A randomized, double-blind, placebo-controlled, parallel-group, multicenter, phase 3 trial to evaluate the efficacy and safety of tralokinumab in combination with topical corticosteroids in children (age 2 to <12 years) and infants (age 6 months to <2 years) with moderate-to-severe atopic dermatitis. - LP0162-1336

开始日期2024-11-20

申办/合作机构

LEO Pharma A/S

CTIS2022-502653-34-01 / Recruiting

A phase 3b, interventional, adaptive, clinical trial to evaluate the efficacy and safety of tralokinumab 300 mg every second week monotherapy compared with placebo in subjects with moderate-to-severe atopic hand eczema who are candidates for systemic therapy (ADHAND) - LP0162-2328

开始日期2024-06-10

申办/合作机构

LEO Pharma A/S

CTR20232104 / Active, not recruiting临床3期

一项在中重度慢性手部湿疹中国成人和青少年（12至17岁）患者中评价Delgocitinib乳膏20 mg/g每日两次用药的有效性、安全性和药代动力学的III期试验

主要目的：评价每日两次涂抹Delgocitinib 乳膏 20 mg/g 与乳膏赋形剂相比治疗中重度CHE 受试者的有效性。次要目的：评价每日两次涂抹Delgocitinib 乳膏 20 mg/g 与乳膏赋形剂相比治疗中重度CHE 受试者的有效性及其健康相关生活质量。评价每日两次涂抹Delgocitinib 乳膏 20 mg/g 与乳膏赋形剂相比治疗中重度CHE 受试者的安全性。评价按需接受 Delgocitinib 乳膏 20 mg/g 每日两次用药治疗中重度 CHE 受试者的长期安全性。评价每日两次涂抹Delgocitinib 乳膏 20 mg/g 治疗中重度 CHE 成人受试者的PK。

开始日期2023-09-05

申办/合作机构

LEO Laboratories Ltd.

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100 项与 LEO Pharma A/S 相关的临床结果

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0 项与 LEO Pharma A/S 相关的专利（医药）

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266

项与 LEO Pharma A/S 相关的文献（医药）

2024-11-01·Biochimie

Matrix metalloproteinase landscape in the imiquimod-induced skin inflammation mouse model

Article

作者: Malmsten, Martin ; Koch, Janne ; Lind, Marianne ; Auf dem Keller, Ulrich ; Heinz, Andrea ; Canbay, Vahap ; Jensen, Louise Bastholm ; Petersson, Karsten ; Savickas, Simonas ; Noddeland, Heidi Kyung

Inflammation and autoimmunity are known as central processes in many skin diseases, including psoriasis. It is therefore important to develop pre-clinical models that describe disease-related aspects to enable testing of pharmaceutical drug candidates and formulations. A widely accepted pre-clinical model of psoriasis is the imiquimod (IMQ)-induced skin inflammation mouse model, where topically applied IMQ provokes local skin inflammation. In this study, we investigated the abundance of a subset of matrix metalloproteinases (MMPs) in skin from mice with IMQ-induced skin inflammation and skin from naïve mice using targeted proteomics. Our findings reveal a significant increase in the abundance of MMP-2, MMP-7, MMP-8, and MMP-13 after treatment with IMQ compared to the control skin, while MMP-3, MMP-9, and MMP-10 were exclusively detected in the IMQ-treated skin. The increased abundance and broader representation of MMPs in the IMQ-treated skin provide valuable insight into the pathophysiology of skin inflammation in the IMQ model, adding to previous studies on cytokine levels using conventional immunochemical methods. Specifically, the changes in the MMP profiles observed in the IMQ-treated skin resemble the MMP patterns found in skin lesions of individuals with psoriasis. Ultimately, the differences in MMP abundance under IMQ-induced inflammation as compared to non-inflamed control skin can be exploited as a model to investigate drug efficacy or performance of drug delivery systems.

