A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab With Open-Label Induction, Randomized Double-Blind Maintenance, and Open-Label Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) With Moderately to Severely Active Ulcerative Colitis

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how Risankizumab moves through the body as well as how safe and effective it is in treating pediatric participants with moderate to severely active UC. Adverse events and change in disease activity will be assessed.
Risankizumab is an approved medication for moderate to severe UC in multiple countries and is being developed for the treatment of UC in pediatrics. This study is comprised of 3 cohorts that may participate in 3 substudies (SS). Cohort 1 will enroll participants with ages from 6 to less than 18 years. Cohort 2 will enroll participants with ages from 2 to less than 6 years. Cohort 3 will enroll participants with ages from 2 to less than 18 years. SS1 is an open-label induction period where participants will receive a weight-based induction regimen of risankizumab. SS2 is a double-blind maintenance period where participants will be randomized to receive 1 of 2 doses of weight-based maintenance regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Around 120 pediatric participants with UC will be enrolled at around 80 sites worldwide.
Participants in SS1 will receive risankizumab intravenously during the 12-week induction period. Participants in SS2 will receive risankizumab subcutaneously during the 52-week randomized maintenance period. Participants in SS3 will receive risankizumab subcutaneously during the 208-week open label period. Participants will be followed-up for approximately 140 days.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

开始日期2025-08-01

申办/合作机构

AbbVie, Inc.

NCT06880744

/ Recruiting临床3期

Phase 3b, Multicenter, Randomized, Open-Label Study of Risankizumab Compared to Vedolizumab for the Treatment of Adult Subjects With Moderate to Severe Ulcerative Colitis Who Are Na?ve to Targeted Therapies

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).This study will evaluate how safe and effective risankizumab is compared to vedolizumab in treating adult participants with moderate to severe UC who are naive to targeted therapies (TaTs).
Risankizumab and vedolizumab are approved medications for moderate to severe UC in multiple countries. Participants who meet the eligibility criteria will be randomized in a 1:1 ratio to receive open label risankizumab or vedolizumab. Approximately 530 adult participants with moderate to severe UC who are na?ve to targeted therapies (TaTs) will be enrolled at 285 sites worldwide.
For participants randomized to risankizumab, drug will be administered intravenous(IV) during the induction period followed by subcutaneous injection during the maintenance period. Participants randomized to vedolizumab will receive drug IV throughout the study.
The duration of the study is approximately 69 weeks for participants randomized to risankizumab and 71 weeks for participants randomized to vedolizumab. This includes up to a 35-day screening period followed by a treatment period of 44 weeks for risankizumab and 46 weeks for vedolizumab.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular outpatient visits during the study. The effect and safety of the treatment will be checked by medical assessments, evaluation of side effects and completing questionnaires.

开始日期2025-06-17

申办/合作机构

AbbVie, Inc.

NCT07007091

/ Recruiting临床1期

A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Bioavailability of Risankizumab Subcutaneous Administration With On-Body Injector Relative to Prefilled Syringe

This study will assess the pharmacokinetics and relative Bioavailability of risankizumab following subcutaneous administration with an on-body injector relative to a prefilled syringe

开始日期2025-06-12

申办/合作机构

AbbVie, Inc.

100 项与利生奇珠单抗相关的临床结果

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100 项与利生奇珠单抗相关的转化医学

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100 项与利生奇珠单抗相关的专利（医药）

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648

项与利生奇珠单抗相关的文献（医药）

2025-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Switching biologic agent in patients with psoriasis: a systematic review and meta-analysis

Review

作者: Sun, YuanQiang ; Zhao, XiTong ; Li, WenChao ; Liu, Hong ; Zhang, LiHong

BACKGROUND:

Multiple biologics are available for psoriasis treatment, but switching treatments is often necessary at some point. The choice between intraclass or interclass biologic switching has not been extensively investigated.

METHODS:

Two independent authors searched the databases PubMed and EMBASE for studies reporting on biologic switching in psoriasis patients. Our study was performed in line with the Preferred Reporting Items for Systematic Reviews and Meta Analyses (PRISMA) guidelines.

RESULTS:

A total of 19 publications, comprising 679 patients, were included. The intraclass switching group consisted of 519 patients, while the interclass switching group included 139 patients. For intraclass switching, there are respectively 160, 326 and 33 patients switched of TNF-α, IL-17, IL-23. For interclass switching, 11 patients switched from TNF-α to IL-17, 6 from IL-17 to IL-23, 41 from IL-17 to IL-12/23, 29 from IL-17 to TNF-α, 15 from IL-12/23 to IL-17, 8 from IL-12/23 to IL-23. After 12 weeks, the proportion of patients achieving Psoriasis Area and Severity Index (PASI)75 was significantly higher in the intraclass switching group compared to the interclass switching group. However, after 16-52 weeks, the PASI75 proportions were comparable between the groups.

CONCLUSION:

Intraclass switching shows better short-term efficacy than interclass switching. However, in the long term, both switching strategies are effective and safe. This study also shows that adalimumab, ixekizumab, and risankizumab are the preferred agents for intraclass switching, whereas guselkumab serves as the primary agent for interclass transitions.

2025-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Interleukin-23p19 inhibitors for the treatment of moderate-to-severe psoriasis: an expert opinion of real-world evidence studies in Europe

Review

作者: Thaçi, D. ; Ständer, S.

