Multicentre Non-interventional Retrospective Cohort Study of the Outcomes of Olokizumab Therapy in Hospitalized Patients With SARS-CoV-2 (COVID-19) Infection

The study purpose was to assess the outcomes of therapy with olokizumab within complex therapy of Coronavirus disease 2019 (COVID-19) in hospitalised patients in real clinical practice setting. The study investigated patients' characteristics, disease progression, and efficacy and safety of olokizumab therapy.

开始日期2021-07-14

申办/合作机构

R-Pharm JSC

[+2]

NCT05187793 / Active, not recruiting临床3期

A Multicenter, Open-label, Randomized Study of the Efficacy and Safety of Artlegia (INN: Olokizumab) New Dosing Regimen in Patients With Coronavirus Infection (COVID-19) With Signs of Hyperinflammation

The primary objective of the study is to evaluate the efficacy and safety of Artlegia (INN: olokizumab) new dosing regimen in patients with moderate coronavirus infection (COVID-19) with signs of hyperinflammation.
This study is a multicentre, open-label, randomized, comparative, parallel group, active-controlled clinical trial.

开始日期2021-07-08

申办/合作机构

R-Pharm JSC

NCT04246762 / Completed临床1期

A Phase 1, Open-label, Study in Subjects With Rheumatoid Arthritis to Evaluate the Effect of a Single Dose of Olokizumab on the Pharmacokinetics of Substrates for CYP1A2, CYP2C9, CYP2C19, and CYP3A4

Olokizumab (OKZ) has been shown to reverse the inhibitory effect of IL-6 on the activity of Cytochrome P450 (CYP450) isozymes CYP1A2, CYP2B6, CYP2C9, CYP2C19, and CYP3A4/5 in vitro.
The goal of the study is to assess the effect of OKZ on the pharmacokinetics (PK) of the CYP450 probe substrates, caffeine (CYP1A2), S-warfarin (CYP2C9), omeprazole (CYP2C19), and midazolam (CYP3A4) in subjects with rheumatoid arthritis (RA).

开始日期2021-04-06

申办/合作机构

R-Pharm International, LLC

[+1]

100 项与 Olokizumab 相关的临床结果

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100 项与 Olokizumab 相关的转化医学

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100 项与 Olokizumab 相关的专利（医药）

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项与 Olokizumab 相关的文献（医药）

2024-02-01·Zeitschrift für Rheumatologie

Comparison of the efficacy and safety of olokizumab at different dosages in patients with active rheumatoid arthritis: a network meta-analysis of randomized controlled trials

Article

作者: Song, Gwan Gyu ; Lee, Young Ho

OBJECTIVEThis study aimed to assess the relative efficacy and safety of olokizumab at different dosages in patients with active rheumatoid arthritis (RA).METHODSWe performed a Bayesian network meta-analysis to combine direct and indirect evidence from randomized controlled trials (RCTs) to examine the efficacy and safety of olokizumab administered intravenously to RA patients at 64 mg/kg every 2 or 4 weeks (Q2 or Q4W).RESULTSFive RCTs comprising 2609 patients met the inclusion criteria. Both olokizumab Q2 and Q4W treatments achieved a significant American College of Rheumatology 20% response (ACR20) compared with the placebo (odds ratio [OR] 3.21, 95% credible interval [CrI] 2.53-4.09; OR 3.05, 95% CrI 2.43-3.86). However, olokizumab Q2W was associated with the most favorable surface using the cumulative ranking curve (SUCRA) for the ACR20 response rate. The ranking probability based on the SUCRA indicated that olokizumab Q2W had the highest probability of being considered the best treatment option for achieving the ACR20 response rate, followed by olokizumab Q4W, adalimumab, and placebo. The ACR50 and 70 response rates showed a similar distribution pattern to the ACR20 response rate, except that olokizumab Q4W had a higher-ranking probability than olokizumab Q2W for ACR50. The SUCRA rating likelihood of adverse events (AEs) and withdrawal due to AEs showed that a placebo was likely to be the best intervention.CONCLUSIONBoth olokizumab Q2 and Q4W were efficacious and well-tolerated treatments for active RA.

2024-02-01·Zeitschrift für Rheumatologie

Comparison of the efficacy and safety of tocilizumab, sarilumab, and olokizumab in patients with active rheumatoid arthritis: a network meta-analysis of randomized controlled trials

Article

作者: Ho Lee, Young ; Gyu Song, Gwan

OBJECTIVEThis study compared the relative efficacy and safety of olokizumab, tocilizumab, and sarilumab in rheumatoid arthritis (RA) patients who were intolerant or responding inadequately to methotrexate (MTX).METHODSWe performed a Bayesian network meta-analysis to combine direct and indirect evidence from randomized controlled trials (RCTs) to examine the efficacy and safety of olokizumab, tocilizumab, and sarilumab in RA patients who were intolerant or responding inadequately to MTX.RESULTSSix RCTs comprising 4439 patients met the inclusion criteria. Tocilizumab, sarilumab, olokizumab, and adalimumab treatments achieved a significant American College of Rheumatology 20% (ACR20) response rate compared with placebo. However, tocilizumab was associated with the most favorable surface area using the cumulative ranking curve (SUCRA) for the ACR20 response rate. The ranking probability based on the SUCRA indicated that tocilizumab treatment had the highest probability of providing the best ACR20 response rate, followed by sarilumab, olokizumab every 2 weeks (Q2W), olokizumab Q4W, adalimumab 40 mg, and placebo. The ACR50 and 70 response rates showed a distribution pattern similar to that of the ACR20 response rate. However, olokizumab Q4W had a higher ranking probability than olokizumab Q2W. The SUCRA rating showed that the placebo was the best intervention with the least adverse events (AEs) and withdrawal due to AEs, followed by interleukin‑6 inhibitors.CONCLUSIONTocilizumab, sarilumab, and olokizumab are more effective than adalimumab and have similar efficacy and safety in RA patients with inadequate responses to MTX.

