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更新于：2025-08-01
Icotrokinra
更新于：2025-08-01
概要
基本信息
最高研发阶段申请上市 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评- |
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结构/序列
Sequence Code 1311911322
来源: *****
关联
29
项与 Icotrokinra 相关的临床试验CTRI/2025/04/084956
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-experienced Participants with Active Psoriatic Arthritis - ICONIC-PsA 2
开始日期2025-05-16 |
申办/合作机构- |
CTRI/2025/04/084370
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-na ve Participants with Active Psoriatic Arthritis - ICONIC-PsA 1
开始日期2025-05-08 |
申办/合作机构- |
NCT06934226
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Ustekinumab Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
The main purpose of this study is to assess how well JNJ-77242113 works when compared to placebo and ustekinumab in participants with moderate to severe plaque psoriasis.
开始日期2025-04-15 |
100 项与 Icotrokinra 相关的临床结果
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100 项与 Icotrokinra 相关的转化医学
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100 项与 Icotrokinra 相关的专利（医药）
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6
项与 Icotrokinra 相关的文献（医药）2025-03-01·JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
FRONTIER-2: A phase 2b, long-term extension, dose-ranging study of oral JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis
Article
作者: Ferris, Laura K ; Iaconangelo, Charles ; Tyring, Stephen K ; Huang, Yu-Huei ; Ota, Takayuki ; Shen, Yaung-Kaung ; Bissonnette, Robert ; Pink, Andrew E ; Bagel, Jerry ; Kokolakis, Georgios ; Li, Shu ; DeLozier, Amy M
BACKGROUND:
More patients with moderate-to-severe plaque psoriasis achieved responses with JNJ-77242113, a targeted oral peptide inhibiting interleukin-23 receptor signaling, versus placebo (PBO) at week (W)16 of the phase 2 FRONTIER-1 study.
OBJECTIVE:
FRONTIER-2, a long-term extension of FRONTIER-1, evaluated JNJ-77242113 through 1 year.
METHODS:
FRONTIER-1 participants received JNJ-77242113 at doses from 25 mg daily to 100 mg twice daily or PBO through W16. Patients completing FRONTIER-1 could enroll in FRONTIER-2 and continue JNJ-77242113 at the same dose through W52. Those on PBO crossed over to JNJ-77242113 100 mg daily for W16-52. Safety follow-up continued through W56.
RESULTS:
Most (89%) FRONTIER-1 patients continued to FRONTIER-2. Across outcomes, response rates were maintained from W16-52. The highest response rates generally occurred with JNJ-77242113 100 mg twice daily. At W52, 76% of patients achieved up to 75% improvement in Psoriasis Area and Severity Index (PASI75) with 100 mg twice daily; rates of clear or almost clear skin were 64% (PASI90), 74% (Investigator's Global Assessment 0/1), 40% (PASI100), and 43% (Investigator's Global Assessment 0). From W16-56, 59% of JNJ-77242113-treated patients had ≥1 adverse events. Serious adverse events, considered unrelated to treatment by investigators, occurred in 4% of patients.
LIMITATIONS:
The study was limited by the small number of patients in each treatment group and the descriptive nature of the longer-term data.
CONCLUSION:
Rates of skin clearance with JNJ-77242113 were durable to 1 year and no safety signals were identified.
2025-02-01·The Journal of clinical and aesthetic dermatology
From the Masterclasses in Dermatology 2024 Meeting: Updates in Psoriasis Treatments.
Review
作者: Merola, Joseph F ; Gottlieb, Alice B ; Childs, Beth ; Romanelli, Sarah
Psoriasis (PsO) is an immune-mediated, chronic inflammatory skin disease that significantly impairs quality of life. Its treatment landscape is rapidly evolving, providing better disease control. Here, we highlight updates in biologics, obtaining coverage for biologics under Medicare, the PsO-to-psoriatic arthritis (PsA) transition, and orally administered drugs, as presented at the 2024 Masterclass in Dermatology in Puerto Rico. We provide a concise overview of the evolving therapeutic landscape and its impact on personalized care for patients with PsO. The toolkit of biologics is expanding, with agents that target interleukin (IL)-17 and IL-23 pathways addressing symptoms across multiple disease domains. Interchangeable biosimilars reduce financial barriers to access, particularly for tumor necrosis factor (TNF) inhibitors. An IL-36 receptor antibody, spesolimab, demonstrates efficacy in generalized pustular psoriasis. Further, Medicare has expanded coverage of certain biologics, addressing challenges to treating patients of this population. PsA is an important comorbidity that can significantly reduce quality of life. Recent studies suggest that biologic therapies-including TNF inhibitors, as well as anti-IL-17, anti-IL-23, and anti-IL-12/23 agents-protect against arthritis onset in PsO patients. In addition to traditional modes of delivery, novel formulations address widespread preference for orally administered therapies. Deucravacitinib, a tyrosine kinase (TYK) 2 inhibitor, is highly selective, effective, and safe. Additionally, JNJ-77242113, an investigational IL-23 receptor antagonist, constitutes an orally administered, targeted biologic therapy. Together, these developments are shaping the future for patients with PsO. It is our goal to simplify the complexities of emerging treatment options, offering clinicians a concise and useful guide for patient management.
