Recurrent implantation failure (RIF), defined as the absence of clinical pregnancy after the transfer of three good-quality embryos, concerns up to 40% of IVF couples and is associated with a low success rate. The causes remain unexplained in over 50% of cases.
Various dysimmune changes (related to immune T cells profiles, pro-inflammatory cytokines levels) have been described in unexplained RIF as compared to fertile controls, and it has been estimated that such dysimmunity may occur in 50% of unexplained RIFs. Previous data on a benefit of general immune modulation by steroids or immunoglobulins are heterogenous and failed to demonstrate clinically significant benefit. The proinflammatory cytokine Tumor Necrosis Factor (TNF) α participates in the regulation of the immune balance of the endometrium, its peripheral blood and endometrial concentrations are increased in RIF patients as compared to fertile controls. In 2009, a pilot placebo controlled study showed that TNF-α antagonist treatment allowed a 56% live birth rate (versus 13% in controls) in 13 women with unexplained RIF. Due to the lack of maternal and fetal tolerance data, TNF-α antagonists were not further evaluated. Today, safety data issued from 1200 pregnancies are reassuring allowing the use of TNF-α antagonists during pregnancy (www.lecrat.org). In addition the TNF-α antagonist certolizumab does not cross the placental barrier.
We hypothesize that certolizumab may improve clinical pregnancy rates in women with unexplained RIF with a good safety profile.

开始日期2023-11-30

申办/合作机构

Assistance Publique des Hôpitaux de Paris SA

NCT06028438

/ Completed临床2期

A Phase 2a Multicenter, Randomized, Double Blind, Parallel, Proof of Concept Study Evaluating the Efficacy and Safety of Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis Despite Prior Treatment With Advanced Therapies (bDMARD or tsDMARD)

The purpose of this study is to evaluate the efficacy of combination therapy with nipocalimab and certolizumab compared to certolizumab monotherapy.

开始日期2023-08-15

申办/合作机构

Janssen Research & Development LLC

NCT05115903

/ Active, not recruiting临床4期IIT

A Prospective, Randomized Biologic Tapering Study of TNF Inhibitors in Axial Spondyloarthritis

Current evidence on tapering of tumor necrosis factor inhibitors (TNFi) in axial spondyloarthritis (axSpA) is still hampered by heterogeneity in tapering regimens, selection and performance biases, and lack of data on optimized treatment dosing strategies especially in real-world clinical settings. This study aims to contribute to the ongoing investigation of disease-activity-guided tapering of TNFi in axSpA in the form of a prospective, randomized controlled trial.

开始日期2021-12-01

申办/合作机构

University Health Network

100 项与培塞利珠单抗相关的临床结果

登录后查看更多信息

100 项与培塞利珠单抗相关的转化医学

登录后查看更多信息

100 项与培塞利珠单抗相关的专利（医药）

登录后查看更多信息

1,157

项与培塞利珠单抗相关的文献（医药）

2025-02-01·JOURNAL OF DERMATOLOGY

Possible effectiveness of switching biologics from adalimumab to certolizumab pegol in pyoderma gangrenosum

Letter

作者: Endo, Yukie ; Kimura, Minoru ; Yasuda, Masahito ; Motegi, Sei‐ichiro ; Uchiyama, Akihiko

Pyoderma gangrenosum (PG) is a rare and challenging neutrophilic dermatosis often resistant to conventional treatments, including steroids and immunosuppressive agents.We report the case of a 25-yr-old Japanese woman who developed PG following skin grafting for chem. burns.Initially treated with oral prednisolone and cyclosporine, she exhibited progressive ulceration and necrosis, necessitating transfer to our facility.Despite starting adalimumab, her condition improved but deteriorated again upon steroid tapering.After obtaining ethics committee approval, the treatment was switched to infliximab, leading to reduced disease activity.However, PG flared up again after three months.A subsequent switch to certolizumab pegol (400 mg every two weeks) resulted in significant ulcer size reduction and sustained remission for six months, although a relapse occurred at seven months.Certolizumab pegol, a polyethylene glycolated anti-TNF-α monoclonal antibody, differs from other biologics due to its lack of an Fc region, affecting its pharmacokinetics and immune interactions.In this case, the switch to certolizumab pegol may have been effective due to the secondary failure of adalimumab at maintenance doses and its enhanced targeting of TNF-α.While prior cases have reported pos. outcomes with certolizumab in PG, further studies are warranted to establish its efficacy and optimal use in this condition.This case highlights the potential of certolizumab pegol as a therapeutic option for patients with treatment-resistant PG, emphasizing the need for individualized treatment strategies in managing this complex dermatosis.Future research should focus on the long-term outcomes and mechanisms underlying the effectiveness of biol. therapies in PG.

