A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Nemolizumab in Patients with Acquired Reactive Perforating Collagenosis

开始日期2023-11-09

申办/合作机构-

JPRN-jRCT2031230174

/ Recruiting临床3期IIT

A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-Center Study to Evaluate the Efficacy and Safety of nemolizumab in Japanese Infant and Pediatric Atopic Dermatitis Patients with moderate to severe pruritus

开始日期2023-06-25

申办/合作机构-

NCT05405985

/ Completed临床1期

A Randomized, Single-Dose, Open-Label, Parallel-Group Study in Healthy Volunteers to Assess the Relative Bioavailability of a Subcutaneous Dose of Nemolizumab When Administered With Auto-Injector Compared to Dual-Chamber Syringe

This study was to compare the rate and extent of absorption of a single dose of nemolizumab administered with auto-injectors [AI] (test) versus dual-chamber syringes [DCS] (reference) under controlled conditions in healthy adult subjects.

开始日期2022-08-11

申办/合作机构

Galderma Holding SA

100 项与尼莫利珠单抗相关的临床结果

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100 项与尼莫利珠单抗相关的转化医学

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100 项与尼莫利珠单抗相关的专利（医药）

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141

项与尼莫利珠单抗相关的文献（医药）

2025-06-01·JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Diffusion dimensionality modeling of subcutaneous/intramuscular absorption of antibodies and long-acting injectables

Article

作者: Ramanathan, Murali ; Krzyzanski, Wojciech

To evaluate the role of diffusion process dimensionality in drug absorption following subcutaneous or intramuscular administration. The diffusion dimensionality model is based on analytical solutions of the 1-, 2- or 3-dimensional diffusion equations for a bolus input linked to a central compartment with first-order elimination. The model equations were reparameterized to contain three parameters for the time needed for the drug diffusion from the administration site, drug absorption into the central compartment, and the elimination rate constant. The diffusion dimensionality models were challenged with previously published subcutaneous absorption data for 13 antibody drugs and insulin lispro, and the long-acting injectable antipsychotic drugs: subcutaneous Perseris™, intramuscular Invega Sustenna®, Risperdal Consta®, and olanzapine. The Bayesian information criterion was used for model selection. The solution to the diffusion equation for a bolus dose administration is strongly dependent on the number of dimensions. The maximal concentration is lowest for the 3-dimensional diffusion equation. The pharmacokinetic profiles of all 13 antibodies were satisfactorily approximated by a diffusion dimensionality model. Three antibodies (CNTO5825, ACE910 and ustekinumab) were best described by the 2-dimensional diffusion equation. The 2- and 3-dimensional diffusion equations were equivalent for ABT981, guselkumab, adalimumab, nemolizumab, omalizumab, and secukinumab. Golimumab, DX2930, AMG139, and mepolizumab were best described by the 3-dimensional diffusion equation. All the long-acting antipsychotic dosage forms except Risperdal Consta were modeled satisfactorily. Diffusion dimensionality models are a parsimonious and effective approach for modeling drug absorption profiles of subcutaneously and intramuscularly administered small molecule and protein drugs and their dosage forms.

2025-05-01·The journal of allergy and clinical immunology. Global

Clinical factors predicting nemolizumab response in atopic dermatitis

Article

作者: Sawada, Yu ; Nakajima, Saeko ; Kabashima, Kenji ; Masuo, Yumi ; Yonekura, Satoru

Clinical predictors of response to nemolizumab, an anti-IL-31 receptor A antibody, were evaluated in patients with atopic dermatitis (AD). In a retrospective study of 14 Japanese patients, longer disease duration was significantly associated with poor response to treatment. While serum IgE levels and baseline Eczema Area Severity Index (EASI) scores alone were not predictive, their combination with disease duration improved discrimination between responders and nonresponders. Disease duration, serum IgE levels, and baseline EASI scores can be useful to predict nemolizumab efficacy in AD.

2025-05-01·Journal of Allergy and Clinical Immunology-In Practice

Deciding which patients with atopic dermatitis to prioritize for biologics and Janus kinase inhibitors

