This is a Phase II, open-label study designed to evaluate the safety, efficacy, and immunogenicity of NM8074 in PNH patients undergoing complement-inhibitor therapy with Soliris.

开始日期2025-03-01

申办/合作机构

NovelMed Therapeutics, Inc.

NCT05726916 / Recruiting临床3期

Eculizumab in Hypertensive Emergency-associated Hemolytic Uremic Syndrome: a Randomized Multicenter Controlled Trial

Hemolytic and uremic syndrome (HUS) is a clinic-biological syndrome related to thrombotic microangiopathy affecting predominantly the kidney. Atypical HUS (aHUS) has been historically defined as HUS occurring in the absence of infectious event. The role of complement dysregulation in aHUS pathophysiology has been largely demonstrated, since C genetic rare variants are present in 60-70% aHUS patients. In line with the frequency of C dysregulation in aHUS, Eculizumab, an anti-C5 monoclonal antibody, has dramatically improved aHUS patients prognosis.
Numerous conditions have been associated with aHUS, including hypertensive emergency (HE), a syndrome of acute blood pressure flare associated with end-organ damage. In cases of HE-aHUS, whether primary aHUS is complicated by secondary HE, or primary HE leads to secondary aHUS is still debated.
The investigators recently demonstrated that C genetic variants frequency was similar in patients with HE-aHUS and patients with aHUS without HE, suggesting a major role for C dysregulation in HE-aHUS. Consequently, the investigators propose to evaluate, in HE-aHUS patients, the benefit of a strategy with early Eculizumab therapy (used within its marketing authorization and its conditions of refunding by the health insurance in usual care), compared to standard of care including tight blood pressure control.
The hypothesis suggests that C dysregulation may impact renal prognosis of HE-aHUS patients. The investigator's aim to demonstrate that early Eculizumab therapy improves prognosis of HE-aHUS patients.
Method
The HYPERSHU study is a randomized, controlled, open-labelled study including HE-aHUS patients with severe AKI and no evidence of other conditions associated with HUS (infections, autoimmunity, drugs, pregnancy). The investigators plan to include 62 patients. Patients will be randomized in 2 arms:
Early Eculizumab therapy (for 3 months) added to standard of care (tight blood pressure control).
Standard of care alone with tight blood pressure control. Renal function after 6 months is the primary evaluation criterium.
HE is a frequently associated with aHUS, and strongly impacts patient renal prognosis. Efficient therapeutic strategies are still lacking for this condition. The HYPERSHU study will allow to evaluate the benefit of early Eculizumab therapy in patients with HE-aHUS and severe renal dysfunction.

开始日期2023-11-09

申办/合作机构

Assistance Publique des Hôpitaux de Paris SA

NCT05876351 / Recruiting临床3期

Prospective, Single-Arm, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Complement Inhibitor Treatment-Naïve Pediatric and Adult Participants With Atypical Hemolytic Uremic Syndrome (aHUS) in China

This is a Phase 3b, open-label, single-arm, multicenter study to evaluate the efficacy and safety of eculizumab in participants with atypical hemolytic uremic syndrome (aHUS) in China

开始日期2023-07-14

申办/合作机构

Alexion Pharmaceuticals, Inc.

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项与依库珠单抗生物类似药(Samsung Bioepis) 相关的文献（医药）

2023-12-01·Drugs in R&D

In-Use Stability of SB12 (Eculizumab, Soliris Biosimilar) Diluted in Saline and Dextrose Infusion Solution after an Extended Storage Period

Article

作者: Lee, Yoonsook ; Kim, Soyeon ; Tak, Minji ; Kim, Jihyun ; Jeong, Hawon ; Park, Su Jin ; Yun, Jihoon

INTRODUCTION:

SB12 is a biosimilar to eculizumab reference product [Soliris^TM (Soliris is a trademark of Alexion Pharmaceuticals, Inc.)] that acts as a C5 complement protein inhibitor. The infusion stability of in-use (diluted) SB12 outside the conditions stated in the reference product's label is unknown.

OBJECTIVE:

The objective of this study was to assess the stability of SB12 after extended storage in conditions not claimed in the originator label.