Background: Psoriasis is a chronic inflammatory disease affecting about 2% of the global population, with moderate-to-severe forms requiring systemic treatment for successful disease management. By targeting the interleukin (IL)-23p19 subunit of IL-23, the master cytokine of psoriasis pathogenesis, guselkumab, tildrakizumab, and risankizumab offer improved risk-benefit profiles.Objective: While randomized clinical trials (RCTs) provide controlled data, real-world evidence (RWE) offers insights into the performance of these therapies in diverse patient populations, including those with comorbidities or difficult-to-treat areas affected. With RWE on these inhibitors constantly emerging, a comprehensive overview and expert interpretation are essential for providing key insights into psoriasis management in clinical practice.Methods: This review, therefore, examined RWE on the effectiveness and safety of IL-23p19 inhibitors compared to their pivotal RCTs.Results: Despite some gaps between RCT and RWE outcomes, particularly in underrepresented subpopulations, IL-23p19 inhibitors show strong effectiveness and favorable safety across both settings in the short- and especially in the long term, accompanied by an improvement in health-related quality of life and reduction of the main symptoms.Conclusion: Altogether, these factors make these medicines ideal treatment options. Future research should focus on improving patient-reported outcomes, specifically addressing psychological and quality-of-life aspects, to further optimize psoriasis management.

2025-08-01·Lancet Gastroenterology & Hepatology

Development and validation of a novel Endoscopic ulcer Activity Score for Evaluation of Crohn's Disease (EASE-CD) using data from two randomised controlled trials

Article

作者: Mosli, Mahmoud ; Shackelton, Lisa M ; Peyrin-Biroulet, Laurent ; Maguire, Bryan R ; Rubin, David T ; Danese, Silvio ; Panaccione, Remo ; Sands, Bruce E ; Ma, Christopher ; Leong, Rupert W ; Khanna, Reena ; Rémillard, Julie ; Sparrow, Miles P ; Hindryckx, Pieter ; Jairath, Vipul ; Bressler, Brian ; Hart, Ailsa L ; Feagan, Brian G ; Zou, Guangyong ; D'Haens, Geert R

BACKGROUND:

Endoscopy is essential for measuring luminal disease activity in Crohn's disease. Existing indices for evaluating endoscopic Crohn's disease activity are only modestly correlated with clinical disease activity, contain items with ambiguous definitions and poor interobserver reliability, and do not have validated thresholds for defining clinically relevant changes. To address these issues, we conducted a multiphase study to develop and validate a novel endoscopic index for Crohn's disease.

METHODS:

Paired baseline and post-induction ileocolonoscopy videos from a phase 3b adalimumab trial (NCT00348283) and phase 2 risankizumab trial (NCT02031276) were assessed by multiple central readers using candidate endoscopic items with face validity derived using modified RAND/UCLA appropriateness methods. The four readers were masked to all clinical information, including treatment assignment and patient symptom scores. A total of 112 and 99 paired ileocolonoscopy videos with treatment assignment were available from the adalimumab trial and risankizumab trial, respectively; after the four readers assessed the 112 videos, two readers then reassessed 44 post-treatment videos to assess inter-rater reliability in index development. Items with acceptable inter-rater reliability (with an intraclass correlation coefficient [ICC] of ≥0·41) and responsiveness (win probability [WinP], the probability that a patient receiving active treatment has a better endoscopy score than a patient receiving placebo, of ≥0·56) were included as covariables in regression for model building with internal validation with bootstrapping. External validation was conducted using the paired videos from the risankizumab trial.

FINDINGS:

Ten endoscopic items met ICC and WinP thresholds and were considered for novel index development. They included items from the SES-CD (presence and size of ulcers, extent of ulcerated surface, and extent of affected surface) and CDEIS (percentage of surface involved by Crohn's disease, percentage of ulcerated surface, deep ulceration, and superficial ulceration) and exploratory items (presence of Crohn's disease-related lesions, Crohn's disease-related lesion severity, and Crohn's disease-related lesion involvement). The final model, Endoscopic ulcer Activity Score for Evaluating CD (EASE-CD), included the presence and size of ulcerations measured on an ordinal scale of 0 (none), 1 (ulcers <5 mm), 2 (ulcers between 5 mm and 20 mm), and 3 (ulcers >20 mm); the presence or absence of deep ulcerations measured dichotomously, with 0 for absent and 1 for present; and the proportion of ulcerated surface area, expressed as a continuous proportion from 0-1, with each item evaluated and averaged across visualised bowel segments. The total score ranges from 0-100 with higher scores indicating greater endoscopic activity. The r² and optimism adjusted r² of EASE-CD in internal validation were 0·608 and 0·554, and the index was well calibrated with a slope of 0·983. In external validation, the adjusted r² was 0·565 and the calibration slope was 0·997. EASE-CD also demonstrated substantial inter-rater reliability (ICC 0·798 [95% CI 0·711-0·836]) and a large degree of responsiveness (WinP 0·769 [95% CI 0·658-0·851], p<0·001) in external validation. A 10-point reduction in EASE-CD had 82·4% specificity (95% CI 78·6-86·0) and 69·9% sensitivity (63·3-76·4) for endoscopic response, defined by at least 50% reduction in SES-CD or CDEIS. Ulcer-free endoscopic remission results in EASE-CD score of 0.