2025-02-01·BIOLOGICAL TRACE ELEMENT RESEARCH

Recuperative Effects of Cinnamon (Cinnamomum zeylanicum) in Catla catla After Sub-Lethal Exposure to Lead

Article

作者: Sarker, Pallab K ; Ali, Shafaqat ; Hussain, Syed Makhdoom ; Al-Ghanim, Khalid A ; Yousaf, Zeeshan

This research was conducted to validate the beneficial effects of incorporating dietary cinnamon (Cinnamomum zeylanicum) powder (CzP) in alleviating lead (Pb) poisoning in fish. Healthy Catla catla individuals (16.36 ± 0.19 g/fish) were distributed across 18 tanks in triplicate groups. The experimental groups were as follows: Control group: fish without supplementation or exposure to Pb; positive control group: fish without supplementation but exposed to 1 mg/L Pb; 5 g/kg CzP along with 1 mg/L Pb exposure; 10 g/kg CzP along with 1 mg/L Pb exposure; 15 g/kg CzP along with 1 mg/L Pb exposure; and 20 g/kg CzP along with 1 mg/L Pb exposure. The trial continued for a period of 60 days. Waterborne Pb had a deleterious effect on fish growth performance, body composition, blood profile, and digestive enzyme activity, along with elevated Pb accumulation in various tissues. Conversely, consumption of cinnamon effectively mitigated the toxic potential of Pb and enhanced fish longevity. Notably, 10 g/kg CzP boosted growth, improved carcass quality, reversed blood indices, restored enzyme function in the gut, and mitigated Pb accumulation in tissues. In summary, the findings revealed that incorporating 10 g/kg of CzP as a dietary supplement in C. catla aquaculture could effectively counteract heavy metal toxicity.

2025-01-25·Journal of the Anus Rectum and Colon

Management of Anal Fistula with Crohn's Disease

Review

作者: Yoshimoto, Takafumi ; Tsuji, Yoriyuki ; Nakamura, Yasushi ; Irei, Yasue ; Takano, Shota ; Tamaoka, Kohei

Crohn's disease (CD) causes gastrointestinal symptoms (i.e., diarrhea and abdominal pain), systemic symptoms (i.e., fatigue, anemia, weight loss, and fever), and perianal fistulas that produce anal pain. Because of the frequent occurrence of diarrhea and ulcers in the rectum, CD is often exacerbated by perianal abscesses and/or fistulas. Perianal fistulizing CD (PFCD) has an unknown etiology and recurring symptoms such as pain and discharge, which seriously affects the patient's quality of life (QOL). In the past, radical surgery was performed for PFCD, but due to the risk of anal sphincter impairment, conservative therapy using antibiotics and immunosuppressive medications is currently the first treatment option. PFCD management has greatly improved with the use of biologics such as the antitumor necrosis factor alpha (TNF-α) antibodies infliximab and adalimumab. In this review, the results of the administration of anti-TNF-α (certolizumab pegol), anti-interleukin-12/23 (ustekinumab), and anti-α₄β₇ integrin antibodies (vedolizumab) were evaluated. Our investigation showed that these medications may be effective for maintenance therapy to prevent the recurrence of anal fistulas. In addition to biologics, molecular target drugs and even regenerative medicine using mesenchymal stem cells have been introduced to further expand the treatment options for consideration by medical personnel. We herein discuss the management of PFCD by focusing on studies conducted in the United States and Europe where researchers used recommended guidelines and consensus statements to evaluate the efficacy of each medication and published their findings in peer-reviewed journals.

