Open-label Safety Study in Adults and Adolescents With Haemophilia A With and Without FVIII Inhibitors Switching Directly From Emicizumab Prophylaxis to NNC0365-3769 (Mim8) Prophylaxis

This study is looking at how safe it is to switch from emicizumab to Mim8, in people with haemophilia A. Mim8 is a new medicine that is used to prevent bleeding episodes in people with haemophilia A. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected under the skin using a pen-injector either once every week, once every two weeks or once every month. The participants will be trained in using the pen injector. The participants can choose themselves, in collaboration with the study doctor how often they get Mim8 in this study. When the participant will get their first Mim8 injection depends on their current treatment with emicizumab. The participants will get their first Mim8 injection at Visit 2. Participants will have between 6 and 27 Mim8 injections. The total number of injections participants will have depends on their dosing frequency. The study will last for about 6-12 months. While taking part in this study, there are some restrictions about what medicine participant can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.

开始日期2023-06-26

申办/合作机构

Novo Nordisk A/S

NCT05685238

/ Recruiting临床3期

Open-label, Long-term Safety and Efficacy Study of Mim8 in Participants With Haemophilia A With or Without Inhibitors

This study is looking at how Mim8 works in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used to avoid bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). The study will last for up to 5.5 years. The duration of the study depends on when the participant enrolled in this study. The study will end if Mim8 is approved and marketed in participant's country during the study, or the study will end in June 2028, whichever comes first. Participants will get up to 262 injections; the number of injections depends on how often participants will get injections and how long time participants take part in the study. While taking part in this study, there are some restrictions about what medicine participants can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.

开始日期2023-02-13

申办/合作机构

Novo Nordisk A/S

100 项与迪纳西米单抗相关的临床结果

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100 项与迪纳西米单抗相关的转化医学

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100 项与迪纳西米单抗相关的专利（医药）

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项与迪纳西米单抗相关的文献（医药）

2026-04-30·NEW ENGLAND JOURNAL OF MEDICINE

Mim8 Bispecific Antibody Prophylaxis in Hemophilia A with or without Inhibitors.

Article

作者: Chowdary, Pratima ; Rakhmatullin, Ilgiz ; Oldenburg, Johannes ; Lentz, Steven R ; Mancuso, Maria Elisa ; Shanmukhaiah, Chandrakala ; Chan, Anthony K C ; Lyu, Chuhl Joo ; Mahlangu, Johnny ; van Vulpen, Lize F D ; Matsushita, Tadashi ; Zdziarska, Joanna ; Yang, Renchi ; Clausen, Wan Hui Ong

BACKGROUND:

Mim8 (denecimig), a bispecific antibody mimicking activated factor VIII, was developed for bleeding prophylaxis in patients with hemophilia A with or without factor VIII inhibitors.

METHODS:

In this phase 3, randomized trial, we assigned patients 12 years of age or older with hemophilia A with or without inhibitors to receive subcutaneous Mim8 once weekly or once monthly at a dose tiered according to body weight and given in a fixed injection volume (0.8 ml). Patients who had been receiving on-demand treatment before the trial were assigned in a 1:1:1 ratio to continue on-demand treatment (group 1) or receive Mim8 once weekly (group 2a) or once monthly (group 2b). Patients who had been receiving clotting factor concentrates during a run-in phase were assigned in a 1:1 ratio to receive Mim8 once weekly (group 3) or once monthly (group 4). The first primary end point was the annualized rate of treated bleeding events (those treated with a coagulation factor product) in an evaluation of Mim8 in group 2a and Mim8 in group 2b as compared with on-demand treatment in group 1. The second was the annualized rate of treated bleeding events in an intrapatient evaluation of Mim8 in group 3 and Mim8 in group 4 as compared with clotting factor concentrate prophylaxis during the run-in phase.