2024-11-01·Dermatology and Therapy

Development and Validation of a Patient-Reported Outcome Measure of the Impact of Chronic Hand Eczema on Health-Related Quality of Life: the Hand Eczema Impact Scale (HEIS)

Article

作者: Balita-Crisostomo, Cherry Lou ; Grant, Laura ; Agner, Tove ; Larsen, Lotte Seiding ; Yüksel, Yasemin Topal ; Fromy, Piper ; Weisshaar, Elke ; Jones, Amy M ; Mathiasen, Nanna Nyholm ; Apfelbacher, Christian ; Arbuckle, Rob ; Thoning, Henrik

INTRODUCTION:

Chronic Hand Eczema (CHE) is an inflammatory skin disease that causes significant impact on health-related quality of life (HRQoL). The Hand Eczema Impact Scale (HEIS) is a new patient-reported outcome (PRO) measure designed to assess the impact of CHE on key domains of HRQoL. This study aimed to develop and evaluate content and psychometric validity of the HEIS.

METHODS:

The HEIS was initially developed on the basis of a literature review and concept elicitation interviews. Qualitative cognitive debriefing interviews (n = 20) were conducted with patients with CHE to assess relevance and understanding of items, response options, and recall period. Psychometric properties (item performance, dimensionality, reliability, validity, responsiveness, and estimation of meaningful change thresholds) were then assessed using data (n = 258) from a phase 2b trial (NCT03683719).

RESULTS:

Cognitive debriefing confirmed all items were understood and relevant to patients. Inter-item correlations (all > 0.50) and confirmatory factor analysis (factor loadings ≥ 0.80) supported unidimensionality of the HEIS score, and mostly provided support for the HEIS Proximal Daily Activity Limitations (PDAL) score, with only one item loading below the prespecified threshold. Item properties and previous qualitative work supported retaining this item in the total score but removed from the HEIS PDAL domain. Internal consistency (Cronbach's alpha ≥ 0.89) and test-retest reliability (intra-class correlation coefficient ≥ 0.79) results were very strong. Strong correlations with concurrent measures (0.66-0.87) and significant differences between severity groups (p < 0.001) supported construct validity. Large effect sizes for mean change scores in participants that improved and significant differences between groups indicated ability to detect change. Anchor-based analyses supported within-individual responder definitions of ≥ 1.3 points for improvements in both HEIS score and HEIS PDAL score (covering three items) and of ≥ 1.5 points for HEIS embarrassment with the appearance of hands (Emb) score (covering two items).

CONCLUSIONS:

The 9-item HEIS is the first CHE-specific PRO measure developed and validated according to regulatory guidance for assessment of the impact of CHE on key domains of HRQoL. This article provides evidence of strong content and psychometric validity and shows improvements of ≥ 1.3 points in HEIS score and HEIS PDAL score, and improvements of ≥ 1.5 points in HEIS Emb score represent clinically meaningful, important changes.

TRIAL REGISTRATION:

NCT03683719.

2024-09-16·Bioanalysis

The European Bioanalysis Forum recommendation on establishing appropriate drug tolerance levels in antidrug antibody assays

Article

作者: Venema, Foka ; Rieger, Martin ; Goodman, Joanne ; Carlsen, Morten Funch ; Van de Vyver, Ortwin ; Timmerman, Philip ; Cowan, Kyra J ; Revell, Heather ; Dyer, Daniel ; Kromminga, Arno ; Golob, Michaela ; Genin, Jean-Christophe ; Geary, Laura ; Nelson, Rob ; Champion, Lysie

The European Bioanalysis Forum, in collaboration with several key industry stakeholders, has recently led discussions that address international immunogenicity guidance documents, specifically the three tier approach for immunogenicity testing strategies, after more than 20 years of experience with biotherapeutics. As part of this, the strategy and methods used to assess drug tolerance across all immunogenicity assays are challenged, emphasizing that bioanalytical scientists need to consider the context-of-use of each assay. Here, recommendations for drug tolerance assessments, driven by strong scientific rationale and subject to reevaluation as needed, are provided. This includes carefully considering the drug and positive control concentrations considered to be appropriate and which tiers are most relevant for performing drug tolerance assessments.