项与培塞利珠单抗相关的新闻（医药）

2025-02-07

·小药说药

PEG化风靡制药40年，经久不衰的秘密

01 聚乙二醇化应用广泛聚乙二醇（PEG）是一种高分子材料，通常情况下溶于水和多种有机溶剂，不溶于脂肪烃、苯、乙二醇等，不会水解变质，有广泛的溶解范围和优良的相容性、很好的稳定性、润滑性、成膜性、增塑性、分散性等。低毒物质，且无刺激性，属非离子型聚合物。PEG应用广泛，涵盖领域包括化妆品、化纤、橡胶、塑料、造纸、油漆、电镀、农药、金属加工及食品加工等行业。此外，在制药工业中被用于蛋白质和多肽等的共价修饰。图1 聚乙二醇（PEG） 02 改善药物理化性质的有效途径聚乙二醇化（PEGylation）是将活化的PEG通过化学方法以共价键偶联到蛋白质或多肽分子上。自Davis在1977年首次用PEG 修饰牛血清白蛋白以来，PEGylation技术已广泛应用于改善蛋白质（肽类）、酶、抗体及小分子药物的理化性质和生物学活性的研究和应用中。 PEG本身具有无毒、无免疫原性、无抗原性、水溶性好等优点。同时PEGylation会改变药物的构象、静电结合能力、亲疏水性等理化性质，增加药物的体内保留时间，提高血浆半衰期，延长吸收时间，改善药物与细胞受体的亲和力，并且研究显示PEGylation可提高药物的肿瘤靶向性。正是基于以上特性，PEG常被用作药物传递和药物修饰技术，可以直接与药物偶联，或附着在药物表面封装于纳米材料里。实践中发现，经PEGylation后的药物可减少给药次数、提高疗效、改善耐受性、降低免疫原性/抗原性、改善药物的药代动力学和毒性，降低不良事件发生率。同时PEG还可以增加蛋白质的溶解度和稳定性，也有利于药物的生产和储存。图2 聚乙二醇化的优点：改善药代动力学、药理和毒理学性质目前，PEGylation已成为临床上较成熟的半衰期延长技术，其安全性在多年的临床实践中已得到充分的验证，并已被大多数国家/地区药监局批准供人静脉、口服和皮肤使用。 03 PEGylated分子的药效与药代动力 PEG分子的吸收依赖于给药方式，PEG分子体积相对大，不易通过胃肠道进入血液循环；经皮给药吸收率与其分子量相关，分子量过大则不易通过细胞旁运输或胞吞作用被上皮细胞吸收；皮下和肌肉注射同样表现出分子量依赖性质。 PEGylated可明显改善药物分子的循环周期。PEG分子可通过吸附水分子使得PEGylated大分子体积整体扩大5-10倍，可以有效降低对应蛋白质或多肽被水解酶降解的速度，进而延长其在体内的半衰期，并进一步改善蛋白类和多肽类分子的体内分布。例如，PEGylation-GLP-1明显改善了体内胰岛素的释放速率，其中Lys- PEGylation-GLP-1在血浆中、肝脏中和肾脏中的半衰期分别延长了40、10和28倍，整体提高了分子利用度。 PEGylated的空间位阻能有效屏蔽血浆酶以及减少RES吞噬作用，以达到调控药代动力学的效果。另一方面，空间位阻会降低药物与靶点亲和力，虽然损失部分药效，却可被更长的药物循环半衰期所抵消。因此PEGylated的作用实际上是重新建立了药效和药代动力之间的平衡。此外，PEGylated还可用于调节药物的免疫原性，PEG通过与药物的非活性必需基团结合，在其表面形成屏蔽，使其抗原决定簇不易被识别、不产生相应抗体，抑制相应的免疫反应。图3 PEG体内特性：吸收、代谢、分布和代谢 04 成功的PEGylated案例鉴于PEGylated能够有效改善药物的药效与药代动力，一些药物在设计过程中利用PEGylated解决了天然分子在临床使用中固有的不足之处，获得极大的商业成功。 1.赛妥珠单抗赛妥珠单抗（商品名：Cimzia）为肿瘤坏死因子阻滞药，是一种PEGylated人源化Fab片段的抗INF-α单克隆抗体，结合40kDa的PEG延长了赛妥珠单抗血浆消除半衰期。赛妥珠单抗不包括Fc片段，因此不能锚定补体或引起抗体依赖细胞介导的细胞毒性。在体外，不能诱导人类外周血衍生的单核细胞或淋巴细胞的程序性细胞死亡，也不能诱导中性粒细胞脱粒作用。一项针对662名患者的随机、双盲、安慰剂对照试验显示，使用赛妥珠单抗患者的临床响应率和临床症状缓解率明显高于安慰剂治疗。FDA于2008年批准赛妥珠单抗上市，首批适应症为克罗恩病，随后扩展到类风湿性关节炎、银屑病性关节炎和强直性脊柱炎。上市后赛妥珠单抗的全球销售额迅速攀升，2019年的全球销售额为19.2亿美元。 2.聚乙二醇非格司亭非格司亭（商品名：Neupogen）由Amgen研发，于1991年获FDA批准，2006年专利到期。非格司亭是由大肠杆菌表达产生的细胞生长因子（rhG-CSF），通过调节骨髓中性粒细胞，促进中性粒细胞前体的增殖和分化，用于治疗先天性中性白细胞减少症、周期性中性粒细胞减少症、特发性中性粒细胞减少症和骨髓移植及化疗相关中性细胞减少症。