INTERPRETATION:

EASE-CD is a novel, internally and externally validated continuous measure of endoscopic ulcer activity in Crohn's disease that is reliable and responsive to treatment.

FUNDING:

None.

754

项与利生奇珠单抗相关的新闻（医药）

2025-07-22

·E药经理人

大变天！2030年全球制药TOP10：礼来登顶，辉瑞“垫底”，BMS、GSK掉队！

在不确定性成为常态的年代，决定企业生死的并非谁踩中了“下一个风口”，而是谁能在“风来前”就打下临床价值与技术效率的根基。撰文| Kathy一场席卷全球制药行业的“地震”正在逼近。Evaluate近日发布的《World Preview 2025》预测报告，或许是近年来对全球制药格局最具冲击力的一次行业预判。报告显示，五年后，也就是2030年的全球制药行业，处方药市场规模将突破1.75万亿美元，年复合增长率超过7%。然而，这场增长的背后，却隐藏着一场前所未有的行业大洗牌：这一次将不仅仅是简单的几个药企名次的前后调换，而是一场彻底的乾坤大挪移。以肿瘤、自免、疫苗为主的老牌药企逐渐退潮，糖尿病与肥胖治疗药物GLP-1激动剂迅速崛起，礼来与诺和诺德两家企业一跃成为新的行业霸主。辉瑞、诺华的排名剧烈下滑，而BMS与GSK等昔日巨头更是直接从TOP10榜单中消失。这些变化，不仅体现在制药公司的排名，也深入影响了畅销药的榜单与研发管线的布局。Evaluate认为，未来几年，行业的焦点将集中在几个核心趋势上：GLP-1药物的崛起、专利悬崖的巨大冲击、小规模精准并购趋势的兴起、药企研发开支的放缓以及来自中国药企日益增长的全球竞争压力。座次洗牌，从礼来和诺和诺德的登顶说起站在2025年的节点来说，GLP-1药物改变制药格局已不是新事。只是这一赛道药物的凶猛程度将在未来五年更甚。在Evaluate的预测中，礼来与诺和诺德将在2030年分列全球药企销售收入的第一和第二位。这一结果若放在五年前，恐怕难以让人信服。曾经，礼来的市值不足强生一半，诺和诺德在众多巨头中仅算中坚，常年徘徊在TOP20左右。但如今，这两家公司凭借GLP-1产品线正在彻底改变游戏规则与制药公司的座次。礼来的替尔泊肽（Mounjaro与Zepbound）和诺和诺德的司美格鲁肽（Ozempic与Wegovy）不仅将这两家公司保送到了全球最赚钱药企的位置，GLP-1双姝也稳居畅销药榜单前两名。如此看来，礼来与诺和诺德凭借GLP-1强势“逆袭”也就不让人意外了。而与这场代谢风暴相对的，是一众曾经的制药巨头逐步被冲刷到了边缘。曾长期位居高座次的强生、艾伯维、罗氏，虽然仍在Top10内，但排名全部下滑。默沙东由于K药专利即将到期，预计2030年销售额将大幅减少，公司排名也滑至第八。辉瑞、诺华更是跌至榜单末位，GSK和BMS干脆被挤出了前十。Covid-19疫苗造就了辉瑞的再一次业绩高点，但也带来了断崖式回落。Evaluate直言，辉瑞在疫苗红利消退后缺乏持续性增长动能。GSK和BMS则在关键资产专利到期后“无接力者可继”，核心管线整体表现疲软。与此同时，赛诺菲将是唯一非GLP-1推动下实现排名上升的公司。靠着度普利尤单抗的强劲增长，其2030年将跃居第六，成为“非代谢领域”的最大赢家。推荐阅读 * AZ猛增、华东首入、百济反超恒瑞，2025制药50强“改朝换代”进行时* 礼来“杀疯”，辉瑞乏力，全球TOP20畅销药格局大变！百济、传奇有望跻身？王座易主，“药王”不是永恒的封号比起TOP10座次的乾坤大挪移，更惊人的是2030年的畅销药Top10中将有五款为GLP-1类药物，构建出一个前所未有的代谢统治阵列。Evaluate指出，到2030年，替尔泊肽（Mounjaro与Zepbound）和司美格鲁肽（Ozempic与Wegovy）这两款产品的年销售额将分别达到620亿与470亿美元，超过历史上任何一款药物的峰值表现。“GLP-1类药物如今已成为一个独立门类，到2030年，这类药物的销售额将占全球处方药总销售额的近9%。”Evaluate的数据显示。代谢药物的风暴之下，传统的肿瘤药虽然仍是总销售额最大的治疗领域，但头部的统治力正在减弱，甚至排不到全球畅销药TOP5之列。最畅销的肿瘤药依然是默沙东的K药。虽然仍保有较高的年销售额，但其即将失去专利保护，Evaluate预测2030年的销售额将比2024年下滑近一半。昔日K药的对手，BMS的Opdivo（O药）甚至已不见于榜单之中。