Prospective Observational Study to Evaluate Secukinumab Treatment Effectiveness in Pediatric Patients With Active Juvenile Enthesitis-related or Psoriatic Arthritis (Toddler)

This is a multicenter, non-interventional, cohort study in pediatric patients with active juvenile enthesitis-related or psoriatic arthritis

开始日期2025-04-30

申办/合作机构

Novartis Pharmaceuticals Corp.

PER-031-18 / Completed临床3期

A RANDOMIZED, OPEN-LABEL, MULTICENTER TRIAL TO ASSESS THE EFFICACY OF SUBCUTANEOUS SECUKINUMAB AFTER TWELVE WEEKS OF TREATMENT, AND TO ASSESS THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY IN SUBJECTS FROM 6 TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS

开始日期2024-11-01

申办/合作机构-

NCT06398106 / Not yet recruiting临床4期IIT

Proactive Therapeutic Drug Monitoring Versus Routine Care With the Novel Biologics in Psoriasis : a Pragmatic, Multicentric, Randomised, Controlled Study

Biologics are effective agents for the treatment of psoriasis. The newest generation of biologics block interleukin 17 and 23. Physicians always prescribe these drugs in a fixed dose, but this may lead to under- and overdosing in some patients. Underdosing may lead to inadequate response or loss of response over time. Overdosage, on the other hand, can lead to higher risk of side effects and higher costs for the healthcare system. In daily clinical practice, physicians often tackle this real-world issue by blind trial- and- error dose modifications or switching to another biologic. In this study, we want to rationalize these dose modifications and optimize dosing based on the drug concentrations, measured in the blood of the patient (i.e. therapeutic drug monitoring). Depending on the drug concentration, the interval between injections will be lengthened or shortened with the aim to reach the required drug concentration to reach the best clinical result. The trial will be conducted in 14 Belgian hospitals where patients will be divided into 2 study groups: a group that will be advised on the dosing scheme of their biologic based on the measured drug concentration and a group that continues dosing as in daily clinical practice. We will monitor if the clinical response and quality of life remains stable. With this study, we will track drug concentrations as we believe that they can guide dosing of biologics and we hope to achieve better safety, lower healthcare expenses and higher patients' treatment satisfaction while striving for the best clinical response.

开始日期2024-09-01

申办/合作机构

Ghent University Hospital

100 项与司库奇尤单抗相关的临床结果

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100 项与司库奇尤单抗相关的转化医学

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100 项与司库奇尤单抗相关的专利（医药）

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1,990

项与司库奇尤单抗相关的文献（医药）

2024-12-31·Autoimmunity

Interplay between COVID-19 and Secukinumab treatment in Spondylarthritis patients during the omicron surge: a retrospective cohort study

Article

作者: Huang, Deying ; Chen, Ye ; Li, Yanhong ; Herrmann, Martin ; Wu, Tong ; Cheng, Lu ; Wu, Yinlan ; Liang, Xiuping ; Tan, Chunyu ; Xu, Fang ; Liu, Yi ; Xia, Zijing ; Liao, Zehui ; Zhao, Jing

The objective of this retrospective cohort study was to assess the relationship between Corona Disease 2019 (COVID-19) and Secukinumab treatment in patients with Spondylarthritis (SpA) in China during the omicron surge. Researchers retrieved 1018 medical records of Secukinumab-treated patients between January 2020 and January 2023 from the West China Hospital of Sichuan University. Out of these, 190 SpA patients from the rheumatology clinic were selected for the study. Guided phone questionnaires were administered by research staff to collect baseline characteristics, SpA disease status, and COVID-19 clinical outcomes. Cohabitants served as the control group and provided COVID-19 related data. Of the 190 potential SpA patients, 122 (66%) completed the questionnaire via phone, along with 259 cohabitants. 84.4% of SpA patients were diagnosed with Ankylosing Spondylitis (AS), and 15.6% were diagnosed with Psoriatic Arthritis (PsA). The rate of SARS-CoV-2 infection was 83.6% in the Secukinumab group and 88.8% in the cohabitants control group, with no significant difference (OR = 0.684, CI 0.366-1.275). One instance of severe COVID-19 was observed in the Secukinumab group, while two were identified in the cohabitants control group. Patients in the Secukinumab group had less time with fever caused by COVID-19 (p = 0.004). Discontinuing Secukinumab after SARS-CoV-2 infection did not significantly affect the course of COVID-19 or worsen SpA status according to our data. Our study suggests that administering Secukinumab to SpA patients does not increase their susceptibility to contracting SARS-CoV-2, and may have a positive effect on the course of SARS-CoV-2 infection.

