Hailey-Hailey disease (HHD) is a debilitating genetic skin disorder, affecting mainly body folds with erythema and painful erosions and blisters. Histopathological findings include epidermal hyperplasia, suprabasilar clefting, dyskeratosis and acantholysis of keratinocytes. A final diagnosis of HHD is usually confirmed based on clinical and histopathological findings in line with genetic testing.
Several treatment options have been proposed for this chronic and disabling disorder, however, there is no reproducibly effective therapeutic for it.
The primary objective is to evaluate the treatment response of guselkumab. Single-center, non-randomized, single-arm, open-label, phase II trial to evaluate the efficacy and safety of guselkumab for the treatment of patients with HHD.

开始日期2025-03-01

申办/合作机构

Yale University

[+1]

NCT06563323

/ Not yet recruiting临床2期IIT

A Single-arm Open-label Study Assessing Short-term (Week 6, 16) and Long-term (Week 32) Efficacy of Guselkumab in Adult Participants With Pyoderma Gangrenosum

A single-arm open-label study assessing short-term (week 6, 16) and long-term (week 32) efficacy of guselkumab in adult participants with pyoderma gangrenosum (PG)

开始日期2025-01-01

申办/合作机构

Oregon Health & Science University

[+2]

NCT06586281

/ RecruitingN/AIIT

Elucidating Shared Mechanisms Contributing to Non-Alcoholic Fatty Liver Disease (NAFLD) and Psoriatic Arthritis (PsA) Disease Severity With Guselkumab Therapy

While many studies examine Nonalcoholic fatty liver disease (NAFLD), little is known about its progression to high-risk nonalcoholic steatohepatitis (NASH) in PsA patients. Shared disease mechanisms may explain the increased severity in PsA. This study involves two visits from PsA patients with NAFLD and active disease signs (e.g., swollen joint, enthesitis, or psoriatic plaque). It aims to assess the impact of biological therapies on liver disorders, joints, and skin in PsA patients.

开始日期2025-01-01

申办/合作机构

University of California San Diego

[+1]

100 项与古塞奇尤单抗相关的临床结果

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100 项与古塞奇尤单抗相关的转化医学

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100 项与古塞奇尤单抗相关的专利（医药）

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755

项与古塞奇尤单抗相关的文献（医药）

2025-12-01·IMMUNOLOGIC RESEARCH

Residual non-specific and disease-specific inflammatory markers in successfully treated young psoriasis patients: a cross-sectional study

Article

作者: Kraner Šumenjak, Tadeja ; Merzel Šabović, Eva Klara ; Božič Mijovski, Mojca ; Janić, Miodrag

Abstract:

Psoriasis is a chronic, immune-mediated disease. The systemic inflammation triggered by psoriasis contributes significantly to increased cardiovascular risk. While various treatments completely clear the skin, the associated effects on systemic inflammation are not yet clear. We investigated residual systemic inflammation in successfully treated patients. Circulating disease-specific and non-specific inflammatory markers were measured and compared in 80 psoriasis patients (aged 30–45 years) successfully treated with topical therapy, methotrexate, adalimumab, secukinumab or guselkumab, and in 20 healthy controls. Non-specific inflammatory markers (high-sensitivity C-reactive protein (hs-CRP), complete blood count (CBC) parameters, neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), mean platelet volume-to-platelet ratio (MPR), and red blood cell distribution width-to-platelet ratio (RPR)) and disease-specific inflammatory markers (interferon-γ (IFN-γ), tumor necrosis factor (TNF), interleukin (IL)-1β, IL-12p70, IL-17, and IL-23) were measured and compared between groups. Disease-specific cytokines (IFN-γ, TNF, IL-1β, IL-12p70, and IL-17, but not IL-23), were significantly elevated in patients compared to controls, while non-specific inflammatory markers showed no differences compared to controls. The residual disease-specific cytokines were similarly elevated in all five treated groups. In addition, they correlated significantly with body mass index (BMI) and waist circumference. Our results suggest that psoriasis patients have elevated residual disease-specific cytokines despite successful treatment, while the non-specific inflammatory markers are similar to those in control subjects. Residual disease-specific inflammatory markers correlated with BMI and waist circumference. A possible beneficial effect of body weight control in psoriasis patients merits further investigation. The study was registered at http://clinicaltrials.gov (identifier: NCT05957120) on July 24, 2023.