而PEGylated非格司亭（Pegfilgrastim）是长效型非格司亭，由PEG与rhG-CSF的N端甲硫氨基共价结合而成。PEGylated可降低rhG-CSF的肾脏清除率、减少细胞对药物分子的摄取、减少蛋白水解，使PEGylated非格司亭的半衰期显著长于非格司亭。PEGylated非格司亭在药效学及不良事件方面与非格司亭相仿甚至更好。据此，FDA于2002年批准PEGylated非格司亭（商品名：Neulasta）上市，2011年NMPA批准石药集团研发的PEGylated rhG-CSF（商品名:津优力）上市，用于降低化疗后发热性中性粒细胞减少引起的感染发生率。2014年Neulasta的销售额为46.86亿美元，2019年Neulasta的销售额下降至32.2亿美元，主要原因是多款生物类似药的上市使得市场竞争更加充分。 05 PEGylated在研管线和上市情况表1 已上市或尚处于临床研究阶段的PEGylated药物[3] 目前已有许多PEGylated蛋白质药物用于临床，上市的PEGylated药物主要是干扰素、白介素、肿瘤坏死因子以及天冬酰胺酶等，PEGylated后使得药物在体内维持血峰时间得到提高、清除率和分布容积下降，减少了用药剂量和用药次数。此外，PEGylated还能够有效降低蛋白类药物的免疫原性，如治疗ALL的L-天冬酰胺酶有比较明显的肝损伤、中枢神经损伤、凝血因子降低等副作用，20%左右的患者还会发生严重的过敏反应。 PEG-L-天冬酰胺酶能够极大减缓此类副作用，研究表明对L-天冬酰胺酶过敏的患者在使用PEG-L-天冬酰胺酶后并未出现过敏反应，并且PEG-L-天冬酰胺酶在体内的半衰期得到很大提升，临床剂量也因此大幅下降（针对儿童ALL的临床试验，PEG-L-天冬酰胺酶2500IU·m2，每2周1次，15次；L-天冬酰胺酶25000IU·m2，每1周1次，30次，两组无事件生存率相似，但PEG-L-天冬酰胺酶的毒性发生率有明显降低）。随着技术和工艺的成熟，以及不断丰富的临床使用经验，工业界越发重视PEGylated在调控药效和药代动力方面的作用。围绕PEGylated的管线逐渐活跃起来，相关在研管线包括细胞因子类（生物类似药为主），小分子类包括PEGylated伊立替康、PEGylated纳洛酮、PEGylated喜树碱、PEGylated表柔比星、PEGylated吉西他滨等；抗体类包括PEGylated甘妥单抗，以及某些抗体和抗体片段。 SUMMARY 小结作为调控药效与药代动力的有效手段，PEG在制药工业中的优势日益突出。PEGylated后可以显著提高药物的亲水性，增加药物的体内保留时间，增加全身暴露量，延长吸收时间；较大的空间位阻可以有效降低对应蛋白质或多肽被水解酶降解的速度，进而延长药物的体内半衰期，并进一步改善蛋白类和多肽类分子的体内分布。同理，药物分子的靶向亲和力也随之下降，但该效应可被更长的体内半衰期所抵消，达到新的药效与药代动力平衡。此外，PEGylated在降低大分子的免疫原性和抗原性方面也有独特优势。参考文献： [1] Zhang X , Wang H , Ma Z , et al. Effects of pharmaceutical PEGylation on drug metabolism and its clinical concerns[J]. Expert Opinion on Drug Metabolism & Toxicology, 2014, 10(12):1691-702. [2] 吴叶红, 白秋江, 雷兵团. 肿瘤坏死因子阻滞药赛妥珠单抗[J]. 中国药师, 2009(7):3. [3] Kozma G T , Shimizu T , Ishida T , et al. Anti-PEG antibodies: Properties, formation and role in adverse immune reactions to PEGylated nano-biopharmaceuticals[J]. Advanced Drug Delivery Reviews, 2020. [4] 李晓媛, 陈建华, 吴梧桐. PEG-L-天冬酰胺酶的临床研究近况[J]. 药学进展, 2009, 33(11):8. 公众号内回复“ADC”或扫描下方图片中的二维码免费下载《抗体偶联药物：从基础到临床》的PDF格式电子书！公众号已建立“小药说药专业交流群”微信行业交流群以及读者交流群，扫描下方小编二维码加入，入行业群请主动告知姓名、工作单位和职务。