METHODS:

Infusion stability was assessed in SB12 samples (diluted in 0.9% NaCl, 0.45% NaCl, and 5% dextrose, final concentration of 5 mg/mL per clinical trial protocol and the reference product's label) kept at 5 ± 3 °C for up to 3 months, then 30 ± 2 °C/65 ± 5% relative humidity (RH) for 72 h. The product was stored in different containers [polyolefin (PO) bags, glass bottles and syringes], and the protocol followed International Conference on Harmonisation (ICH) and European Medicines Agency (EMA) requirements for stability evaluation of biological products. Stability was evaluated using complementary assays, including pH, protein concentration (A₂₈₀), purity (size exclusion-high-performance liquid chromatography, capillary electrophoresis-sodium dodecyl sulfate, and imaged capillary isoelectric focusing), biological activity (C5 binding and inhibition), and safety (subvisible particles).

RESULTS:

Except for charge variants in SB12 diluted in 5% dextrose, all results met the stability acceptance criteria. There were no major changes in terms of physicochemical stability, biological activity, and subvisible particles.

CONCLUSIONS:

The infusion stability of SB12 after extended storage (5 ± 3 °C for up to 3 months, then 30 ± 2 °C/65 ± 5% RH for 72 h) was demonstrated for longer periods and at higher temperatures than what is stated in the EU and US labels of the reference product. The physicochemical properties, biological activity, and subvisible particles of in-use SB12 diluted in 0.9% NaCl and 0.45% NaCl were maintained under the described conditions and for all tested containers. However, instability was observed for the diluted SB12 in 5% dextrose. These results may reduce the workload of clinical staff and minimize drug waste from treatment delays without any loss in product quality and biological activity.

2023-08-12·Molecules (Basel, Switzerland)

Scaffold Morphing and In Silico Design of Potential BACE-1 (β-Secretase) Inhibitors: A Hope for a Newer Dawn in Anti-Alzheimer Therapeutics.

Article

作者: Singh, Thakur Gurjeet ; Sharma, Pratibha ; Singh, Tanveer ; Singh, Varinder ; Mujwar, Somdutt ; Mishra, Krishna Kumar ; Singh, Manjinder ; Bhatia, Shiveena ; Ahmad, Sheikh Fayaz

Alzheimer's disease (AD) is the prime cause of 65-80% of dementia cases and is caused by plaque and tangle deposition in the brain neurons leading to brain cell degeneration. β-secretase (BACE-1) is a key enzyme responsible for depositing extracellular plaques made of β-amyloid protein. Therefore, efforts are being applied to develop novel BACE-1 enzyme inhibitors to halt plaque build-up. In our study, we analyzed some Elenbecestat analogues (a BACE-1 inhibitor currently in clinical trials) using a structure-based drug design and scaffold morphing approach to achieve a superior therapeutic profile, followed by in silico studies, including molecular docking and pharmacokinetics methodologies. Among all the designed compounds, SB306 and SB12 showed good interactions with the catalytic dyad motifs (Asp228 and Asp32) of the BACE-1 enzyme with drug-likeliness properties and a high degree of thermodynamic stability confirmed by the molecular dynamic and stability of the simulated system indicating the inhibitory nature of the SB306 and SB12 on BACE 1.

2023-07-01·BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy

Characterization for the Similarity Assessment between Proposed Biosimilar SB12 and Eculizumab Reference Product Using a State-of-the-Art Analytical Method.

Article

作者: Kim, Yikwon ; Lee, Jungmin ; Cho, Miju ; Yoo, Taekyung ; Hong, Eunkyoung ; Kim, Hyunsoo ; Kim, Jihye ; Hong, Seokku

BACKGROUND:

SB12 is being developed as a proposed biosimilar to eculizumab reference product (RP), a humanized monoclonal antibody (IgG2/4 kappa immunoglobulin) that binds to the human C5 complement protein. Binding to this protein inhibits complement-mediated intravascular hemolysis by blocking its cleavage into C5a and C5b. Eculizumab RP is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy, generalized myasthenia gravis who are anti-acetylcholine receptor antibody-positive, and neuromyelitis optica spectrum disorder in adult patients who are anti-aquaporin-4 antibody-positive.

OBJECTIVE:

The objective of this study was to demonstrate structural, physicochemical, and biological similarity between eculizumab RP and SB12 using various state-of-the-art analytical methods.

METHODS:

Comprehensive analytical characterization was conducted with side-by-side comparison of SB12 with European Union (EU) and United States (US) eculizumab RPs using various analytical methods (more than 40 state-of-the-art assays). Comparisons included purity, product-related impurity, charge heterogeneity, primary structure, post-translational modification, higher-order structure, quantity, Fab-related biological activities (potency and binding activity), and Fc-related biological activities.