2024-02-08·The New England journal of medicine1区 · 医学
An Oral Interleukin-23–Receptor Antagonist Peptide for Plaque Psoriasis
1区 · 医学
Article
作者: Li, Shu ; Papp, Kim ; Kannan, Arun ; Bissonnette, Robert ; Shen, Yaung-Kaung ; Pinter, Andreas ; Ferris, Laura K. ; Miller, Megan ; Vender, Ronald ; Gerdes, Sascha ; Rich, Phoebe ; DeKlotz, Cynthia
BACKGROUND:
The use of monoclonal antibodies has changed the treatment of several immune-mediated inflammatory diseases, including psoriasis. However, these large proteins must be administered by injection. JNJ-77242113 is a novel, orally administered interleukin-23-receptor antagonist peptide that selectively blocks interleukin-23 signaling and downstream cytokine production.
METHODS:
In this phase 2 dose-finding trial, we randomly assigned patients with moderate-to-severe plaque psoriasis to receive JNJ-77242113 at a dose of 25 mg once daily, 25 mg twice daily, 50 mg once daily, 100 mg once daily, or 100 mg twice daily or placebo for 16 weeks. The primary end point was a reduction from baseline of at least 75% in the Psoriasis Area and Severity Index (PASI) score (PASI 75 response; PASI scores range from 0 to 72, with higher scores indicating greater extent or severity of psoriasis) at week 16.
RESULTS:
A total of 255 patients underwent randomization. The mean PASI score at baseline was 19.1. The mean duration of psoriasis was 18.2 years, and 78% of the patients across all the trial groups had previously received systemic treatments. At week 16, the percentages of patients with a PASI 75 response were higher among those in the JNJ-77242113 groups (37%, 51%, 58%, 65%, and 79% in the 25-mg once-daily, 25-mg twice-daily, 50-mg once-daily, 100-mg once-daily, and 100-mg twice-daily groups, respectively) than among those in the placebo group (9%), a finding that showed a significant dose-response relationship (P<0.001). The most common adverse events included coronavirus disease 2019 (in 12% of the patients in the placebo group and in 11% of those across the JNJ-77242113 dose groups) and nasopharyngitis (in 5% and 7%, respectively). The percentages of patients who had at least one adverse event were similar in the combined JNJ-77242113 dose group (52%) and the placebo group (51%). There was no evidence of a dose-related increase in adverse events across the JNJ-77242113 dose groups.
CONCLUSIONS:
After 16 weeks of once- or twice-daily oral administration, treatment with the interleukin-23-receptor antagonist peptide JNJ-77242113 showed greater efficacy than placebo in patients with moderate-to-severe plaque psoriasis. (Funded by Janssen Research and Development; FRONTIER 1 ClinicalTrials.gov number, NCT05223868.).
225
项与 Icotrokinra 相关的新闻（医药）2025-07-26
·药明康德