RESULTS:

Of the 58 patients in the pretrial on-demand treatment cohort, 17 were assigned to group 1, 21 to group 2a, and 20 to group 2b. The estimated mean annualized rate of treated bleeding events was 0.57 (95% confidence interval [CI], 0.25 to 1.30) in group 2a and 0.20 (95% CI, 0.06 to 0.71) in group 2b, as compared with 15.76 (95% CI, 10.70 to 23.20) in group 1 (relative decrease, 96.4% and 98.7%, respectively; P<0.001 for both comparisons). Of the 196 patients in the pretrial prophylaxis cohort, 98 each were assigned to group 3 or group 4. The estimated mean annualized rate of treated bleeding events was 2.25 (95% CI, 1.37 to 3.71) in group 3, as compared with 4.90 (95% CI, 3.65 to 6.56) during the run-in phase (relative decrease, 54.0%; P = 0.006), and 1.78 (95% CI, 1.18 to 2.71) in group 4, as compared with 3.12 (95% CI, 2.25 to 4.32) (relative decrease, 42.8%; P = 0.006). Injection-site reactions were reported in 103 of 4005 injections (2.6%). No patient was reported to have a thromboembolic event or clinical evidence of neutralizing anti-Mim8 antibodies.

CONCLUSIONS:

Among patients with hemophilia A with or without inhibitors, Mim8 prophylaxis was superior to on-demand treatment and clotting factor concentrate prophylaxis regarding the annualized rate of treated bleeding events. (Funded by Novo Nordisk; FRONTIER2 ClinicalTrials.gov number, NCT05053139.).

2026-03-04·Expert Review of Clinical Pharmacology

Factor-VIII mimetic bispecific antibodies for the treatment of hemophilia A: an update

Review

作者: Camelo, Ricardo Mesquita ; Alvares-Teodoro, Juliana ; Muniz Júnior, Roberto Lúcio ; Lamounier de Almeida, Douglas ; Eduarda Alves de Jesus, Vitória ; Pierce, Glenn F

INTRODUCTION:

Bispecific antibodies are used to treat various conditions, with notable results in hemophilia A, a rare bleeding disorder characterized by reduced or absent activity of the coagulation factor VIII (FVIII). Emicizumab is a bispecific antibody that mimics FVIII activity, reducing bleeds in people with hemophilia A (PwHA). The real-world effectiveness and safety profile of emicizumab stimulated the development of additional FVIII-mimetic antibodies.

AREAS COVERED:

This review covers recent progress in hemophilia A treatment, focusing on FVIII-mimetic bispecific antibodies. Emicizumab, the only currently approved FVIII-mimetic bispecific antibody, has shown effectiveness in reducing bleeding rates in PwHA with and without inhibitors, enabling improved musculoskeletal health and quality of life. Other FVIII-mimetic bispecific antibodies are in clinical trials (Mim8 and NXT007). We discuss mechanisms, preclinical and clinical outcomes, real-world data, safety, and new molecules expanding the therapeutic repertoire under development.

EXPERT OPINION:

The advent of FVIII-mimetic bispecific antibodies marks a shift in hemophilia A prophylaxis away from FVIII replacement therapies. Next-generation agents may offer enhanced activity and safety. Despite advances, challenges remain in monitoring activity, managing breakthrough bleeds, and understanding non-hemostatic FVIII roles. As long-acting, subcutaneous agents mature, they may redefine care, enabling personalized, safer, and more accessible prophylaxis across the lifespan.

2026-01-01·Research and Practice in Thrombosis and Haemostasis

Factor VIII in vitro bioequivalence of denecimig (Mim8) hemostatic effect by thrombin generation assays

Article

作者: Lund, Jacob ; Ezban, Mirella ; Jensen, Kasper ; Lillicrap, David

Background:

Denecimig (Mim8, Novo Nordisk A/S) is a next-generation bispecific antibody designed to mimic activated factor (F)VIII and restore hemostasis in persons with hemophilia A. The extent to which activated FVIII mimetics, such as denecimig and emicizumab, can correct clotting deficiency remains unclear.

Objectives:

To assess the in vitro FVIII bioequivalence of denecimig hemostatic activity using thrombin generation assays (TGAs).

Methods:

Thrombin generation was analyzed in severe hemophilia A platelet-poor plasma, spiked with various levels of FVIII or with clinical doses of denecimig (5 μg/mL) or emicizumab (50 μg/mL), using a sequence-identical analog (SIA). TGA used 4 trigger conditions: tissue factor (TF), activated FXI, a combination of TF and activated FXI, or activated FIX.