RESULTS:

Based on the analytical similarity assessment, the structural, physicochemical, and biological characterization results demonstrated that SB12 is highly similar to the EU and US eculizumab RP. In the structural aspects, it was confirmed that there is no difference between post-translational modification profiles and higher-order structures of SB12 compared with the eculizumab RP. Product-related impurities in the form of aggregates and charge variants were also confirmed to be similar. Mechanism of action (MoA)-related biological activities showed that SB12 is highly similar to the EU and US eculizumab RP with respect to overall critical and non-critical quality attributes analyzed. Moreover, similarity of comparative binding tendency of SB12 and eculizumab RP to Fc gamma receptors and C1q was confirmed through additional characterization methods. Based on these results, SB12 is expected to have highly similar safety and efficacy compared with eculizumab RP.

CONCLUSION:

In summary, the overall analytical characterization and similarity assessment results show that SB12 is highly similar to the EU and US eculizumab RP in terms of structural, physicochemical, biophysical, and biological attributes.

项与依库珠单抗生物类似药(Samsung Bioepis) 相关的新闻（医药）

2024-06-14

·GlobeNewswire-Health Care

Samsung Bioepis Presents Post-hoc Analysis of Phase 3 Study for EPYSQLI™ (SB12; Eculizumab Biosimilar), at the European Hematology Association (EHA) Congress 2024