近期，全球多肽和寡核苷酸（TIDES）领域迎来系列进展。浩博医药旨在治疗慢性乙型肝炎以实现功能性治愈的反义寡核苷酸（ASO）疗法AHB-137在中国获批启动3期临床试验。Avidity Biosciences公司用于治疗杜氏肌营养不良（DMD）的在研疗法delpacibart zotadirsen（del-zota）获得美国FDA授予的突破性疗法认定，公司计划在2025年年底按计划向FDA提交上市申请。Ionis Pharmaceuticals公司用于治疗遗传性血管性水肿（HAE）的在研ASO疗法donidalorsen的3期临床试验结果积极，有望近期获FDA批准上市。本文将节选其中部分重要进展做简单介绍，仅供读者参阅。AHB-137：在中国获批启动3期临床试验浩博医药宣布，中国国家药品监督管理局（NMPA）药品审评中心（CDE）已批准AHB-137启动3期临床试验。AHB–137是一种ASO疗法，旨在治疗慢性乙型肝炎以实现功能性治愈。该疗法通过与乙肝病毒的RNA精准匹配，招募肝细胞中的酶摧毁来自病毒的RNA，从而中止乙肝病毒的复制和病毒蛋白的产生。此次3期临床试验为一项在中国开展的随机、双盲、多中心研究，旨在评估治疗为期24周、剂量300 mg的AHB-137在接受稳定核苷（酸）类似物治疗的乙型肝炎e抗原（HBeAg）阴性慢性乙型肝炎患者中的疗效与安全性。浩博医药此前新闻稿表示，AHB-137治疗可以使乙型肝炎表面抗原（HBsAg）快速下降并诱导较高的乙肝表面抗体转阳。AHB-137在临床2b期试验中展现出令人振奋的有效性数据和良好的安全性数据，进一步确认了其在2a期试验中展现的临床疗效。此次3期临床试验的获批，是浩博医药向实现慢性乙肝临床治愈目标迈出的关键一步。Delpacibart zotadirsen（del-zota）：获FDA授予的突破性疗法认定Avidity Biosciences公司宣布，其用于治疗DMD的在研疗法del-zota获得了美国FDA授予的突破性疗法认定，用于治疗适用于外显子44跳跃治疗的杜氏肌营养不良（DMD44）患者。该疗法目前正在进行2期EXPLORE44开放标签延伸试验（EXPLORE44-OLE）。Avidity预计将在2025年年底按计划向FDA提交生物制品许可申请（BLA）。之前公布的研究结果显示，剂量为5 mg/kg和10 mg/kg的del-zota均表现出强有力的骨骼肌递送能力，骨骼肌中寡核苷酸水平达到200 nM。外显子44跳跃效率显著增加40%。抗肌萎缩蛋白生成显著增加，平均增加至正常水平的25%，最高达到正常水平的58%。肌酸激酶水平下降至接近正常水平，相比基线减少了超过80%。Del-zota由靶向1型转铁蛋白受体（TfR1）的单克隆抗体和促进编码抗肌萎缩蛋白的mRNA前体产生外显子44跳跃的寡核苷酸偶联而成，TfR1在肌肉组织中高度表达。这款疗法通过改变mRNA剪接过程，产生几乎与正常抗肌萎缩蛋白功能相同的蛋白。靶向TfR1的单克隆抗体可以通过与肌肉细胞表面的受体相结合，增强寡核苷酸的肌肉特异性递送。Donidalorsen：公布3期临床试验结果Ionis Pharmaceuticals公司宣布，其用于治疗遗传性血管性水肿的在研ASO疗法donidalorsen在3期OASISplus研究中取得积极结果。作为一种靶向前激肽释放酶（PKK）的在研ASO疗法，donidalorsen旨在通过抑制PKK的生成来预防HAE急性发作。Donidalorsen目前正在接受美国FDA的审评，以作为HAE的潜在“first-in-class”预防性治疗药物，该申请的PDUFA日期为8月21日。研究中，患者依照预设的标准化方案从原有治疗过渡至donidalorsen，在此过程中未观察到疾病发作增加。治疗16周后，患者的平均HAE发作频率相较于既往治疗进一步显著降低。血管性水肿控制测试（AECT）评分亦显示，药物切换后报告疾病控制良好的患者比例从67%升至93%，不论使用哪种既往治疗，患者的生活质量评估也获得普遍改善。Icotrokinra（JNJ-2113）：向美国FDA提交NDA强生（Johnson & Johnson）与Protagonist Therapeutics公司宣布，已向美国FDA提交新药申请（NDA），寻求批准其在研、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。Icotrokinra是一款潜在“first-in-class”的靶向口服多肽，能够选择性阻断IL-23受体（IL-23R）。IL-23在中度至重度斑块状PsO的致病性T细胞活化中起着关键作用，是PsO和其他皮肤病、风湿病和IL-23介导肠胃病中炎症反应的基础。Icotrokinra能够以个位数的皮摩尔亲和力与IL-23R结合，并对人类T细胞中的IL-23信号转导产生强效的选择性抑制作用。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。Icotrokinra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PsO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。司美格鲁肽：在中国获批新适应症诺和诺德（Novo Nordisk）宣布，NMPA正式批准了司美格鲁肽注射液新增慢性肾脏病（CKD）适应症。这是一款胰高血糖素样肽‑1（GLP-1）受体激动剂，目前该产品已经获批用于降低伴有慢性肾脏病的2型糖尿病成人患者估算肾小球滤过率（eGFR）持续下降、终末期肾病和心血管死亡的风险。司美格鲁肽注射液此前已在中国获批用于饮食运动、二甲双胍和/或磺脲类药物治疗后血糖不达标的成人2型糖尿病（T2DM），及降低T2DM合并心血管疾病患者的主要心血管不良事件风险，并在心血管结局试验SUSTAIN 6研究中展现出潜在肾脏保护作用：可降低T2DM合并心血管疾病或高风险患者的肾脏复合事件风险达36%。YKYY029注射液：在中国获批临床悦康药业宣布，YKYY029注射液获得临床试验默示许可，拟开发治疗高血压。这是悦康药业子公司悦康科创和杭州天龙自主开发的AGT基因靶向小干扰RNA（siRNA）药物，具有全新的序列。YKYY029注射液作为一款siRNA药物，其独特之处在于偶联了悦康药业研发的GalNAc递送系统，能够实现高效的肝靶向递送。该产品通过siRNA的干扰沉默机制，从源头靶向沉默AGT mRNA，有效阻断AGT蛋白的合成。AGT蛋白为肾素-血管紧张素-醛固酮系统（RAAS）的上游蛋白，抑制其表达将从根本上抑制RAAS系统升高血压的作用，从而降低血压。参考资料（可上下滑动查看）[1] 诺和泰®新增慢性肾脏病适应症，开启GLP-1RA糖尿病肾病综合管理新时代. Retrieved July 21, 2025, from https://www.prnasia.com/story/497073-1.shtml[2] 重磅！