126

项与 LEO Pharma A/S 相关的新闻（医药）

2024-12-03

·Business Wire

MHRA Grants Marketing Authorisation for LEO Pharma’s Anzupgo® ▼(delgocitinib) cream in Great Britain

MAIDENHEAD, England--( BUSINESS WIRE )--NOT FOR UK USE - NOT INTENDED FOR UK MEDIA LEO Pharma, a global leader in medical dermatology, today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for delgocitinib cream for the treatment of adult patients with moderate to severe Chronic Hand Eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate. 1 CHE is a heterogeneous, fluctuating, inflammatory skin disease with key symptoms of itch and pain across the hands and wrists. 2,3 Its pathophysiology is characterised by skin barrier dysfunction, skin inflammation, and skin microbiome alterations. 2 Hand Eczema is categorised as CHE when it lasts for more than three months, or relapses twice or more often per year. 3,4 The condition can have a high psychological, social, and occupational burden. 5,6 “ The physical symptoms of Chronic Hand Eczema can be debilitating, substantially disrupting patients' lives. Additionally, patients report that the disease can profoundly affect their mental well-being, relationships, and daily activities,” shared Prof. Richard Warren, Consultant Dermatologist at Northern Care Alliance NHS Foundation Trust and The University Of Manchester . “ Today’s approval of a first, topical JAK inhibitor treatment option for moderate to severe CHE adult patients adds to the treatment options available for healthcare professionals and patients.” “ Today’s MHRA approval of delgocitinib cream marks a significant milestone for adults in Great Britain living with moderate to severe Chronic Hand Eczema,” said Leanne Walsh, Vice President and General Manager, LEO Pharma UK and Ireland . “ This approval offers a new treatment paradigm and demonstrates our commitment to addressing the unmet needs of people living with skin conditions.” The MHRA decision was based on results from the delgocitinib cream phase 3 program, which included the DELTA 1 and DELTA 2 clinical trials that evaluated the safety and efficacy of delgocitinib cream compared to the cream vehicle. 7-9 Both trials met their primary and all secondary endpoints. 9-11 Subjects who completed the 16-week DELTA 1 or DELTA 2 trials were immediately offered to enrol in the 36-week DELTA 3 open-label extension trial. 12 “ CHE is a truly debilitating condition as patients may live with itchy, sore, scaly, weepy, fissured hands. This can really affect patients' ability to work but also to interact with family and loved ones,” noted Prof. Anthony Bewley, Consultant Dermatologist at Barts Health NHS Trust. “ CHE is so much more than a difficult skin disease, as research has shown that living with CHE can have an impact on patients' psychological well-being, and can lead to anxiety, depression, or both. The development of a new topical treatment for adult patients with moderate to severe CHE is very welcome.” LEO Pharma UK and Ireland is collaborating closely with NICE to make delgocitinib cream available on the NHS. *Ends* Notes to editors About Chronic Hand Eczema Chronic Hand Eczema (CHE) is defined as Hand Eczema (HE) that lasts for more than three months or relapses twice or more within a year. 3,4 CHE is one of the most common skin disorders of the hands 13 with a prevalence rate of approximately 4.7%. 14 In a substantial number of patients, HE can develop into a chronic condition. 13 CHE is a fluctuating disorder characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists. 5 CHE has been shown to cause psychological and functional burdens that impact patient quality of life, 6 with approximately 70% of individuals who live with severe CHE admitting to problems in performing everyday activities, and suffering disruption in their daily life due to the condition. 15 Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE. 16 About delgocitinib Cream Delgocitinib cream is a topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE. It inhibits the activation of JAK-STAT signalling, which plays a key role in the pathogenesis of CHE. 17 The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome. 2 Delgocitinib cream is currently approved in the European Union and Switzerland for the treatment of moderate to severe CHE in adults for whom topical corticosteroids are inadequate or inappropriate. In 2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a license agreement in which LEO Pharma gained exclusive rights to develop and commercialize delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights. About LEO Pharma LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 4,000 people, serving millions of patients across the world. In 2023, the company generated net sales of DKK 11.4 billion. References Anzupgo ® (delgocitinib) cream SmPC. LEO Pharma; December 2024 . Lee GR, et al. Dermatol Ther . 2019;e12840:1–12. Lynde C, et al. J Cutan Med Surg. 2010;14:267–284. Erratum in: J Cutan Med Surg. 2011;15:360. Diepgen TL, et al. J Dtsch Dermatol Ges . 2015;13(1):e1–22. Thyssen J, et al. Contact Dermatitis . 2022;86:357–78. Grant L, et al. Adv Ther . 2020;37(2):692-706. Clinicaltrials.gov. 2024. Available from: https://clinicaltrials.gov/study/NCT04871711 . Clinicaltrials.gov. 2024. Available from: https://clinicaltrials.gov/ct2/show/NCT04872101 . Bissonnette R, et al. Lancet . 2024;404(10451):461-473. Schliemann S, et al. European Academy of Dermatology and Venereology (EADV) Congress . 2023. Bissonnette R, et al. European Academy of Dermatology and Venereology (EADV) Congress . 2023. Clinicaltrials.gov. 2024. Available from: https://clinicaltrials.gov/ct2/show/NCT04949841 . Bissonnette R, et al. JEADV . 2010;24;1–20 Apfelbacher C, et al. European Society of Contact Dermatitis (ESCD) congress . 2024. Cortesi PA, et al. Contact Dermatitis . 2014;70(3):158-168. Voorberg AN, et al. Acta Derm Venereol . 2022;102:adv00626. Dubin C, et al. Ther Clin Risk Manag . 2020;16:1319-1332. Erratum in: Ther Clin Risk Manag . 2021:17:233. MAT-78329 December 2024

