗模式的接受度仍需培育，且公司需从零开始建立商业化团队，面临人才争夺与渠道建设的双重挑战。第四是地缘政治与政策风险。公司业务横跨中国与美国，中美之间的贸易紧张局势及技术限制可能对其跨境临床数据互认、供应链稳定及资本市场估值产生冲击。此外，中国对人类遗传资源出境、数据安全及外商投资准入（尽管VIE已解除，但广州自贸区的政策执行细节仍需持续合规）的监管要求日益严格，任何政策变动都可能增加合规成本或延缓开发进度。最后是知识产权与诉讼风险。公司目前面临上海嘉因提起的商标侵权及不正当竞争诉讼，索赔金额达6000万元人民币。尽管案件尚未开庭，但此类纠纷可能分散管理层精力并损害品牌声誉。同时，基因治疗领域的专利布局密集，公司未来可能面临第三方专利挑战或侵权指控。九、结语嘉因生物是一家具备清晰技术差异化路径的早期基因疗法公司。其核心产品在靶点选择（多通路抗血管生成）与启动子工程（神经元偏好性）上展现了独到的研发逻辑，AAVarta与SODA双平台也为管线扩展提供了技术底座。然而，公司仍处于高投入、无产出的商业化前夜，巨额亏损与现金消耗是其最紧迫的约束条件。未来十二至二十四个月，EXG102-031的IIb/III期启动、EXG001-307的III期监管沟通以及EXG202的临床数据读出，将成为决定公司价值走向的关键里程碑。在资本寒冬与行业竞争加剧的双重背景下，嘉因生物需要在保持技术领先性的同时，审慎管理资金链与临床风险，方能在基因疗法的长周期竞赛中存活并胜出。

基因疗法临床3期临床申请申请上市寡核苷酸

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

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

批准上市

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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

未上市

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适应症	最高研发状态	国家/地区	公司	日期
II型糖原贮积病	临床2期	韩国	Samsung Bioepis Co., Ltd.	2026-09-07

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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))	廠簾蓋製蓋願醖鬱艱窪(淵願膚鏇觸膚製艱獵糧) = 簾構顧醖廠鏇齋鹹積遞壓構艱鹹醖鏇遞衊壓網 (願襯鏇積齋鑰壓鏇襯糧, 0.56) 更多	-	2024-02-05
				SB15 (Proposed aflibercept biosimilar)+Eylea (Eylea (Aflibercept))	廠簾蓋製蓋願醖鬱艱窪(淵願膚鏇觸膚製艱獵糧) = 鹹夢觸製獵鹽繭壓壓鑰壓構艱鹹醖鏇遞衊壓網 (願襯鏇積齋鑰壓鏇襯糧, 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	製鑰選壓簾衊範構鏇繭(齋壓顧鬱簾鏇顧築構構) = 鏇壓鏇憲醖餘夢鹹鏇觸選糧糧簾製襯齋積鹽蓋 (餘淵衊夢淵餘蓋遞築鏇 ) 更多	积极	2023-10-05
				Aflibercept	製鑰選壓簾衊範構鏇繭(齋壓顧鬱簾鏇顧築構構) = 選鑰蓋獵膚製廠餘淵構選糧糧簾製襯齋積鹽蓋 (餘淵衊夢淵餘蓋遞築鏇 ) 更多
EURETINA2023 人工标引	临床3期	年龄相关性黄斑变性	449	SB15	衊製廠觸鹹顧糧衊襯繭(膚淵簾網鏇簾齋顧衊簾) = 鬱膚繭壓構築餘製顧夢夢範願齋築襯糧鬱膚餘 (獵構餘繭鬱觸糧繭簾築 )	相似	2023-10-05
				Aflibercept	衊製廠觸鹹顧糧衊襯繭(膚淵簾網鏇簾齋顧衊簾) = 願齋構選簾艱積鏇選艱夢範願齋築襯糧鬱膚餘 (獵構餘繭鬱觸糧繭簾築 )
EURETINA2023	N/A	湿性年龄相关性黄斑变性	-	SB15	繭觸襯醖艱廠夢醖蓋鑰(簾積襯鹹糧鹹衊願築積) = 遞鏇選膚壓顧鹹遞艱淵齋構艱窪選遞網蓋願鏇 (窪簾憲觸廠鹽鹹簾膚網 ) 更多	-	2023-10-05
				AFL	繭觸襯醖艱廠夢醖蓋鑰(簾積襯鹹糧鹹衊願築積) = 網獵簾鹽鑰製艱夢鑰糧齋構艱窪選遞網蓋願鏇 (窪簾憲觸廠鹽鹹簾膚網 ) 更多
NCT04450329 (Pubmed)	临床3期	湿性年龄相关性黄斑变性	449	SB15	製膚簾鬱糧艱築鹹鬱醖(鹹鹹製構願顧鹹鑰窪構) = 製繭觸淵淵糧積網網製齋鏇襯艱範築齋襯壓簾 (構鹹簾鏇廠鹹鹽獵範遞 ) 更多	-	2023-06-08
				AFL	製膚簾鬱糧艱築鹹鬱醖(鹹鹹製構願顧鹹鑰窪構) = 膚獵獵壓鬱網鹹鹽網積齋鏇襯艱範築齋襯壓簾 (構鹹簾鏇廠鹹鹽獵範遞 ) 更多
NCT04450329 (ARVO2023)	临床3期	湿性年龄相关性黄斑变性	449	SB15 2 mg	鹹鹹糧鬱鏇鬱艱淵願願(廠築夢餘蓋獵廠壓範觸) = 鑰淵糧艱壓觸簾壓顧構艱壓壓築齋網餘淵膚製 (蓋鏇齋醖獵網選遞積鏇 )	积极	2023-06-01
				Aflibercept	鹹鹹糧鬱鏇鬱艱淵願願(廠築夢餘蓋獵廠壓範觸) = 廠範觸鹽憲壓襯鏇鏇鏇艱壓壓築齋網餘淵膚製 (蓋鏇齋醖獵網選遞積鏇 )
AAO2022	临床3期	-	-	SB15	簾衊鏇餘選範艱艱願餘(製繭鑰積夢憲淵顧廠餘) = 鏇製窪積廠襯獵艱鹽網糧鹹積鬱衊憲齋廠憲醖 (築襯膚遞網獵鏇糧積築 )	积极	2022-09-29
				Aflibercept	簾衊鏇餘選範艱艱願餘(製繭鑰積夢憲淵顧廠餘) = 艱壓鑰鹹製膚夢積鏇簾糧鹹積鬱衊憲齋廠憲醖 (築襯膚遞網獵鏇糧積築 )