悦康药业YKYY029注射液获国家药品监督管理局临床试验批准. Retrieved July 21, 2025, from https://mp.weixin.qq.com/s/8VUKULyWhoIAc-n9scbfbQ[3] 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.html[4] Phase 3 OASISplus data demonstrating benefit of donidalorsen for HAE patients who switched from other prophylactics published in JACI In Practice. Retrieved July 22, 2025 from https://ir.ionis.com/news-releases/news-release-details/phase-3-oasisplus-data-demonstrating-benefit-donidalorsen-hae[5] AusperBio Receives China CDE Clearance to Advance AHB-137 into Phase III Clinical Trial for Chronic Hepatitis B. Retrieved July 21, 2025 from https://www.prnewswire.com/news-releases/ausperbio-receives-china-cde-clearance-to-advance-ahb-137-into-phase-iii-clinical-trial-for-chronic-hepatitis-b-302509921.html[6] Avidity Biosciences Receives FDA Breakthrough Therapy Designation for Delpacibart Zotadirsen (del-zota) for the Treatment of DMD in People with Mutations Amenable to Exon 44 Skipping. Retried July 23, 2025 from https://www.prnewswire.com/news-releases/avidity-biosciences-receives-fda-breakthrough-therapy-designation-for-delpacibart-zotadirsen-del-zota-for-the-treatment-of-dmd-in-people-with-mutations-amenable-to-exon-44-skipping-302511334.html免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新
突破性疗法临床3期快速通道上市批准临床结果
2025-07-26
点击蓝字关注我们本周，热点不少。首先是审批审批方面，扬子江和Replimune悲欢各不相同，扬子江药业1类新药妥诺达非获NMPA批准上市，而Replimune的溶瘤病毒+PD-1联合疗法被FDA拒绝批准；其次是研发方面，也是有人欢喜有人愁，多个药临床取得阶段成功，比如，可自行给药的阿斯利康纳米抗体Ⅲ期成功，但是罗氏first-in-class抗体Astegolimab的Ⅲ期临床研究却失败了；再次是交易及投融资方面，本周大额投资不多，值得一提的就是，科弈药业BCMA/CD19双靶CAR-T授权出海，总交易额超21亿美元；最后是上市方面，维立志博在港交所正式上市。本周盘点包括审评审批、研发、交易及投融资以及上市四大板块，统计时间为2025.7.21-7.25，包含27条信息。 审评审批NMPA上市批准1、7月25日，NMPA官网显示，扬子江的1类新药盐酸妥诺达非片获批上市，用于勃起功能障碍（ED）。妥诺达非片是一种磷酸二酯酶5（PDE5）抑制剂，国内已有5款原研PDE5抑制剂上市，分别是西地那非（2002/10，辉瑞）、伐地那非（2004/07，GSK/拜耳）、他达拉非（2004/12，礼来）、爱地那非（2021/12，悦康药业）、以及司美那非（2025/7，旺山旺水）。申请2、7月24日，CDE官网显示，艾力斯的三代EGFR-TKI甲磺酸伏美替尼片申报新适应症，用于治疗既往经含铂化疗治疗时或治疗后出现疾病进展，或不耐受含铂化疗，并且经检测确认存在表皮生长因子受体20外显子插入突变（EGFRexon20ins）的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者。伏美替尼于2021年3月获NMPA附条件批准上市。3、7月24日，CDE官网显示，拜耳的1类新药BAY2927088（sevabertinib）申报上市，用于治疗携带HER2（ERBB2）激活突变且既往接受过一种全身性治疗的晚期非小细胞肺癌（NSCLC）成人患者。BAY2927088是拜耳开发的一款口服非共价可逆选择性酪氨酸激酶抑制剂，对携带EGFR和HER2突变（包括HER2exon20插入突变）的肿瘤有抑制活性。4、7月25日，CDE官网显示，康方生物的依沃西单抗新适应症申报上市，联合化疗一线治疗晚期鳞状非小细胞肺癌（sq-NSCLC）。依沃西单抗是康方生物自主研发的、全球首创PD-1/VEGF双特异性肿瘤免疫治疗药物，于2024年5月首次获NMPA批准上市，目前已获批两项适应症。临床批准5、7月22日，CDE官网显示，远大医药的放射性核素偶联药物（RDC）TLX591获批一项前瞻性、随机、对照、开放标签、国际多中心的Ⅲ期临床，拟在中国、美国、澳大利亚、新西兰及欧洲等全球多个国家和地区入组500余名患者，旨在评估TLX591联合标准治疗与仅接受标准治疗相比，在既往接受过雄激素受体通路抑制剂（ARPI）治疗进展的转移性去势抵抗性前列腺癌患者（mCRPC）中的疗效和安全性。6、7月22日，CDE官网显示，正大天晴的TQB2825注射液（皮下注射）获批临床，拟用于CD20阳性血液肿瘤的治疗，包括但不限于弥漫大B细胞淋巴瘤、滤泡性淋巴瘤、套细胞淋巴瘤和边缘区淋巴瘤等。TQB2825是一种全球创新的CD3/CD20双特异性抗体。7、7月23日，CDE官网显示，百济神州的BGB-45035片获批临床，用于治疗类风湿性关节炎。这是继特应性皮炎和结节性痒疹后，BGB-45035获批的第三项临床。BGB-45035是一款靶向白细胞介素1受体相关激酶4（IRAK4）的蛋白降解剂（CDAC）。优先审评8、7月25日，CDE官网显示，第一三共与阿斯利康共同开发的德曲妥珠单抗新适应症拟纳入优先审评，用于HER2阳性乳腺癌患者新辅助治疗。德曲妥珠单抗是采用第一三共的独有技术设计的一款靶向HER2的DXdADC，已在我国获批了4项适应症，其中两项是乳腺癌相关适应症。FDA上市申请9、7月21日，FDA官网显示，BMS的TYK2抑制剂氘可来昔替尼新适应症申报上市，用于治疗活动性银屑病关节炎，PDUFA日期为2026年3月6日。氘可来昔替尼是一款酪氨酸激酶2（TYK2）抑制剂，2022年9月，在美国获批上市，用于成人斑块状银屑病。2023年10月，国内获批上市，用于治疗适合系统治疗或光疗的成年中重度斑块状银屑病患者。