临床3期临床结果引进/卖出上市批准

2024-11-20

·药事纵横

盐酸米诺环素泡沫剂获批上市，国内泡沫剂研发竞赛拉开序幕

一、背景 2024年11月05日，科笛生物医药（上海）有限公司「盐酸米诺环素泡沫剂」(规格：4%)获得中国国家药品监督管理局（NMPA）批准在中国上市，用于治疗九岁或以上患者的非结节性中度至重度寻常痤疮炎症性病变的局部治疗。据笔者了解，该药获得了国家药监局药品审评中心优先审评审批资格。这是目前国内批准的首款盐酸米诺环素外用制剂，也是首款在国内上市销售的原研进口泡沫剂产品。 4%盐酸米诺环素泡沫剂（商品名：Amzeeq®）最早是由位于以色列的一家专门从事泡沫剂产品开发的制药公司Foamix Pharmaceuticals（2020年与Menlo Therapeutics合并成为其全资子公司）研发，于2019年10月18日被美国食品药品监督管理局（FDA）批准上市。2020年4月，Foamix与科笛生物（Cutia Therapeutics）达成协议，将包括Amzeeq®盐酸米诺环素泡沫剂在内的多个盐酸米诺环素外用制剂产品在大中华区的独家许可权授予科笛生物，向科笛供应用于临床和商业用途的许可产品。根据公开的信息，Foamix通过该授权可获得1000万美元的预先现金付款，产品一旦在中国获批上市销售，还将获得额外的100万美元付款。此外，根据协议Foamix还会根据科笛在大中华区销售这些被许可产品的净销售额，获得一定比例的版税收入。科笛生物于2021年在中国境内开展了一项评价盐酸米诺环素泡沫剂（4%）局部给药治疗中度至重度寻常痤疮的多中心、随机、双盲、安慰剂对照的有效性和安全性的III期注册性临床试验。研究结果显示，经过12周后治疗后，治疗炎性皮损的改善相较于安慰剂组展现出了显著的改善，达到主要终点指标。在安全性方面，治疗组受试者对给药部位局部表现出了良好的耐受性。治疗组与安慰剂组在不良事件的总发生率上相当，且均未报告有药物相关的严重不良事件。口服盐酸米诺环素治疗痤疮疗效较差且容易引起全身的毒副作用，而4%盐酸米诺环素泡沫剂作为的首款盐酸米诺环素的外用制剂成功实现了盐酸米诺环素的局部外用给药，不仅疗效显著且大大降低了口服给药带来的不良反应，具有里程碑意义。笔者曾于2023年9月在本公众号（“药事纵横”）上发表了《浅析盐酸米诺环素油泡沫剂处方设计及泡沫形成原理》一文，简要介绍了盐酸米诺环素外用制剂开发面临的挑战以及其泡沫剂处方及发泡原理。具体来说，Foamix利用了其独特的分子稳定技术（Molecular Stabilizing Technology, MST）技术，有效解决了盐酸米诺环素药物的稳定性（如对光、氧、水、某些质子性溶剂和表面活性剂等不稳定）问题，成功开发出了无水、无表面活性剂的盐酸米诺环素泡沫剂。该技术将微粉化的盐酸米诺环素分散在大量的油性基质中，利用抛射剂汽化后处方中高级脂肪醇和高级脂肪酸吸附空气-油界面，形成稳定的油泡沫，方便患者涂抹于患处。二、关于泡沫剂泡沫剂（foam）是指将原料药和辅料灌装到加压容器或者非加压容器后将内容物呈泡沫状喷出一类药物制剂。