2024-05-01·Journal of the European Academy of Dermatology and Venereology : JEADV

Dramatic early improvement of psoriasis in an 11‐year old boy after four doses of secukinumab following an alternative dosing scheme

Letter

作者: Spora, Leo ; Fang, Yongxing ; Möhrenschlager, Matthias ; Brüggen, Marie-Charlotte ; Hoff, Julia

2024-05-01·Clinical pharmacology and therapeutics

Comparative Effectiveness of Bimekizumab in Psoriatic Arthritis: A Model‐Based Meta‐Analysis of American College of Rheumatology Response Criteria

Article

作者: Ahmed, Ghada F ; Dua, Pinky ; Maloney, Alan

A model‐based meta‐analysis (MBMA) was conducted to compare the efficacy of bimekizumab with other psoriatic arthritis (PsA) treatment regimens using ≥ 20%/50%/70% improvements in American College of Rheumatology (ACR) criteria (ACR20/50/70) for patients with PsA. Forty‐nine trials of 16 drugs were identified in the literature, comprising 21,340 patients. Trial‐level covariates, including prior biologic use, concomitant methotrexate use, time since diagnosis, trial completion year, and active comparator were considered for exploratory models. The final model was selected using leave‐one‐out cross‐validation (LOO CV) to assess predictive performance based on prespecified criteria. LOO CV was conducted for 15 trials; the final model demonstrated that 91.5% (952/1,040) of the observed treatment differences, and 96.1% of the observed ACR20/50/70 response rates were within the 95% prediction interval (PI). Median ACR50 response rates (95% PI) at week 16 in biologic‐naïve patients were predicted to be 44% (40–49%) for bimekizumab 160 mg, among the highest of all treatments analyzed. Response rates for secukinumab 150 mg and risankizumab 150 mg were 28% (25–32%) and 27% (24–31%), respectively. The MBMA was also used to predict the probability of success (PoS) of potential head‐to‐head trials using ACR50 response as the end point with varying sample sizes: vs. secukinumab 150 mg, the PoS for bimekizumab 160 mg was 62% (N = 200) and 90% (N = 400). Versus risankizumab 150 mg, the PoS for bimekizumab 160 mg was 68% (N = 200) and 94% (N = 400). In summary, a predictive MBMA described ACR20/50/70 outcomes in PsA, allowing accurate and precise treatment comparisons and robust PoS calculations.

502

项与司库奇尤单抗相关的新闻（医药）

2024-06-25

·GlobeNewswire-Health Care

Shape Therapeutics Appoints Healthcare Industry Leaders David Epstein and Todd Simpson to its Board of Directors

Epstein and Simpson bring significant life sciences industry expertise that will be integral to the Company’s continued growth as a leader in AI for genomic medicineSEATTLE, June 25, 2024 (GLOBE NEWSWIRE) -- Shape Therapeutics, Inc. (ShapeTX), a leader at the convergence of AI and RNA editing to revolutionize genomic medicine, announces the appointments of David Epstein, former CEO of Seagen, and Todd Simpson, former CFO of Seagen, to its board of directors. “We are at a pivotal moment where our investment in breakthrough technologies is now yielding industry-leading results. As we prepare to advance our RNA editing therapies to the clinic, we are thrilled to welcome David and Todd to our board," said Francois Vigneault, Ph.D., chief executive officer of ShapeTX. "Their expertise in scaling life sciences companies, from drug development to clinical success and commercialization, will be invaluable.” David Epstein is a highly respected leader in the pharmaceutical and biotech sectors, renowned for steering Seagen towards a pivotal $44.5 billion acquisition by Pfizer. With over 30 years of global experience in drug development, commercialization, and leadership, David has previously served as an executive partner at Flagship Pioneering and as CEO of Novartis Pharmaceuticals, including its Oncology and Molecular Diagnostic units, transforming it into the second-largest oncology division globally. He has overseen the development and launch of more than 30 new molecular entities, including notable treatments such as Glivec, Tasigna, Gilenya, Afinitor, Cosentyx, Entresto and Padcev. David holds a bachelor's degree in pharmacy from Rutgers University and an MBA from Columbia University. He also serves on the boards of Tempus AI and Valo Health. "Throughout my career, I've been fortunate to be part of companies at the forefront of scientific innovation, witnessing firsthand the profound impact on patients and families." said David Epstein. "Shape has married AI, superior engineering and efficient manufacturing to cure horrific CNS and retinal disease with revolutionary AI RNA-targeted therapy, and I am eager to contribute my experience to accelerate their growth.” Todd Simpson brings more than 40 years of diverse life sciences and industry experience to the ShapeTX board. During his nearly two decades at Seagen, Todd played a crucial role in launching and commercializing four oncology medicines across more than a dozen labeled indications in the United States. He also spearheaded Seagen's international expansion, leading to the commercialization of three medicines in the Americas and Europe. Before Seagen, Todd held several leadership roles, including VP of Finance and Administration, CFO, Treasurer, Secretary at Targeted Genetics Corp. and worked almost ten years in public accounting. He holds a bachelor's degree in accounting and computer science from Oregon State University and has served on the boards of Neoleukin Therapeutics, Aquinox Pharmaceuticals Inc., and Life Science Washington (formerly Washington Biotech and Biomedical Association). "I see remarkable similarities between ShapeTX and the early days of Seagen. It's refreshing and invigorating to work with a team dedicated to long-term, platform-based therapeutic innovation and driven by a mission to help patients in need," said Todd Simpson. About ShapeTX: Shape Therapeutics operates at the convergence of AI and RNA editing to revolutionize genomic medicine. Our proprietary RNA editing technology, RNAfix®, represents a significant leap forward over CRISPR-based tools, achieving 95% editing efficiency in vivo, and a path to one-time curative treatments for thousands of diseases. With over 90 million laboratory-validated guide RNA and 12 billion AAV data points, ShapeTX is building the largest therapeutic RNA foundation model in the industry and becoming the leader in AI for genomic medicine. You can find us at ShapeTX.com and on LinkedIn and X. Media Contact: Lisa Ash TaylorGeneral Counsel and Head of OperationsShape Therapeuticslisa@shapetx.com