Transfusion avoidance results were comparable between SB12 and reference eculizumab-treated groups, supporting clinical efficacy between SB12 and reference eculizumab INCHEON, Korea, June 14, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today presented the post-hoc analysis of the Phase 3 clinical study results for EPYSQLI™ (SB12), a biosimilar to Soliris1 (eculizumab), at the 29th European Hematology Association 2024 (EHA2024) Hybrid Congress held in Madrid, Spain and virtually, from June 13 to 16, 2024. The post-hoc analysis of SB12 pivotal Phase 3 study compared the proportion of patients remaining transfusion-free (“transfusion avoidance”) among those treated with SB12 or reference eculizumab (ECU), respectively. Eculizumab is known to significantly reduce hemolysis resulting in improvements in anemia as indicated by increased hemoglobin stabilization and reduced need for red blood cell (RBC) transfusions.2 For this study, 50 adults with PNH who were complement-inhibitor naïve were randomized (1:1) to treatment sequence I (TS1: SB12 to ECU, n=25) or II (TS2: ECU to SB12, n=25), to receive 600 mg of SB12 or ECU intravenously every week for first 4 weeks and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter. At Week 26, patients were switched to ECU or SB12, respectively, and received infusion until Week 50 (i.e., Period 1 followed by Period 2 from Week 26). This efficacy analysis was conducted in pooled patients treated with SB12 or ECU in either Periods 1 or 2. Transfusion avoidance was 68.1% for patients who received SB12 versus 72.9% for patients who received reference eculizumab, with a difference of -5.3% [95% confidence interval (CI), (-18.9%, 8.4%), p-value 0.4492], resulting in non-significant difference between the two treatment groups. “This post-hoc analysis supports the previously demonstrated comparable clinical efficacy of SB12 with reference eculizumab in treating PNH patients, with no significant difference in reducing transfusion burden compared to reference eculizumab,” said Hyejin Kim, Vice President and Medical & Lifecycle Safety Team Leader at Samsung Bioepis. “Our dedication to make a meaningful difference to our patients remain steadfast. We will continue to work collaboratively with clinicians and physicians to further expand the treatment options for patients with orphan diseases.” Details of the SB12 abstract are as follows: Abstract title: Transfusion Avoidance with EPYSQLI™(SB12), A Biosimilar to Reference Eculizumab: A Post-hoc Analysis from the Pivotal Phase 3 StudyAbstract number: P1916Program type: e-Poster PresentationAuthors: Jun Ho Jang, Jihye Park, Younsoo Kim, Jihyun Han and Paola Russo In May 2023, the European Commission (EC) approved SB12 as a biosimilar to Soliris (eculizumab) under the brand name EPYSQLI for the treatment of adults and children with PNH. In March 2024, EPYSQLI was granted an indication expansion for the treatment of adults and children with atypical haemolytic uremic syndrome (aHUS).3 About EPYSQLI (Eculizumab Biosimilar) in the European Union (EU) EPYSQLI is indicated in adults and children for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). EPYSQLI is not approved for and should not be used for the treatment of generalised myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). EPYSQLI must be administered by a healthcare professional and under the supervision of a physician experienced in the management of patients with hematological disorders or renal disorders. EPYSQLI EU Important Safety Information The EU Summary of Product Characteristics for EPYSQLI includes the following Special warning and Precautions: Meningococcal Infection EPYSQLI increases patient's susceptibility to Meningococcal infection (Neisseria meningitidis). Meningococcal disease due to any serogroup may occur. To reduce the risk of infection, all patients must be vaccinated at least 2 weeks prior to receiving eculizumab unless the risk of delaying eculizumab therapy outweighs the risks of developing a meningococcal infection. Patients who initiate eculizumab treatment less than 2 weeks after receiving a tetravalent meningococcal vaccine must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination. Vaccines against serogroups A, C, Y and W 135 are recommended in preventing the commonly pathogenic meningococcal serogroups. Vaccines against serogroup B where available are also recommended. Patients must receive vaccination according to current national vaccination guidelines for vaccination use. Vaccination may further activate complement. As a result, patients with complement-mediated diseases, including PNH and aHUS, may experience increased signs and symptoms of their underlying disease, such as haemolysis (PNH) or TMA (aHUS). Therefore, patients should be closely monitored for disease symptoms after recommended vaccination. Vaccination may not be sufficient to prevent meningococcal infection. Consideration should be given to official local guidance on the appropriate use of antibacterial agents. Cases of serious or fatal meningococcal infections have been reported in eculizumab-treated patients. All patients should be monitored for early signs of meningococcal infection, evaluated immediately if infection is suspected, and treated with appropriate antibiotics if necessary. Patients should be informed of warning signs and symptoms and steps taken to seek medical care immediately. Other Systemic Infections Patients may have increased susceptibility to other type of serious infections, especially with Neisseria and encapsulated bacteria. Infusion Reactions Administration of eculizumab may result in infusion reactions or immunogenicity that could cause allergic or hypersensitivity reactions (including anaphylaxis). Eculizumab administration should be interrupted in all patients experiencing severe infusion reactions and appropriate medical therapy administered. Anticoagulant therapy Treatment with EPYSQLI should not alter anticoagulant management. PNH Laboratory Monitoring PNH patients should be monitored for signs and symptoms of intravascular haemolysis, including serum lactate dehydrogenase (LDH) levels, and may require dose adjustment within the recommended 14±2 day dosing schedule during the maintenance phase (up to every 12 days). aHUS Laboratory Monitoring aHUS patients receiving eculizumab therapy should be monitored for thrombotic microangiopathy by measuring platelet counts, serum LDH and serum creatinine, and may require dose adjustment within the recommended 14±2 day dosing schedule during the maintenance phase (up to every 12 days). Treatment Discontinuation for PNH If patients discontinue treatment with eculizumab they should be closely monitored for signs and symptoms of serious intravascular haemolysis. Treatment Discontinuation for aHUS If aHUS patients discontinue treatment with eculizumab, they should be monitored closely for signs and symptoms of severe thrombotic microangiopathy complications. The most common adverse reaction observed with eculizumab treatment in clinical trials was found to be headache, whereas the most serious adverse reaction was found to be meningococcal infection. Refer to the Summary of Product Characteristics for EPYSQLI’s full safety 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 biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, endocrinology, hematology and nephrology. For more information, please visit: www.samsungbioepis.com and follow us on social media – follow us on social media – X, LinkedIn. MEDIA CONTACT Yoon Kim, yoon1.kim@samsung.com References: 1 Soliris is a trademark of Alexion Pharmaceuticals 2 European Medicines Agency. Soliris Product Information. https://www.ema.europa.eu/en/documents/product-information/soliris-epar-product-information_en.pdf. Accessed May 2024 3 European Medicines Agency. Epysqli Product Information. https://www.ema.europa.eu/en/documents/product-information/epysqli-epar-product-information_en.pdf. Accessed May 2024

临床3期临床结果上市批准

2024-05-31

·生物制药小编

FDA批准首个补体“可互换生物类似药”