前者需要填充抛射剂才能形成在喷出后形成泡沫，因此又称“泡沫气雾剂”（foam aerosol）。在国内，一般提到泡沫剂都默认指的是泡沫气雾剂。泡沫剂具有吸附性强、易于涂布、美观、经皮渗透能力强等优点。此外，对于腔道给药，泡沫剂给药后泡沫能够迅速在腔道内（如阴道、直肠等）充盈，覆盖给药部位，给药便捷，这是很多传统剂型所不具备的优势。美国FDA迄今已批准了18种泡沫剂NDA上市申请，其最早批准的一款泡沫剂产品可以追溯到1999年上市的戊酸倍他米松泡沫剂（见本公众号文章《盘点泡沫气雾剂给药系统中应用的平台技术》）。目前除了盐酸米诺环素泡沫剂的进口上市申请已经获批，笔者注意到利奥制药（LEO Pharma）也于近期正式向国家药品管理局提交了Enstilar®泡沫剂（卡泊三醇/丙酸倍他米松泡沫剂）进口上市许可申请。在国内，2023年12月中国药品监督管理局才批准第一款化药泡沫剂产品——米诺地尔泡沫剂仿制药上市。截至目前，尚没有一款国内企业自主研发的泡沫剂NDA上市申请获批。但是，从国家药品监督管理局药品审评中心CDE受理品种目录可以看出，国内泡沫剂国内泡沫剂研发竞赛已经悄然拉开了序幕。最近两年最为热门的泡沫剂仿制品种当属米诺地尔泡沫剂和盐酸米诺环素泡沫剂。目前CDE已经受理了浙江三生蔓迪药业有限公司（已获批）、辰光（天津）制药有限公司、山西振东安欣生物制药有限公司、山东致泰医药技术有限公司/济宁为民制药有限公司、广东红珊瑚药业有限公司等5家公司的米诺地尔泡沫剂仿制药上市申请。而山西振东安欣的盐酸米诺环素泡沫剂仿制药上市申请也于今年6月份获得CDE受理。可以看出，目前国内药企于泡沫剂这一剂型的重视程度和研发热情较前些年有了明显的高涨。这其中的热情并不难理解。米诺地尔作为一种有效的脱发治疗药物，其泡沫剂型相比传统搽剂具有更好的使用体验和患者依从性。随着脱发问题的日益普遍和年轻化，米诺地尔泡沫剂的市场需求持续增长。而盐酸米诺环素泡沫剂在治疗痤疮方面显示出良好的疗效和安全性，且痤疮是一种常见的皮肤问题，尤其在青少年和年轻成人中发病率较高，因此该药物的市场需求也很大。此外，泡沫剂作为一种高端药物递送系统，处方工艺复杂，仿制难度大，进入壁垒高，一旦成功研发并上市，将能够在一定程度上避免激烈的市场竞争。且由于泡沫剂研发难度大、成本高，市场上同类竞品相对较少，这有助于产品在市场上占据一定的份额，并享受较高的利润空间。与传统仿制药相比，泡沫剂这种高端制剂由于技术壁垒和独特优势，受集采政策的影响相对较小，这就意味着在集采压力下，其仍能保持一定的价格优势和市场竞争力。三、结语随着米诺地尔泡沫剂、盐酸米诺环素泡沫剂的相继获批上市，国内泡沫剂市场正式迎来了一个全新的竞争格局。这两款产品的上市到来不仅为患者提供了更多的治疗选择，也将极大地激发国内药企对泡沫剂研发的热情和动力。可以预见，在未来将会有更多的泡沫剂产品涌现市场，为患者带来福音，这也将促使国内药企在泡沫剂研发创新、质量控制、市场推广等方面不断提升自身实力，推动企业自身发展和中国医药产业进步。药事纵横征稿启事