而在免疫炎症领域，赛诺菲的度普利尤单抗和艾伯维的利生奇珠单抗则高歌猛进，两者均前突破250亿美元销售额，努力与GLP-1“掰手腕”。Evaluate认为，不论是代谢、肿瘤还是自免，这些超级重磅炸弹的共同点是具备多适应证的扩展潜力，且生命周期管理体系成熟。回看他们的崛起之路，都是从最初的单病种适应证出发，不断延展至其他疾病场景，实现收入增长与市场壁垒的双重巩固。它们所体现出的“管线即产品”（pipeline-in-a-product）模式，也正成为头部药企应对未来市场波动的通用策略。专利悬崖带来并购风再起3000亿美元，这将是专利悬崖带来的冲击波。据Evaluate预测，到2028年，全球制药产业将迎来一个集中的专利到期高峰，仅这一年就有超过25款年销售额超10亿美元的药物面临专利保护失效，默沙东、BMS、艾伯维、强生、罗氏和诺华都将不同程度受到冲击。到了2030年，全球前25家药企将面临累计超过3000亿美元的销售专利风险，占全球处方药市场近6.6%的份额。专利悬崖带来的不仅是财务上的挑战，更是对巨头们未来的战略选择与执行力的考验——能否在产品失效前完成新资产的临床转化与市场放量，决定了药企是否具备“跨周期作战”的能力。面对专利挑战和管线衔接压力，大型制药公司们自然不愿坐以待毙，并购潮有所回升。然而Evaluate观察到，巨头们的交易策略正在发生变化。过去那种数百亿美元级的公司整合式并购鲜少出现，取而代之的是聚焦于临床后期资产的“小而精”收购。Evaluate认为，如BMS收购Karuna、强生收购Intra-Cellular Therapies、艾伯维收购ImmunoGen为代表，这些交易金额在百亿上下，但标的公司通常只围绕一个重点管线。同时，交易结构也更趋保守，越来越多的并购采用阶段性付款、基于里程碑的递延支付方式，以降低项目失败带来的资金风险。这也反映出当前生物医药行业投资人心态的转变——“确定性”正在取代“想象力”成为第一要义。同时，由于一级市场资金紧张，大量Biotech公司难以IPO，也无力独立商业化，主动出售也成为不少创业企业的生存选择。全球研发支出放缓，中国创新崛起与并购策略变化相对应，Evaluate预测全球制药行业的研发支出将在未来几年放缓。2030年全球R&D支出预计为3430亿美元，年复合增长率降至2.9%，而这一数据在2016-2023年期间曾达到7.7%。研发支出增长的下降，表面上看是企业降本控费的正常反应，但本质上反映出宏观不确定性与投资回报周期的不对称所带来的压制。Evaluate在报告中指出，FDA审批效率的不稳定、《通胀削减法案》（IRA）所带来的药价谈判压力，以及全球资本市场避险情绪上升，都促使药企在研发投入上更为谨慎。与此同时，尽管AI在早期药物筛选与临床设计方面取得一定进展，但其尚未在整个新药开发流程中形成系统性提效，Evaluate认为短期内“AI并不构成实际杠杆”。但是，在全球格局剧烈变化之际，中国生物医药的角色也正在悄然升级。Evaluate在报告中首次用如此明确的语气指出：“中国不再是仿制药工厂，而是first-in-class资产的重要输出国。”2025年以来，来自中国全球授权交易占据总量的40%，远高于2020年的不足3%。这不仅是数量的跃升，更意味着中国资产在全球制药体系中的“可信度”大幅提升。Evaluate指出，随着中国Biotech在靶点创新、分子工程、临床效率等方面持续提升，全球药企未来在“创新合作地图”上的路线，势必将越来越多地指向东方。参考资料：Evaluate Pharma 《World Preview 2025》一审| 黄佳二审| 李芳晨三审| 李静芝精彩推荐大事件 | IPO | 融资&交易 | 财报季 | 新产品 | 研发日 | 里程碑 | 行业观察 | 政策解读 | 深度案例 | 大咖履新 | 集采&国谈 | 出海 | 高端访谈 | 技术&赛道 | E企谈 | 新药生命周期 | 市值 | 新药上市 | 商业价值 | 医疗器械 | IND | 周年庆大药企 | 竞争力20强 | 恒瑞 | 石药 | 中生制药 | 齐鲁 | 复星 | 科伦 | 翰森 | 华润 | 国药 | 云南白药 | 天士力 | 华东 | 上药创新药企 | 创新100强 | 百济 | 信达 | 君实 | 复宏汉霖 | 康方 | 和黄 | 荣昌 | 亚盛｜康宁杰瑞｜贝达｜微芯｜再鼎｜亚虹跨国药企｜ＭＮＣ卓越｜辉瑞｜AZ｜诺华｜罗氏｜BMS｜默克｜赛诺菲｜GSK｜武田｜礼来｜诺和诺德｜拜耳供应链｜赛默飞｜药明｜凯莱英｜泰格｜思拓凡｜康龙化成｜博腾｜晶泰｜龙沙｜三星启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 中国医药手册