2025-03-01·AMERICAN JOURNAL OF CLINICAL DERMATOLOGY

The Impact of Family History on Clinical Presentation and Biologic Treatment Response in Patients with Psoriasis: A Multicenter Prospective Cohort Study

Article

作者: Zhong, Xiaoyuan ; Wang, Yu ; Shi, Yuling ; Liu, Xiaoke ; Ma, Rui ; Yao, Lingling ; Jiang, Yuxiong ; Huang, Dawei ; Lu, Jiajing ; Zhang, Xilin ; Li, Ying ; Xu, Shuang

BACKGROUND:

Family history (FH) of psoriasis has been implicated as a risk factor for developing psoriasis. However, whether FH also carries information on clinical presentation and treatment response to biological agents in patients with psoriasis remains unclear.

OBJECTIVE:

This prospective, multicenter observational study aimed to analyze the clinical presentation and efficacy differences between patients with psoriasis with and without a FH.

PATIENTS AND METHODS:

The SPEECH registry is an observational, multicenter, and prospective registry that has been collecting data on psoriasis treatment since November 2022. This study included adult patients diagnosed with moderate-to-severe plaque psoriasis initiating treatment with biologics, including guselkumab, secukinumab, ixekizumab, ustekinumab, and adalimumab. FH of psoriasis was identified through patient self-report in which a positive FH was defined as a first-degree relative having psoriasis. The primary outcome measures include 75% improvement in Psoriasis Area and Severity Index (PASI75) and the Physician's Global Assessment score of cleared/minimal (PGA 0/1) after 3 months of treatment. Logistic regression was employed to determine the adjusted odds ratios (aOR) and 95% confidence intervals (CI) for the achievement of response in selected outcomes for patients with a FH compared with those without a FH.

RESULTS:

The study included a total of 859 patients, of whom 22.9% had a FH of psoriasis. Patients with psoriasis who had a FH experienced an earlier onset of the disease and more severe anxiety symptoms than those without a FH. After 3 months of treatment, patients with psoriasis with a FH exhibited a higher likelihood of achieving PASI75 (aOR 1.60 [95% CI 1.02, 2.51]) and PGA 0/1 (aOR 1.54 [95% CI 1.03, 2.31]). Notably, these differences persisted after 6 months of treatment, confirming the sustained effectiveness of biologic treatments in patients with a positive FH. Further mediation analysis uncovered a significant indirect effect of FH on the treatment response to biologics through age of onset (p = 0.028), and the proportion mediated was 20.5%.

CONCLUSION:

FH of psoriasis may affect the clinical course of patients and enhance their treatment response to biologics, highlighting the importance of FH assessment in optimizing treatment outcome and guiding clinical decision of biologic selection. Future studies on biologic treatment responses in psoriasis should consider family history as a significant confounding factor.

CHINESE CLINICAL TRIAL REGISTRY:

ChiCTR2000036186.

2025-03-01·JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY

Effectiveness of guselkumab in patients with facial and/or genital psoriasis: Interim analysis results at Week 12 from the GULLIVER study

Article

作者: Romanelli, M. ; Atzori, L. ; Prignano, F. ; Micali, G. ; Satolli, F. ; Pallotta, S. ; Zichichi, L. ; Rongioletti, F. ; Corazza, M. ; Di Lernia, V. G. ; Costanzo, A. ; Peris, K. ; Carrera, C. G. ; Offidani, A. ; Stinco, G. ; Donini, M. ; Fargnoli, M. C. ; Gramiccia, T. ; Stingeni, L. ; Guarneri, C. ; Loconsole, F. ; Bardazzi, F. ; Potenza, C. ; Cantini, G. ; Giofrè, C. ; Richetta, A. G. ; Lasagni, C. ; Savoia, P. ; Fabbrocini, G. ; Argenziano, G. ; Bongiorno, M. R. ; Piaserico, S. ; Papini, M. ; Dapavo, P. ; Lembo, S. ; Burlando, M. ; Bianchi, L. ; Bonifati, C.

Abstract:

Background:

Facial (FP) and genital psoriasis (GP) significantly affect patients' quality of life. Despite the advances in treatments, limited data on efficacy and safety are available on these difficult‐to‐treat areas. Guselkumab is an interleukin (IL)‐23 inhibitor which has been proven effective in treating patients with moderate‐to‐severe plaque psoriasis.

Objectives:

The aim of this interim analysis was to report the efficacy and safety of guselkumab in the treatment of patients with FP and/or GP.

Materials and Methods:

GULLIVER is a 52‐week Italian observational study to evaluate the effectiveness and safety of guselkumab in a real‐life setting in patients with FP and/or GP. Adult patients with facial and/or genital moderate‐to‐severe psoriasis (sPGA score ≥ 3) were included. The primary endpoint of this analysis was the percentage of patients achieving a facial or genital sPGA score of 0 (clear) or 1 (almost clear), at Week 12. The change in the score of the facial or genital sPGA components in patients with a score ≥3 for each sPGA component was assessed. PASI score in patients with a baseline PASI above or below 10 was evaluated.