2024-01-01·International Journal of Medical Sciences

Text Mining and Drug Discovery Analysis: A Comprehensive Approach to Investigate Diabetes-Induced Osteoporosis

Article

作者: Liang, Feng ; Hu, Yihe ; Wang, Chenfeng

Purpose: Osteoporosis (OP) and diabetes are prevalent diseases in orthopedic and endocrinology departments, with OP potentially arising as a complication of diabetes. However, the mechanism underlying diabetes-induced osteoporosis (DOP) remains enigmatic, and drug discovery in this domain is restricted, hindering research into the DOP's etiology and treatment. With the ultimate goal of preventing OP in diabetic patients, the objective of this study is to mine the genes and pathways linked to DOP using bioinformatics and databases. Method: The present study employed text mining as the initial approach to retrieve genes commonly associated with diabetes and OP. Subsequently, functional annotation was conducted to investigate the roles and functionalities. In order to explore the interactions between proteins relevant to DOP, we constructed protein-protein interaction (PPI) networks. Furthermore, to obtain key genes and candidate drugs for DOP treatment, we conducted drug-gene interaction (DGI) analysis, complemented by a thorough examination of transcriptional factors (TFs)-miRNA co-regulation. Results: The results through text mining revealed 110 genes that are commonly associated with both diabetes and OP. Subsequent enrichment analysis narrowed down the list to 95 symbols that were involved in PPI analysis. After DGI analysis, we identified 7 genes targeted by 11 drugs, which represent candidates for treating DOP. Conclusion: This study unveils ANDECALIXIMAB, SILTUXIMAB, OLOKIZUMAB, SECUKINUMAB, and IXEKIZUMAB as promising potential drugs for DOP treatment, demonstrating the significance of utilizing text mining and pathway analysis to investigate disease mechanisms and explore existing therapeutic options.

项与 Olokizumab 相关的新闻（医药）

2023-12-11

·CPHI制药在线

金笔奖|掘金千亿$自免疾病市场，IL靶向药当仁不让，多款新药进入临床后期

关注并星标CPHI制药在线白细胞介素（IL）是由多种细胞产生并作用于多种细胞的一类细胞因子，因最初由白细胞产生、在白细胞间发挥作用而得名。IL是先天性及适应性免疫细胞以及非免疫细胞与组织间的通讯手段，在传递信息，激活与调节免疫细胞，介导细胞活化、增殖与分化及在炎症反应中起重要作用。此外，IL与多种癌症的发生和发展也密切相关。 IL是目前发现种类最多，调控作用最为广泛的一类细胞因子，已发现成员至少有38个，分别命名为IL-1~IL-38。研究发现，IL是自身免疫性疾病、炎性疾病和肿瘤药物研发的重要靶点。其中IL-1、IL-4、IL-5、IL-6、IL-13、IL-17、IL-18、IL-22、IL-23、IL-31、IL-33、IL-36等是自身免疫性疾病药物研发的潜力靶点，IL-2、IL-7、IL-8、IL-15、IL-25、IL-30等是肿瘤药研发的潜力靶点。IL-10、IL-11、IL-12、IL-21等是自身免疫性疾病和肿瘤药物研发的潜力靶点。六款IL靶向药入围2022年全球药品销售额TOP200 IL靶点在自身免疫性疾病领域的潜力已经显现，目前全球已批准多款IL靶向药，详见下表。从作用靶点来看，治疗自身免疫性疾病的IL靶点主要是IL-5、IL-6、IL-17、IL-23。适应症上，上述药物主要被批准用于治疗银屑病、银屑病关节炎、特应性皮炎等。值得一提的是，上述药物中多款进入重磅行列，并入围2022年全球药品销售额TOP200。其中Dupixent表现最好，2022年销售额高达87.31亿美元。Skyrizi排名第二，2022年销售额达51.65亿美元。Consentyx排名第三，2022年销售额达47.88亿美元。Actemra/RoActemra排名第四，2022年销售额达28.34亿美元。Tremfya排名第五，2022年销售额达26.68亿美元。Taltz排名第六，2022年销售额达24.82亿美元。多款新药进入临床后期自身免疫性疾病药物市场规模庞大，据弗若斯特沙利文测算，2022年全球自免疾病药物市场规模总体预计达到1323亿美元。IL作为自身免疫性疾病药物开发的潜力靶点，目前全球还有多款新药处于临床后期，详见下表。这些处于临床后期的IL靶向药主要是单抗，作用靶点主要集中在IL-4R、IL-17A。与上述已获批的IL靶向药不同，处于临床后期的IL靶向药大多是国产创新药。具体品种和靶点上看，康诺亚的司普奇拜单抗是一款针对IL-4Rα的高亲和力、人源化抗体，今年11月其用于治疗外用药控制不佳或不适合外用药治疗的成人中重度特应性皮炎的上市申请在国内被CDE纳入优先审评。优时比的olokizumab是针对IL-6的一款新型单抗，其治疗类风湿性关节炎的上市申请正在美国接受审查。智翔金泰的Xeligekimab和恒瑞医药的Vunakizumab均是IL-17A靶向重组人源化单抗，今年3月和4月这两款药物的上市申请先后获CDE受理。其中Xeligekimab是首款申请上市的国产抗IL-17A单抗，其治疗中重度斑块型银屑病和放射学阳性中轴型脊柱关节炎的临床试验均处于3期阶段。Vunakizumab是一款起效很快的IL-17单抗，两周内平均PASI评分可下降50%，相较而言，司库奇尤单抗需要3-4周，Vunakizumab的半衰期更长。丽珠单抗与鑫康合联合开发的LZM012是国内首个国产创新IL-17A/F双靶向药物。目前国内还没有IL-17A/F双靶向药物获批上市，已完成的3期临床试验（BE RADIANT）结果显示：LZM012对中重度斑块型银屑病疗效优于IL-17A靶向的司库奇尤单抗。此外，还有多款治疗自身免疫性疾病的在研IL靶向药处于1期临床、2期临床。整体来看，IL-4、IL-13、IL-17三个靶点竞争相对比较激烈，不过这三个靶点在研药物适应症侧重有所不同。IL-4、IL-13靶向药主要被开发用于治疗特应性皮炎、哮喘，IL-17靶向药主要被开发用于治疗银屑病。总结 TNF、JAK、BTK、CD20、IL等是自身免疫性疾病药物布局的热门靶点，且均有多款药物获批上市。目前，全球获批治疗自免疾病的IL靶向药主要为单抗，且靶点相对集中，主要在IL-6、IL-17、IL-23。鉴于多款重磅IL靶向药在自身免疫性疾病领域取得可喜战绩，越来越多的药企开始布局IL靶点。值得国民骄傲的是，多款国产创新IL靶向药进入临床后期。期待越来越多的IL靶向药被批准用于治疗自身免疫性疾病。参考资料： 1.《靶点黑马IL-4，有望进军慢阻肺》.药研网.2023-03-24 2.《研发 | 从礼来Lebrikizumab惨遭FDA拒批，浅谈IL-13靶向药进展》. CPHI制药在线.2023-10-09 3.《自免明星靶点：IL-17》.同写意Biotech.2023-07-18 作者简介：@忆，医院药师，关注国内外新药研发动态，期望在不断的输入和输出中提升自己，和医药自媒体共同成长。智药研习会12月线上课程报名来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