近日，FDA批准了补体C5单抗Soliris的首个可互换生物类似药Bkemv，其无需更改处方便可替代原研药Soliris。这是FDA批准的第53个生物类似药，也是第13个可互换生物类似药。目前，Bkemv获得了阵发性睡眠性血红蛋白尿症（PNH）、非典型溶血性尿毒症综合征（aHUS）两个适应症的批准使用。Bkemv为安进开发，作为Soliris的可互换生物类似药，Bkemv也附带与其相同的安全警告，包括严重和危及生命的脑膜炎球菌感染风险的黑框警告。新品上位Soliris为罕见病龙头Alexion开发，是全球第一个获批的C5补体抑制剂，能够特异性结合补体蛋白C5，阻止C5裂解为C5a和C5b从而抑制膜攻击复合物（MAC）C5b-9的生成。20220年阿斯利康390亿美元巨资收购Alexion，获得该现金牛产品。2007年3月，Soliris首次获得FDA批准上市，用于治疗阵发性睡眠性血红蛋白尿症（PNH）。此后陆续获批了非典型溶血性尿毒症综合征（aHUS），全身性重肌无力（gMG）以及成人视神经脊髓炎（NMOSD）等适应症。作为一款罕见病用药，Soliris的盈利能力十分出色，2012年便以11.24亿美元销售成绩便跻身重磅炸弹行列。上市至今，Soliris已累计为Alexion贡献近300亿美元的销售收入。虽然Soliris上市的十年来，没有任何一款补体药物取得批准。但是居安思危的Alexion仍然推出了Soliris升级升级版Ultomiris，相比Soliris（每两周一次），Alexion依从性方面有了很大提升，可以实现8周一次给药。2018年12月，Ultomiris首次获FDA批准上市，用于治疗PNH，随后又获批了aHUS和MG适应症。彼时，市场对该药的商业前景十分看好，调研机构EvaluatePharma曾预测，Ultomiris在2024年的销售额将有望达到34.3亿美元。如今Ultomiris离这个目标已经不远，2023年Ultomiris的销售额已达到29.65亿美元，同比增长51%。而Soliris销售额已经下降至31.45亿美元（-16%），未来，Ultomiris将覆盖更大面积的Soliris市场。起诉三星也许正是有了升级迭代产品，Alexion对于Soliris生物类似药推出并没有表现的十分忧心。2019年，Soliris的首款生物类似药已在俄罗斯获批上市，此次Bkemv也顺利获批，没有遭到Alexion的专利侵权指控（Alexion曾和安进传出收购绯闻）。但是不知是何原因，Alexion没有放过三星Bioepis。2024年1月3日，Alexion在美国特拉华州地方法院对三星Bioepis提起了诉讼，指控其2023年7月7日提交SB12的aBLA侵犯了其6项专利，这也是首起涉及Soliris生物类似药的BPCIA（生物制品价格竞争与创新法案）侵权诉讼。Alexion声称，SB12侵犯了9732149、9718880、9725504、10590189、10703809、9447176美国专利，Alexion寻求法院对三星Bioepis做出已经或者将侵犯到其所主张的上述专利的判决，并禁止该公司销售该生物类似药的初步禁令及永久禁令。此前，三星向美国专利审判和上诉委员会（PTAB）递交了多方复审程序IPR，以对Alexion主张的前5项专利发起了无效反击，最近，PTAB已受理了该程序。总结凭借出色的补体药开发能力，Alexion在补体药物领域长期占据主导地位，Soliris在上市销售的十年来都没有竞争对手。而即便专利到期后，Alexion也能恰时推出迭代产品补位，无惧生物类似药的冲击。参考出处：https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761333s000lbl.pdfhttps://www.fda.gov/news-events/press-announcements/fda-approves-first-interchangeable-biosimilar-two-rare-diseases. Published May 28, 2024. Accessed May 28, 2024.https://www.mondaq.com/unitedstates/intellectual-property/1414876/alexion-sues-samsung-over-proposed-eculizumab-biosimilarhttps://www.biospace.com/article/amgen-wins-fda-approval-for-first-interchangeable-biosimilar-to-astrazeneca-s-soliris/生物医药年度最大并购交易，阿斯利康宣布390亿美元收购罕用药巨头Alexion

生物类似药并购

2024-05-30

·GlobeNewswire-Health Care

Samsung Bioepis to Present Post-hoc Analysis of Phase 3 Study for EPYSQLI™ (SB12; Eculizumab Biosimilar), at the European Hematology Association (EHA) Congress 2024