Results:

The average FVIII bioequivalence estimate using 1 pM TF trigger was 42 IU/dL (SD, 14) for 5 μg/mL denecimig and 14 IU/dL (SD, 5) for 50 μg/mL emicizumab-SIA using peak thrombin. The FVIII bioequivalence estimates of denecimig and emicizumab-SIA for hemostatic activity were generally highest for endogenous thrombin potential, followed by peak thrombin and velocity index across trigger concentrations. FVIII bioequivalence increased with decreasing trigger concentrations. Denecimig demonstrated a higher thrombin peak in conditions with limited activated FIX compared with emicizumab-SIA, suggesting differences in mechanisms of action.

Conclusion:

Estimation of denecimig in vitro FVIII bioequivalence with TGA depends on the TGA parameter and the type and concentration of the trigger. Denecimig demonstrated higher in vitro FVIII bioequivalence than emicizumab-SIA, indicating the potential for effective hemostatic coverage. Further studies are needed to fully understand the hemostatic effects of bispecific antibodies.

109

项与迪纳西米单抗相关的新闻（医药）

2026-07-22

·药融分享

刚刚！诺和诺德“王炸”双抗报上市：每月皮下注射，出血直降99%

媒体/设展/演讲宣传合作：金女士15158066904（微信同号）扫码加入交流群商务合作 2026年7月22日，中国国家药监局药品审评中心（CDE）官网最新公示，诺和诺德（Novo Nordisk）申报的1类治疗用生物制品「迪纳西米单抗注射液」（Denecimig，研发代号 Mim8）上市申请已获受理（受理号：JXSS2600067）。作为诺和诺德在中国递交的首个双特异性抗体新药，该药物目标适应症为伴/不伴FVIII抑制物的成人、青少年及儿童A型血友病（先天性凝血因子VIII缺乏症）的常规预防治疗。这不仅是诺和诺德双抗管线在国内的首秀，更是对现有血友病疗法的一次强力冲击。一、药物定位与作用机制：不补因子，直接“模拟”FVIIIa 迪纳西米单抗是一款皮下注射的凝血因子VIIIa（FVIIIa）模拟物双特异性抗体。它并非直接替代FVIII，而是通过一端结合FIXa、一端结合FX，将两者“桥接”起来，在凝血级联中代偿FVIIIa的辅因子功能，从而恢复机体生成凝血酶的能力。这一机制带来了两大关键临床优势：无惧抑制物：不依赖体内FVIII水平，无论患者是否携带FVIII抑制物均可使用。给药更便捷：支持皮下注射，避开了传统凝血因子静脉输注的频繁就诊负担。二、全球临床证据：FRONTIER项目撑起申报底座 Mim8的全球申报由FRONTIER1–5系列研究支撑，核心数据已在NEJM（FRONTIER2）、ISTH 2026（FRONTIER4中期分析）等国际权威场合读出，展现出卓越的疗效与安全性。 