优先审批申请上市免疫疗法临床研究

2023-07-27

·药融圈

不断收购、剥离：比利时制药巨头UCB，在纯粹与专注中发展壮大

▲8月03-04日 CMC-China大会 · 限时免费扫码报名中注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。从药融云数据www.pharnexcloud.com获悉，2023年6月7日，全球生物制药公司UCB Pharma宣布，欧盟委员会(EC)已授予BIMZELX(bimekizumab)上市许可，用于治疗患有活动性银屑病关节炎（PsA）和患有活动性轴向脊柱关节炎（axSpA）的成人患者。欧盟的这些批准代表了bimekizumab在PsA和axSpA中的首次上市许可，也是bimekizumab继2021年8月获批用于治疗中度至重度斑块状银屑病后在欧盟的第二和第三个适应症。UCB也再一次证明了老牌企业的实力不容小觑。药融云数据www.pharnexcloud.com；药品信息从工业化学品到生物制药公司UCB（优时比）是一家总部位于比利时的生物制药公司，由比利时商人Emmanuel Janssen于1928年在布鲁塞尔创立，最初专注于工业化学品；20世纪30年代扩张进入美国市场；20世纪50年代取得了第一个突破性治疗，随后在20世纪60年代对生物技术领域进行了深入研究；20世纪80年代，UCB注册的Zyrtec（一种新型抗组胺药产品）取得了重大突破；20世纪90年代推出Keppra，进一步刺激了全球增长。21世纪初，UCB开始转型为一家纯粹的生物制药公司，重要的里程碑包括2004年收购英国生物技术公司Celltech和2006年收购德国制药公司Schwarz Pharma。收购Celltech相关报道收购Schwarz使UCB能够推出两种针对CNS疾病的新药：Neupro（rotigotine）和Vimpat（拉考沙胺），Neupro（rotigotine）是一种用于治疗帕金森病的透皮贴剂，Vimpat (lacosamide)是一种抗惊厥药。收购Schwarz相关报道2008年，UCB与Beryllium建立了多年的合作关系，Beryllium是免疫和中枢神经系统疾病治疗的开发商。到2014年，UCB收购了该公司的少数股权；2015年，UCB将其在印度和南亚的品牌仿制药业务出售给Dr. Reddy's Laboratories；2020年4月，优时比宣布已完成对免疫系统疾病专家Ra Pharma的收购；2022年1月，UCB宣布以19亿美元收购Zogenix，2022年3月，UCB宣布已完成对其收购。当前UCB正继续努力解决免疫学和神经学未满足的需求，公司建立了三个研究平台：新化学实体（小分子和肽）、新生物实体（单克隆抗体）和先进治疗药物（ATMP）。通过评估药物之外的解决方案，并在早期研究中通过数据和人工智能扩展到设备或数字健康解决方案，UCB的目标是通过在研究和早期开发的各个方面进行持续创新，确保最佳的个体患者体验。在全球范围内，UCB已建立了三个战略研究中心（比利时、英国和美国），四个制造站点（比利时、中国、日本、瑞士）以及八个研发站点，相信在技术平台以及数据共享的基础上，UCB必将在未来为所有需要其药物的患者带来所得。做“纯粹”的专家作为比利时数一数二的制药企业，在进行一系列收购以及剥离非核心业务之后，UCB主要专注于神经系统领域和免疫学领域的药物研发，除此之外，UCB还是一个合格的疾病宣传者，直接体现了欧洲老牌企业的人文关怀。在中枢神经系统疾病领域，公司专注于癫痫、糖尿病神经性疼痛、多发性硬化症、纤维肌痛症、不宁腿综合征和帕金森娜氏病，免疫学领域主要研究过敏、骨质疏松症、克罗那氏病、类风湿关节炎和系统性红斑狼疮等。一神经系统领域产品神经领域产品1 癫痫癫痫发作主要分为局灶性癫痫发作和全身性癫痫发作。局灶性癫痫发作仅从大脑的一个部位开始，全身性癫痫发作是整个大脑同时异常活动的结果。当前已经确定了100多种不同的癫痫综合征。癫痫病因有五大类，包括：感染、结构性原因、遗传原因、自身免疫性癫痫和代谢原因。在开发过程中，UCB正在研究一种可能使癫痫发作快速终止的新型救援药物，并探索CDKL5缺乏症（一种罕见的发育性癫痫性脑病）的治疗方法。针对癫痫已获批药物的情况如下：● Briviact（布瓦西坦[brivaracetam]）在欧洲，Briviact（布瓦西坦）被用于辅助治疗成人、青少年和2岁以上癫痫儿童部分性癫痫发作伴或不伴继发性全身性发作的辅助治疗；在美国，Briviact（布瓦西坦）CV用于治疗1个月及以上患者的部分性癫痫发作。● Vimpat（拉考沙胺[lacosamide]）在欧盟，Vimpat（拉考沙胺）（薄膜包衣片剂、糖浆和输注溶液）被用于单药治疗成人、青少年和2岁以上癫痫儿童伴或不伴继发性全身性的部分性癫痫发作；在美国，Vimpat有口服片剂、口服溶液和注射剂两种形式，Vimpat（拉考沙胺）CV用于治疗1个月及以上患者的部分性癫痫发作、4岁及以上患者原发性全身强直阵挛发作的辅助治疗。