高管变更并购

2024-06-24

·信狐药迅

长春澜江苯海拉明布洛芬和住友制药来法莫林注射用浓溶液等潜在首仿提交上市申请|新受理（6.17-6.23）

本周药品注册受理数据，分门别类呈现，一目了然。(6.17-6.23）新药上市申请无新药临床申请药品名称企业注册分类受理号CVL237片甫康(上海)健康科技有限责任公司1CXHL2400623TQC3721吸入粉雾剂正大天晴药业集团股份有限公司1CXHL2400625TQC3721吸入粉雾剂正大天晴药业集团股份有限公司1CXHL2400624HS-10502片江苏豪森药业集团有限公司1CXHL2400620HS-10502片江苏豪森药业集团有限公司1CXHL2400619RG002C0106注射液北京炫景瑞医药科技有限公司1CXHL2400617177Lu-TR0471注射液通瑞生物制药(成都)有限公司1CXHL2400616吸入用LH-1901江苏联环药业股份有限公司1CXHL2400615吸入用LH-1901江苏联环药业股份有限公司1CXHL2400614HRS9950片成都盛迪医药有限公司1CXHL2400611HRS9950片成都盛迪医药有限公司1CXHL2400610HRS-5635注射液福建盛迪医药有限公司1CXHL2400609PG-033片北京普祺医药科技股份有限公司1CXHL2400607PG-033片北京普祺医药科技股份有限公司1CXHL2400606TY751注射液天津药物研究院有限公司1CXHL2400605注射用醋酸曲普瑞林缓释微球南京恒生制药有限公司2.2CXHL2400621ZP036华润紫竹药业有限公司2.2CXHL2400618JW202313吸入粉雾剂山东京卫制药有限公司2.2CXHL2400613HCD干混悬剂浙江圣博康药业有限公司2.2CXHL2400612HY22005I片长春海悦药业股份有限公司2.2CXHL2400608BCM476胶囊上海云晟研新生物科技有限公司2.3CXHL2400622盐酸卡利拉嗪胶囊成都奥邦药业有限公司3CYHL2400125盐酸卡利拉嗪胶囊成都奥邦药业有限公司3CYHL2400124盐酸米诺环素泡沫剂山西振东安欣生物制药有限公司3CYHL2400123盐酸米诺环素泡沫剂山西振东安欣生物制药有限公司3CYHL2400122去氧胆酸注射液北京藏卫信康医药研发有限公司3CYHL2400121立他司特滴眼液浙江莎普爱思药业股份有限公司3CYHL2400120氟[18F]妥司特注射液北京先通国际医药科技股份有限公司3CYHL2400119布立西坦片辰欣药业股份有限公司3CYHL2400118布立西坦片辰欣药业股份有限公司3CYHL2400117布立西坦片辰欣药业股份有限公司3CYHL2400116盐酸卡利拉嗪胶囊武汉人福药业有限责任公司3CYHL2400115盐酸卡利拉嗪胶囊武汉人福药业有限责任公司3CYHL2400114去氧胆酸注射液北京诺博特生物科技有限公司3CYHL2400113SCTV04C注射液神州细胞工程有限公司1.2CXSL2400397SCTV04C注射液神州细胞工程有限公司1.2CXSL2400396注射用SSGJ-709沈阳三生制药有限责任公司1CXSL2400408注射用HS-20093上海翰森生物医药科技有限公司1CXSL2400406注射用HS-20089上海翰森生物医药科技有限公司1CXSL2400407AK135注射液中山康方生物医药有限公司1CXSL2400405CS01单抗注射液中山恒动生物制药有限公司1CXSL2400402TQB2825注射液正大天晴药业集团南京顺欣制药有限公司1CXSL2400404TQB2825注射液正大天晴药业集团南京顺欣制药有限公司1CXSL2400403VUM02注射液武汉光谷中源药业有限公司1CXSL2400401RJMty19注射液浙江瑞加美生物科技有限公司1CXSL2400400MG-K10人源化单抗注射液上海麦济生物技术有限公司1CXSL2400399SYSA1801注射液石药集团巨石生物制药有限公司1CXSL2400395注射用重组A型肉毒毒素苏州迪新宸科生物科技有限公司2.4CXSL2400398 仿制药申请药品名称企业注册分类受理号阿达帕林过氧苯甲酰凝胶苏州高迈药业有限公司3CYHS2401869间苯三酚口腔崩解片河北汇德旭盛医药科技有限公司3CYHS2401867恩格列净二甲双胍缓释片浙江昂利康制药股份有限公司3CYHS2401866吡格列酮二甲双胍片浙江江北药业有限公司3CYHS2401853注射用青霉素钠辽宁省连科药业有限公司3CYHS2401852注射用青霉素钠辽宁省连科药业有限公司3CYHS2401851注射用青霉素钠辽宁省连科药业有限公司3CYHS2401850注射用磷霉素钠广州艾奇西新药研究有限公司3CYHS2401849注射用磷霉素钠广州艾奇西新药研究有限公司3CYHS2401848重酒石酸卡巴拉汀口服液上海美优制药有限公司3CYHS2401833注射用拉氧头孢钠山东宜和生物医药科技有限公司3CYHS2401826富马酸酮替芬滴眼液成都普什制药有限公司3CYHS2401825西格列汀二甲双胍缓释片广东东阳光药业股份有限公司3CYHS2401819盐酸甲氧氯普胺注射液江苏瑜兴医药科技有限公司3CYHS2401815枸橼酸苯海拉明布洛芬片长春澜江医药科技有限公