Post-hoc analysis of Phase 3 study to highlight transfusion avoidance results of SB12 compared to reference eculizumab-treated groups INCHEON, Korea, May 30, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that a post-hoc analysis of the Phase 3 clinical study results for EPYSQLI™ (SB12), a biosimilar to Soliris1 (eculizumab), will be presented at the 29th European Hematology Association 2024 (EHA2024) Hybrid Congress held in Madrid, Spain and virtually, from June 13 to 16, 2024. SB12 has shown equivalent efficacy with reference eculizumab (ECU) by lactate dehydrogenase (LDH) and comparable safety, pharmacokinetics, pharmacodynamics, and immunogenicity profiles in paroxysmal nocturnal hemoglobinuria (PNH) through the pivotal Phase 3 study.2 The post-hoc analysis of SB12 pivotal Phase 3 study presented at EHA2024 compared the proportion of patients remaining transfusion-free (“transfusion avoidance”) among those treated with SB12 or ECU, respectively. Eculizumab is known to significantly reduce hemolysis resulting in improvements in anemia as indicated by increased hemoglobin stabilization and reduced need for red blood cell (RBC) transfusions.3 “We are excited to present this data at EHA2024, that adds to the growing body of evidence that supports comparable clinical efficacy of SB12 with reference eculizumab in treating PNH patients,” said Hyejin Kim, Vice President and Medical & 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 for rare disease treatment and hope our study results serve as a guidance for clinicians.” Details of the SB12 abstract are as follows: Abstract title: Transfusion Avoidance with EPYSQLI™(SB12), A Biosimilar to Reference Eculizumab: A Post-hoc Analysis from the Pivotal Phase 3 StudyAbstract number: P1916Program type: e-Poster PresentationAuthors: Jun Ho Jang, Jihye Park, Younsoo Kim, Jihyun Han and Paola Russo In May 2023, European Commission (EC) approved SB12 as a biosimilar to Soliris (eculizumab) under the brand name EPYSQLI for the treatment of adults and children with PNH. In March 2024, EPYSQLI was granted an indication expansion for the treatment of adults and children with atypical haemolytic uremic syndrome (aHUS).4 About EPYSQLI (Eculizumab Biosimilar) in the European Union (EU) EPYSQLI is indicated in adults and children for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). EPYSQLI must be administered by a healthcare professional and under the supervision of a physician experienced in the management of patients with hematological disorders or renal disorders. EPYSQLI EU Important Safety Information The EU Summary of Product Characteristics for EPYSQLI includes the following Special warning and Precautions: Meningococcal Infection EPYSQLI increases patient's susceptibility to Meningococcal infection (Neisseria meningitidis). Meningococcal disease due to any serogroup may occur. To reduce the risk of infection, all patients must be vaccinated at least 2 weeks prior to receiving eculizumab unless the risk of delaying eculizumab therapy outweighs the risks of developing a meningococcal infection. Patients who initiate eculizumab treatment less than 2 weeks after receiving a tetravalent meningococcal vaccine must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination. Vaccines against serogroups A, C, Y and W 135 are recommended in preventing the commonly pathogenic meningococcal serogroups. Vaccines against serogroup B where available are also recommended. Patients must receive vaccination according to current national vaccination guidelines for vaccination use. Vaccination may further activate complement. As a result, patients with complement-mediated diseases, including PNH and aHUS, may experience increased signs and symptoms of their underlying disease, such as haemolysis (PNH) or TMA (aHUS). Therefore, patients should be closely monitored for disease symptoms after recommended vaccination. Vaccination may not be sufficient to prevent meningococcal infection. Consideration should be given to official local guidance on the appropriate use of antibacterial agents. Cases of serious or fatal meningococcal infections have been reported in eculizumab-treated patients. All patients should be monitored for early signs of meningococcal infection, evaluated immediately if infection is suspected, and treated with appropriate antibiotics if necessary. Patients should be informed of warning signs and symptoms and steps taken to seek medical care immediately. Other Systemic Infections Patients may have increased susceptibility to other type of serious infections, especially with Neisseria and encapsulated bacteria. Infusion Reactions Administration of eculizumab may result in infusion reactions or immunogenicity that could cause allergic or hypersensitivity reactions (including anaphylaxis). Eculizumab administration should be interrupted in all patients experiencing severe infusion reactions and appropriate medical therapy administered. Anticoagulant therapy Treatment with EPYSQLI should not alter anticoagulant management. PNH Laboratory Monitoring PNH patients should be monitored for signs and symptoms of intravascular haemolysis, including serum lactate dehydrogenase (LDH) levels, and may require dose adjustment within the recommended 14±2 day dosing schedule during the maintenance phase (up to every 12 days). aHUS Laboratory Monitoring aHUS patients receiving eculizumab therapy should be monitored for thrombotic microangiopathy by measuring platelet counts, serum LDH and serum creatinine, and may require dose adjustment within the recommended 14±2 day dosing schedule during the maintenance phase (up to every 12 days). Treatment Discontinuation for PNH If patients discontinue treatment with eculizumab they should be closely monitored for signs and symptoms of serious intravascular haemolysis. Treatment Discontinuation for aHUS If aHUS patients discontinue treatment with eculizumab, they should be monitored closely for signs and symptoms of severe thrombotic microangiopathy complications. The most common adverse reaction observed with eculizumab treatment in clinical trials was found to be headache, whereas the most serious adverse reaction was found to be meningococcal infection. Refer to the Summary of Product Characteristics (SmPC) for EPYSQLI’s full safety 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 biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, endocrinology, hematology and nephrology. For more information, please visit: www.samsungbioepis.com and follow us on social media – follow us on social media – X, LinkedIn. References: _____________________1 Soliris is a trademark of Alexion Pharmaceuticals 2 Jang JH, Gomez RD, Bumbea H, Nogaieva L, Wong LLL, Lim SM, Kim Y, Park J. A phase III, randomised, double-blind, multi-national clinical trial comparing SB12 (proposed eculizumab biosimilar) and reference eculizumab in patients with paroxysmal nocturnal haemoglobinuria. EJHaem. 2022 Dec 20;4(1):26-36. doi: 10.1002/jha2.632. PMID: 36819188; PMCID: PMC9928655. 3 European Medicines Agency. Soliris Product Information. https://www.ema.europa.eu/en/documents/product-information/soliris-epar-product-information_en.pdf. Accessed May 2024 4 European Medicines Agency. Epysqli Product Information. https://www.ema.europa.eu/en/documents/product-information/epysqli-epar-product-information_en.pdf. Accessed May 2024