● Keppra（左乙拉西坦[levetiracetam]）在欧洲，Keppra（左乙拉西坦）被用于治疗16岁以上新诊断癫痫成人和青少年的部分性癫痫发作伴或不伴继发性全身性发作；在美国，用于治疗1个月及以上患者的部分性癫痫发作、12岁及以上青少年肌阵挛性癫痫患者肌阵挛发作的辅助治疗、6岁及以上特发性全身性癫痫患者的原发性全身强直阵挛发作的辅助治疗。● Nayzilam（咪达唑仑[midazolam]）Nayzilam（咪达唑仑）是一种苯二氮卓类药物，在美国用于急性治疗间歇性、刻板的频繁癫痫发作活动（即癫痫发作群、急性重复性癫痫发作），这些发作不同于12岁及以上癫痫患者的常规癫痫发作模式。2 帕金森病帕金森病是第二常见的神经退行性疾病，随着疾病的进展，症状逐渐出现并慢慢恶化。每个帕金森氏症患者都有不同的症状，但最容易识别的症状与称为运动症状（如震颤）的运动有关。当产生多巴胺的脑细胞死亡或无法有效运作时，就会发生帕金森氏症。在欧洲，Neupro（罗替戈汀透皮贴剂）用于治疗早期特发性帕金森病的体征和症状，作为单一疗法（即无左旋多巴）或与左旋多巴联合使用；在美国，Neupro（罗替戈汀透皮系统）适用于治疗帕金森病。3 不宁腿综合征（RLS）不宁腿综合征（RLS），也称为威利斯-埃克博姆病（WED），是一种慢性神经系统疾病。它的特点是腿部无法控制。RLS的确切原因尚不清楚。有证据表明，当使用神经递质多巴胺的大脑通路中断时，就会发生RLS，这是产生平滑肌活动和运动所必需的。在欧洲，Neupro（罗替戈汀透皮贴剂）用于成人中度至重度特发性不宁腿综合征的对症治疗；在美国，Neupro（罗替戈汀透皮系统）用于治疗中度至重度原发性不宁腿综合征。4 Dravet综合征(DS) 和Lennox-Gastaut综合征(LGS)Dravet综合征是一种发育性和癫痫性脑病，超过80%被诊断患有Dravet综合征的人具有SCN1A基因突变，这种通常不是遗传的突变会影响离子通道在大脑中的运作方式，并非所有SCN1A突变都会导致Dravet综合征，Dravet综合征有时与其他基因突变有关。在欧盟和英国，Fintepla（芬氟拉明[fenfluramine]）用于治疗与Dravet综合征相关的癫痫发作，作为2岁及以上患者其他抗癫痫药物的附加疗法；在美国，Fintepla（芬氟拉明）用于治疗2岁及以上患者的Dravet综合征（DS）和Lennox-Gastaut综合征（LGS）相关癫痫发作。二免疫学领域产品免疫学领域产品1 Cimzia(塞妥珠单抗[certolizumab pegol])Cimzia（塞妥珠单抗）是一种肿瘤坏死因子（TNF）阻滞剂在美国用于治疗成人活动性强直性脊柱炎（AS）；减轻克罗恩病的体征和症状，并维持对常规治疗反应不足的中度至重度活动性疾病成人患者的临床反应；治疗适合全身治疗或光疗的中度至重度斑块型银屑病（PsO）成人患者；治疗活动性银屑病关节炎（PsA）成年患者；治疗成人中度至重度活动性类风湿关节炎（RA）。在欧洲用于治疗患有严重活动性轴向脊柱关节炎的成年患者；治疗适合全身治疗的成人中度至重度斑块状银屑病；用于与甲氨蝶呤（MTX）联合用于对包括甲氨蝶呤在内的疾病改善抗风湿药物（DMARDs）的反应不足的成人活动性银屑病关节炎；以及用于成人患者中度至重度活动性类风湿关节炎（RA）的治疗不足。在瑞士用于诱导临床反应以及对常规治疗反应不充分的活动性克罗恩病患者的临床反应和缓解维持。2 EVENITY（罗莫珠单抗[romosozumab]在欧洲，EVENITY（罗莫珠单抗）用于治疗骨折风险高的绝经后妇女的严重骨质疏松症。3 Bimzelx（比美吉珠单抗[bimekizumab]在欧盟和英国，Bimzelx（比美吉珠单抗）用于治疗适合全身治疗的成人中度至重度斑块状银屑病。在研管线到2022年，UCB完成了关键研究，启动了监管文件，并为管道增加了新的临床开发项目，截止2022年研发管道情况如下：研发管线（截止2022.12.31）1 rozanolixizumab（FcRn抑制剂）rozanolixizumab是一种SC给药的人源化单克隆抗体，具有高亲和力与人新生儿Fc受体（FcRn）特异性结合。它旨在阻断FcRn和免疫球蛋白G（IgG）的相互作用，加速抗体的分解代谢并降低致病性IgG自身抗体的浓度。药融云数据www.pharnexcloud.com针对MOG抗体病的研究目前进行到临床试验三期，预计2024年下半年得到三期顶线结果；针对自身免疫性脑炎和严重纤维肌痛综合征的研究目前均进行到临床试验二期，预计2024年上半年获得二期顶线结果2 fenfluramine（5-HT激动剂）fenfluramine是一种血清素释放剂，因此通过释放血清素刺激多种5-HT受体亚型。针对CDKL5缺乏症的研究目前进行到临床试验三期，预计2024年下半年得到三期顶线结果（在收购Zogenix后，UCB决定继续开发fenfluramine治疗CDKL5缺乏症或CDD的3期临床试验项目。