1. FRONTIER2（≥12岁，伴/不伴抑制物）出血直降：对比按需治疗及传统FVIII预防，Mim8显著降低年化出血率（ABR）。每月一次组较按需治疗出血减少近99%，每周一次组减少约96%。高比例零出血：64%–95%的受试者在主试验期内无治疗性出血。安全性良好：未见血栓栓塞事件，未出现中和性抗药抗体，注射部位反应占注射次数约2.6%。 2. FRONTIER3（儿童人群）在每周一次预防治疗下，74.3%的儿童患者未发生需治疗的出血事件。 3. FRONTIER4（长期扩展，ISTH 2026中期分析）该研究纳入426例≥1岁患者（365例成人/青少年，中位观察0.50年；61例儿童，中位观察0.33年），所有给药频次合并分析显示：极低ABR：成人/青少年ABR为0.75（95% CI 0.60–0.93）；儿童ABR为0.37（95% CI 0.17–0.76）。零出血率高：71%的成人/青少年、89%的儿童实现零治疗性出血。耐受性极佳：注射部位反应率极低（儿童2.0%、成人青少年1.8%），均为轻度一过性反应；无中和抗体临床证据。患者体验优：患者报告结局（PRO）显示，≥12岁患者关节疼痛改善，整体治疗负担下降；94.1%的使用者认为注射笔易用，89.7%认为准备/注射过程快捷。 4. FRONTIER5（从艾美赛珠单抗切换）证实从艾美赛珠单抗（emicizumab）直接换用Mim8无需洗脱期。凝血酶生成可升至正常参考范围但未过度激活，无血栓信号，为临床序贯治疗提供了可行方案。三、监管节奏：美国BLA在先，中国紧随 2025年9月：诺和诺德向美国FDA提交生物制品许可申请（BLA），目前在审理中。 2026年7月22日：中国CDE正式受理其上市申请（进口1类生物制品）。若顺利获批，迪纳西米单抗将成为国内继艾美赛珠单抗之后，又一款非因子、皮下注射、覆盖抑制物阳性的A型血友病双抗预防药。其支持每周、每两周甚至每月一次的灵活给药方案，将极大提升患者的生活质量与治疗依从性。免责声明：网上信息整理，若有涉及侵权请予以告知，我们会尽快在24小时内删除相关内容资源对接、沟通交流找项目、找供应商、找资源 1V1供需对接专员服务群聊: 资源共享群仅为公众号粉丝供需交流群添加公众号专员加入活动推荐找批文、找项目、找CRO/CMO、找场地欢迎会议现场深度对接交流~ 点击了解详情 ▼ 展位/招商合作：金女士15158066904（微信同号）【关于药融圈】【药融圈PRHub】流量渠道覆盖150万+垂直用户，已完成了百余场线下千人规模的生物医药研发类会议，涵盖创新药，改良型新药，仿制药，MAH，合成生物学等领域，以及生物医药上下游研发到产业端全覆盖的【中国制药工业博览会 CMC-CHINA】，服务了百余家上市/独角兽/生物技术/制药企业。【生态圈合作伙伴· CXO企业】善渊制药、美迪西、富祥药业、睿智医药、华仁医学、珠海亿胜、倍特药业、杭州澳亚、华阳制药、亚邦生缘、华威医药、汉康医药、国标医药、斯坦德生物医药、艾奇西医药、百奥信康、慧聚药业、瀚合瑞、汇宇制药、广东星昊、兄弟药业、普利制药、大连美创、深圳药欣、FLAMMA、中肽生化、昂博生物、湖北益泰、常熟神隆、上海玉函、星诺医药、天晟药业、皓元/药源、常州阳光、湖北澳格森、杭州肽佳、世纪迈劲、南京哈柏、宏昇药业、健元医药、木槿化学、维亚生物、蓬勃生物、嗣新、合肥国肽【生态圈合作伙伴· 制药装备&仪器】深圳华溶、ATS安拓思、齐蓁科技、赛默飞、安捷伦、艾本德、宣健仪器、德衡纳米、河北华胜、博奥思、莱顿科学、思勃分离、泰灵佳、相流科技、诺泽流体、康乐辉、上海汉尧、北京全式金【生态圈合作伙伴·综合服务企业】仅三生物、微纯生物、宝利包材、双峰格雷斯海姆、钱塘隆越、桐晖医药、壹生科、STD标准药物、嘉树医疗、青岛明月海藻、盛德伟业、诚利恩、泰矶林、青松医药、奥普迪诗、Gempex德恩咨询、星诚达、艾里奥斯【生态圈合作伙伴·创新合作伙伴企业】迈威生物、士泽生物、云顶新耀、英矽智能、拓领博泰、翰森、天境生物、凌科药业点分享点收藏点在看点点赞