10、7月21日，FDA官网显示，强生的Icotrokinra申报上市，用于治疗12岁及以上成人和青少年的中重度斑块状银屑病（PsO）。这是一款全球首创在研靶向口服肽类药物，可选择性阻断白细胞介素-23（IL-23）受体，由Protagonist Therapeutics原研，2017年，强生与Protagonist Therapeutics就开发一代IL-23R药物达成许可和合作协议。11、7月22日，Replimune宣布，收到FDA就RP1联合纳武利尤单抗治疗晚期黑色素瘤的生物制品许可申请（BLA）发出的完整回复函（CRL）。FDA在CRL中表示，IGNYTE研究不是一项充分且对照良好的临床试验，无法提供证明RP1有效性的实质性证据，RP1是一款溶瘤病毒，将其专有的单纯疱疹病毒经过融合蛋白（GALV-GPR-）和GM-CSF的改造和基因武装。临床批准12、7月23日，FDA官网显示，悦康药业子公司悦康科创的YKYY029注射液获批临床，用于治疗高血压。YKYY029注射液是悦康科创和天龙药业自主开发的靶向AGT基因的小干扰核糖核酸（siRNA）药物。快速通道资格13、7月25日，FDA官网显示，劲方医药的口服KRASG12D抑制剂GFH375/VS-7375被授予快速通道资格，用于KRASG12D突变局部晚期或转移性胰腺导管腺癌（PDAC）的一线及后线治疗。GFH375目前已在中国进入Ⅱ期研究；GFH375/VS-7375在美国开展的Ⅰ/Ⅱa期研究由劲方合作伙伴Verastem Oncology于2025年启动推进。研发临床状态14、7月21日，药物临床试验登记与信息公示平台显示，海思科登记了一项多中心、随机、双盲、阳性和安慰剂对照Ⅲ期临床试验，旨在评价HSK21542注射液用于骨科手术术后镇痛的有效性及安全性。该试验拟在国内入组405人，主要终点是给药后不同时间范围内的静息疼痛情况（SPID0-t）。HSK21542是一款强效外周kappa阿片受体（KOR）选择性激动剂。15、7月22日，药物临床试验登记与信息公示平台显示，百济神州基于全面利益/风险评估，主动终止了一项BGB-30813的I期临床试验。BGB-30813是一款DGKζ抑制剂，于2023年6月首次启动I期（NCT05904496/CTR20233404），旨在评估单药治疗或与抗PD-1单克隆抗体替雷利珠单抗联合治疗在晚期或转移性实体瘤患者中的安全性、耐受性、药代动力学、药效学和初步抗肿瘤活性。16、7月22日，ClinicalTrials.gov显示，齐鲁制药启动了一项多中心、随机、双盲、对照Ⅲ期临床（n=602），旨在评估QLS31905联合化疗（白蛋白紫杉醇+吉西他滨）对比安慰剂联合化疗一线治疗CLDN18.2阳性晚期胰腺癌成人患者的有效性和安全性，主要终点是治疗第48个月的无进展生存期（PFS）。QLS31905是齐鲁制药自主研发的一款同时靶向Claudin18.2（CLDN18.2）和CD3的双特异性T细胞衔接器。17、7月23日，药物临床试验登记与信息公示平台官网显示，荣昌生物登记了一项多中心Ⅰ/Ⅱ期临床研究，Ⅰ期旨在评估ADC药物RC278的安全性、耐受性、MTD和/或MAD、RP2D、PK、免疫原性以及初步的抗肿瘤疗效；Ⅱ期旨在评估RC278在RP2D剂量水平下对多个晚期恶性实体瘤的疗效、安全性、PK和免疫原性。该试验计划在国内入组312人。18、7月23日，药物临床试验登记与信息公示平台官网显示，科伦博泰登记了一项评估SKB107治疗晚期实体瘤骨转移受试者的安全性、耐受性、药代动力学、辐射剂量学和有效性的Ⅰ期临床研究（SKB107-Ⅰ-01）。SKB107是一款放射性核素偶联药物（RDC）。临床数据19、7月21日，华东医药公布了子公司中美华东的皮肤外用制剂0.3%罗氟司特乳膏（ZORYVE）治疗中国斑块状银屑病的Ⅲ期研究。结果表明，0.3%罗氟司特乳膏在中国6岁及以上的斑块状银屑病患者中表现出积极的疗效和良好的安全性。20、7月21日，丽珠医药公布了LZM012（XKH004）对比司库奇尤单抗（可善挺）治疗伴或不伴银屑病关节炎的中度至重度斑块型银屑病患者的Ⅲ期研究结果。结果显示：治疗第12周，LZM012组和司库奇尤单抗达到PASI100的患者比例分别为49.5%和40.2%，达到非劣效标准并且达到优效标准。司库奇尤单抗是全球首款获批上市的IL-17A单抗，LZM012是丽珠医药自鑫康合生物引进的一款IL-17A/IL-17F单抗。21、7月21日，罗氏公布了全人源抗ST2单抗Astegolimab治疗慢性阻塞性肺病（COPD）的关键性Ⅲ期ARNASA研究结果。结果显示，在52周的治疗期内，Astegolimab（每2周1次）组患者出现中度和重度COPD恶化的年化发生率（AER）较安慰剂组降低了14.5%，但无统计学意义。2016年1月，基因泰克与安进达成协议，获得该药物的全球独家权益。22、7月21日，阿斯利康公布了奥希替尼联合化疗一线治疗局部晚期或转移性表皮生长因子受体突变（EGFRm）非小细胞肺癌（NSCLC）患者Ⅲ期Flaura2研究结果。结果显示，最终总生存期（OS）分析取得积极结果：奥希替尼联合培美曲塞和铂类化疗相较于奥希替尼单药治疗在关键次要终点OS方面显示出统计学显著和临床意义的改善。23、7月22日，Abivax公布了微小RNA（miRNA）药物Obefazimod（ABX464）治疗溃疡性结肠炎（UC）的两项Ⅲ期研究（ABTECT-1和ABTECT-2）结果。结果显示，两项研究都达到了主要终点。Obefazimod是Abivax开发的一种口服、全球首创（firstinclass）、增强miR-124（一种抗炎miRNA）表达的HIVRNA剪接调节因子。24、7月24日，阿斯利康公布了gefurulimab治疗抗乙酰胆碱受体（AChR）抗体阳性（Ab+）的全身型重症肌无力（gMG）成人患者的Ⅲ期研究结果。结果显示，与安慰剂相比，gefurulimab在第26周时，在重症肌无力日常生活活动能力量表（MG-ADL）总分上显示出具有统计学显著性和临床意义的、相较于基线的改善。Gefurulimab是一种迷你双抗（25kD）。交易及投融资25、7月22日，科弈药业宣布，与ERIGENLLC签署了关于科弈药业自主研发的全球首个并联增强型BCMA/CD19双靶向CAR-T产品KQ-2003的独家海外授权协议。根据协议，科弈药业将获得1500万美元开发里程碑付款，并有资格获得总金额最高达13.2亿美元的研发、注册及商业化阶段里程碑付款，此外，科弈药业还将有望获得最高8亿美元的销售分成。26、7月22日，赛诺菲宣布，收购英国Vicebio。根据协议条款，赛诺菲将以总计11.5亿美元的预付款项收购Vicebio的全部股本，并根据开发和监管里程碑的实现情况支付最高达4.5亿美元的潜在里程碑款项。此次收购为赛诺菲带来了一款针对呼吸道合胞病毒（RSV）和人偏肺病毒（hMPV）的早期联合候选疫苗。上市27、7月25日，维立志博在港交所正式上市，联席保荐人为摩根士丹利、中信证券。本次IPO最终发行定价35港元/股，所得款项净额11.793亿港元。截至目前，维立志博已开发14款候选药物，其中6款已进入临床阶段，正在进行共计10项临床试验。另外，还有8款候选药物处于临床前阶段。END智药研习社近期直播预告来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~