临床3期上市批准临床结果疫苗

100 项与依库珠单抗生物类似药(Samsung Bioepis) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L04AA25	DB01257

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
阵发性睡眠性血红蛋白尿症	欧盟	Samsung Bioepis Co., Ltd.	2023-05-26
阵发性睡眠性血红蛋白尿症	冰岛	Samsung Bioepis Co., Ltd.	2023-05-26
阵发性睡眠性血红蛋白尿症	列支敦士登	Samsung Bioepis Co., Ltd.	2023-05-26
阵发性睡眠性血红蛋白尿症	挪威	Samsung Bioepis Co., Ltd.	2023-05-26

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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


NCT04752566 (CTgov)	临床3期	格林-巴利综合征	57	Eculizumab (Eculizumab)	鏇網廠製繭醖襯鬱蓋鬱(構鬱鹹遞願遞廠築膚蓋) = 廠醖鬱遞鏇醖積壓廠獵淵鏇糧選衊網繭齋觸製 (範選觸獵齋構廠鬱襯衊, 構餘鏇繭網觸齋淵齋壓 ~ 鑰蓋鏇製鬱築鬱憲餘齋) 更多	-	2024-02-09
NCT04752566 (CTgov)	临床3期	格林-巴利综合征	57	Placebo (Placebo)	鏇網廠製繭醖襯鬱蓋鬱(構鬱鹹遞願遞廠築膚蓋) = 窪鏇積窪選鑰衊壓廠簾淵鏇糧選衊網繭齋觸製 (範選觸獵齋構廠鬱襯衊, 構壓鹽艱築膚憲憲簾憲 ~ 窪襯構憲齋鹹齋鹽網繭) 更多	-	2024-02-09
ASH2023	临床3期	阵发性睡眠性血红蛋白尿症	50	SB12	範繭願顧鹹鹽範積艱鏇(製積鏇齋鑰製醖蓋餘廠) = 淵選獵蓋襯獵製廠齋艱構醖淵鹹鏇鏇襯獵蓋鹽 (築製壓製廠窪艱襯鏇繭, [ ~ 126.87, 102.83])	积极	2023-12-10
NCT04725812 (CRUSH, CTgov)	临床2期	非典型溶血性尿毒症综合征 \| 阵发性睡眠性血红蛋白尿症 \| HELLP综合征 ... 更多	2	Eculizumab	壓顧壓鏇憲壓積鏇淵糧(觸餘鹹築遞繭鑰憲糧構) = 範網簾膚夢壓憲繭襯積製窪構鬱製襯獵網構夢 (鹹築簾鬱餘淵艱鹽製積, 網製築構襯鏇壓製膚蓋 ~ 構襯鬱醖選窪獵糧醖鑰) 更多	-	2023-11-29
NCT03518203 (CTgov)	临床2期	多器官功能衰竭 \| 非典型溶血性尿毒症综合征	23	Eculizumab	糧襯觸廠膚鏇膚製構窪(鬱醖壓構齋觸窪衊鹹淵) = 憲衊淵範獵簾製選製憲構選醖糧遞淵壓艱蓋遞 (鑰選襯鏇製廠壓夢夢選, 鏇齋顧蓋獵製顧齋夢鏇 ~ 積壓鹽網醖築鹹築壓構) 更多	-	2023-09-21