临床结果申请上市临床1期

2026-07-22

·三弟药闻

2026年07月22日CDE承办生物制品

1. 迪纳西米单抗注射液(Denecimig/Mim8) 受理号:JXSS2600067、JXSS2600066、JXSS2600065、JXSS2600064 企业名称:Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co., Ltd. 治疗机制:全球首创FVIIIa模拟双特异性抗体，利用Genmab的DuoBody技术平台开发。通过皮下注射给药，桥接凝血因子IXa(FIXa)和凝血因子X(FX)，模拟FVIIIa功能恢复凝血酶生成，凝血活性约为艾美赛珠单抗的15倍。注册分类:治疗用生物制品，进口，1类(NDA申报) 适应症:伴或不伴FVIII抑制物的A型血友病成人和儿童患者的常规预防治疗(已在美国申报上市，此次在华NDA)。 2. Frexalimab注射液受理号:JXSB2600119 企业名称:Sanofi-Aventis Recherche & Développement; Sanofi-Aventis Deutschland GmbH 治疗机制:第二代抗CD40L全人源化IgG1单克隆抗体，通过Fc区工程化突变避免血小板聚集风险(解决第一代CD40L抗体的血栓问题)。阻断CD40/CD40L共刺激通路，同时调节适应性(T/B细胞)和先天性(巨噬细胞/小胶质细胞/树突状细胞)免疫，不引起淋巴细胞耗竭。II期OLE 2.5年数据：92%患者无复发，NfL下降至健康人水平。注册分类:治疗用生物制品，补充申请，1类适应症:复发型多发性硬化(RMS，III期FREXALT头对头特立氟胺)；非复发性继发进展型多发性硬化(nrSPMS，III期FREVIVA)；系统性红斑狼疮(II期)；1型糖尿病(II期)。 3. Pasritamig注射液受理号:JXSB2600118、JXSB2600117 企业名称:Janssen Research & Development, LLC; Cilag AG 治疗机制:全球首创first-in-class靶向KLK2(人激肽释放酶2)×CD3的双特异性T细胞衔接器(BiTE)，KLK2为前列腺特异性抗原，在前列腺外表达极低。静脉给药每6周一次，通过激活T细胞定向杀伤KLK2阳性前列腺癌细胞。I期RP2D组：PSA50应答率42.4%，中位rPFS 7.9个月，无ICANS，CRS仅发热(8.9%且仅G1)。注册分类:治疗用生物制品，补充申请，1类适应症:转移性去势抵抗性前列腺癌(mCRPC，III期KLK2-comPAS研究头对头安慰剂)；联合多西他赛一线mCRPC(III期KLK2-PASenger)。 4. 13价肺炎球菌多糖结合疫苗受理号:JTS2600125 企业名称:Pfizer Ireland Pharmaceuticals; Pfizer Europe MA EEIG; 辉瑞投资有限公司治疗机制:13种肺炎球菌血清型荚膜多糖分别与CRM197载体蛋白共价结合，诱导T细胞依赖性免疫应答产生型特异性抗体和免疫记忆。注册分类:生物制品(进口/补充申请) 适应症:预防13种肺炎球菌血清型所致的侵袭性疾病(菌血症、脑膜炎、肺炎等)和急性中耳炎，适用于6周龄至5岁婴幼儿和儿童。 5. GZC8072片受理号:CXSL2600761、CXSL2600760、CXSL2600759、CXSL2600758 企业名称:甘李药业山东有限公司治疗机制:未知(甘李药业1类创新口服生物制品片剂，公开资料中尚未披露具体靶点和作用机制)。注册分类:治疗用生物制品，新药，1类(IND申请) 适应症:未知 6. BCP601胰岛细胞注射液受理号:CXSL2600757 企业名称:贝康医学科技有限公司; 盛泰英诺(嘉兴)医疗科技有限公司治疗机制:多能干细胞(PSC)定向分化来源的胰岛细胞治疗产品，通过将体外分化获得的胰岛β细胞经动脉导管移植至胰腺组织，在体内替代受损胰岛细胞分泌胰岛素，实现对胰岛素依赖型重症糖尿病的机体功能重建。注册分类:治疗用生物制品，新药，1类(IND申请) 适应症:胰岛素依赖型重症糖尿病(尤其1型糖尿病和胰岛功能衰竭的2型糖尿病)，拟通过替代受损胰岛细胞实现功能性治愈。 7. JNJ-95597528注射液受理号:CXSL2600756 企业名称:强生(中国)投资有限公司(Janssen) 治疗机制:未知(强生1类生物制品新药，Janssen原研，2025年I期FIH启动，2026年1月进入IIb期特应性皮炎研究NCT07230860。机制未公开披露，AdisInsight分类为抗炎/抗哮喘/皮肤病治疗药物。Phase I也在哮喘中评估。注册分类:治疗用生物制品，新药，1类(IND申请) 适应症:中重度特应性皮炎(AD，IIb期)；哮喘(I期)；其他自身免疫性疾病。 8. 重组呼吸道合胞病毒疫苗(CHO细胞) 受理号:CXSL2600755 企业名称:北京绿竹生物技术股份有限公司; 绿竹生物制药(珠海市)有限公司治疗机制:基于CHO细胞表达系统的重组RSV疫苗，通过基因工程表达呼吸道合胞病毒关键保护性抗原(F蛋白融合前构象)，诱导产生高滴度RSV特异性中和抗体。注册分类:预防用生物制品，新药，1.4类适应症:预防呼吸道合胞病毒(RSV)感染所致下呼吸道疾病(婴幼儿、老年人等高危人群)。 9. 注射用重组人赛普辛希受理号:CXSL2600754 企业名称:常州长吉生物技术开发有限公司治疗机制:未知注册分类:治疗用生物制品，新药，1类(IND申请) 适应症:未知 10. 注射用重组人脑利钠肽受理号:CXSB2600168 企业名称:四川泸州步长生物制药有限公司治疗机制:重组人脑利钠肽(rhBNP)生物类似药，通过结合血管平滑肌和内皮细胞鸟苷酸环化酶耦联受体，升高细胞内cGMP水平，产生扩血管、利尿、利钠、抑制RAAS和交感神经系统作用，迅速降低心脏前后负荷。注册分类:治疗用生物制品，补充申请，3.4类(生物类似药) 适应症:急性失代偿性心力衰竭(ADHF)伴休息或轻微活动时呼吸困难的住院患者的静脉治疗。 11. CMS-X016注射液受理号:CXSL2600747 企业名称:深圳市康哲维盛医药发展有限责任公司(康哲药业眼科平台) 治疗机制:未知(康哲维盛专注于眼科创新药械，公开资料中尚未披露具体靶点和作用机制)。注册分类:治疗用生物制品，新药，1类(IND申请) 适应症:未知 [本日点评] 迪纳西米单抗注射液(denecimig/Mim8)——诺和诺德全球首创FVIIIa模拟双特异性抗体以4个受理号在华申报NDA。该药通过桥接FIXa和FX替代FVIIIa功能，凝血活性为艾美赛珠单抗(2024年全球销售额约50亿美元)的15倍。FRONTIER III期数据：每月一次皮下注射即实现年化出血率中位数为0、86-95%患者零出血，且支持从艾美赛珠直接转换。诺和诺德继司美格鲁肽后在血液罕见病领域的首次重大突破，若获批将成为A型血友病预防治疗的新标准。