2024-12-11

·凯莱英药闻

全球第二，潜在“最佳”！国产首创IL-17A/F抗体药物治疗强直性脊柱炎（AS）达III期临床终点

欢迎关注凯莱英药闻今日，鑫康合生物医药宣布，公司开发的XKH004完成治疗强直性脊柱炎(AS)的III期临床研究首次分析，成功达到试验的临床终点。 XKH004是一款IL-17A/F抑制剂，由丽珠医药和鑫康合生物合作研发，也是国产进展最快的IL-17A/F双靶点药物。关于III期临床最新数据该III期临床是一项多中心、随机、双盲、安慰剂对照试验，共入组323例中重度活动性AS受试者，结果显示：主要终点：采用160mg每四周一次（Q4W）XKH004药物治疗的受试者，第16周ASAS40应答率显著高于安慰剂组（45.5% XKH004 vs 19.4% PBO；P＜0.001），且在接受过 TNFi 治疗的和未接受过TNFi治疗的患者亚组中的疗效趋势是一致的。关键次要终点：第16周ASAS20应答率也具有显著差异(62.2% XKH004 vs 34.8% PBO；P＜0.001)；其他次要疗效指标，包括ASAS50、ASAS70、ASAS5/6、总背痛评分、炎症评分、hs-CRP、ESR、ASDAS-CRP、ASDAS-ESR等，治疗组表现也均显著优于安慰剂组。在安全性上，药物总体耐受性良好，大多数患者发生的TEAE均为Ⅰ-Ⅱ级，XKH004组和安慰剂组的总体不良事件（AE）发生率相当，与已上市的同类药物不良事件（AE）发生率相当，未发现新的安全性信号。关于XKH004 XKH004是一款可同时靶向IL-17A和IL-7F的IgG1型人源化单克隆抗体，通过阻断IL-17A/F与其受体的相互作用而抑制下游炎症信号通路，目前正开发用于中重度斑块型银屑病、强直性脊柱炎等自身免疫相关的适应症，具有同类最佳的治疗潜力。关于IL-17药物 IL-17（白介素-17）是促炎细胞因子家族，主要由Th17细胞产生，包括IL-17A-IL-17F六个家族成员，共有IL-17RA-RD和SEF五个受体。IL-17能够诱导多种趋化因子、细胞因子、抗菌肽等释放，参与免疫系统调控。该靶点在多种疾病中发挥作用，包括自身免疫疾病、癌症、感染等。近期，NMPA批准恒瑞医药的IL-17A单抗夫那奇珠单抗、智翔金泰的IL-17A 单抗赛立奇单抗上市，成为国内市场头两个获批上市的国产IL-17A；除此以外，国内市场已获批司库奇尤单抗、依奇珠单抗、布罗利尤单抗、比吉利珠单抗等4 款进口IL-17靶点相关生物药，仅比吉利珠单抗为IL-17A/F双靶点药物。据不完全统计，目前处于临床阶段的在研IL-17药物约30余种。根据PDB 国内药品终端市场销售数据，国内IL-17 靶点相关生物药主流药物司库奇尤单抗、依奇珠单抗在2023 年的销售额分别为37.64亿元、3.34 亿元，合计销售额达40.98 亿元；未来，IL-17 靶点相关生物药的上市销售其市场规模有望进一步扩大。关于强直性脊柱炎 AS属于炎症性全身性免疫疾病，可导致脊柱强直、畸形、易致残，且发病可累及全身多器官，如眼、皮肤、肠道等。据弗罗斯特沙利文测算，2020 年中国AS 患病人数为389.5万人，预计到2030 年将达到405.4 万人。目前，AS 尚无根治方法，其治疗目标是缓解疼痛、僵硬和疲劳，同时维持良好的姿势以及良好的生理和心理功能。用药方面，目前治疗主要是一线NSAIDs（非甾体抗炎药）和二线生物制剂。NSAIDs 疗效有限、副作用大；生物制剂以TNFα 制剂为主，包括依那西普、英夫利昔单抗、阿达木单抗、赛妥珠单抗等，可能导致继发性失效、注射给药依从性差的问题，临床仍存在未被满足的需求。近年来，中国AS 药物市场由2017 年的12 亿美元增加至2021年的16 亿美元，复合年增长率为6.8%。预计2030 年将达到67 亿美元，2021年至2030 年复合年增长率为17.1%。强直性脊柱炎患病人数和市场规模(百万美元/百万人) 参考资料 1、公司官网 2、华创证券、国投证券、华源证券、国泰君安证券、太平洋证券感谢关注、转发，转载授权、加行业交流群，请加管理员微信号“hxsjjf1618”。 “在看”点一下