司3CYHS2401813西格列汀二甲双胍缓释片常州制药厂有限公司3CYHS2401812阿仑膦酸钠口服溶液广州一品红制药有限公司3CYHS2401811马来酸曲美布汀片浙江华海药业股份有限公司3CYHS2401822他达拉非片迪沙药业集团有限公司4CYHS2401871他达拉非片迪沙药业集团有限公司4CYHS2401870非诺贝特胶囊江苏德源药业股份有限公司4CYHS2401868伊班膦酸钠注射液上海旭东海普药业有限公司4CYHS2401865伊班膦酸钠注射液上海旭东海普药业有限公司4CYHS2401864伊班膦酸钠注射液上海旭东海普药业有限公司4CYHS2401863硫酸氨基葡萄糖胶囊安徽九洲方圆制药有限公司4CYHS2401862聚多卡醇注射液成都市海通药业有限公司4CYHS2401861聚多卡醇注射液成都市海通药业有限公司4CYHS2401860聚多卡醇注射液成都市海通药业有限公司4CYHS2401859波生坦分散片华润双鹤利民药业(济南)有限公司4CYHS2401858地屈孕酮片浙江爱生药业有限公司4CYHS2401857氧(液态)河北舜广联合气体有限公司4CYHS2401856蛋白琥珀酸铁口服溶液四川海梦智森生物制药有限公司4CYHS2401855左卡尼汀注射液成都市海通药业有限公司4CYHS2401854比索洛尔氨氯地平片华益药业科技(安徽)有限公司4CYHS2401847注射用头孢唑肟钠南京恩泰医药科技有限公司4CYHS2401846乳果糖口服溶液南京海纳制药有限公司4CYHS2401845硫酸氨基葡萄糖胶囊合肥康惠医药技术有限公司4CYHS2401844乳果糖口服溶液南京海纳制药有限公司4CYHS2401843他氟前列素滴眼液海南斯达制药有限公司4CYHS2401842比索洛尔氨氯地平片华润赛科药业有限责任公司4CYHS2401841盐酸奥洛他定滴眼液江西马应龙美康药业有限公司4CYHS2401840注射用亚胺培南西司他丁钠深圳华药南方制药有限公司4CYHS2401839泊沙康唑注射液山东新时代药业有限公司4CYHS2401838依折麦布辛伐他汀片北京百奥药业有限责任公司4CYHS2401837马来酸氟伏沙明片重庆赛维药业有限公司4CYHS2401836马来酸氟伏沙明片重庆赛维药业有限公司4CYHS2401835硫酸镁钠钾口服用浓溶液浙江百代医药科技有限公司4CYHS2401834沙格列汀二甲双胍缓释片(III)平光制药股份有限公司4CYHS2401832沙格列汀二甲双胍缓释片(I)平光制药股份有限公司4CYHS2401831左卡尼汀口服溶液岳阳新华达制药有限公司4CYHS2401830亚叶酸钙注射液西藏海金药业有限公司4CYHS2401829左卡尼汀口服溶液海南卓科制药有限公司4CYHS2401828左卡尼汀口服溶液江苏盈科生物制药有限公司4CYHS2401827注射用硫酸艾沙康唑成都天台山制药股份有限公司4CYHS2401824吸入用布地奈德混悬液艾特美(苏州)医药科技有限公司4CYHS2401818醋酸来法莫林注射用浓溶液住友制药(苏州)有限公司4CYHS2401817盐酸尼卡地平注射液浙江沣华医药科技有限公司4CYHS2401816二甲双胍恩格列净片(I)北京圣永制药有限公司4CYHS2401814碘美普尔注射液北京北陆药业股份有限公司4CYHS240181010%脂肪乳(OO)/5.5%氨基酸(15)/葡萄糖(20%)注射液四川科伦药业股份有限公司4CYHS2401823阿法骨化醇软胶囊东海制药(河北)有限公司4CYHS2401821注射用尼可地尔山东新华鲁抗医药有限公司4CYHS2401820精氨酸布洛芬片海南先声药业有限公司4CYHS2401809注射用重组人促甲状腺激素苏州泽璟生物制药股份有限公司3.2CXSS2400060 进口申请药品名称企业注册分类受理号甲磺酸奥希替尼片AstraZeneca AB2.4JXHS2400042甲磺酸奥希替尼片AstraZeneca AB2.4JXHS2400041司库奇尤单抗注射液Novartis Pharma Schweiz AG3.1JXSS2400048注射用坦昔妥单抗Incyte Biosciences Distribution B.V.3.1JXSS2400050司库奇尤单抗注射液Novartis Pharma Schweiz AG3.1JXSS2400049BRII-835 (VIR-2218) 注射液Brii Biosciences Limited1JXHL2400142奥贝胆酸(OCA)Intercept Pharmaceuticals, Inc.2.4JXHL2400144奥贝胆酸(OCA)Intercept Pharmaceuticals, Inc.2.4JXHL2400143BRII-179注射液Brii Biosciences Limited1JXSL2400115贝利尤单抗注射液GlaxoSmithKline (Ireland) Limited2.2JXSL2400116注射用戈沙妥珠单抗Gilead Sciences, Inc.2.2JXSL2400114 中药相关申请药品名称企业注册分类受理号白脉软膏西藏奇正藏药股份有限公司2.3CXZL2400034 不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市