CDD是一种罕见的发育性癫痫性脑病，由CDKL5基因突变引起，虽然很罕见，但CDD是最常见的遗传性癫痫形式之一）3 doxecitine/doxribtimine（MT1621，核苷治疗）针对TK2缺乏症的研究目前进行到临床试验三期，预计2024年上半年正式开始提交4 dapirolizumab pegol（抗CD40L抗体）与Biogen合作研发系统性红斑狼疮，目前进行到临床试验三期，预计2024年上半年获得顶线结果5 staccato alprazolam (benzodiazepine)针对典型的长时间癫痫发作研究，目前进行到临床试验三期，预计2024年上半年获得顶线结果6 bepranemab（抗tau蛋白抗体）bepranemab是一种重组、人源化、全长免疫球蛋白G4单克隆抗tau蛋白抗体，正在与Roche、Genentech合作用于阿尔兹海默症患者的研究，目前进行到临床试验二期，预计2024年第四季度获得顶线结果7 UCB0599（α-syn-错误折叠抑制剂）UCB0599是一种口服生物可利用和脑屏障渗透小分子，可防止核素的病理错误折叠和积累。核素是一种在帕金森病（PD）病理中起关键作用的蛋白质。通过抑制突触核蛋白错误折叠的致病生物学特性，人们认为PD的进展可以被减缓或停止。根据与诺华公司达成的全球联合开发和联合商业化协议，目前该项目进行到临床试验二期，预计2024年第四季度获得顶线结果8 UCB9741和UCB1381UCB启动了特应性皮炎的1b期研究，针对UCB9741和UCB1381的两种不同的靶向免疫途径。早期研究评估了中度至重度特应性皮炎患者的安全性、药代动力学和有效性。注：特应性皮炎是一种慢性疾病，会导致皮肤干燥、发痒和炎症，可影响所有年龄段的人。年报信息UCB 2022年收入达到55.17亿欧元，净销售额为51.4亿欧元。这归因于UCB产品组合的持续增长，即CIMZIA、BRIVIACT、NAYZILAM、EVENITY以及新推出的BIMZELX、FINTEPLA。这一表现被VIMPAT在美国和欧洲以及KEPPRA在日本失去排他性的影响所抵消。特许权使用费收入和费用为8500万欧元，其他收入2.92亿欧元，增长了28%，这归因于研发合作伙伴的里程碑和其他付款，其中包括来自知识产权销售（olokizumab）的一次性7000万欧元。 2022年营收报告2022年运营费用增加到31.68亿欧元，反映了由于Zogenix的加入和整合而产生的费用增加。运营费用包括：营销和销售费用为14.89亿欧元，研发费用16.7亿欧元以及2.25亿欧元的一般和管理费用，其他营业收入为2.16亿欧元。基本运营盈利能力（调整后的EBITDA）达到12.6亿欧元，反映了由于失去排他性和Zogenix的整合而导致的收入下降，这解释了总运营费用的增加。营销和销售费用反映了正在进行的和即将推出的投资，研发费用反映了管道的进展。其他营业收入的增长是由EVENITY推动的。2022年利润下降至4.18亿欧元。核心每股收益为4.37欧元，而2021年为6.49欧元。对于比利时这样经济高度对外依赖的国家，外贸可以说是整个国家的经济命脉，如今美国和欧洲仍然是UCB的主要市场，但是UCB貌似也在对中国的战略布局进行调整。从20世纪晚期进入中国，UCB有一段高速发展的时期，随着专利到期以及集采风波，UCB貌似不再像之前一样“顺风顺水”，公司的药物接连遭遇滑铁卢，当前UCB正在不断创新并努力寻找新的方法，公司坚持每年投入资金的30%进行药物研发，专注于神经系统和免疫学领域的研究，相信UCB会在自己选择的领域走得更远。一最新获批资讯2023年6月23日，UCB宣布FDA批准RYSTIGGO（罗扎诺利珠单抗[rozanolixizumab-noli]）用于治疗抗乙酰胆碱受体（AchR）或抗肌肉特异性酪氨酸激酶（MuSK）抗体阳性的成年全身性重症肌无力（gMG）患者。并将于2023年第三季度在美国上市。（在美国以外，罗扎诺利珠单抗未被全球任何其他监管机构批准用于任何适应症）图文：获批新闻报道此文仅用于向医疗卫生专业人士提供科学信息，不代表平台立场参考：NMPA/CDE；药融云数据www.pharnexcloud.com；FDA/EMA/PMDA；相关公司公开披露（除标注外，正文图片均来自企业官网）；https://www.ucb.com/；https://www.ucbchina.com/；https://mp.weixin.qq.com/s/IG8TS6vIfOJvdDh2J2mTeA；https://mp.weixin.qq.com/s/Kl3PcxagYv4M1-qXEQnKfw；https://mp.weixin.qq.com/s/oxA0I5y62Q5VULbbqexJgQ；等等。关于CMC-China 博览会融合产业力量，重构行业未来！本次CMC-China博览会汇聚300+医药及上下游全产业链的企业积极报名参展，数千名专业观众报名参观，展会现场将举办15场专业论坛。充分体现了“医药人办医药展，专业人办专业展”的理念。了解更多：一文看最全议程！8月3-4日：2023第五届中国国际生物&化学制药博览会点分享点点赞点在看