上市批准临床3期临床结果临床成功

2024-10-29

·PRNewswire

Genascence Appoints Jeymi Tambiah as Chief Medical Officer

—Accomplished physician-scientist with more than 15 years' biopharmaceutical industry experience in medical affairs, clinical development, and drug development —Visionary leader skilled at leveraging scientific and clinical expertise to build innovative first-in-class therapeutic programs in areas of osteoarthritis, immunology, oncology, and neuroscience PALO ALTO, Calif., Oct. 29, 2024 /PRNewswire/ -- Genascence Corporation ("Genascence"), a clinical-stage biotechnology company revolutionizing the treatment of prevalent musculoskeletal diseases with gene therapy, today announced the appointment of Jeymi Tambiah, MBChB, FRCS, MS, FAPCR, MFPM(Dis) as its chief medical officer. Dr. Tambiah is an accomplished physician-scientist with more than 15 years' biopharmaceutical industry experience creating and leading strategies for medical affairs, clinical development, and drug development programs. He also brings deep experience in translational medicine, commercialization, and health outcomes research to Genascence. Continue Reading Jeymi Tambiah, Chief Medical Officer, Genascence "Jeymi is a visionary leader skilled at leveraging scientific and clinical expertise to build innovative first-in-class therapeutic programs in the areas of osteoarthritis, immunology, oncology, and neuroscience and I am excited to welcome him to Genascence as our chief medical offer," said Thomas Chalberg, Ph.D., founder and CEO of Genascence. "His experience includes all phases of drug development from bench through Phase 1-4 clinical studies and building elite high performance medical affairs teams. Jeymi's development and research expertise, particularly within the osteoarthritis research community, will be invaluable as we execute on our strategy to bring gene therapy to people suffering from prevalent musculoskeletal diseases." "Genascence is a company that is transforming how we treat debilitating musculoskeletal diseases like osteoarthritis by pioneering the development of gene therapy," said Dr. Tambiah. "I am thrilled to join this outstanding team under Tom's leadership and apply my knowledge and experience to advance our clinical program so that we can bring potentially curative therapies to patients in desperate need of better treatments." Before joining Genascence, Jeymi was senior vice president of clinical development and external innovation at Biosplice Therapeutics, a start-up biotech developing molecules modulating mRNA splicing in oncology, arthritis, and neurodegenerative diseases, where he was primarily responsible for clinical development, medical affairs, and external thoughtleader and scientific partnerships. Previously, Jeymi worked for UCB Pharma in various roles of increasing leadership within medical affairs, launching the TNF-inhibitor certolizumab pegol within the European Union, U.K., and U.S. across multiple immunology indications. Before his move into pharma, Jeymi trained and practiced in cardiothoracic surgery at Guys' and St. Thomas' Hospitals in London. Jeymi is very active in the osteoarthritis research community, with numerous research awards and publications, holding many committee appointments, and regularly presenting at international conferences. He is the North American representative for the Faculty of Pharmaceutical Medicine UK, and in this role is dedicated to supporting the education and mentoring of physicians in drug development. Jeymi earned his medical degree from the University of Manchester, UK, a doctorate degree in vascular biology from Imperial College London where he was a Wellcome Research Fellow, and a BSc (Hons) in medical science from the University of St. Andrews, UK. He is a fellow of the Royal College of Surgeons of England and Edinburgh, a member of Faculty of Pharmaceutical Physicians UK by Distinction, and a fellow of the Academy of Physicians in Clinical Research. About Genascence Corporation Genascence, a clinical-stage biotechnology company revolutionizing the treatment of prevalent musculoskeletal diseases with gene therapy, is developing life-changing treatments for highly prevalent conditions affecting millions of people. The company was founded in 2017 with technology licensed from three leading U.S. research institutions: Mayo Clinic, University of Florida, and NYU Langone Health. Headquartered in Palo Alto, California, Genascence's founders and leadership team have deep experience in the design, development, and manufacturing of successful gene therapies and biological medicines. For more information, please visit . SOURCE Genascence WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

高管变更基因疗法

100 项与培塞利珠单抗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D03441	培塞利珠单抗	L04AB05	DB08904