2024-06-20

·研发客

Q1收入+31%，Q2换帅，还有哪些增长空间？| 投资观察

// 2024年Q1，诺华的PSCK9抑制剂英克司兰钠、心衰药Entresto以及自免药司库奇尤单抗在中国的表现可圈可点。 2024年Q1，诺华中国实现10亿美元收入，同比增长31%。时任中国区总裁张颖在调任总部之前交出了这份抢眼的成绩单，也让接棒者站上了非常高的起点。 6月12日，诺华中国区新总裁Leo Lee宣布了上任后的第一个好消息：卡马替尼在中国正式获批，用于未经系统治疗的携带间质上皮转化因子（MET）外显子14跳跃突变的局部晚期或转移性非小细胞肺癌成人患者。回顾今年上半年，诺华已经实现了两款新药、4个适应症在中国的落地：针对METex14跳跃突变的新药卡马替尼，治疗阵发性睡眠性血尿的新药伊普可泮，以及老产品芦可替尼治疗慢性移植物抗宿主病的新适应症，司库奇尤单抗的银屑病关节炎新适应症。 PCSK9自费市场出人意料去年8月刚刚获批的PSCK9抑制剂英克司兰钠注射液，在中国展现出意想不到的潜力。拓展阅读本土siRNA主战场在哪？诺华Q1的财务报告中表示，这款产品在美国和美国以外市场的增长表现势均力敌。并且格外提到，在自费的情况下，中国市场每天有200名新增患者接受英司克兰的治疗。目前该产品在中国的定价为9988元/针，年治疗费用在2万元左右，比海外市场费用减少近一半。来源|诺华官网诺华计划在明年推进英克司兰钠注射液纳入医保，压力给到安进和赛诺菲。目前，安进和赛诺菲的PCSK9抑制剂产品均已纳入医保。安进的依洛尤单抗注射液420毫克每月一次，或280毫克每两周一次；赛诺菲的阿利西尤单抗注射液推荐用法75毫克每两周一次。从用药周期来看，英克司兰更胜一筹。未来进入医保之后，恐怕会引发PCSK9抑制剂的一场价格战。事实上，降脂竞赛诺华并未全部押注PCSK9靶点，其另一款创新降脂产品Pelacarsen早已进入3期临床阶段。这是一种针对心血管疾病潜在靶点脂蛋白(a)的反义寡核苷酸类药物，能够通过抑制合成从而降低脂蛋白(a)水平。 Entresto还有多少空间作为诺华当前最重要的业绩支撑，2024年Q1的Entresto全球销售额达到18.79亿美元，同比增长36%。高血压适应症在中国市场的放量成为增长的重要动力之一。来源|诺华官网目前，Entresto的心衰和高血压适应症均已纳入医保目录，并在2023版高血压指南中，被列为一线治疗药物。据中康数据，2023年上半年，Entresto在国内等级医院的销售额为17.22亿元，在零售市场的销售额为4.86亿元，占全球销售额的1/10。诺华在今年Q1业绩说明会上表示，将进一步提高Entresto高血压适应症在中国市场的渗透率。不过，留给Entresto的时间不会太多。2023年8月，两款沙库巴曲缬沙坦钠片仿制药获批上市，分别来自一心和医药、石药集团。另有多家申报企业紧随其后。诺华第一时间发布了有关专利保护的申明。当然，Entresto的专利保护至2026年11月，在这之前，这片市场仍然属于诺华。司库奇尤单抗的增速司库奇尤单抗在2024 Q1表现强势，实现13.26亿美元收入，同比增长25%，成为公司业绩的重要贡献者。