上市批准临床3期优先审批免疫疗法细胞疗法
2025-07-25
A roundup of the most newsworthy healthcare press releases from PR Newswire this week, including Sanofi's $1.6B acquisition and a groundbreaking surgical nerve treatment for veterans.
NEW YORK, July 25, 2025 /PRNewswire/ -- With thousands of press releases published each week, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the week's most newsworthy and popular releases, here's a recap of some major stories from the week that shouldn't be missed.
The list below includes the headline (with a link to the full text) and an excerpt from each story. Click on the press release headlines to access accompanying multimedia assets that are available for download.
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PR Newswire Weekly Health Press Release Roundup, July 21-25, 2025.
Waystar to Acquire Iodine Software, Accelerating the AI-Powered Transformation of Healthcare Payments
Waystar brings a decade-long track record of applying AI pervasively across its software platform to simplify healthcare payments. Iodine extends that leadership into clinical intelligence software, leveraging proprietary AI models trained on one of the industry's largest clinical datasets, representing more than a third of all U.S. inpatient discharges.
Vicebio, next-generation vaccine biotech, to be acquired by Sanofi for US$1.6 billion
"Vicebio and its incredibly passionate team have been driven by the ambition to develop next-generation vaccines aimed at targeting multiple life-threatening respiratory viruses simultaneously. This acquisition validates our ability to combine innovation and deep scientific expertise towards a common goal of advancing public health prevention," said Dr. Emmanuel Hanon, Chief Executive Officer of Vicebio.
Former Sandoz Inc. CEO Don DeGolyer Leads PharmaTech Startup Ategenos as Company Prepares Public Launch
Ategenos has been quietly developing a novel platform that integrates pharmaceutical science with real-time digital health technologies to address adherence in critical dose management. The company will share details on its SmartPatch platform and initial partnerships in the coming weeks.
Cambridge Innovation Institute Announces Acquisition of Integrative Healthcare Symposium and Integrative Practitioner from Diversified
"CII has been a leader in life science conferences for over three decades, and we are excited to add this new conference and publication covering other essential aspects of healthcare to our expanding CHI portfolio. The many facets of holistic medicine are growingly important within healthcare and will benefit from additional advancement via opportunities for knowledge sharing and collaboration," said Benjamin Lakin, PhD, CEO of Cambridge Innovation Institute.