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
红皮病性银屑病	日本	UCB Japan Co. Ltd.	2019-12-20
寻常性银屑病	日本	UCB Japan Co. Ltd.	2019-12-20
脓疱型银屑病	日本	UCB Japan Co. Ltd.	2019-12-20
非放射性轴性脊柱关节炎	澳大利亚	UCB Australia Pty Ltd.	2010-01-20
斑块状银屑病	澳大利亚	UCB Australia Pty Ltd.	2010-01-20
强直性脊柱炎	欧盟	UCB Pharma GmbH	2009-10-01
强直性脊柱炎	冰岛	UCB Pharma GmbH	2009-10-01
强直性脊柱炎	列支敦士登	UCB Pharma GmbH	2009-10-01
强直性脊柱炎	挪威	UCB Pharma GmbH	2009-10-01
银屑病关节炎	欧盟	UCB Pharma GmbH	2009-10-01
银屑病关节炎	冰岛	UCB Pharma GmbH	2009-10-01
银屑病关节炎	列支敦士登	UCB Pharma GmbH	2009-10-01
银屑病关节炎	挪威	UCB Pharma GmbH	2009-10-01
中轴性脊柱关节炎	欧盟	UCB Pharma GmbH	2009-10-01
中轴性脊柱关节炎	冰岛	UCB Pharma GmbH	2009-10-01
中轴性脊柱关节炎	列支敦士登	UCB Pharma GmbH	2009-10-01
中轴性脊柱关节炎	挪威	UCB Pharma GmbH	2009-10-01
类风湿关节炎	美国	UCB, Inc.	2009-05-13
克罗恩病	美国	UCB, Inc.	2008-04-22