疫苗专利到期并购

2025-07-22

·药时代

全球首款！强生IL-23口服多肽申报上市

首款靶向IL-23口服多肽药物，或将上市！2025年7月21日，强生与Protagonist Therapeutics宣布已向美国FDA提交NDA，寻求批准其每日一次口服多肽疗法icotrokinra（JNJ-2113）上市，用于治疗12岁及以上中度至重度斑块状银屑病（PsO）成人与儿科患者。JNJ-2113是全球首款口服IL-23受体拮抗剂，原研是Protagonist。2021年，强生以9.8亿美元的交易总价从Protagonist手中拿到了两款IL-23在研产品的全球权益，JNJ-2113便是其中之一。可以预见，JNJ-2113的上市，或将改变现有银屑病治疗格局。临床数据优于上市疗法此次申请包括四项关键的3期临床研究数据，这些研究均为ICONIC临床开发项目的一部分（包括ICONIC-LEAD、ICONIC-TOTAL以及ICONIC-ADVANCE 1和ICONIC-ADVANCE 2）。JNJ-2113在上述3期研究中成功达成所有主要终点与共同主要终点，在12岁及以上中度至重度斑块状银屑病成人与儿科患者中，显示出显著的皮肤症状清除效果和良好的安全性。ICONIC-LEAD研究显示，JNJ-2113用药16周时，65%的患者达到IGA评分为0/1（皮肤症状清除或几乎清除），50%的患者达到PASI 90，而安慰剂组在这两个指标的数值分别仅为8%和4%。该研究的主要终点有两个，分别为：1）16周时达到研究者总体评估 IGA 0/1且评分变化>=2的受试者比例；2）16周时达到面积与严重程度指数PASI 90的受试者比例。到第24周，患者缓解率进一步提高，74%的患者达到IGA评分为0/1，46%达到IGA 0分；65%的患者达到PASI 90，40%达到PASI 100。在ICONIC-ADVANCE 1和2研究中，JNJ-2113显示出了优于已上市银屑病口服疗法氘可来昔替尼（deucravacitinib）的疗效。据悉，氘可来昔替尼是全球首个口服选择性TYK2抑制剂，由BMS研发。安全性方面，JNJ-2113整体耐受性良好。整合所有研究数据显示，治疗组（49.1%）与安慰剂组（51.9%）的不良事件发生率相似，目前尚未发现新的安全性信号。强生“专利悬崖”的困局从自身管线来看，强生堪称银屑病治疗领域的“领头羊”。公司旗下拥有乌司奴单抗、英夫利西单抗、戈利木单抗和古塞奇尤单抗等多款银屑病等自免领域的重磅产品，形成了覆盖广泛治疗需求的产品矩阵。其中，乌司奴单抗是当之无愧的百亿美元重磅单品，2024年全球销售额达103.6亿美元。然而，该药在美国的专利已于2023年9月到期，安进随即推出了生物类似药。强生通过法律手段阻挠了类似药的上市进程，但这只是缓兵之计。目前，三星生物、山德士、梯瓦、Biocon、Celltrion、百奥泰、费森尤斯等多家企业如雨后春笋般陆续获得相关批准，市场竞争压力日益加剧。目前的强生，核心产品乌司奴单抗正面临“专利悬崖”，销售额出现下滑趋势；而另一款古塞奇尤单抗的增长也趋于放缓。强生亟需一款新药接棒，以支撑其自身免疫疾病领域的产品格局。口服IL-23受体拮抗剂JNJ-2113的推进，正是强生巩固和扩大在银屑病治疗领域领先地位的重要一环。从市场需求来看，银屑病治疗领域潜力巨大。由于疾病进展缓慢，大多数患者需长期甚至终身治疗，庞大的患者基数与长期用药需求催生了一个数百亿美元级的市场。截至2023年6月的12个月内，全球银屑病药物市场规模约为340亿美元，占免疫疾病整体市场的30%左右。巩固银屑病的百亿市场，成了强生突破困境的首要任务之一。强生的破局之路——口服多肽随着疗效普遍提升，用药便捷性和患者依从性正成为影响治疗选择的关键因素。开发便捷、安全、高效的口服药物，已成为各大药企竞相争夺的“制高点”，尤其在慢性病长期管理中，口服剂型展现出显著的临床价值与市场潜力。其中，多肽类药物不仅继承了抗体类大分子药物高亲和力和高特异性的优势，还具备可通过化学方法合成、生产成本相对较低等优点，展现出良好的开发前景和商业化潜力。若能突破技术瓶颈，实现类似小分子药物的口服给药方式，则有望在保持其优异疗效的同时，大幅提升用药的便捷性和患者依从性，从而显著增强其临床价值和市场竞争力。近年来备受关注的GLP-1受体激动剂——司美格鲁肽（Semaglutide）便是一个典型案例。该药物原本需通过皮下注射给药，但诺和诺德借助“SNAC吸收促进剂”这一创新技术，成功开发出口服剂型Rybelsus，实现了GLP-1类药物通过口服途径给药的历史性突破，使Rybelsus成为全球首个真正意义上的口服多肽类药物。而JNJ-2113的上市或将复刻这一路径，其依托Protagonist独有的多肽技术平台，成功突破了口服多肽类药物在生物利用度低、渗透性和稳定性差、以及易被胃肠道降解等方面的开发瓶颈。JNJ-2113能够以个位数皮摩尔级别的高亲和力结合IL-23R，并在人类T细胞中对IL-23信号通路展现出强效且选择性的抑制作用，具有显著的治疗潜力。为证明JNJ-2113的口服疗效，强生选择了自己“头对头”自己。该公司启动了一项III期ICONIC-ASCENDf研究，旨在证明口服药JNJ-2113优于注射生物制剂乌司奴单抗。除此之外，艾伯维也在积极布局银屑病口服药物领域，不久前收购了一家专注于开发口服多肽疗法的生物技术公司Nimble Therapeutics，并获得其核心资产，包括主打项目——口服肽类IL-23受体抑制剂，以及覆盖多种自身免疫疾病的创新口服肽候选药物管线。值得注意的是， IL-23靶点与艾伯维现有的重磅注射剂利生奇珠单抗相同，表明Nimble的研发方向与其现有产品线高度契合，具备显著的协同效应，有望实现从注射到口服治疗路径的顺利过渡。结语然而，口服多肽药物在开发与生产仍面临诸多挑战。多肽类药物通常结构复杂、稳定性差，对合成和生产的精度要求极高，在制备和储存过程中极易发生降解。相比传统小分子药物，多肽药物的生产成本更高，尤其是在确保其生物活性与稳定性方面，往往需要投入更多资源和技术支持。因此，如何在保障药物质量与活性的前提下，优化生产工艺、控制成本，并提升可扩展性，将是强生、艾伯维等企业在推进口服多肽疗法过程中必须面对和解决的关键问题。参考资料：1.Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionize treatment paradigm for adults and adolescents with plaque psoriasis. Retrieved July 21, 2025 from https://www.prnewswire.com/news-releases/johnson--johnson-seeks-first-icotrokinra-us-fda-approval-aiming-to-revolutionize-treatment-paradigm-for-adults-and-adolescents-with-plaque-psoriasis-302509221.html2.银屑病潜在新兴疗法：多肽药物能否开辟“第三战场”？（药渡）3.银屑病药物研发管线与市场全景（小药说药）4.太卷了！强生口服银屑病新药公布III期积极顶线结果（药时代）5.银屑病正在迎来“生物制剂时代”（新药前沿）图片来源：豆包AI21.35亿美元！国产双靶点CAR-T出海2025-07-22又一款重磅COPD药物III期临床失败2025-07-21狂犬病疫苗卖不动了？“温州鞋王”退场2025-07-21版权声明/免责声明本文为原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢!药时代官方网站:www.drugtimes.cn联系方式:电话:13651980212微信:27674131邮箱:contact@drugtimes.cn点击这里，查看更多精彩！