诺华表示，在欧洲和中国，司库奇尤单抗拥有IL-17产品的领导者地位。来源|诺华官网来自兴业证券的数据显示，2020年司库奇尤单抗在中国的收入是5亿元人民币，2022年攀升到了45亿元。今年初，司库奇尤单抗在中国又获批了银屑病关节炎适应症，将进一步拓展中国市场空间。目前，司库奇尤单抗在国内确实还没有特别突出的竞争者。进展最快的是智翔金泰的赛立奇单抗，去年3月递交了上市申请。据智翔金泰表示，经非头对头数据结果比较，长期疗效或优于司库奇尤单抗。丽珠医药展现更大的雄心，选择与司库奇尤单抗头对头。公司的IL-17在研产品，正在进行对比司库奇尤在中度至重度慢性斑块状银屑病受试者中的有效性与安全性，该试验为随机、双盲的3期临床研究，主要终点为以第12周时达到银屑病面积与严重程度指数（PASI）100的受试者比例（PASI100应答率）。全球范围内，司库奇尤单抗曾通过一系列头对头临床试验，证明自己优于乌司奴单抗。不过在与阿达木单抗针对银屑病关节炎（PsA）的疗效与安全性头对头实验中，司库尤其单抗并没有展现出优势。对比几款银屑病产品的全球业绩，2023年表现最好的是强生的乌司奴单抗，全年收入108亿美元，同比增长11.7%，司库奇尤单抗以49.8亿美元收入位列第二，同比增长4%。古赛奇尤单抗完成31.47亿美元销售，同比增长17.9%。依奇珠单抗2023年获得27.6亿美元，同比增长11%。从去年的业绩增速来看，司库奇尤表现并不理想。后续产品布局除了已经收获的市场份额，诺华也在着手其他产品的布局。今年4月，诺华的一款口服补体B因子抑制剂伊普可泮在中国获批上市，用于治疗阵发性睡眠性血红蛋白尿症（PNH）。不过，在伊普可泮获批前两个月，罗氏的同款适应症药物可伐利单抗也获NMPA批准。可伐利单抗每四周家庭注射一次，相比之下，伊普可泮最大的优势在于口服，也是目前成人PNH治疗的首个口服单药疗法。但伊普可泮和可伐利单抗还需要面对一个共同的劲敌：阿斯利康C5补体抑制剂依库珠单抗。今年，依库珠单抗针对治疗成人和儿童阵发性睡眠性血红蛋白尿症等三个适应症均已纳入医保目录。今年融资交易火爆的核药，也将是诺华中国非常重要的一颗棋子。去年，诺华在中国设立了一家放射性药物生产基地，有意加快创新型放射配体疗法进入中国。拓展阅读蓄谋已久的核药目前，诺华手握两款放射性配体疗法产品。今年4月，FDA批准Lutathera用于治疗12岁及以上的胃肠胰神经内分泌肿瘤（GEP-NET）儿童患者。早前，Pluvicto经FDA获批用于接受雄激素受体通路抑制剂和紫杉醇化疗的PSMA阳性转移性去势抵抗性前列腺癌成人患者，成为全球首款靶向PSMA的放射性配体疗法。今年5月，诺华以10亿美元预付款和7.5亿美元的潜在里程碑款，收购了Mariana Oncology，用以补充创新放射性药物管道和平台。同样也在5月，诺华再次与多肽药物开发明星公司PeptiDream达成合作，开发新型大环肽，有可能未来用于诺华的放射性配体疗法（RLTs）的偶联。编辑 | 姚嘉 yao.jia@PharmaDJ.com 总第2140期访问研发客网站可浏览更多文章 www.PharmaDJ.com