Article

作者: Paller, Amy S ; Sun, Dingyuan I ; Kamata, Masahiro

Atopic dermatitis (AD) is a common, chronic inflammatory skin disorder associated with reduced quality of life related to itch, sleep disturbance, risk of cutaneous infections, mental health issues, and high caregiver stress. Biologics and Janus kinase (JAK) inhibitors are transformative treatments for moderate-to-severe AD, providing options for patients unresponsive to conventional topical therapies. Dupilumab, tralokinumab, lebrikizumab, and nemolizumab are injectable biologics that offer durable control by targeting the underlying skewing to type 2 inflammation. Dupilumab, the first available biologic, is approved for patients as >6 months old and concurrently manages atopic comorbidities, particularly allergic asthma. In contrast, JAK inhibitors-upadacitinib, abrocitinib, and baricitinib-are oral therapies, offering rapid relief of inflammation and pruritus by inhibiting the JAK-STAT (signal transducer and activator of transcription) pathway, which is downstream of type 2 immune receptors. JAK inhibitors are approved for >12 years old in the USA, but in other geographic regions for those >2 years of age (baricitinib). This review highlights key considerations for selecting among these advanced therapies, including age, comorbidities, efficacy, and safety profiles. By integrating the latest evidence, this article provides a practical guide for clinicians to tailor treatment approaches and improve outcomes for individuals with AD.

