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.

EUCTR2019-003883-28-CZ / Not yet recruiting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

开始日期2020-05-07

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）

2023-12-19·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: Se Joon Woo ; SriniVas R Sadda ; Mario Bradvica ; Attila Vajas ; Min Sagong ; Jan Ernest ; Jan Studnička ; Miroslav Veith ; Edward Wylegala ; Sunil Patel ; Cheolmin Yun ; Michal Orski ; Sergei Astakhov ; Edit Tóth-Molnár ; Adrienne Csutak ; Lajos Enyedi ; Wooree Choi ; Inkyung Oh ; Hyerin Jang

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.

2023-06-08·JAMA ophthalmology

Efficacy and Safety of the Aflibercept Biosimilar SB15 in Neovascular Age-Related Macular Degeneration: A Phase 3 Randomized Clinical Trial.

Article

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

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.

2023-06-01·Materials today. Chemistry

COVID-19 impedimetric biosensor based on polypyrrole nanotubes, nickel hydroxide and VHH antibody fragment: specific, sensitive, and rapid viral detection in saliva samples.

Article

作者: A Santos ; A P Macedo de Souza Brandão ; B M Hryniewicz ; H Abreu ; L Bach-Toledo ; S Schuster da Silva ; A E Deller ; V Z Rogerio ; D S Baêta Rodrigues ; P M Hiraiwa ; B G Guimarães ; L F Marchesi ; J Carvalho de Oliveira ; D F Gradia ; F L F Soares ; N I T Zanchin ; C Camargo de Oliveira ; M Vidotti

SARS-CoV-2 rapid spread required urgent, accurate, and prompt diagnosis to control the virus dissemination and pandemic management. Several sensors were developed using different biorecognition elements to obtain high specificity and sensitivity. However, the task to achieve these parameters in combination with fast detection, simplicity, and portability to identify the biorecognition element even in low concentration remains a challenge. Therefore, we developed an electrochemical biosensor based on polypyrrole nanotubes coupled via Ni(OH)₂ ligation to an engineered antigen-binding fragment of heavy chain-only antibodies (VHH) termed Sb#15. Herein we report Sb#15-His6 expression, purification, and characterization of its interaction with the receptor-binding domain (RBD) of SARS-CoV-2 in addition to the construction and validation of a biosensor. The recombinant Sb#15 is correctly folded and interacts with the RBD with a dissociation constant (K_D) of 27.1 ± 6.4 nmol/L. The biosensing platform was developed using polypyrrole nanotubes and Ni(OH)₂, which can properly orientate the immobilization of Sb#15-His6 at the electrode surface through His-tag interaction for the sensitive SARS-CoV-2 antigen detection. The quantification limit was determined as 0.01 pg/mL using recombinant RBD, which was expressively lower than commercial monoclonal antibodies. In pre-characterized saliva, both Omicron and Delta SARS-CoV-2 were accurately detected only in positive samples, meeting all the requirements recommended by the World Health Organization for in vitro diagnostics. A low sample volume of saliva is needed to perform the detection, providing results within 15 min without further sample preparations. In summary, a new perspective allying recombinant VHHs with biosensor development and real sample detection was explored, addressing the need for accurate, rapid, and sensitive biosensors.

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

2024-04-05

·GlobeNewswire-Health Care

Samsung Bioepis Initiates Phase 3 Clinical Trial for SB27, Proposed Biosimilar to Keytruda (Pembrolizumab)

INCHEON, Korea, April 05, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced the initiation of Phase 3 clinical trial for SB27, the company's proposed biosimilar referencing Keytrudai (pembrolizumab). The Phase 3 clinical trial for SB27 is a randomized, double-blind, parallel group, multicenter studyii to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB27 and Keytruda in patients with metastatic non-squamous non-small cell lung cancer. Patients will be randomized in a 1:1 ratio to receive either SB27 or Keytruda 200 mg intravenously every 3 weeks concurrently with chemotherapy (pemetrexed 500 mg/m2 with vitamin supplementation intravenous (IV) infusion over 10 minutes every 3 weeks and carboplatin area under the curve [AUC] 5 IV infusion over 15-60 minutes every 3 weeks for the first 4 cycles). More information on this study is available at clinicaltrials.gov (NCT06348199). “We are thrilled to announce the initiation of Phase 3 clinical trial for SB27, after our successful Phase 1 clinical trial initiation in February 2024,” said Ilsun Hong, Vice President, Product Evaluation Team Leader of Samsung Bioepis. “Based on our extensive clinical trial experience accumulated over the years, we will work closely with study investigators to ensure successful completion of the clinical trials for SB27.” As of April 2024, Samsung Bioepis has eight biosimilars approved and seven available around the worldiii – SB4 (etanercept), SB2 (infliximab), SB5 (adalimumab), SB3 (trastuzumab), SB8 (bevacizumab), SB11 (ranibizumab), SB12 (eculizumab), and SB15 (aflibercept)iv – along with three biosimilar candidates in pipeline – SB16 (denosumab), SB17 (ustekinumab) and SB27 (pembrolizumab).v 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 biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – LinkedIn, X. i KEYTRUDA is a trademark of Merck Sharp & Dohme Corp. ii The countries of recruitment include Bosnia and Herzegovina, Brazil, Georgia, Germany, India, Japan, Malaysia, Mexico, Philippines, Romania, Serbia, Spain, Thailand, and Turkey. iii “Approval” and “Availability” signify regulatory approval/launch in one or more markets and do not necessarily indicate approval/launch in all markets worldwide. iv SB15 (aflibercept) is approved in Korea by the Ministry of Food and Drug Safety (MFDS) and is not yet available in the market. v In the United States, the Biologics License Application (BLA) for SB17 is under review by the U.S. Food and Drug Administration (FDA). In Europe, SB17 has been recommended for approval by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP), having received positive CHMP opinion in February 2024.