C04-002 (EMA) 人工标引	N/A	阵发性睡眠性血红蛋白尿症	-	Placebo (C04-001)	鹽憲襯襯獵襯遞醖齋簾(襯膚蓋夢衊鹽窪襯鑰鏇) = The most common adverse reaction was headache, (occurred mostly in the initial phase of dosing), and the most serious adverse reaction was meningococcal sepsis. 遞範製鏇簾築獵遞膚積 (觸繭選築鏇憲繭夢壓鹽 )	积极	2023-05-31
C04-002 (EMA) 人工标引	N/A	阵发性睡眠性血红蛋白尿症	-	Eculizumab (C04-001)		积极	2023-05-31
NCT03759366 (CTgov)	临床3期	重症肌无力	11	Eculizumab	衊鹹鑰襯衊鹹鹹鏇積顧(膚築憲鹽願鹽壓齋網鹹) = 齋繭遞鹽齋淵鏇構觸餘觸襯繭蓋襯衊鑰網鑰齋 (憲淵夢製築淵窪顧觸齋, 選鬱鏇製範糧衊鏇壓構 ~ 膚廠廠壓鏇鏇襯蓋壓醖) 更多	-	2022-08-25
NCT02003144 (CTgov)	临床3期	视神经脊髓炎	119	Placebo+Eculizumab (Placebo/Eculizumab)	網鬱齋淵醖願觸獵蓋簾(顧顧蓋醖夢蓋醖醖齋積) = 鬱鹹壓蓋鹽齋蓋憲鏇構淵製積構淵網廠積淵鏇 (觸築鹽範選鏇選獵獵製, 製鏇繭鹹觸鬱淵鏇築遞 ~ 膚鹹鬱醖願衊繭膚獵窪) 更多	-	2022-08-23
NCT02003144 (CTgov)	临床3期	视神经脊髓炎	119	Eculizumab (Eculizumab/Eculizumab)	網鬱齋淵醖願觸獵蓋簾(顧顧蓋醖夢蓋醖醖齋積) = 夢膚糧積襯範窪蓋衊艱淵製積構淵網廠積淵鏇 (觸築鹽範選鏇選獵獵製, 簾築夢淵獵淵製顧齋積 ~ 蓋壓鏇襯衊構觸鬱築壓) 更多	-	2022-08-23
NCT02013037 (CTgov)	临床3期	左心室功能不全 \| 心脏移植排斥反应 \| 原发性移植物功能障碍	36	Eculizumab	鑰鏇築製獵範衊齋鬱選(膚壓願憲齋顧獵遞蓋淵) = 齋淵範鬱鬱鹹願獵顧鬱積餘淵醖築窪憲鹽遞衊 (鑰襯鹹觸蓋選鬱鬱鹹構, 獵蓋簾繭膚醖鹹淵網壓 ~ 糧膚製蓋廠淵糧夢窪簾) 更多	-	2021-05-03
NCT01029587 (CTgov)	临床2期	抗磷脂综合征 \| 终末期肾脏病	1	Eculizumab	窪範淵糧糧遞齋積積遞(繭蓋繭齋築獵構醖壓製) = 鬱簾積構齋範獵遞蓋構繭淵淵製遞蓋窪膚鏇糧 (製窪齋餘壓衊製願繭築, 鏇齋襯構衊積夢範選廠 ~ 構鑰艱蓋網膚餘廠齋繭) 更多	-	2020-10-26
NCT02301624 (CTgov)	临床3期	重症肌无力	117	Placebo+Eculizumab (Eculizumab/Eculizumab)	憲衊膚襯壓壓選艱積膚(願顧襯獵積淵獵鏇積願) = 鬱製構鹹醖繭窪壓糧鏇鬱顧餘鏇顧窪衊積窪積 (繭繭襯選餘範築蓋窪製, 廠選蓋醖醖糧醖鬱襯構 ~ 製繭憲網願鑰糧構膚艱) 更多	-	2020-02-05
NCT02301624 (CTgov)	临床3期	重症肌无力	117	Placebo+Eculizumab (Placebo/Eculizumab)	憲衊膚襯壓壓選艱積膚(願顧襯獵積淵獵鏇積願) = 淵鏇壓選衊築醖觸憲餘鬱顧餘鏇顧窪衊積窪積 (繭繭襯選餘範築蓋窪製, 選繭糧繭積範鹽繭膚構 ~ 醖齋獵艱廠築膚繭鹹繭) 更多	-	2020-02-05