并购突破性疗法

2023-01-09

·PRNewswire

Rheumatoid Arthritis Market is Expected to Showcase Significant Growth in the 7MM at a Minimal CAGR of 1.9% During the Study Period (2019-2032), Predicts DelveInsight

The dynamics of the rheumatoid arthritis market are anticipated to change in the coming years owing to the increasing awareness and expected increase in investment in the R&D activities. Companies like GlaxoSmithKline [Otilimab (MOR103/GSK3196165)], Taisho Pharmaceutical [Ozoralizumab (TS-152)], Aclaris Therapeutics [Zunsemetinib (ATI-450)], Abivax [ABX464], and others with their key candidates are in the late clinical and filing stage. LAS VEGAS, Jan. 9, 2023 /PRNewswire/ -- DelveInsight's Rheumatoid Arthritis Market Insights report includes a comprehensive understanding of current treatment practices, rheumatoid arthritis emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into the 7MM [the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Rheumatoid Arthritis Market Report As per DelveInsight analysis, the rheumatoid arthritis market size in the 7MM was approximately USD 27 billion in 2021. According to the assessment done by DelveInsight, the estimated total rheumatoid arthritis prevalent population in the 7MM was approximately 4. 7 million in 2021. Leading rheumatoid arthritis companies such as Taisho Pharmaceuticals, R-Pharm, GlaxoSmithKline, Aclaris Therapeutics, Pfizer, Abivax, Bristol Myers Squibb, Oscotec/Genosco, Mesoblast, Pfizer Akros Pharma/Japan Tobacco, Abbvie, Horizon Therapeutics, Eli Lilly and Company, Taiho Pharmaceutical, Gilead Sciences, Kiniksa Pharmaceuticals, Istesso, SynAct Pharma, Cyxone, and others are developing novel rheumatoid arthritis drugs that can be available in the rheumatoid arthritis market in the coming years. The promising rheumatoid arthritis therapies in the pipeline include Ozoralizumab (TS-152), Artlegia (Olokizumab), Otilimab (GSK3196165/MOR103), Zunsemetinib (ATI-450), Ritlecitinib (PF-06651600), ABX464, Branebrutinib, Cevidoplenib (SKI-O-703), MPC-300-IV, PF-06650833, JTE -051, ABBV-154, TAS5315, MBS2320, AMT-101, AP1189, Rabeximod (Rob 803), and others. In June 2022, Cyxone received a response from a Type B Pre-IND meeting with the US FDA. The response from the FDA facilitates Cyxone to continue planning the Phase IIb study with Rabeximod in RA. In December 2021, Taisho Pharmaceuticals presented the interim results from a 24-week administration in Phase II/III clinical trial (OHZORA study) of ozoralizumab in adult patients with RA at the annual meeting of the Japanese Society for Clinical Rheumatology and Related Research. Discover which therapies are expected to grab the major rheumatoid arthritis market share @ Rheumatoid Arthritis Market Report Rheumatoid Arthritis Overview Rheumatoid arthritis is a type of autoimmune disease. It happens when our immune system, which is supposed to defend us, malfunctions and starts attacking our own tissues. It causes inflammation in the joint lining (the synovium). As a result, joints may become red, warm, swollen, and painful, which are all symptoms of rheumatoid arthritis. The precise causes of rheumatoid arthritis are still unknown. Because the early signs and symptoms of rheumatoid arthritis are similar to those of many other diseases, it can be difficult to detect in its early stages. There is no single blood test or physical finding that can confirm the diagnosis of rheumatoid arthritis. There is no known cure for rheumatoid arthritis. However, clinical trials of rheumatoid arthritis show that remission of symptoms is more common when rheumatoid arthritis treatment with disease-modifying antirheumatic medicines begins early (DMARDs). Rheumatoid Arthritis Epidemiology Segmentation DelveInsight estimates that there were approximately 4.7 million prevalent cases of rheumatoid arthritis in the 7MM in 2021. Among the EU4 and the UK countries, Germany accounted for the highest number of rheumatoid arthritis cases, whereas France accounted for the lowest cases in 2021 The rheumatoid arthritis market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total Prevalent Cases Total Diagnosed Prevalent Cases Gender-specific Prevalent Cases Age-specific Prevalent Cases Severity-specific Prevalent Cases Patients on Targeted Therapies Line-Wise Treated Cases Download the report to understand which factors are driving rheumatoid arthritis epidemiology trends @ Rheumatoid Arthritis Epidemiological Insights Rheumatoid Arthritis Treatment Market Over the last few years, there has been a dramatic improvement in rheumatoid arthritis outcomes as a direct result of paradigm shifts in rheumatoid arthritis treatment. At the moment, the main rheumatoid arthritis treatment options are Medicine (for long-term relief of symptoms and slowing the progression of the condition), Supportive treatments (including physiotherapy and occupational therapy, to help keep the patient mobile and manage any problems related to daily activities), and Surgery (to correct any joint problems that develop over a period of time). Nonsteroidal anti-inflammatory drugs (NSAIDs) are typically used only for symptomatic treatment until a rheumatoid arthritis diagnosis is established because they reduce pain and stiffness in patients but have no effect on disease progression. Moreover, disease-modifying antirheumatic drugs (DMARDs) are used to target inflammation and prevent further joint damage and disease progression. DMARDs are a class of drugs that have been shown to affect the underlying cause of rheumatoid arthritis by reducing immune system overactivity, thereby alleviating pain, swelling, and stiffness and preventing joint changes. DMARDs can be prescribed singly or in combination as an initial part of treatment. Methotrexate is the first-line DMARD agent for the majority of rheumatoid arthritis patients. It has a relatively quick onset of action at therapeutic doses (6-8 weeks), good efficacy, a low toxicity