临床3期生物类似药专利到期

2025-07-21

·GlobeNewswire-Health Care

Oruka Therapeutics Announces IND Clearance for EVERLAST-A Phase 2a Trial of ORKA-001 in Psoriasis with Phase 1 Data to be Presented at EADV in September

IND cleared for the EVERLAST-A Phase 2a trial of ORKA-001 in moderate-to-severe psoriasis, with initial data expected 2H 2026 Interim Phase 1 data and further details on EVERLAST-A study design to be shared in an oral presentation at EADV in September MENLO PARK, Calif., July 21, 2025 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis, today announced that the U.S. FDA cleared its investigational new drug (IND) application for its Phase 2a trial of ORKA-001 (the Company’s long-acting anti-IL-23p19 antibody) in moderate-to-severe psoriasis, called EVERLAST-A. “We’re thrilled by this rapid progress into Phase 2 development, and very excited to start our first psoriasis study,” said Lawrence Klein, PhD, CEO of Oruka. “We think that ORKA-001 can redefine the standard of care in this important disease with potential for once per year dosing, off-treatment remissions and higher rates of disease clearance.” The U.S. FDA cleared the Company’s IND submission to initiate EVERLAST-A. EVERLAST-A is a randomized, double-blind, placebo-controlled Phase 2a trial designed to evaluate the safety and efficacy of a single dose level of ORKA-001 in moderate-to-severe psoriasis patients. EVERLAST-A will enroll approximately 80 patients, randomized 3:1 to receive ORKA-001 or matching placebo. The primary endpoint is PASI 100 at Week 16. ORKA-001 exposures are expected to match or exceed exposures in the KNOCKOUT study, providing a definitive test of whether higher exposures of an anti-IL-23p19 antibody can lead to greater efficacy. At Week 28, patients who have achieved PASI 100, or completely clear skin, will be randomized 2:1 to either (1) an arm where they do not receive another dose until disease recurs or (2) ORKA-001 every six months. This “no-dose” arm will provide evidence for both yearly dosing and the potential for extended off-treatment remissions. Patients who have not yet achieved PASI 100 at Week 28 will receive ORKA-001 every six months. Additional details on the EVERLAST-A design, as well as interim data from the ORKA-001 Phase 1 study, will be presented at the European Academy of Dermatology and Venereology (EADV) Congress in September. The Company expects to share efficacy and response duration data from EVERLAST-A in 2H 2026. "We have made great strides in our ability to treat psoriatic disease, but many patients are still seeking improved treatment options. I’m excited about EVERLAST-A and the potential that ORKA-001 could enable long dosing intervals and greater efficacy than current IL-23 inhibiting medications. There is evidence now that these improvements could be within reach, and they would be a significant step forward for both patients and the field,” commented Bruce Strober, MD, PhD, the lead Principal Investigator on the EVERLAST-A study on behalf of Oruka’s Scientific Advisory Board. Oruka’s Scientific Advisory Board played a key role in designing the EVERLAST clinical program. Other SAB members include Drs. Andy Blauvelt, Joel Gelfand, Johann Gudjonsson, Mark Lebwohl, James Kreuger, and Joe Merola, all leading physicians whose work has underpinned advances in the psoriasis treatment landscape over the last 25 years. About ORKA-001 ORKA-001 is a novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-23p19. Inhibitors of IL-23p19 have become the preferred first-line therapy for patients with moderate-to-severe PsO given their strong efficacy and safety profile. Currently approved therapies are dosed four to six times per year and deliver PASI 100, or fully clear skin, for less than half of patients after four months. ORKA-001 has the potential to be dosed just once or twice a year and is designed to achieve higher exposures than currently marketed IL-23p19 antibodies, which could lead to higher rates of disease clearance. Data from studies in non-human primates and other preclinical assays show that ORKA-001 binds to a similar epitope with similar affinity as risankizumab and has a significantly extended half-life over three times longer than risankizumab. About Oruka Therapeutics Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice a year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com and follow Oruka on LinkedIn. Financial Disclosures Oruka’s SAB members receive compensation as scientific advisors. Forward Looking Statements Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Oruka’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, Oruka’s ability to achieve the expected benefits or opportunities with respect to ORKA-001, including timelines to clinical and data release milestones, the details of its clinical studies, the potential half-life and exposures of ORKA-001 and its potential dosing interval as well as the potential of ORKA-001 treatment to lead to off-treatment remissions and/or higher rates of disease clearance than other treatments. There can be no assurance that future developments affecting Oruka will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Oruka's control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those uncertainties and factors described under the heading “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in Oruka’s most recent filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K, its Quarterly Reports on Form 10-Q and its registration statement on Form S-1. Should one or more of these risks or uncertainties materialize, or should any of Oruka’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein and in Oruka’s SEC filings. Oruka does not undertake or accept any duty to make any updates or revisions to any forward-looking statements. Investor Contact: Alan Lada (650)-606-7911 alan.lada@orukatx.com