优先审批上市批准临床3期引进/卖出医药出海

2024-11-19

·生物制药进展杂评

三生国健IL-17A单抗申报上市，竞争大战已开启，价格战不可避免？

1、IL-17产品市场快速增长； 2、国内产品上市，竞争进一步加剧 3、原研药专利马上到期，2`3年新药窗口期 4、突围策略有没有？ 5、在研产品今天，CDE官网显示，三生国健的重组抗IL-17A人源化单克隆抗体注射液SSGJ-608上市申请已获得受理，用于治疗成人中重度斑块状银屑病再次之前，翔金泰和恒瑞的IL-17单抗新药已经获批上市，国产新药市场大战拉开帷幕。 1、IL-17产品市场快速增长，国内定地板价 1.1 全球市场 2023年诺华营收454.4亿美元，同比增长10%，第一大产品Entresto全球销售额60.35亿美元，第二大产品司库奇尤单抗是IL-17靶点抗体药物。IL-17靶点抗体药物对银屑病、强直性脊柱炎和中轴型脊柱关节炎等具有较好的治疗效果。全球IL-17靶点抗体药物销量快速增长，司库奇尤单抗其全球销售收入从2019年的35.51亿美元增长到2023年的49.8亿美元，稳居全球畅销药前30名。礼来的依奇珠单抗2023年销售27.6亿美元。注：LEO Pharma AS、协和麒麟的布罗利尤单抗2020年销售0.71亿、0.26亿美元，协和麒麟布罗利尤单抗2021年销售0.25亿美元。 1.2 中国市场快速增长国内司库奇尤单抗和依奇珠单抗是我国使用靶向IL-17药物治疗方案的主流药物，2020-2022年销售额持续增高，2020年司库奇尤单抗销售额0.43亿元，依奇珠单抗销售额0.05亿元；2022年司库奇尤单抗、依奇珠单抗中国销售额为17亿、0.81亿元，布罗利尤单抗暂无数据。2023年是上半年库奇尤单抗销售约11.6亿，预计全年超过20亿。这应该是国内最成功的自免领域产品。毕竟诸如“药王”阿达木，在国内也是混的悄无声息的小虫一只。国内成功的前提应该是主动的降价。 2023年3月1日医保正式执行后，司库奇尤单抗价格将由1188元/支降至870元/支，进一步降低患者经济负担。而依奇珠单抗进入医保后价格为1218元/支。如果没概念可以比较一下其他同类产品的价格 2023年银屑病生物制剂医保后价格如下。 1、阿达木单抗：1290元/支。 2、司库奇尤单抗：870元/支。 3、依奇珠单抗：1218元/支。 4、乌司奴单抗：4318元/支。 5、古塞奇尤单抗：4571元/支。 IL-17这两个品种的价格直接比已经专利过期的阿达木还要便宜，以价换量还是成功的，只是苦了后来者。 2、国内产品上市，竞争进一步加剧早先全球共5款靶向IL-17获批上市药物分别是诺华的司库奇尤单抗、礼来的依奇珠单抗、协和麒麟、LEO Pharma AS的布罗利尤单抗、优时比的Bimekizumab。在国内批了4个分别是，司库奇尤单抗、依奇珠单抗、布罗利尤单抗;比奇珠单抗。再加上刚获批的三生国健、智翔金泰赛立奇单抗、恒瑞医药夫那奇珠单抗，国内已有7款产品。此外国内还有 9个产品正在临床三期（两个司库奇尤单抗生物类似药），3个产品在二期、9个产品在临床一期。竞争十分激烈！关键是价格在国内产品上市前已经被经降低到了千元左右/支；一般来说国产产品上市后价格都会低于原研进口产品，这么看价格还会进一步降低，估计进医保后价格会在600-800之间。即使开始留点降价的余地，最多应该也就在千元左右了。 3、原研药专利马上到期，2`3年新药窗口期司库奇尤单抗的核心序列专利CN101001645B于2012年获得授权，专利保护期至2025年。