2026-07-22

·医药地理

诺和诺德迪纳西米单抗注射液上市申请获得受理

7月22日，国家药监局药品审评中心（CDE）官网显示，诺和诺德“迪纳西米单抗注射液”上市申请已获受理。根据公开资料及临床试验进展推测，本次申报适应症为A型血友病。这也是诺和诺德首个在中国申报上市的双抗新药。迪纳西米单抗（Denecimig，研发代号Mim8）是一款凝血因子VIIIa模拟物双特异性抗体，通过皮下注射将凝血因子IXa和X桥接，模拟FVIIIa功能以恢复凝血酶生成。2025年9月，诺和诺德已向美国FDA递交该药上市申请，用于预防或减少伴/不伴抑制物的成人、青少年及儿童A型血友病患者的出血事件。迪纳西米单抗的疗效和安全性正通过全面的FRONTIER临床试验项目进行评估，目前已完成三项III期研究。其中，FRONTIER2研究显示，相较按需或既往预防治疗，迪纳西米单抗在降低出血事件上显著优效，64%–95%患者主试验期无治疗性出血；FRONTIER3中期分析显示，每周一次预防治疗的儿童中74.3%未发生需治疗出血；FRONTIER5则证实，从艾美赛珠单抗直接换用本品无需洗脱期，耐受性良好，凝血酶生成持续增加至正常范围且未达血栓风险水平。 END 获取更多创新药情报请关注【医药地理数据库】如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

100 项与迪纳西米单抗相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
血友病A	申请上市	欧盟	Novo Nordisk A/S	2025-09-01

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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