临床3期上市批准临床1期

2024-01-26

·药事纵横

三星生物：2024年预计收入增长10-15%

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。2024年1月24日，三星集团旗下专注于生物药CDMO领域的三星生物宣布了2023年财年和第四季度的强劲财务业绩：全年综合营收36946亿韩元（约为27.64亿美元），同比增长23.1%。全年综合营业利润为11137亿韩元（约为8.33亿美元），同比增长13.2%。三星生物在Q4更是显示出强劲的业绩增长，Q4综合营收10735亿韩元（约为8.03亿美元），同比增长11.2%。三星生物预测，2024年的销售额将呈上升趋势，预计收入将增长10-15%。三星生物表示营收增长主要得益于4号工厂（Plant 4）的成功投产和强劲的销售积压。4号工厂包含1期和2期，总产能24万升，预计到2025年4号工厂内的新设施将贡献原料药制造收入的30% 左右。此外，三星生物正在建设5号工厂，预计工程将于2025年4月投产。2023年，三星生物2023年合同量创历史新高，与辉瑞、诺华、GSK、BMS等全球大型制药公司达成多项大型交易，累计签订了价值超过120亿美元的合同。全球前20强制药客户数量从2022年的12家增至2023年的14家。2023年9月，三星生物与百时美施贵宝子公司Swords Laboratories签订了价值2.42亿美元（约为17.67亿人民币）的生产合同，将生产到2030年的抗体类抗肿瘤药物。根据这项新协议，三星生物制剂将在其位于韩国松岛的最新也是最大的4号工厂生物制造工厂提供生产服务。2023年7月，三星生物接到诺华订单，双方签订了一项价值近3.91亿美元的5年协议，这份为期5年的生产和供应协议将侧重于原料药的生产，期限为2024年至2028年。2023年7月，三星生物宣布与辉瑞达成两项协议，总价值达8.97亿美元，包括一份7.04亿美元的合同，以及一份1.93亿美元的订单，这是此前3月份宣布的一项交易的后续订单。2023年6月，三星生物还和辉瑞签署了一项4.113亿美元的长期协议，三星生物将为辉瑞生产药品，不过两家公司没有透露“长期”合同的期限。三星生物也在积极布局ADC管线，去年4月，三星生物与瑞士Araris Biotech合作，后者拥有自己的ADC连接技术——“Ara Linker”；9 月，三星生物对拥有大量ADC管线的韩国生物公司Aimd Bio进行了股权投资。目前管线中3款在研产品（SB15、SB16、SB17）正准备上市，6款未披露产品正在研发中。参考资料：公司官网

财报抗体药物偶联物

2023-10-07

·GlobeNewswire-Health Care

Samsung Bioepis Presents Post-hoc Analysis of Phase 3 Clinical Trial for SB15, a Proposed Biosimilar to Eyleaⁱ (Aflibercept), at EURETINA 2023