profile, is easy to administer, and is relatively inexpensive. To know more about rheumatoid arthritis guidelines, visit @ Rheumatoid Arthritis Management Rheumatoid Arthritis Pipeline Therapies and Key Companies Artlegia (Olokizumab): R-Pharm TS-152 (Ozoralizumab): Taisho Pharmaceuticals Otilimab (GSK3196165/MOR103): GlaxoSmithKline ATI-450 (Zunsemetinib/CDD-450): Aclaris Therapeutics Branebrutinib: Bristol Myers Squibb LY3462817: Eli Lilly and Company TAS5315: Taiho Pharmaceutical Rabeximod (Rob 803): Cyxone GS-5718: Gilead Sciences KPL-404: Kiniksa Pharmaceuticals MBS2320: Istesso AMT-101: Applied Molecular Transport Dazodalibep (HZN-4920): Horizon Therapeutics Cevidoplenib (SKI-O-703): Genosco/Oscotec HB-AdMSCs: Hope Biosciences ABX464: Abivax MPC-300-IV: Mesoblast PF-06650833: Pfizer JTE 051: Akros Pharma/Japan Tobacco Dekavil (F8IL10): Pfizer/Philogen ABBV-154: AbbVie PF-06651600 (Ritlecitinib): Pfizer AP1189: SynAct Pharma Learn more about the FDA-approved drugs for rheumatoid arthritis @ Drugs for Rheumatoid Arthritis Treatment Rheumatoid Arthritis Market Dynamics The dynamics of the rheumatoid arthritis market is anticipated to change in the future due to the increasing awareness and expected increase in investment in the R&D activities by the leading companies working in the rheumatoid arthritis market space. Moreover, current therapies, such as biological DMARDs, have shown promising results in treating rheumatoid arthritis patients, and market penetration is expected to increase in the future, driving rheumatoid arthritis market growth. Furthermore, there is still a high demand for therapies with a similar efficacy profile to current therapies but a better safety profile and a more patient-friendly RoA. Oral classes, such as JAKi and the upcoming BTKi, are expected to contribute to the rheumatoid arthritis market growth due to patient-friendly RoA. However, several factors are likely to hamper the rheumatoid arthritis market growth. The rheumatoid arthritis market is highly competitive, and new entrants are expected to face some resistance and low uptake because anti-TNFs currently dominate the rheumatoid arthritis market, and the entry of biosimilars will pose significant challenges to new and upcoming treatment options in the rheumatoid arthritis market. In addition, the entry of biosimilars has already begun in the US and EU (i.e., Remicade biosimilars), and as a result, sales value has started to decline. The impact will be more pronounced when biosimilars/ generics of some blockbuster drugs, such as Humira (i.e., 2023 in the US), Xeljanz (i.e., 2025 in the US), will enter the rheumatoid arthritis market, and this will significantly impact the growth of the rheumatoid arthritis market. Scope of the Rheumatoid Arthritis Market Report Therapeutic Assessment: Rheumatoid Arthritis current marketed and emerging therapies Rheumatoid Arthritis Market Dynamics: Rheumatoid Arthritis market drivers and barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Unmet Needs, KOL's views, Analyst's views, Rheumatoid Arthritis Market Access and Reimbursement Discover more about rheumatoid arthritis drugs in development @ Rheumatoid Arthritis Clinical Trials Table of Contents Related Reports Rheumatoid Arthritis Epidemiology Forecast Rheumatoid Arthritis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted rheumatoid arthritis epidemiology in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. Juvenile Rheumatoid Arthritis Pipeline Juvenile Rheumatoid Arthritis Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products and the key juvenile rheumatoid arthritis companies, including Novartis, AbbVie, Eli Lilly and Company, Sanofi, among others. Juvenile Rheumatoid Arthritis Market Juvenile Rheumatoid Arthritis Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key juvenile rheumatoid arthritis companies, including Novartis, AbbVie, Eli Lilly and Company, Sanofi, among others. Psoriatic Arthritis Pipeline Psoriatic Arthritis Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key psoriatic arthritis companies, including Mylan, Celltrion, Pfizer, Amgen, among others. Psoriatic Arthritis Market Psoriatic Arthritis Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key psoriatic arthritis companies, including Mylan, Celltrion, Pfizer, Amgen, among others. Other Trending Reports Tay-sachs Disease Or Gm2 Gangliosidosis Market | Onycholysis Market | Diagnostic Imaging Equipment Market | Chemotherapy-induced Peripheral Neuropathy Market | Global Electrophysiology Devices Market | Anaphylaxis Market | Atherectomy Devices Market | Helicobacter Pylori Infections Market | Ophthalmic Imaging Equipment Market | Androgenetic Alopecia Market | Allergic Rhinitis Market | Chronic Inflammatory Demyelinating Polyneuropathy Market | Chronic Inflammtory Demyelinating Polyneuropathy Market | Colorectal Cancer Crc Market | Opioid Induced Constipation Market | Vertigo Market | Bone Anchored Hearing Systems Market | Wound Closure Devices Market | Hip Replacement Devices Market | Hemodynamic Monitoring Systems Market | Egfr Non-small Cell Lung Cancer Market | Helicobacter Pylori Infection Market | Hyperkalemia Market | Polycythemia Market Neurostimulation Devices Market | Carpal Tunnel Syndrome Market | Ventilator Market | Cerebral Aneurysm Market | Alpha Antitrypsin Market | Binge Eating Disorder Market | Bunion Market | Concussions Market Size | Exocrine Pancreatic Insufficiency Market | Healthcare Due Diligence Services | Minimal Residual Disease Market Related Healthcare Blogs Rheumatoid Arthritis Emerging Drugs Knee Osteoarthritis Pipeline Rheumatoid Arthritis Market Scenario Juvenile Idiopathic Arthritis Therapy Market Related Healthcare Services Healthcare Business Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Additionally, get in touch with our business executive to explore @ Healthcare Due Diligence Services Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