106

项与尼莫利珠单抗相关的新闻（医药）

2025-05-29

·动脉网

再鼎医药高管领衔，纳米抗体Biotech融资9000万美元

从6000万美元的首轮融资到如今9000万美元的C轮融资，Attovia Therapeutics（以下简称Attovia）一直在打破自己的融资上限。作为一家临床阶段的生物治疗公司，Attovia专注于搭建免疫介导疾病和肿瘤学领域的生物治疗管线。在C轮融资中，Deep Track Capital、Vida Ventures、Sanofi Ventures等一众明星机构纷纷入局，押注Attovia的未来发展。目前，Attovia已经完成了3轮融资，累计融资2.55亿美元。更值得关注的是，短短两年时间，Attovia便实现了从获得技术授权到推进多个项目进入临床阶段的跨越。这样的发展速度，在竞争激烈的医药研发领域并不多见。这家年轻的Biotech公司究竟凭借什么，一次次吸引资本的目光？01再鼎医药团队领衔，通过授权获得纳米抗体平台1989年，比利时科学家在骆驼的血液中发现一种特殊的单域抗体片段，它由天然缺失轻链的重链抗体（HcAb）衍生而来，仅含重链抗体的可变区（VHH），分子质量约15kDa，仅为传统抗体的1/10，是目前已知可结合抗原的最小单位，因而被命名为纳米抗体。其三维结构紧凑，CDR3区域长且柔韧，可深入抗原裂隙，实现高亲和力与特异性结合。随着生物技术的发展，纳米抗体的优势愈发凸显，成为医药研发热点。它体积小，在动物体内和组织中穿透力强，甚至能穿透血脑屏障抵达肿瘤内部；抗原结合能力广泛，便于通过基因改造针对不同病原；仅含一个结构域，稳定性更高，在体内留存时间长，对温度、pH等环境变化适应性强，药效持久。因此，作为更具优势的新型抗体药物形式，纳米抗体的潜力备受关注。目前，纳米抗体行业的研发与商业化整体处于早期状态。自2018年全球首个纳米抗体Caplacizumab在欧盟获批上市，纳米抗体正在探索应用于治疗从病毒感染到癌症等多种疾病，为创新药研发企业的发展布局不断蓄能。在此契机下，Alamar Biosciences和Frazier Life Sciences联合成立Attovia，通过全球独家授权的方式获得了纳米抗体ATTOBODY技术平台的知识产权。Attovia正基于该平台专注开发免疫介导疾病与肿瘤的管线。Attovia管理团队与中国药企颇有渊源，实力雄厚。首席执行官傅涛、首席科学官Petter Veiby、早期发现和转化医学部门副总裁David Bellovin均来自创新型生物制药公司再鼎医药。团队长期深耕生物研发领域，曾深度参与再鼎医药关于肿瘤、自免及神经系统疾病等多个领域创新药物的全球研发与商业化进程，具备丰富的行业经验与专业技术积累。自2023年成立，Attovia就锚定免疫介导疾病和肿瘤领域，首轮6000万美元融资用于ATTOBODY平台技术优化与早期项目规划。2024年，1.05亿美元B轮融资推动重点管线ATTO-1310和ATTO-002进入临床筹备阶段，同时公司扩充研发团队。2025年，9000万美元C轮融资助力下，ATTO-1310进入临床Ⅰ期，ATTO-3712也计划于下半年启动Ⅰ期临床研究。02双表位结合模式赋能，专有纳米抗体的五大优势Attovia的核心技术是ATTOBODY平台，利用纳米抗体相对分子质量小、稳定性高、组织穿透性好、易于基因工程改造等特性，将两个针对同一抗原不同表位的纳米抗体进行连接，形成双表位的结构。其设计是通过专有空间定位技术连接两个结合臂，形成独特的分子结构。这种技术的核心目标是通过优化两个结合臂的空间排列，使其以最佳构象与抗原、受体等目标分子结合，从而增强药物的靶向性和生物活性。具体来看，ATTOBODY的结合臂采用VHH结构域，通过专有连接技术将两个VHH纳米抗体按特定方向排列，实现对目标分子上两个不同表位的同时结合，形成双表位结合模式。这一设计使其可针对难成药靶点，具有可调节的半衰期：ATTOBODY技术概述来自：Attovia官网超高亲和力：传统抗体往往是单表位结合，亲和力相对较弱。ATTOBODY利用双表位结合模式，产生picomole（pmol）级别的亲和力，极大地增强了与靶点结合的紧密程度，且解离速率慢，能长时间与靶点结合，增强药物疗效。精准特异性：通过与目标分子上的两个表位相互作用，能精准识别目标，可区分传统方法难以区分的相似分子，如G蛋白偶联受体、离子通道或肿瘤特异性变体等，减少对非目标组织的影响，提高治疗的精准性和安全性。高效内化：相较于传统抗体或纳米抗体，其双表位结合模式可促进目标分子更高效地被细胞内化，使它成为抗体偶联药物（ADC）或放射核素偶联药物（RDC）的理想递送选择，能更有效地将治疗物质递送至细胞内部，发挥更强的治疗作用。快速组织渗透：分子体积小，单个纳米抗体约15kDa，双表位纳米抗体约30kDa，比传统抗体（150kDa）更小，可快速穿透组织，在疾病部位迅速发挥作用，实现更快、更深入的治疗效果，尤其适用于治疗一些需要药物快速到达病变部位的疾病，如炎症性皮肤病等。模块化结构：ATTOBODY具有模块化结构优势，可通过灵活组合不同模块构建多特异性生物制品。例如，通过多种形式组合，该结构能够实现对多个不同靶点或同一靶点不同区域的同时靶向，达成更精准、高效的治疗效果。