Switching study conducted to evaluate whether switching from reference aflibercept to SB15 maintains comparable clinical efficacy and safetyPost-hoc analysis demonstrates biosimilarity between SB15 and reference aflibercept before and after switching INCHEON, Korea, Oct. 07, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that it presented a post-hoc analysis of the Phase 3 clinical study results for SB15, a proposed biosimilar to Eylea (aflibercept), at EURETINA 2023 being held from October 5 to 8 in Amsterdam, the Netherlands. In this Phase 3, randomized, double-masked, parallel-group multicenter studyii, a total of 449 study participants were randomized 1:1 to receive 3 monthly intravitreal injections of either 2 mg SB15 or reference aflibercept (AFL) initially, followed by treatment once every 8 weeks up to week 48. The aim of the post-hoc analysis was to find out biosimilarity between SB15 and reference aflibercept. This post-hoc analysis demonstrated that switching to SB15 from AFL maintained comparable clinical efficacy and safety in treating patients with neovascular age-related macular degeneration (nAMD), confirming biosimilarity between these agents before and after switching. The primary endpoint was change from baseline in best corrected visual acuity (BCVA) at week 8; all endpoints were followed through week 56. The efficacy and safety after switching were compared with that of prior to switching. A post-hoc analysis was conducted on efficacy endpoints including change in BCVA and central subfield thickness (CST), using data measured at time of re-randomization at week 32 prior to injection as the new baseline to compare clinical biosimilarity between SB15 and AFL post-switching (AFL/SB15 group vs AFL/AFL group). “We are pleased to present the switching data of SB15 from reference aflibercept that continues to demonstrate its comparable clinical efficacy and safety in treating patients with nAMD. We hope the study results also help allay concerns over safety and efficacy of biosimilars for their use in patients who were previously treated with reference product,” said Hyejin Kim, Vice President and Medical and Lifecycle Safety Team Leader at Samsung Bioepis. “We will continue to advance with our scientific research, publication and educational activities to bring more awareness of biosimilars among ophthalmologists,” she added. Samsung Bioepis and Biogen announced in November 2019 that they had entered into an exclusive commercialization agreement for two ophthalmology biosimilar candidates, SB11/BYOOVIZ™ (ranibizumab) and SB15 (aflibercept) in major markets around the world. “This post-hoc analysis provides valuable insights on the outcomes of switches from the reference biologic to SB15 and may help clinicians to make well informed decisions on potential use of SB15 if approved”, said Mourad Farouk Rezk, Vice President and Head of Global Medical and Development, Biogen Biosimilars Unit. SB15 switching data aside, Samsung Bioepis also showcased two other presentations at EURETINA and the details are as below: Presentation TitlePresentation DetailsPre-to-Post Switching Efficacy and Safety Assessments of SB15 (Proposed Aflibercept Biosimilar) in Neovascular Age-Related Macular Degeneration: Findings from a Post-hoc Analysis of a Phase III Clinical TrialSession: Free Paper Session 13: AMD IIIDate/Time: Oct 7 (Sat), 16:19-16:25 PM CESTAbstract Number: CA23211 Authors: Srinivas Sadda, Se Joon Woo, Mario Bradvica, Attila Vajas, Min Sagong, Jan Ernest, Jan Studnicka, Miroslav Veith, Edward Wylegala, Sunil Patel, Cheolmin Yun, Inkyung Oh, Mercy Yeeun Kim, Hyerin Jang, Taehyung Kim, Seungkee Kim, Wooree Choi, Neil M. BresslerPhase III Randomized Clinical Trial Comparing SB15 with Reference Aflibercept in Neovascular Age-Related Macular Degeneration: 56-Week ResultsiiiSession: AMDAbstract Number: CA23305Authors: Se Joon Woo, Srinivas Sadda, Mario Bradvica, Attila Vajas, Min Sagong, Jan Ernest, Jan Studnicka, Miroslav Veith, Edward Wylegala, Sunil Patel, Cheolmin Yun, Michal Orski, Sergei Astakhov, Edit Tóth-Molnár, Adrienne Csutak, Lajos Enyedi, Taehyung Kim, Inkyung Oh, Hyerin JangImmunogenicity with Ranibizumab Biosimilar SB11 (Byooviz) and Reference Product Lucentis and Association with Efficacy, Safety, and Pharmacokinetics: A Post Hoc Analysis of a Phase III Randomized Clinical TrialivSession: AMDAbstract Number: CA23250Authors: Se Joon Woo, Mercy Yeeun Kim, Inkyung Oh, Taehyung Kim, Neil M. Bressler SB15 Post-hoc Analysis A total of 449 study participants were randomized 1:1 to receive 3 monthly 0.05 mL intravitreal injections of either 2 mg SB15 or AFL initially, followed by treatment once every 8 weeks up to week 48. At week 32, a total of 438 participants were re-randomized, resulting in 219 continuing SB15, 108 continuing AFL (AFL/AFL), and 111 switched from AFL to SB15 (AFL/SB15). 425 (97.0%) re-randomized participants completed the study up to week 56. The new baseline (W32; prior to re-randomization) characteristics were comparable between the continued (AFL/AFL) group and the switched (AFL/SB15) group. The efficacy was well-maintained post-switching as the mean BCVA letter score (~Snellen equivalent) was 65.3 (20/50) at Week 32 (pre-switching) and 65.8 (20/50) at Week 56 (post-switching) for the AFL/SB15 group compared with 65.2 (20/50) at Week 32 and 65.8 (20/50) at Week 56 within AFL/AFL group. Also, there was no difference in efficacy between the two groups post-switching as the least square (LS) mean for change from W32 in BCVA at week 56 for AFL/AFL was 0.0 letters and 0.2 letters for AFL/SB15 (difference: 0.3 [95% CI: -1.2, 1.8] letters). The LS mean for change from W32 in CST at week 56 for AFL/AFL was -13 μm and for AFL/SB15 was -9 μm (difference: 4 [95% CI: -7, 14] μm). There were no additional safety signals identified and the immunogenicity profile was also similar after switching. 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 biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, endocrinology, and gastroenterology. For more information, please visit: www.samsungbioepis.com and follow us on social media – Twitter, LinkedIn. References i Eylea is a trademark of Regeneron. ii Srinivas R Sadda, Se Joon Woo, et al. Pre-to-Post Switching Efficacy and Safety Assessments of SB15 (Proposed Aflibercept Biosimilar) in Neovascular Age-Related Macular Degeneration: Findings from a Post-hoc Analysis of a Phase III Clinical Trial. Presentation Presented at EURETINA 2023. iii The same study results were first presented at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting (Apr 23-27, 2023). iv The same analysis results were first presented at the American Academy of Ophthalmology (AAO) 2022 Annual Meeting (Sep 30-Oct 3, 2022) under the title “Correlation Analysis between Immunogenicity and Clinical Outcomes of an Approved Ranibizumab Biosimilar, Byooviz™ (SB11)” (Neil M Bressler, Se Joon Woo et al).