临床2期临床1期临床申请

100 项与利生奇珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	利生奇珠单抗	L04AC18	DB14762

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
活动性中度克罗恩病	中国	AbbVie, Inc.	2025-03-04
活动性重度克罗恩病	中国	AbbVie, Inc.	2025-03-04
溃疡性结肠炎	日本	AbbVie, Inc.	2022-09-26
克罗恩病	澳大利亚	AbbVie Pty Ltd.	2019-07-16
活动性中度溃疡性结肠炎	澳大利亚	AbbVie Pty Ltd.	2019-07-16
活动性重度溃疡性结肠炎	澳大利亚	AbbVie Pty Ltd.	2019-07-16
斑块状银屑病	加拿大	AbbVie, Inc.	2019-04-17
银屑病关节炎	日本	AbbVie, Inc.	2019-03-26
红皮病性银屑病	日本	AbbVie, Inc.	2019-03-26
寻常性银屑病	日本	AbbVie, Inc.	2019-03-26
脓疱型银屑病	日本	AbbVie, Inc.	2019-03-26
手掌和足底脓疱病	日本	AbbVie, Inc.	2019-03-26

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
幼年特发性关节炎	临床3期	美国	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	澳大利亚	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	加拿大	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	法国	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	德国	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	意大利	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	波兰	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	西班牙	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	英国	AbbVie, Inc.	2024-07-08
掌跖角化病	临床3期	美国	AbbVie, Inc.	2021-02-26

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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