此外，通过与不同半衰期延长片段融合，可将药物的给药间隔延长至两到三个月，显著减少患者给药次数，提高用药依从性。基于此，ATTOBODY平台通过双表位结合模式，显著加速药物开发过程，不仅能提供丰富多样的候选药物，扩大可靶向的疾病范围，还能降低研发风险，助力推出具有领先潜力的治疗药物。03双核心管线即将进入临床阶段，瞄准“明星靶点”IL-31目前，依托ATTOBODY技术平台，Attovia已成功开发5条管线，部分项目已进入临床阶段。其中，IL-31是公司研发的核心靶点。Attovia围绕该靶点布局了ATTO-1310和ATTO-3712两条重点管线，这两款产品均有望成为治疗各种免疫介导疾病的潜在BIC（best-in-class）药物。其主打在研产品ATTO-1310为一款长半衰期抗IL-31单抗，主要用于治疗慢性瘙痒。在慢性瘙痒患者体内，IL-31往往处于异常高表达状态，持续刺激神经末梢产生瘙痒感。该药物的作用机制正在于精准靶向IL-31细胞因子，通过与IL-31特异性结合，阻断IL-31与其受体的相互作用，进而抑制下游瘙痒相关信号通路的激活。目前Attovia已宣布首位患者在ATTO-1310治疗慢性瘙痒的人体首次临床Ⅰ期试验中完成给药。另一款在研产品ATTO-3712是长半衰期IL-13/IL-31双抗，它同时作用于IL-13和IL-31两个关键细胞因子。在特应性皮炎和慢性自发性荨麻疹等疾病中，IL-13和IL-31都参与了炎症反应和免疫失衡的过程。IL-13可促进炎症细胞浸润、诱导上皮细胞产生炎症介质，IL-31则与瘙痒症状密切相关。ATTO-3712通过同时阻断这两个细胞因子的信号传导，更全面地调节免疫反应，减轻炎症、缓解瘙痒症状。目前该药物处于IND申请阶段，计划于2025年下半年开展Ⅰ期临床研究。Attovia现有管线布局来自：Attovia官网值得关注的是，IL-31靶点竞争日趋激烈。其中，由Galderma研发的Nemluvio（nemolizumab-ilto，奈莫利珠单抗）已获批上市，为第1款获批用以抑制IL-31信号的单抗。Nemluvio在美获批适应症包括成人结节性痒疹、中重度特应性皮炎等。除此之外，多款靶向药物正处于研发阶段：强生的双特异性抗体NM26靶向IL-31和IL-4Rα，即将进入临床II期；再鼎医药的IL-13/IL-31双抗ZL-1503同时靶向炎症和致痒信号通路，预计于2025年递交IND申请。04国内纳米抗体形成初步产业链纳米抗体市场已成为生命科学相关领域的主要市场之一。从市场规模来看，根据贝哲斯咨询数据，2024—2029年全球纳米抗体的市场将以24.2%的复合年均增长率高速增长，预计到2029年规模将增至12.3亿美元。这一蓬勃发展的市场态势，也为Attovia这类专注于纳米抗体技术的企业提供了广阔的发展空间。全球纳米抗体市场规模数据来源：贝哲斯咨询由于纳米技术的不断进步，全球纳米抗体市场行业的需求正在激增。在诊断领域，纳米抗体被广泛应用于免疫测定、生物传感器及分子成像技术，可精准识别肿瘤特异性抗原或感染性疾病标志物，实现癌症、艾滋病等复杂疾病的早期精准诊断；在治疗领域，纳米抗体有效穿透组织和细胞的能力使它们成为将治疗有效载荷直接输送到患病部位、最大限度地减少全身副作用并提高治疗效果的理想选择。据美国市场研究机构Wise Guy Reports数据，2024年，全球纳米抗体市场在区域市场北美、欧洲、亚太地区、南美、中东和非洲的收入预计为22亿美元，预计到2032年将达到92亿美元，复合年增长率为19.58%。海外市场方面，赛诺菲旗下原Ablynx公司，作为纳米抗体先驱，2018年推出全球首款纳米抗体药物Caplacizumab，用于治疗获得性血小板减少紫癜，此后基于其NANOBODY技术平台，多款纳米抗体药物处于临床Ⅰ期。LAVA Therapeutics则专注γ-δT细胞募集双抗开发，其Gammabody平台独具特色，基于此研发的靶向EGFR实体瘤的LAVA-1223虽处临床前，但已吸引Seagen达成合作授权。国内纳米抗体领域同样发展迅猛。康宁杰瑞、信达生物、博生吉、友芝友、爱思迈生物、普米斯、科望医药、普瑞金、晶准生物、洛启生物、班科生物等企业积极投身纳米抗体药物研发；金斯瑞生物、义翘神州、泰克生物、卡梅德生物、百英生物、南京传奇生物、耀海生物等企业则更多聚焦于纳米抗体的研发服务、生产工艺开发或试剂供应。像康宁杰瑞自主研发的恩沃利单抗（商品名：恩维达），是一种由纳米抗体和Fc段组成的单特异性抗体，为全球首个获批上市的皮下注射PD-(L)1抗体。根据康宁杰瑞财报，2023年—2024年，恩沃利单抗分别给康宁杰瑞带来1.96亿、1.59亿人民币的收入，彰显出纳米抗体药物的市场潜力。总体而言，国内纳米抗体产业已形成从研发到应用的初步产业链，作为一股抗生领域的新生力量，纳米抗体无论从成本还是本身的开发价值上都值得期待。如果您想对接文章中提到的项目，或您的项目想被动脉网报道，或者发布融资新闻，请与我们联系；也可加入动脉网行业社群，结交更多志同道合的好友。近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。文中如果涉及企业信息和数据，均由受访者向分析师提供并确认。动脉网，未来医疗服务平台