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
银屑病	临床3期	比利时	UCB SA	2022-01-30
活动性中度克罗恩病	临床3期	美国	UCB Biopharma SRL	2017-11-03
泛发性脓疱型银屑病	临床3期	日本	UCB Biopharma SRL	2017-02-21
间质性膀胱炎	临床3期	美国	UCB Pharma GmbH	2015-12-15
炎症	临床3期	美国	UCB BioSciences GmbH	2015-09-01
炎症	临床3期	澳大利亚	UCB BioSciences GmbH	2015-09-01
炎症	临床3期	保加利亚	UCB BioSciences GmbH	2015-09-01
炎症	临床3期	加拿大	UCB BioSciences GmbH	2015-09-01
炎症	临床3期	捷克	UCB BioSciences GmbH	2015-09-01
炎症	临床3期	匈牙利	UCB BioSciences GmbH	2015-09-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00844285 (SECURE Registry, Pubmed \| Crohns Colitis 360)	N/A	克罗恩病	3,072	Certolizumab Pegol (CZP)	顧窪積願鬱選夢憲願衊(襯範鹽鏇淵襯夢範遞願) = concomitant use of thiopurines was associated with higher odds of NMSC (odds ratio: 2.30 [95% CI: 1.09, 4.89]) 鏇壓範膚夢顧遞夢構齋 (願顧顧獵鬱鏇築獵憲鏇 ) 更多	积极	2024-12-30
				Corticosteroids
NCT04163016 (CHERISH, CTgov)	临床1期	斑块状银屑病 \| 银屑病关节炎 \| 炎症 ... 更多	22	CZP (CZP 200 mg Q2W)	製構鑰糧觸憲範獵蓋獵(鏇夢構鹹簾糧簾範壓夢) = 醖繭窪膚簾獵艱鹹襯蓋顧構鏇糧鏇鹽網膚繭築 (壓觸壓繭網壓繭淵選鹹, 築窪願獵鬱膚膚齋築築 ~ 遞觸製製襯壓夢壓顧築) 更多	-	2024-09-19
				CZP (CZP 400 mg Q2W)	簾遞簾鏇範簾廠選壓簾(鑰獵齋獵積夢觸鹹繭餘) = 艱膚醖願衊構築顧願製範餘顧齋餘蓋簾窪窪構 (衊遞繭蓋餘顧廠選鑰繭, 襯鹽觸鹹憲膚淵壓願範 ~ 網獵選獵獵衊鏇築醖憲) 更多
NCT04053881 (CIMREAL, Pubmed)	N/A	斑块状银屑病 tumor necrosis factor alpha (TNFα)	399	Certolizumab pegol 400 mg	獵構夢襯窪餘膚製鹹憲(窪獵範顧醖範網願觸餘) = 糧觸鹹夢糧構窪廠糧襯鑰構壓糧鬱齋築膚顧顧 (鑰醖艱廠鬱艱醖憲衊繭 ) 更多	积极	2024-06-27
				Certolizumab pegol 200 mg	獵構夢襯窪餘膚製鹹憲(窪獵範顧醖範網願觸餘) = 製觸襯蓋鹹廠鏇醖願築鑰構壓糧鬱齋築膚顧顧 (鑰醖艱廠鬱艱醖憲衊繭 ) 更多
NCT04163016 (CHERISH, EULAR 12024 \| EULAR 22024) 人工标引	临床1期	自身免疫性疾病	21	CERTOLIZUMAB PEGOL	積選鑰願獵廠製蓋窪壓(鏇鏇網廠範壓積網鑰蓋) = 衊願壓蓋膚觸獵壓艱選蓋淵構獵餘壓鬱觸構顧 (齋網衊襯窪襯鬱蓋鹽範 )	积极	2024-06-14
EULAR2024	N/A	中轴性脊柱关节炎	-	Certolizumab	網餘選壓選襯網範艱膚(鏇淵選構壓鑰淵遞壓膚) = 糧範網遞齋製鹽憲網鹽齋壓鹽積簾積鏇鬱襯壓 (積築齋齋鏇鑰鏇製網壓 )	积极	2024-06-05
				Secukinumab	網餘選壓選襯網範艱膚(鏇淵選構壓鑰淵遞壓膚) = 壓鬱襯選積餘淵艱網壓齋壓鹽積簾積鏇鬱襯壓 (積築齋齋鏇鑰鏇製網壓 )
Apulian BIOPURE registry (EULAR2024)	N/A	慢性关节炎	542	Certolizumab (Fertile female patients)	製構顧獵鑰網壓製築製(鹹蓋膚襯廠齋鹹鑰齋鏇) = 壓憲獵鹽製餘築觸膚遞網範顧蓋觸構鏇鹹襯廠 (網壓積糧觸餘簾製鹽顧 ) 更多	积极	2024-06-05
				Certolizumab (Menopausal female patients)	製構顧獵鑰網壓製築製(鹹蓋膚襯廠齋鹹鑰齋鏇) = 願壓糧淵繭膚齋製選餘網範顧蓋觸構鏇鹹襯廠 (網壓積糧觸餘簾製鹽顧 ) 更多
EULAR2024	N/A	类风湿关节炎	-	Biologic and targeted synthetic DMARDs	積獵範鑰積夢簾襯遞築(選蓋遞鹽膚憲齋窪淵襯) = 鏇淵夢觸餘願鹹簾願簾襯遞製艱膚壓願壓廠顧 (窪餘範窪鏇憲壓衊遞夢 ) 更多	-	2024-06-05
EULAR2024	N/A	IL-17A	135	Adalimumab (ADA)	願觸觸糧鏇夢獵鏇選餘(廠網壓齋齋壓餘願壓網) = 顧遞膚構壓淵簾鬱構齋鏇遞襯醖願顧壓鏇餘鹹 (觸築膚淵壓鹹繭襯憲製 )	积极	2024-06-05
				Infliximab (IFX)	願觸觸糧鏇夢獵鏇選餘(廠網壓齋齋壓餘願壓網) = 淵築鹹遞繭鑰鏇鏇鬱夢鏇遞襯醖願顧壓鏇餘鹹 (觸築膚淵壓鹹繭襯憲製 )
NCT01500278 (EXXELERATE, ACR2023) 人工标引	临床4期	类风湿关节炎	907	Certolizumab Pegol+Methotrexate	鹽範鹽積選積艱築糧構(繭顧獵鹹窪獵願蓋遞壓) = 獵鹹襯簾壓鬱網築餘積餘選壓夢築夢遞鑰網廠 (鹹製窪網壓餘願衊鏇構 ) 更多	非优	2023-11-14
				Adalimumab+Methotrexate	鹽範鹽積選積艱築糧構(繭顧獵鹹窪獵願蓋遞壓) = 簾憲築襯製範簾鑰衊憲餘選壓夢築夢遞鑰網廠 (鹹製窪網壓餘願衊鏇構 ) 更多
ACR2023	N/A	Rheumatoid Factor (RF)	755	Certolizumab Pegol	範鏇艱獵網顧鏇窪構網(範夢顧鹽鬱獵膚鏇製顧) = 膚餘鏇襯糧襯襯淵衊壓網構網遞範醖簾鬱齋築 (繭鹹選顧觸襯夢醖築願, 3.7 ~ NA)	积极	2023-11-13
				Monoclonal Antibodies (mAB)	範鏇艱獵網顧鏇窪構網(範夢顧鹽鬱獵膚鏇製顧) = 窪憲範觸鑰築蓋觸衊糧網構網遞範醖簾鬱齋築 (繭鹹選顧觸襯夢醖築願, 3.3 ~ 8.7)