NCT04435600 (OptIMMize-1, CTgov)	临床3期	斑块状银屑病 \| 慢性大斑块银屑病	139	Risankizumab (Part 1: Risankizumab)	鬱齋範遞選繭網憲願壓 = 壓簾壓獵選鬱膚衊願製艱鹽膚鹹構顧襯簾襯餘 (繭齋壓構膚製範餘獵網, 壓築襯膚壓鹽繭憲鑰膚 ~ 襯壓遞構鹹鏇製築夢鏇) 更多	-	2025-05-20
				Ustekinumab (Part 2 Period A: Ustekinumab)	鬱齋範遞選繭網憲願壓 = 鑰鏇構襯夢鏇窪壓構選艱鹽膚鹹構顧襯簾襯餘 (繭齋壓構膚製範餘獵網, 築壓廠膚憲願醖醖淵蓋 ~ 廠築艱齋膚窪糧範築餘) 更多
ADVANCE, MOTIVATE, FORTIFY (Pubmed \| J Crohns Colitis)	临床3期	克罗恩病引起的肛周瘘维持 high-sensitivity C-reactive protein (hs-CRP) \| fecal calprotectin (FCP)	748	Risankizumab 600 mg	鑰壓醖積衊餘範餘廠網(簾窪衊憲繭淵蓋選餘夢) = 鹽鏇網願鏇鑰願淵憲齋遞憲艱選製膚蓋鹹窪壓 (構淵膚膚網築壓襯鏇鏇 ) 更多	积极	2025-04-04
				Risankizumab 180 mg	鑰壓醖積衊餘範餘廠網(簾窪衊憲繭淵蓋選餘夢) = 廠鑰窪艱繭艱窪構窪願遞憲艱選製膚蓋鹹窪壓 (構淵膚膚網築壓襯鏇鏇 ) 更多
NCT03105128 (MOTIVATE, ADVANCE, FORTIFY, Pubmed \| Clin Gastroenterol Hepatol)	临床3期	克罗恩病引起的肛周瘘 anti-interleukin-23 p19 monoclonal antibody	-	Risankizumab 1200 mg IV	鹹鹽鬱淵襯鹹艱淵艱鏇(蓋製獵鬱醖鬱構壓鏇壓) = 淵艱蓋製觸淵鬱鑰築願齋窪鹹製襯廠構夢選餘 (簾齋獵艱獵齋醖築襯顧 ) 更多	积极	2025-02-01
				Risankizumab 180 mg SC	鹹鹽鬱淵襯鹹艱淵艱鏇(蓋製獵鬱醖鬱構壓鏇壓) = 觸膚顧壓膚膚壓衊膚鹹齋窪鹹製襯廠構夢選餘 (簾齋獵艱獵齋醖築襯顧 ) 更多
FORTIFY (Pubmed \| Gastro Hep Adv)	临床3期	克罗恩病维持	-	Risankizumab	觸夢廠簾憲遞鏇鹽獵餘(淵範鏇膚廠襯範鬱壓醖) = 鏇膚獵鏇積網艱鹹鏇鬱齋範夢鏇顧艱膚艱齋蓋 (鏇築遞醖鹹憲蓋鑰衊觸 )	积极	2025-01-01
NCT03047395 (LIMMitless, CTgov)	临床3期	斑块状银屑病 \| 慢性大斑块银屑病	2,170	Risankizumab	衊構艱築選鬱齋蓋簾膚 = 憲淵廠築獵鹹觸簾構構憲鬱製膚範蓋築積廠糧 (齋構鏇夢簾艱觸壓簾糧, 夢齋遞艱構遞醖築積鬱 ~ 膚壓選壓顧夢鏇餘夢獵) 更多	-	2024-12-11
NCT04524611 (SEQUENCE, UEGW2024)	临床3期	克罗恩病	-	Risankizumab	衊願醖淵築糧範鏇鬱構(繭構齋醖糧艱築糧壓齋) = 網壓範構鏇醖襯壓築蓋簾鏇襯壓遞鬱鹹鹽壓遞 (鹽壓艱蓋範齋繭醖壓蓋, 48.2 ~ 79.6) 更多	积极	2024-10-13
				Ustekinumab	衊願醖淵築糧範鏇鬱構(繭構齋醖糧艱築糧壓齋) = 鹽齋獵艱鹹鑰鬱壓糧構簾鏇襯壓遞鬱鹹鹽壓遞 (鹽壓艱蓋範齋繭醖壓蓋, 36.2 ~ 66.1) 更多
UEGW2024	N/A	克罗恩病引起的肛周瘘	-	Risankizumab	艱鹹願觸築製鏇鹹醖範(窪繭膚顧鹹糧窪鑰餘衊) = documented in 12.6% (32/253) of patients, including fatigue, pruritus, nausea, joint pain, and upper-respiratory tract infection 襯餘鏇觸選範膚衊網願 (構蓋繭醖選艱壓蓋餘醖 ) 更多	-	2024-10-13
				Risankizumab (Ustekinumab-naïve patients)
NCT04524611 (SEQUENCE, UEGW2024)	临床3期	克罗恩病	-	Risankizumab	網選遞艱蓋夢積淵積糧(膚選窪積觸夢餘獵艱選) = 窪顧夢鑰糧鏇積蓋齋衊構構鬱築壓齋獵廠顧範 (願積窪膚網選繭製鬱鏇 ) 更多	积极	2024-10-13
				Ustekinumab	網選遞艱蓋夢積淵積糧(膚選窪積觸夢餘獵艱選) = 觸夢築壓糧壓鬱蓋願窪構構鬱築壓齋獵廠顧範 (願積窪膚網選繭製鬱鏇 ) 更多
UEGW2024	N/A	活动性中度溃疡性结肠炎	-	Risankizumab 1200 mg IV	選製鹹憲齋獵製網蓋鹽(繭範鑰窪遞窪膚齋構積) = 網鬱遞鹽窪簾網醖網艱鹹鹽鹽鑰醖餘顧憲廠餘 (衊獵顧淵網齋繭鹽蓋襯 )	-	2024-10-13
				Placebo IV	選製鹹憲齋獵製網蓋鹽(繭範鑰窪遞窪膚齋構積) = 蓋積選鏇獵鏇憲襯齋構鹹鹽鹽鑰醖餘顧憲廠餘 (衊獵顧淵網齋繭鹽蓋襯 )
NCT03398148 \| NCT03398135 (INSPIRE \| COMMAND, UEGW2024)	临床3期	溃疡性结肠炎维持 high-sensitivity C-reactive protein	650	Risankizumab 1200 mg IV	蓋築簾獵廠糧蓋鑰糧夢(製鹽廠蓋鏇遞範築觸鬱) = 淵製願遞齋選廠製艱廠積艱衊獵衊糧簾窪淵餘 (鏇齋選醖鹽窪艱獵選鑰, 18.4 ~ 26.8) 更多	积极	2024-10-13
				Placebo IV	蓋築簾獵廠糧蓋鑰糧夢(製鹽廠蓋鏇遞範築觸鬱) = 夢鏇網簾鑰夢衊繭鹽顧積艱衊獵衊糧簾窪淵餘 (鏇齋選醖鹽窪艱獵選鑰, 4.1 ~ 11.9) 更多