上市批准临床研究

2025-05-15

·PRNewswire

Cushing's Disease Market Poised for Significant Growth Across the 7MM During the Study Period (2020-2034) with Rising Awareness and Diagnostic Improvements | DelveInsight

The Cushing's disease pipeline possesses some drugs in mid and late-stage development to be approved in the near future. The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including relacorilant, clofutriben, atumelnant, and others. The expected launch of these therapies shall further create a positive impact on the Cushing's disease market. LAS VEGAS, May 15, 2025 /PRNewswire/ -- DelveInsight's Cushing's Disease Market Insights report includes a comprehensive understanding of current treatment practices, Cushing's disease emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Cushing's Disease Market Report According to DelveInsight's analysis, the market size for Cushing's disease was found to be USD 1 billion in the 7MM in 2024. In 2024, among all the current therapies for Cushing's disease, the highest revenue was generated by Mifepristone (KORLYM and generics) in the US. Based on DelveInsight's assessment in 2024, the 7MM had approximately 37K diagnosed prevalent cases of Cushing's disease. These cases are expected to rise due to advancements in diagnostic capabilities and increased awareness about the disease during the forecast period (2025–2034). Leading Cushing's disease companies developing emerging therapies, such as Corcept Therapeutics, Sparrow Pharmaceuticals, Crinetics Pharmaceuticals, H. Lundbeck, Stero Therapeutics, and others, are developing novel Cushing's disease drugs that can be available in the Cushing's disease market in the coming years. The promising Cushing's disease therapies in the pipeline include DUPIXENT (dupilumab), Linerixibat (GSK2330672), NEMLUVIO/MITCHGA (nemolizumab), Volixibat, and others. In March 2025, Corcept Therapeutics announced that the FDA had assigned a PDUFA target action date of December 30, 2025, for relacorilant to treat patients with endogenous hypercortisolism. In February 2025, Crinetics Pharmaceuticals mentioned that the company anticipates beginning enrollment for Atumelnant (CRN04894) in Phase Ib/IIa trials for Cushing's disease in late 2025 or early 2026. In October 2024, Sparrow Pharmaceuticals announced that clofutriben had been granted Orphan Drug Designation (ODD) by the US FDA for the treatment of endogenous Cushing's syndrome. Discover which therapies are expected to grab the major Cushing's disease market share @ Cushing's Disease Market Report Cushing's Disease Overview Cushing's disease is a rare but serious endocrine disorder caused by a pituitary tumor that triggers excessive cortisol production. It presents with a variety of symptoms such as weight gain, fatigue, mood disturbances, high blood pressure, and impaired glucose tolerance. Cushing's syndrome is responsible for 80–85% of hypercortisolism cases, with 75–80% of those linked to ACTH-producing pituitary adenomas. Without treatment, the 5-year survival rate is only about 50%, emphasizing the urgent need for effective therapies. Diagnosing Cushing's disease is especially difficult because it is rare, shares symptoms with other disorders, and presents in various ways. Only 40–60% of patients have a detectable tumor on standard Magnetic Resonance Imaging (MRI), and the diagnosis is often delayed by an average of 7 years. Cushing's Disease Epidemiology Segmentation The Cushing's disease epidemiology section provides insights into the historical and current Cushing's disease patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The Cushing's disease market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Prevalent Cases of Cushing's Disease Total Diagnosed Prevalent Cases of Cushing's Disease Gender-Specific Diagnosed Prevalent Cases of Cushing's Disease Age-Specific Diagnosed Prevalent Cases of Cushing's Disease Cushing's Disease Treatment Market The primary treatment for Cushing's disease is usually transsphenoidal surgery to remove the pituitary tumor, which often leads to remission. However, some patients may experience a recurrence. When surgery is unsuccessful or not an option, medical therapies are used to control cortisol levels. Various medications are available for managing Cushing's disease, especially in cases where surgery is ineffective or not feasible. One such drug is KORLYM, developed by Corcept Therapeutics, approved for treating hyperglycemia in patients with Cushing's syndrome who also have Type 2 diabetes or glucose intolerance. In 2024, a generic version by Teva Pharmaceuticals entered the market, adding competition, and Corcept itself has released a generic version as well. Other approved options include S IGNIFOR and SIGNIFOR LAR, ISTURISA, and RECORLEV. In addition, off-label drugs like ketoconazole, metyrapone, cabergoline, mitotane, and etomidate are also used in the U.S., with some marketed in Europe by HRA Pharma. SIGNIFOR (pasireotide), developed by Recordati, was the first drug specifically approved for Cushing's disease by the FDA in 2012, and also gained EU approval. Recordati also markets SIGNIFOR LAR, a long-acting injectable version approved by the FDA and Japan's PMDA