在美国，该药的同族专利US7807155B由于存在专利期调整和专利期延长，专利保护期至2029年。（目前国内有两个生物类似药在III期，三个在I期）依奇珠单抗中序列专利CN101326195B于2012年在中国获得授权，专利保护期至2026年。其美国同族专利US7838638B权利要求1也保护了依奇珠单抗的轻重链可变区序列，由于存在专利期延长，专利保护期至2030年。这意味着留给智翔金泰赛立奇单抗、恒瑞医药夫那奇珠单抗的新药窗口期会在两到三年。随后就需要和生物类似药进行一下正面PK 价格大战是必然的，如果更悲观一点，生物药的集采如果开始，那又会是另一个悲惨的故事了。 4、突围策略有没有？除了降价，其他的研发策略呢，可以参考，自免系列6：IL-5/IL-5Rα未来如何立项突围？恒瑞vs正大天晴，新药对决生物类似药很有意思，国内的企业做的新药基本就压线原研药专利到期前两年上市，这个时间窗实在是有点少了，大家有什么高见，欢迎留言~~ 关于IL-17更多的临床和作用机制可参考: 自免系列2：国内IL-17单抗市场超20亿，自免市场已打开，智翔金泰和恒瑞抢先撞线 5、在研产品表中国在研三期产品我们对自免领域一直在深入研究和跟踪，如需行业研究、产品评估，立项或对被投企业商业尽调业务，市场调研等咨询欢迎交流，具体咨询业务简介如下公众号有个实名群，有兴趣可以加一下，虽然都喜欢潜水，偶尔也会分享点报告资料参考阅读： 13、自免系列6：IL-5/IL-5Rα未来如何立项突围？恒瑞vs正大天晴，新药对决生物类似药 12、自免系列5：IL-23靶向药利生奇珠单抗头对头研究结果好，国内仅信达进入临床Ⅲ期 11、自免系列4：度普利尤单抗COPD领域取得进展，预计2024年中国销售额超20亿 10、自免系列3：乌司奴单抗百亿美元市场，康方、百奥泰、荃信争上市 9、自免系列2：国内IL-17单抗市场超20亿，自免市场已打开，智翔金泰和恒瑞抢先撞线 8、自身免疫专题系列开篇（1）：常见疾病、重磅药物及靶点 7、自免靶点JAK1：阿斯利康的JAK1抑制剂AZD4604分子设计和优化详解 6、证明Me-better？四款IL-23抗体非临床研究比较 5、自免明星靶点IL-17：从发现到靶向治疗 4、大交易频繁，IL-2摇摆在肿瘤免疫和自身免疫领域的舞者 3、特异性皮炎药物之一：Dupilumab（度普利尤单抗） 2、Dupilumab会否是下一个阿达木，IL-4R靶点适应症的拓展 1、IL13——哮喘还是特应性皮炎？纠结中前行~~~ 自身免疫疾病综述相关文章： 7、特异性皮炎（湿疹）的江湖 6、特异性皮炎药物之一：Dupilumab（度普利尤单抗） 5、特异性皮炎 4、溃疡性结肠炎（UC）市场概览：肿瘤之后，自免领域的必争之地 3、银屑病靶向药现状及研发前沿 2、2019年战“狼”（SLE）药物频传喜讯（上） 1、2019年战“狼”（SLE）药物频传喜讯（下）

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药物(靶点)	适应症	全球最高研发状态

巨大戟醇甲基丁烯酸酯 ( PKCα x PKCδ )	光化性角化病更多	批准上市
德戈替尼 ( JAK )	慢性湿疹更多	批准上市
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戊酸二氟可龙 ( GR )	湿疹更多	批准上市
曲罗芦单抗 ( IL-13 )	特应性皮炎更多	批准上市