Answer ALS Launches AI Drug Development Collaboration with GATC Health, Pennington Biomedical Research Center, and Tulane to Advance ALS Treatment Discovery At the center of this effort is Dr. Jeffrey Keller of Pennington Biomedical, working in close partnership with Dr. Aron Culotta of Tulane. Together, they will lead a coordinated statewide effort of connecting researchers with expertise in AI, drug discovery, neuroscience, and clinical care, while all working together to drive innovation toward ALS treatments.
Tulavi and VHSS Partner to Bring Groundbreaking Surgical Nerve Treatment to Veterans Impacted by Amputations and Traumatic Injuries
The allay™ Hydrogel Cap is a novel, fully absorbable, and entirely sutureless medical device that provides a perfectly conforming and protective barrier to the injured nerve, supporting nerve recovery while reducing the risk of neuroma formation. Once deployed, the hydrogel cap remains in place for approximately eight months, protecting the nerve and blocking axonal escape during the critical period of neuroma formation.
Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionize treatment paradigm for adults and adolescents with plaque psoriasis
"The rapid patient enrollment across our ICONIC clinical program underscores the unmet need for an advanced plaque psoriasis treatment that meaningfully addresses their needs and preferences," said Liza O'Dowd, MD, Vice President, Immunodermatology and Respiratory Disease Area Lead, Johnson & Johnson Innovative Medicine.
New Non-Invasive Glaucoma Treatment Offered for First Time in U.S.
Eyetronic therapy provides external neural stimulation to the optic nerve of patients suffering from glaucoma, a disease in which the optic nerve is permanently damaged resulting in vision loss. Glaucoma is the leading cause of irreversible blindness in the world, affecting over 4 million people in the U.S. and more than 80 million people worldwide
.
Klotho Neurosciences, Inc. Partners with AAVnerGene Inc. to Make Klotho's Gene Therapy Assets
"KLTO hopes to work with AAVnerGene for manufacturing several of our product candidates composed of a tissue-specific promoter driving our Klotho gene to produce the Klotho protein and elevated concentrations of the protein in specific, targeted tissues and organs affected by these neurologic and neuromuscular diseases," said Dr. Joseph Sinkule, the CEO of KLTO.
Fangzhou and Novo Nordisk Signed Collaboration Memorandum to Establish a New Ecosystem for Health Management
By leveraging Novo Nordisk's expertise and innovative products in diabetes and obesity treatment, Fangzhou plans to employ its smart healthcare ecosystem and robust technology infrastructure to create a comprehensive health management service. This will include medication guidance, reminders, efficacy tracking, and health education, effectively shaping the value chain in the glucose control and weight loss sector.
Avidity Biosciences Receives FDA Breakthrough Therapy Designation for Delpacibart Zotadirsen (del-zota) for the Treatment of DMD in People with Mutations Amenable to Exon 44 Skipping