临床3期核酸药物siRNA寡核苷酸财报

100 项与司库奇尤单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09967	司库奇尤单抗	L04AC10	DB09029

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
化脓性汗腺炎	欧盟	Novartis Europharm Ltd.	2023-06-02
化脓性汗腺炎	冰岛	Novartis Europharm Ltd.	2023-06-02
化脓性汗腺炎	列支敦士登	Novartis Europharm Ltd.	2023-06-02
化脓性汗腺炎	挪威	Novartis Europharm Ltd.	2023-06-02
幼年型关节炎	欧盟	Novartis Europharm Ltd.	2023-06-02
幼年型关节炎	冰岛	Novartis Europharm Ltd.	2023-06-02
幼年型关节炎	列支敦士登	Novartis Europharm Ltd.	2023-06-02
幼年型关节炎	挪威	Novartis Europharm Ltd.	2023-06-02
附着点炎相关关节炎	美国	Novartis Pharmaceuticals Corp.	2021-12-22
脓疱型银屑病	日本	Novartis Pharma KK	2015-12-21
强直性脊柱炎	欧盟	Novartis Europharm Ltd.	2015-01-14
强直性脊柱炎	冰岛	Novartis Europharm Ltd.	2015-01-14
强直性脊柱炎	列支敦士登	Novartis Europharm Ltd.	2015-01-14
强直性脊柱炎	挪威	Novartis Europharm Ltd.	2015-01-14
中轴性脊柱关节炎	欧盟	Novartis Europharm Ltd.	2015-01-14
中轴性脊柱关节炎	冰岛	Novartis Europharm Ltd.	2015-01-14
中轴性脊柱关节炎	列支敦士登	Novartis Europharm Ltd.	2015-01-14
中轴性脊柱关节炎	挪威	Novartis Europharm Ltd.	2015-01-14
非放射性轴性脊柱关节炎	欧盟	Novartis Europharm Ltd.	2015-01-14
非放射性轴性脊柱关节炎	冰岛	Novartis Europharm Ltd.	2015-01-14

未上市

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
风湿性多肌痛	临床3期	-	Novartis Pharmaceuticals Corp.	2023-03-14
肩袖肌腱炎	临床3期	德国	Novartis Pharmaceuticals Corp.	2022-12-02
肌腱病	临床3期	德国	Novartis Pharmaceuticals Corp.	2022-12-02
脊椎关节炎	临床3期	-	Novartis Pharmaceuticals Corp.	2022-08-16
格雷夫斯眼病	临床3期	德国	Novartis Pharmaceuticals Corp.	2021-11-29
巨细胞动脉炎	临床3期	芬兰	Novartis AG	2021-10-06
巨细胞动脉炎	临床3期	法国	Novartis AG	2021-10-06
巨细胞动脉炎	临床3期	葡萄牙	Novartis AG	2021-10-06
涎腺多形性腺瘤	临床3期	中国	Novartis Pharmaceuticals Corp.	2021-06-24
狼疮性肾炎	临床3期	美国	Novartis Pharma Schweiz AG	2020-07-07