临床3期临床结果引进/卖出

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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研发状态

适应症	最高研发状态	国家/地区	公司
糖尿病性黄斑水肿	临床3期	新加坡更多	上海蔼睦医疗科技有限公司更多
湿性年龄相关性黄斑变性	临床3期	新加坡更多	上海蔼睦医疗科技有限公司更多

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适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


PO381 (AAO2022)	临床3期	湿性年龄相关性黄斑变性	-	SB15	(鹹夢製醖願膚壓壓艱廠) = 願餘鏇淵餘鬱鹽獵範鹹築壓衊構糧繭網簾夢壓 (獵選繭獵壓淵膚製襯糧 )	积极	2022-09-29
				Aflibercept	(鹹夢製醖願膚壓壓艱廠) = 淵鹽製艱願憲鏇糧蓋構築壓衊構糧繭網簾夢壓 (獵選繭獵壓淵膚製襯糧 )
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))	簾齋糧範衊願築繭糧鑰(築鹹膚醖淵積觸窪鏇襯) = 鬱觸壓築顧窪觸壓窪餘壓窪襯積醖範膚醖艱蓋 (積築願選淵遞糧鬱廠蓋, 糧顧醖淵衊鑰顧積鹹築 ~ 鏇憲構築積夢鹽製齋壓) 更多	-	2024-02-05
				SB15 (Proposed aflibercept biosimilar) (Eylea (Aflibercept))	簾齋糧範衊願築繭糧鑰(築鹹膚醖淵積觸窪鏇襯) = 窪夢構齋積蓋壓網鹽窪壓窪襯積醖範膚醖艱蓋 (積築願選淵遞糧鬱廠蓋, 願衊壓網築淵網觸窪範 ~ 齋齋窪糧鹽艱鹽憲餘糧) 更多
Phase III Randomized Clinical Trial Comparing SB15 with Reference Aflibercept in Neovascular Age-Related Macular Degeneration (ARVO2023)	临床3期	湿性年龄相关性黄斑变性	449	SB15 2 mg	(積襯構鏇獵範夢鑰獵壓) = 製積壓衊築廠網艱襯鏇醖繭鬱範繭獵獵鬱廠窪 (鬱淵範鏇夢蓋膚襯衊構 )	积极	2023-06-01
				Aflibercept	(積襯構鏇獵範夢鑰獵壓) = 廠壓遞餘襯繭齋簾繭範醖繭鬱範繭獵獵鬱廠窪 (鬱淵範鏇夢蓋膚襯衊構 )
NCT04450329 (Pubmed)	临床3期	年龄相关性黄斑变性	449	SB15	(醖簾範築蓋構鹹鬱夢遞) = 鹽鹹願鬱範製繭鬱鏇夢襯襯鹹範顧夢積憲窪選 (築膚獵膚壓襯糧糧願餘 ) 更多	-	2023-06-08
				AFL	(醖簾範築蓋構鹹鬱夢遞) = 構製廠壓簾蓋夢積餘夢襯襯鹹範顧夢積憲窪選 (築膚獵膚壓襯糧糧願餘 ) 更多