NCT04204408 (FRONTIER1, Pubmed \| Res Pract Thromb Haemost)	临床1/2期	血友病A	41	Mim8 maintenance doses	鹽襯糧夢鹽繭鑰衊憲願(醖繭遞糧淵製構鹽鹹壓) = 製窪壓顧膚繭鏇顧膚衊糧鏇積製淵齋膚糧糧網 (淵廠壓鹽襯醖艱憲簾衊 ) 更多	积极	2025-10-01
FRONTIER3 (GlobeNewswire) 人工标引	临床3期	血友病A	70	Mim8	顧築製膚襯蓋鬱製衊艱(鹹齋膚鬱積遞築窪範蓋) = 觸廠製製齋鹹蓋願鑰鏇憲齋鑰窪繭鏇艱遞齋齋 (製憲淵衊鏇廠襯構範鏇 ) 更多	积极	2025-02-07
NCT05685238 (FRONTIER4, ASH2024)	-	血友病A	37	Mim8	選遞遞簾鏇淵網淵夢網(構膚淵衊遞範艱鹹選鬱) = 憲簾壓鹽襯鑰齋遞積餘製膚遞觸願壓糧鏇遞獵 (廠鏇鹹鹹餘製蓋獵積鹹 )	积极	2024-12-09
NCT05053139 (Frontier 2, Corporate Publications) 人工标引	临床3期	血友病A	254	Mim8 once-weekly prophylaxis (no prior prophylaxis treatment)	淵遞鑰醖獵窪製鏇繭窪(夢膚築製顧選憲鹽膚糧) = 築製鬱糧鑰憲衊顧壓鏇製艱齋繭鑰獵構蓋製積 (顧鑰窪積遞鏇遞衊鏇夢 ) 更多	积极	2024-06-23
NCT05053139 (Frontier 2, Corporate Publications) 人工标引	临床3期	血友病A	254	Mim8 once-monthly prophylaxis (no prior prophylaxis treatment)	淵遞鑰醖獵窪製鏇繭窪(夢膚築製顧選憲鹽膚糧) = 範選淵鹽夢繭積獵糧廠製艱齋繭鑰獵構蓋製積 (顧鑰窪積遞鏇遞衊鏇夢 ) 更多	积极	2024-06-23
NCT05053139 (FRONTIER 2, GlobeNewswire) 人工标引	临床3期	血友病A	254	Mim8 once-weekly	鹹憲壓網範膚淵廠淵積(膚鏇繭壓窪衊簾艱蓋憲) = 糧觸鏇廠窪觸憲糧獵顧繭範淵鹽壓膚憲顧鏇餘 (蓋鹽淵衊鏇壓鑰築齋醖 ) 达到更多	积极	2024-05-13
NCT05053139 (FRONTIER 2, GlobeNewswire) 人工标引	临床3期	血友病A	254	Mim8 once-monthly	鹹憲壓網範膚淵廠淵積(膚鏇繭壓窪衊簾艱蓋憲) = 憲顧築夢廠壓襯獵膚構繭範淵鹽壓膚憲顧鏇餘 (蓋鹽淵衊鏇壓鑰築齋醖 ) 达到更多	积极	2024-05-13
EUCTR2019-000465-20-AT \| NCT04204408 (FRONTIER 1, ASH 12022 \| ASH 22022) 人工标引	临床1/2期	血友病A	42	Mim 8	窪願鹹衊製遞願鹽窪餘(願遞構鏇願夢構鹹膚艱) = 積築獵積鹹夢製膚選觸築襯觸鹽願遞網繭夢衊 (膚窪憲製遞鹽鹹膚憲築 ) 更多	积极	2022-11-15
EUCTR2019-000465-20-AT \| NCT04204408 (FRONTIER1, ISTH2022) 人工标引	临床1/2期	-	-	Mim 8 (SAD phase)	憲鬱衊齋繭積襯壓醖顧(醖餘獵鏇網簾膚顧觸簾) = Mim8 was well tolerated following both single and multiple dosing, and no thromboembolic events or related serious adverse events were reported 淵廠窪鹹網網窪餘獵製 (鹹顧醖膚廠願夢鏇糧獵 )	积极	2022-07-11
	临床1/2期	-	-	Mim 8 (MAD phase)		积极	2022-07-11
NCT04204408 (FRONTIER1, ISTH2022)	临床1/2期	血友病A	-	Mim8	膚觸淵蓋憲夢衊網積積(壓淵範鏇窪淵獵壓壓遞) = 鹹鑰鏇蓋顧淵襯廠獵鏇鏇壓衊網繭繭窪獵糧積 (獵糧繭遞製觸範積選積 ) 更多	-	2022-07-09