in 2018. This formulation, administered intramuscularly once every four weeks, shares the same mechanism as SIGNIFOR but offers a different delivery route. Recordati is recognized as a leading player in this therapeutic area. Another key product from the company is ISTURISA (osilodrostat), the first FDA-approved oral drug that inhibits cortisol production by targeting the enzyme 11β-hydroxylase (CYP11B1), which is involved in the final step of cortisol synthesis. Its oral administration makes it more convenient for patients compared to injectable therapies. ISTURISA is also being studied for pediatric use in an ongoing Phase II trial (NCT03708900). RECORLEV, originally developed by Strongbridge Biopharma and later acquired by Xeris Pharmaceuticals, was approved by the FDA in 2021. It is indicated for adults with endogenous Cushing's syndrome who are not surgical candidates or did not achieve a cure through surgery. Unlike ISTURISA, RECORLEV works by inhibiting cortisol production at multiple points in the steroidogenesis pathway, offering a distinct mechanism of action. To know more about Cushing's disease treatment guidelines, visit @ Cushing's Disease Management Cushing's Disease Pipeline Therapies and Key Companies Relacorilant (CORT125134): Corcept Therapeutics Clofutriben (SPI-62): Sparrow Pharmaceuticals Atumelnant (CRN04894): Crinetics Pharmaceuticals Lu AG13909: H. Lundbeck ST-002: Stero Therapeutics Discover more about Cushing's disease drugs in development @ Cushing's Disease Clinical Trials Cushing's Disease Market Dynamics The Cushing's disease market dynamics are expected to change in the coming years. Although Cushing's disease is generally considered a rare condition, growing awareness and recent advances in research suggest that diagnoses may rise in the future; despite a seemingly crowded market, many current hypercortisolism treatments fail to normalize cortisol levels effectively and pose significant side effects highlighting a substantial opportunity for innovation, especially given the limited therapies specifically targeting Cushing's disease and the potential of newer oral alternatives like ISTURISA and RECORLEV to offer greater flexibility compared to SC and intramuscular options such as SIGNIFOR and SIGNIFOR LAR. Furthermore, potential therapies are being investigated for the treatment of Cushing's disease, and it is safe to predict that the treatment space will significantly impact the Cushing's disease market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the Cushing's disease market in the 7MM. However, several factors may impede the growth of the Cushing's disease market. Due to non-specific guidelines and recommendations, patients with Cushing's disease often face suboptimal care, delayed diagnosis, and inconsistent treatment approaches, further compounded by the diagnostic complexity, frequent misdiagnosis, and symptom overlap with more common conditions, which leave many undiagnosed or untreated; while existing therapies such as ketoconazole and metyrapone approved in Europe based on limited retrospective data and used off-label in the US despite high costs are widely trusted and entrenched in clinical practice, posing a significant barrier to the adoption of emerging therapies. Moreover, Cushing's disease treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the Cushing's disease market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the Cushing's disease market growth. Scope of the Cushing's Disease Market Report Therapeutic Assessment: Cushing's Disease current marketed and emerging therapies Cushing's Disease Market Dynamics: Key Market Forecast Assumptions of Emerging Cushing's Disease Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Cushing's Disease Market Access and Reimbursement Download the report to understand which factors are driving Cushing's disease market trends @ Cushing's Disease Market Trends Table of Contents Related Reports Cushing's Syndrome Market Cushing's Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 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 Cushing's syndrome companies including Corcept Therapeutics, Crinetics Pharmaceuticals, Cyclacel Pharmaceuticals, Sparrow Pharmaceuticals, Stero Therapeutics, among others. Cushing's Syndrome Pipeline Cushing's Syndrome Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Cushing's syndrome companies, including Corcept Therapeutics, Crinetics Pharmaceuticals, Cyclacel Pharmaceuticals, Sparrow Pharmaceuticals, Stero Therapeutics, among others. Endogenous Cushing's Syndrome Market Endogenous Cushing's Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 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 endogenous Cushing's syndrome companies including Corcept Therapeutics, Crinetics Pharmaceuticals, Sparrow Pharmaceuticals, among others. Endogenous Cushing's Syndrome Pipeline Endogenous Cushing's Syndrome Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key endogenous Cushing's syndrome companies, including Corcept Therapeutics, Crinetics Pharmaceuticals, Sparrow Pharmaceuticals, among others. 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 . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准孤儿药临床2期