DMD is a rare genetic condition that is characterized by progressive muscle damage and weakness due to the loss of dystrophin protein that typically starts at a very young age. Del-zota is designed to deliver phosphorodiamidate morpholino oligomers (PMOs) to skeletal muscle and heart tissue to specifically skip exon 44 of the dystrophin gene and enable production of near-full length dystrophin.
Novavax's H5N1 Vaccine Candidate Demonstrates Immunogenicity in Preclinical Study
Results showed that a single dose administered by either intranasal (IN) or intramuscular (IM) routes induced neutralizing antibody responses (IN: 1:54; IM: 1:1,160), at or above the 1:40 titer generally considered to be a protective antibody response. The data showed even higher levels of immunity after two doses.
For more news like this, check out all of the latest health-related releases from PR Newswire.
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 斑块状银屑病 | 申请上市 | 美国 | 2025-07-21 | |
| 银屑病关节炎 | 临床3期 | 美国 | 2025-01-09 | |
| 银屑病关节炎 | 临床3期 | 中国 | 2025-01-09 | |
| 银屑病关节炎 | 临床3期 | 日本 | 2025-01-09 | |
| 银屑病关节炎 | 临床3期 | 阿根廷 | 2025-01-09 | |
| 银屑病关节炎 | 临床3期 | 澳大利亚 | 2025-01-09 | |
| 银屑病关节炎 | 临床3期 | 巴西 | 2025-01-09 | |
| 银屑病关节炎 | 临床3期 | 保加利亚 | 2025-01-09 | |
| 银屑病关节炎 | 临床3期 | 加拿大 | 2025-01-09 | |
| 银屑病关节炎 | 临床3期 | 捷克 | 2025-01-09 |
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临床结果
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适应症
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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 |
|---|
临床1期 | - | - | 鹹願膚鑰憲夢鏇壓獵願(繭艱網夢築餘夢遞遞醖) = 夢蓋窪鏇顧網艱繭鹽鏇 繭艱衊選夢鏇窪鏇廠顧 (願膚膚構淵願鬱醖網範 ) 更多 | 积极 | 2025-07-08 | ||
Placebo | 鹹願膚鑰憲夢鏇壓獵願(繭艱網夢築餘夢遞遞醖) = 膚醖遞願網範獵廠製艱 繭艱衊選夢鏇窪鏇廠顧 (願膚膚構淵願鬱醖網範 ) 更多 | ||||||
临床3期 | 311 | 齋窪壓憲餘淵觸選淵窪(襯淵鑰顧壓憲觸網壓壓) = 範獵築夢夢淵蓋窪憲範 製襯憲鑰壓鑰獵憲壓鹽 (鹹鏇網鏇齋製遞壓鹽鹽 ) 达到 更多 | 积极 | 2025-05-09 | |||
placebo | 齋窪壓憲餘淵觸選淵窪(襯淵鑰顧壓憲觸網壓壓) = 窪鑰淵鹹襯壓憲積鹽醖 製襯憲鑰壓鑰獵憲壓鹽 (鹹鏇網鏇齋製遞壓鹽鹽 ) 达到 更多 | ||||||
临床3期 | - | 襯壓願鏇壓蓋網壓築構(顧衊衊鹹糧醖構願衊淵) = 網鹽淵鏇鑰範鹽鹽艱鹹 獵顧築艱獵鬱鹹衊鑰蓋 (獵醖遞築蓋憲鏇淵製夢 ) 更多 | 积极 | 2025-04-10 | |||
Placebo | 襯壓願鏇壓蓋網壓築構(顧衊衊鹹糧醖構願衊淵) = 製範廠膚製齋鹽繭觸齋 獵顧築艱獵鬱鹹衊鑰蓋 (獵醖遞築蓋憲鏇淵製夢 ) 更多 | ||||||
临床2期 | 252 | 範觸繭夢觸構繭夢醖膚(膚衊鹽獵衊遞繭糧觸選) = 蓋鹹餘簾糧鑰製積簾襯 鬱襯願夢獵網獵襯構齋 (壓餘襯壓願壓窪製構製 ) 达到 更多 | 积极 | 2025-03-10 | |||
Placebo | 範觸繭夢觸構繭夢醖膚(膚衊鹽獵衊遞繭糧觸選) = 遞鬱夢製壓簾遞壓鏇艱 鬱襯願夢獵網獵襯構齋 (壓餘襯壓願壓窪製構製 ) 达到 更多 | ||||||
临床3期 | - | 鏇鏇觸簾鑰鹹獵繭範選(醖網選夢醖壓壓範齋範) = 膚醖製鬱顧簾鏇艱壓範 醖願繭齋製餘廠膚獵窪 (衊醖淵鹹築積艱顧製網 ) 达到 更多 | 积极 | 2024-11-18 | |||
Placebo | 鏇鏇觸簾鑰鹹獵繭範選(醖網選夢醖壓壓範齋範) = 遞鬱築築衊蓋顧憲醖膚 醖願繭齋製餘廠膚獵窪 (衊醖淵鹹築積艱顧製網 ) 达到 更多 | ||||||
临床3期 | - | 蓋範襯簾齋衊觸獵膚鏇(艱獵齋簾願製餘蓋範製) = positive topline results from the Phase 3 ICONIC-TOTAL study showed once-daily icotrokinra met the primary endpoint of IGA of 0/1 at week 16 compared to placebo. 網夢鬱鬱齋選鬱齋鹽網 (鏇餘壓夢鏇糧積鑰選構 ) 达到 | 积极 | 2024-11-18 | |||
Placebo | |||||||
临床2期 | 227 | 範膚製願鏇衊觸夢製鑰(鑰鹹襯淵鑰鏇廠醖襯齋) = 鬱選廠餘鏇襯範餘網網 齋淵糧餘鏇鹹艱壓獵積 (餘齋範糧選鹽鹽簾顧鏇 ) 更多 | 积极 | 2024-03-09 | |||
临床2期 | 255 | JNJ-77242113 25 mg once daily | 壓範鹽繭簾鏇廠願淵淵(淵簾鹽顧觸艱網衊鬱齋) = 蓋製繭蓋窪膚鬱壓窪願 製夢夢繭獵遞膚窪網糧 (選夢願簾壓鏇觸齋繭糧 ) 达到 | 积极 | 2024-02-08 | ||
JNJ-77242113 25 mg twice daily | 壓範鹽繭簾鏇廠願淵淵(淵簾鹽顧觸艱網衊鬱齋) = 鬱齋範淵衊餘糧鑰齋鏇 製夢夢繭獵遞膚窪網糧 (選夢願簾壓鏇觸齋繭糧 ) 达到 | ||||||
临床2期 | - | 遞獵觸衊鹽範選簾齋願(繭廠築鬱襯窪鏇憲鏇餘) = similar in the combined JNJ-77242113 dose group (52%) and the placebo group (51%) 構餘淵選餘夢壓選壓憲 (膚淵構遞餘窪鏇顧願夢 ) 更多 | - | 2024-02-08 | |||
临床2期 | 255 | 膚築餘積襯蓋網積淵醖(壓繭蓋獵顧鏇鹽壓積衊) = 鬱願鑰鹽遞獵鑰鑰構鏇 築遞構膚積襯艱網鹹築 (艱鹹簾蓋觸壓餘艱獵艱 ) 达到 更多 | 积极 | 2023-07-04 | |||
膚築餘積襯蓋網積淵醖(壓繭蓋獵顧鏇鹽壓積衊) = 齋遞築鑰鹹願夢壓鑰膚 築遞構膚積襯艱網鹹築 (艱鹹簾蓋觸壓餘艱獵艱 ) 达到 更多 |
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