临床结果

100 项与 Olokizumab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Olokizumab	-	DB13127

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
类风湿关节炎	申请上市	俄罗斯	R-Pharm Overseas, Inc.	2022-01-30
严重急性呼吸道感染	临床1期	-	R-Pharm JSC	2020-06-30
新型冠状病毒感染	临床1期	俄罗斯	R-Pharm Group	2020-04-28
新型冠状病毒感染	临床1期	俄罗斯	R-Pharm Group	2020-04-28
克罗恩病	临床1期	-	UCB BioSciences GmbH	2012-06-01
克罗恩病	临床1期	-	UCB BioSciences GmbH	2012-06-01
肿瘤	临床1期	英国	UCB Pharma GmbH	2010-11-01
肿瘤	临床1期	比利时	UCB Pharma GmbH	2010-11-01
肿瘤	药物发现	美国	UCB Pharma GmbH	2010-11-01

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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


NCT02760407 (CREDO-2, EULAR2023)	临床3期	Charlson Comorbidity Index	1,402	Olokizumab	(齋膚顧糧繭簾構簾膚襯) = 齋壓顧顧鹽艱築壓鹽糧襯廠醖遞壓鑰鑰壓網淵 (積製憲願艱壓齋觸簾願 ) 更多	-	2023-05-31
				Adalimumab	(齋膚顧糧繭簾構簾膚襯) = 鹽鹽淵願簾淵鬱膚構鑰襯廠醖遞壓鑰鑰壓網淵 (積製憲願艱壓齋觸簾願 ) 更多
EULAR2012	N/A	类风湿关节炎 CD161+ \| CD4+ \| CD45RO+ ... 更多	81	anti-IL-6	衊壓糧齋製艱鬱獵鹽願(構鹹壓網範膚夢壓積鏇) = 選齋糧積齋淵構選蓋獵襯鬱夢積積憲顧範窪遞 (醖壓糧網鹽齋夢齋鬱獵 )	-	2012-06-06
				anti-IL-6	衊壓糧齋製艱鬱獵鹽願(構鹹壓網範膚夢壓積鏇) = 簾壓壓鬱簾齋築獵積網襯鬱夢積積憲顧範窪遞 (醖壓糧網鹽齋夢齋鬱獵 )
WCD2023	N/A	白癜风	-	Anti-TNF-α	(壓積膚廠簾觸獵糧鏇鑰) = 廠夢衊齋鹽簾淵積壓簾膚鏇夢艱獵餘繭網襯遞 (壓憲鹹糧衊構繭製鏇夢 )	-	2023-07-07
				Anti-CD52	(壓積膚廠簾觸獵糧鏇鑰) = 鏇壓鑰襯製製遞範顧憲膚鏇夢艱獵餘繭網襯遞 (壓憲鹹糧衊構繭製鏇夢 )
BIOBADASER 3.0 (EULAR2022)	N/A	肿瘤 \| 风湿性疾病	-	Anti-TNF	構獵獵簾衊遞獵積獵蓋(獵獵鬱製獵獵繭醖壓艱) = 窪構積願繭憲範鑰獵醖顧窪襯壓鬱鑰鏇壓夢鏇 (鑰蓋艱繭壓範衊餘鑰夢, 6.1 ~ 8.2)	-	2022-06-01
				JAKi	構獵獵簾衊遞獵積獵蓋(獵獵鬱製獵獵繭醖壓艱) = 憲觸鬱淵鬱簾網醖鑰窪顧窪襯壓鬱鑰鏇壓夢鏇 (鑰蓋艱繭壓範衊餘鑰夢, 2.8 ~ 10.5)
NCT03120949 (ACR2022) 人工标引	临床3期	类风湿关节炎	2,105	Methotrexate +Olokizumab	(淵憲鏇憲願襯鑰觸觸醖) = 蓋糧窪獵夢積艱範醖膚鑰鏇夢遞醖廠衊繭壓廠 (鹹鹽膚簾壓遞膚壓夢膚 ) 更多	积极	2022-09-12
NCT02760407 (CREDO 2, EULAR2022)	临床3期	类风湿关节炎	1,648	Olokizumab 64mg q2w	(範襯蓋膚淵獵鬱鑰選糧): LSM difference = -0.03 (97.5% CI, -0.12 ~ 0.05)	积极	2022-06-01
				Adalimumab 40mg q2w
NCT01242488 (Pubmed \| Arthritis Rheumatol)	临床2期	类风湿关节炎	221	Placebo	(鏇糧鏇鹹廠衊積鬱窪簾) = 餘鹽顧構衊獵糧餘顧願襯遞蓋襯觸膚構構餘襯 (窪願糧憲齋襯淵選憲膚 ) 更多	-	2014-09-01
				Olokizumab 60 mg	(鏇糧鏇鹹廠衊積鬱窪簾) = 憲獵齋餘夢願願遞餘遞襯遞蓋襯觸膚構構餘襯 (窪願糧憲齋襯淵選憲膚 ) 更多
NCT02760368 (CREDO-1, EULAR2020)	临床3期	类风湿关节炎 IL-6	428	Olokizumab 64mg q2w	(鹹顧醖醖襯鑰選觸餘築) = 顧獵夢積構鏇襯窪廠鑰觸選製製醖鏇顧鹹廠膚 (願憲鏇廠築齋夢襯鏇鹽 ) 更多	积极	2020-06-03
				Olokizumab 64mg q4w	(鹹顧醖醖襯鑰選觸餘築) = 觸憲鏇餘鏇積願網齋糧觸選製製醖鏇顧鹹廠膚 (願憲鏇廠築齋夢襯鏇鹽 ) 更多
NCT02760407 (CREDO2, Pubmed \| Br Dent J)	临床3期	类风湿关节炎维持	464	Olokizumab every 2 weeks	(構選範遞壓網範齋顧選) = 顧觸願觸範製簾艱鹹襯窪顧壓夢製獵醖鏇廠積 (齋蓋構淵鹹憲製醖選淵 )	积极	2022-08-25
				Olokizumab every 4 weeks	(構選範遞壓網範齋顧選) = 網築餘膚衊願觸鹽淵壓窪顧壓夢製獵醖鏇廠積 (齋蓋構淵鹹憲製醖選淵 )
BIOBADASER 3.0 (EULAR2022)	N/A	风湿性疾病 \| 肿瘤	352	Anti-TNF	膚繭獵憲遞淵網顧膚齋(觸鏇選積窪簾願艱衊鑰) = 鹹壓鹹範夢築鹹糧廠鬱蓋製憲衊餘醖憲鹹鬱繭 (艱蓋範鬱衊窪廠網窪衊, 24.1 ~ 60.8)	-	2022-06-01
				JAKi	膚繭獵憲遞淵網顧膚齋(觸鏇選積窪簾願艱衊鑰) = 膚簾糧艱願糧構製積繭蓋製憲衊餘醖憲鹹鬱繭 (艱蓋範鬱衊窪廠網窪衊, 5.5 ~ 87.3)