2025-04-17

·生物制药小编

多名再鼎前高管创立，公司再融资9000万美元

近日（2025年4月15日），再鼎前高管创立的公司Attovia Therapeutics宣布完成9000万美元的C轮融资，该轮融资由Deep Track Capital领投。这是Attovia成立以来完成的第三轮融资，算上该轮融资，公司累计融资2.55亿美元（2023年6月6000万美元的A轮融资，2024年5月的1.05亿美元超额认购B轮融资）。在当前的融资环境下，作为一家2023年才成立的初创Biotech公司，Attovia能持续获得现有投资者的支持实属不易，该轮融资中有不少Frazier Life Sciences、Goldman Sachs Alternatives、Illumina Ventures等现有投资者的身影。此次融资筹集所得资金将用于进行ATTOBODY™平台的临床概念验证。多名再鼎前高管Attovia成立于2023年6月，是一家专注于免疫介导疾病开发的Biotech公司。作为一家初创公司，Attovia的创始团队有多名再鼎前高管的身影。公司的首席执行官Tao Fu此前曾担任再鼎的首席运营官&首席战略官，此外，公司能够持续性获得Frazier Life Sciences的投资也与Tao Fu有着密不可分的关系。Tao Fu于2022年曾担任Frazier Life Sciences的风险合伙人，在刚成立的时，Frazier Life Sciences就领投了Attovia 3000万美元的A1轮融资，在其后续公司的B轮、C轮融资也都有其身影。首席科学官（CSO ）Petter Veiby曾担任再鼎BD总监。公早期发现和转化医学部门副总裁David Bellovin此前曾负责再鼎肿瘤免疫学项目。重点布局IL-31目前Attovia已经开发了5条条管线，最快的进入临床Ⅰ期阶段。公司的核心技术平台为来自Alamar开发的一种双表位纳米抗体技术Attobody™，据公司介绍，Attobody™是一种双表位纳米抗体技术，可以生成具有超高亲和力、强内化能力以及快速组织穿透能力的双特异性纳米抗体。从管线布局来看，IL-31是公司研发的战略重点，目前公司围绕该靶点布局了两条管线—ATTO-1310和ATTO-3712。ATTO-1310和ATTO-3712分别是一款长半衰期抗IL-31单抗和长半衰期IL-13/IL-31双抗。目前ATTO-1310已经推进到临床Ⅰ期阶段，被开发用于治疗慢性瘙痒。ATTO-3712则是一款长半衰期IL-13/IL-31双抗，被开发用于治疗特应性皮炎、慢性自发性荨麻疹，目前还在IND Enable阶段，公司计划在今年下半年进行Ⅰ期临床研究。IL-31目前已经有一款上市产品—Nemluvio (nemolizumab)，也有多款IL-31靶向药在研，值得一提的是，再鼎医药也有一款IL-13/IL-31双抗ZL-1503，其预计2025年递交IND。参考出处：https://www.globenewswire.com/news-release/2025/04/15/3061599/0/en/Attovia-Therapeutics-Announces-90-Million-Series-C-Financing-to-Advance-ATTOBODY-based-Programs-through-Clinical-Proof-of-Concept.html