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临床结果

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


NCT03791060 (CTgov)	临床2期	类脂质渐进性坏死	4	Secukinumab	窪膚選選鹽醖襯壓憲艱(膚蓋蓋襯鹽壓築鑰製選) = 壓窪醖積築鏇襯蓋鏇窪構膚鹹襯網廠簾憲範願 (範膚壓顧艱築壓淵夢淵, 製繭廠鑰鑰構夢願顧願 ~ 願艱膚醖襯蓋簾醖製糧) 更多	-	2024-05-17
NCT04209205 (CTgov)	临床3期	银屑病关节炎	381	AIN457 6 mg/kg i.v.	壓鑰構壓蓋獵鬱壓選夢(鏇廠膚壓獵網積壓繭廠) = 衊簾簾簾觸壓網獵憲衊齋鏇膚鏇窪鏇壓獵襯艱 (夢淵製淵願鏇襯膚積蓋, 衊簾簾齋夢鏇構醖顧壓 ~ 鑰範醖鬱製醖齋襯顧醖) 更多	-	2024-04-26
NCT03713619 \| NCT03713632 (FDA) 人工标引	临床3期	化脓性汗腺炎	1,084	Placebo (HS Trial 1)	鹽鑰積獵製淵襯選範鹽(獵積選齋築餘淵繭繭範) = 壓鏇遞獵窪膚範廠範憲蓋繭糧積鏇繭淵鹽膚繭 (遞糧獵夢衊憲遞壓鬱鹽 )	积极	2023-10-31
NCT03713619 \| NCT03713632 (FDA) 人工标引	临床3期	化脓性汗腺炎	1,084	COSENTY X 300 mg every 2 weeks (HS Trial 1)	鹽鑰積獵製淵襯選範鹽(獵積選齋築餘淵繭繭範) = 憲壓觸鹽膚獵衊膚鬱衊蓋繭糧積鏇繭淵鹽膚繭 (遞糧獵夢衊憲遞壓鬱鹽 )	积极	2023-10-31
EADV2023	N/A	化脓性汗腺炎 positive antinuclear antibodies \| latent tuberculosis	16	Secukinumab	襯壓遞遞窪齋觸齋蓋構(夢簾積艱簾顧構構膚壓) = 窪壓獵餘醖範築網壓餘鏇觸廠衊齋獵遞獵夢選 (夢廠獵範選獵築願壓製 )	积极	2023-10-11
SERENA (EADV 12023 \| EADV 22023)	N/A	斑块状银屑病	1,755	Secukinumab	觸構糧構醖遞繭築積顧(願壓淵鹹顧壓觸顧願製) = IR: 0.34 繭願淵蓋廠構構艱顧蓋 (築糧選鹽鹹築淵觸構築 ) 更多	-	2023-10-11
LOGIC study (EADV2023)	N/A	涎腺多形性腺瘤 \| 银屑病	422	Secukinumab	窪鹹鏇繭餘鹹鬱製網鬱(鹽構網願襯襯壓積鬱願) = 選艱襯獵窪餘蓋獵壓窪網廠構夢衊膚壓觸獵顧 (餘鏇憲艱鏇獵醖鬱壓繭 )	-	2023-10-11
EADV2023	N/A	斑块状银屑病	12	Secukinumab	網蓋遞齋壓糧繭鏇鏇顧(繭廠齋窪繭顧願壓壓構) = 遞積築積淵選製積鏇築遞衊構廠蓋範觸餘壓憲 (襯蓋鹽遞選壓夢齋醖鏇 ) 更多	积极	2023-10-11
SUNSHINE and SUNRISE (EADV2023)	临床3期	化脓性汗腺炎	1,084	Secukinumab 300 mg every 2 weeks	艱獵顧鏇範鹹製淵積衊(鬱壓顧膚觸憲蓋築積膚) = 鑰顧範淵廠艱願製糧觸鏇鹹憲網範獵簾淵構簾 (窪夢鬱簾糧壓鏇醖齋簾 ) 更多	积极	2023-10-11
SUNSHINE and SUNRISE (EADV2023)	临床3期	化脓性汗腺炎	1,084	Secukinumab 300 mg every 4 weeks	艱獵顧鏇範鹹製淵積衊(鬱壓顧膚觸憲蓋築積膚) = 鬱顧憲廠觸齋鬱鹽艱鑰鏇鹹憲網範獵簾淵構簾 (窪夢鬱簾糧壓鏇醖齋簾 ) 更多	积极	2023-10-11
UNMASK2 (EADV2023)	N/A	斑块状银屑病	135	Secukinumab	鬱餘鹹簾窪糧鑰淵範築(艱淵蓋觸獵艱鏇壓淵夢) = 廠醖鑰簾艱壓廠衊積繭觸蓋顧壓糧鹽觸網蓋獵 (積簾觸網壓願獵獵範艱 ) 更多	积极	2023-10-11
EADV2023	N/A	银屑病 \| 银屑病关节炎	-	Secukinumab	鏇鑰廠構壓餘範觸糧網(廠鏇夢廠壓壓糧襯鑰鏇) = 夢鬱憲齋積憲遞艱窪簾選襯範獵範構簾鬱範選 (窪壓窪襯淵顧觸築網膚 )	积极	2023-10-11
EADV2023	N/A	银屑病 \| 银屑病关节炎	-	Other biologics	鏇鑰廠構壓餘範觸糧網(廠鏇夢廠壓壓糧襯鑰鏇) = 糧願鹽鹽鑰膚襯遞鑰膚選襯範獵範構簾鬱範選 (窪壓窪襯淵顧觸築網膚 )	积极	2023-10-11