临床1期

100 项与尼莫利珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11080	尼莫利珠单抗	-	DB15252

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
中度特应性皮炎	美国	Galderma Laboratories LP	2024-12-13
重度特应性皮炎	美国	Galderma Laboratories LP	2024-12-13
结节性痒疹	日本	Maruho Co., Ltd.	2024-03-26
特应性皮炎	日本	Maruho Co., Ltd.	2022-03-28

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
瘙痒	临床3期	美国	Galderma Holding SA	2021-12-29
瘙痒	临床3期	匈牙利	Galderma Holding SA	2021-12-29
瘙痒	临床3期	波兰	Galderma Holding SA	2021-12-29
瘙痒	临床3期	西班牙	Galderma Holding SA	2021-12-29
系统性硬皮病	临床2期	日本	Maruho Co., Ltd.	2022-04-20

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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


NCT05075408 (NIKAIA 1, CTgov)	临床2/3期	瘙痒	258	Nemolizumab (Nemolizumab 30 mg)	鹽築獵網廠鑰簾鏇艱範 = 積鹽顧願淵顧觸顧選夢鏇鬱齋醖淵獵觸獵廠網 (憲淵繭鑰觸鑰壓繭餘壓, 繭艱鏇壓衊憲鏇餘窪艱 ~ 餘壓襯餘鬱餘襯襯鬱糧) 更多	-	2025-02-20
				Nemolizumab (Nemolizumab 60 mg)	鹽築獵網廠鑰簾鏇艱範 = 衊窪醖選醖醖壓壓夢窪鏇鬱齋醖淵獵觸獵廠網 (憲淵繭鑰觸鑰壓繭餘壓, 蓋膚夢鑰餘繭網網網餘 ~ 膚築膚簾鹽窪蓋膚壓製) 更多
NCT04562116 (CTgov)	临床2期	中度特应性皮炎 \| 重度特应性皮炎	17	CYP 450 Substrates+Nemolizumab	製鹹願衊艱蓋醖衊憲鬱 = 顧鹹壓繭蓋鏇選淵顧願廠簾願獵積廠獵蓋網衊 (顧鏇繭夢鏇簾夢齋築獵, 願夢構襯繭醖鹽積積網 ~ 襯網簾鹽構範顧夢糧簾) 更多	-	2024-12-05
NCT04501666 (OLYMPIA 1, Pubmed \| JAMA Dermatol)	临床3期	结节性痒疹	286	Nemolizumab 30 mg	鏇選膚鹽衊觸網製繭艱(遞淵襯蓋簾獵鏇遞顧夢) = 選襯齋製積窪鏇鬱憲獵觸餘衊壓鹹願廠衊築鬱 (膚簾鹽鹽淵觸憲遞艱製, 6.7% ~ 22.6%) 更多	积极	2024-11-27
				Placebo	鏇選膚鹽衊觸網製繭艱(遞淵襯蓋簾獵鏇遞顧夢) = 蓋壓蓋膚觸淵鑰襯淵窪觸餘衊壓鹹願廠衊築鬱 (膚簾鹽鹽淵觸憲遞艱製 ) 更多
NCT05052983 (CTgov)	临床3期	结节性痒疹	34	Nemolizumab (Nemolizumab)	餘餘製顧繭憲鑰衊鏇鑰(膚艱簾網遞壓鏇鏇鬱獵) = 窪鏇膚膚鹽蓋簾鏇衊遞築膚獵繭膚艱築製糧醖 (顧網醖鹽網餘餘觸襯淵, 齋構簾憲夢鬱積鏇廠觸 ~ 鏇憲衊襯選鬱構衊構夢) 更多	-	2024-10-08
				Placebo (Placebo)	餘餘製顧繭憲鑰衊鏇鑰(膚艱簾網遞壓鏇鏇鬱獵) = 廠遞淵範齋網願簾鏇鹽築膚獵繭膚艱築製糧醖 (顧網醖鹽網餘餘觸襯淵, 膚憲網壓選糧鏇窪鏇製 ~ 選鑰積獵膚衊膚齋憲顧) 更多
NCT03985943 (ARCADIA 1 \| ARCADIA, CTgov)	临床3期	中度特应性皮炎 \| 重度特应性皮炎	941	Placebo (Initial Treatment Period (Baseline - Week 16 Predose): Placebo)	繭鑰衊膚積簾襯範願積 = 網範膚鏇夢簾鹹積鹽蓋遞築襯簾鹽鹽選構築憲 (積鬱構鬱願壓選構築廠, 鏇積衊築廠蓋範簾獵壓 ~ 糧製構齋獵衊網廠積壓) 更多	-	2024-08-14
				Nemolizumab (Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg)	繭鑰衊膚積簾襯範願積 = 範齋蓋蓋觸淵衊廠繭艱遞築襯簾鹽鹽選構築憲 (積鬱構鬱願壓選構築廠, 築築蓋觸網壓構蓋積願 ~ 餘網鹽選製製鬱衊鏇範) 更多
NCT03989349 (ARCADIA 2, CTgov)	临床3期	中度特应性皮炎 \| 重度特应性皮炎	787	Nemolizumab (Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg)	鏇夢餘鏇醖膚築構淵窪 = 憲蓋簾艱構積齋觸願餘窪範襯鏇鬱衊網鬱夢願 (膚廠廠選鬱遞觸襯鹹夢, 鏇齋獵鏇憲壓衊廠鏇製 ~ 醖襯壓夢獵鏇遞齋淵選) 更多	-	2024-08-14
				Placebo (Initial Treatment Period (Baseline - Week 16 Predose): Placebo)	鏇夢餘鏇醖膚築構淵窪 = 築選餘夢鑰網築網壓獵窪範襯鏇鬱衊網鬱夢願 (膚廠廠選鬱遞觸襯鹹夢, 築夢築積範鹽選構壓鬱 ~ 簾鏇餘鏇夢鑰衊顧鏇鏇) 更多
NCT04501679 \| NCT04501666 (OLYMPIA 2, FDA_CDER) 人工标引	临床3期	结节性痒疹	560	NEMLUVIO (OLYMPIA 1)	廠壓鑰醖餘壓遞餘製夢(範醖簾鬱網壓繭憲網窪) = 選艱廠夢蓋壓顧繭繭夢繭蓋糧鏇夢餘網願願鹽 (襯顧襯簾糧繭積選遞積 ) 更多	积极	2024-08-12
				Placebo (OLYMPIA 1)	廠壓鑰醖餘壓遞餘製夢(範醖簾鬱網壓繭憲網窪) = 廠觸構顧願糧構積鏇襯繭蓋糧鏇夢餘網願願鹽 (襯顧襯簾糧繭積選遞積 ) 更多
NCT03985943 \| NCT03989349 (ARCADIA 2, Lancet 1 \| Lancet 2 \| Pubmed) 人工标引	临床3期	特应性皮炎	1,728	Nemolizumab 30 mg	觸獵衊廠蓋鑰憲願壓鏇(窪夢艱網壓範夢遞膚壓) = 艱鏇糧範願窪糧繭鬱醖齋餘築膚醖範築積夢襯 (膚鏇壓築觸鬱範醖繭膚 ) 更多	积极	2024-07-24
				Placebo	觸獵衊廠蓋鑰憲願壓鏇(窪夢艱網壓範夢遞膚壓) = 構壓蓋製淵艱餘襯範淵齋餘築膚醖範築積夢襯 (膚鏇壓築觸鬱範醖繭膚 ) 更多
NCT04501679 (OLYMPIA 2 \| Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis, CTgov)	临床3期	结节性痒疹	274	Nemolizumab (Nemolizumab)	網鬱糧觸顧窪膚膚糧鹽 = 簾積鬱顧鹹齋簾鏇範選糧鏇襯艱鏇網餘遞簾範 (獵獵衊襯餘膚願窪襯窪, 醖鑰餘觸鹹糧醖膚繭艱 ~ 夢襯鑰鏇構獵鹹鹹壓襯) 更多	-	2024-07-10
				Placebo (Placebo)	網鬱糧觸顧窪膚膚糧鹽 = 繭膚願製壓餘顧衊鹹鹽糧鏇襯艱鏇網餘遞簾範 (獵獵衊襯餘膚願窪襯窪, 糧鑰獵餘衊顧窪獵膚鬱 ~ 壓範網淵壓齋艱製壓蓋) 更多