Results:

Overall, 351 patients were included in the study; 83.3% of FP and 76.5% of GP patients achieved the primary endpoint. Similar response rates were observed for the facial or genital sPGA components in patients with a baseline facial or genital sPGA score ≥3 in each component. Among patients with a baseline PASI score >10, mean PASI score improved from 19.0 (SD 8.3) to 2.2 (SD 4.8). Forty‐four AEs were observed in 32 patients; two mild and transient AEs (fatigue and nausea) were considered treatment related. No SAEs were observed.

Conclusions:

Guselkumab, showing to be effective and safe in treating FP and GP, may be a valid therapeutic option for patients with psoriasis localized in these difficult‐to‐treat areas.

393

项与古塞奇尤单抗相关的新闻（医药）

2025-03-05

·摩熵医药

51款新药IND获批！76款品种过评，石家庄四药领跑…

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 PART 01 周报概述随着全球医药行业的快速发展，新药研发与创新已成为推动行业进步的重要动力。近期，根据摩熵数据统计，新药申请与审批获批频繁，显示出医药创新领域的活跃态势。本文将深入分析2025年2月24日至2025年3月2日期间，国内外新药申请、临床试验批准、仿制药一致性评价等多个方面的最新进展，为用户提供全面的行业资讯。 PART 02 国内51款新药IND获批根据摩熵数据统计，2025年2月24日至202年3月2日期间，共有50个创新药/改良型新药临床申请/上市申请获国家药品监督管理局药品审评中心（CDE）承办（按受理号统计，不含补充申请）。其中国产药品受理号34个，进口药品受理号16个。本周共计51款创新药/改良型新药临床试验申请获得“默示许可”，包括化学药28款，生物药21款，中药2款。本周获批临床创新药/改良型新药（部分）信息速览(不含补充申请) 注：完整数据可识别“文末”二维码下载查看 PART 03 本周全球TOP10创新药研发进展在全球创新药研发领域，2月24日，士泽生物的XS-228注射液在美国获批临床，用于渐冻症治疗。2月25日，华东医药的HDM1005注射液、信达生物的IBI3002、领诺医药的SLN12140、勃林格殷格翰的那来司特片、赛诺菲的盐酸非索非那定口眼混悬液、强生的古塞奇尤单抗注射液、复星医药和Ardenlyx的盐酸替纳帕诺片，以及2月26日萌蒂制药的注射用醋酸瑞卢帕韦和2月27日皮尔法伯的恩考芬尼胶囊等药物分别在中国获批临床或上市，适应症涵盖阻塞性睡眠呼吸暂停合并肥胖或超重、哮喘、原发性IgA肾病、特发性肺纤维化、过敏性鼻炎、慢性特发性荨麻疹、中重度活动性克罗恩病、透析治疗的慢性肾脏病成人患者的高磷血症、念珠菌血症与侵袭性念珠菌病，以及不可切除或转移性黑色素瘤等多种疾病，为患者带来新的治疗选择。本周全球 TOP10 创新药研发进展截图来源：摩熵咨询周报 PART 04 本周全球TOP10临床试验结果本周全球TOP10临床结果中，2月25日，恒瑞医药宣布其在研产品SHR-2004用于治疗卵巢癌手术患者中预防静脉血栓栓塞症获得了积极的结果：基于改良意向性治疗集（mITT），SHR-2004组87例受试者中有11例（12.6%）发生VTE，阳性对照组94例受试者中有19例（20.2%）发生VTE，VTE发生率的组间率差为-8.4%（95% CI，-19.9~3.1；非劣效p值为0.0110）。本周全球 TOP10 积极/失败临床结果截图来源：摩熵咨询周报同日，赛诺菲（Sanofi）与梯瓦的duvakitug（IgG1 TNFSF15）在溃疡性结肠炎和克罗恩病治疗中表现出色，36%的低剂量组和 48%的高剂量组患者实现临床缓解，远高于安慰剂组的20%。此外，恒瑞医药的瑞康曲妥珠单抗在非小细胞肺癌治疗中展现出强大抗肿瘤效果，疾病控制率达 98.9%，且 96.7%的患者肿瘤缩小。 PART 05 76款品种过评，石家庄四药领跑根据摩熵医药数据库统计，2025年2月24日至202年3月2日期间，共有79项仿制药申报上市/申报临床获CDE承办，其中新注册分类上市申请受理号68项（包括化药3类，4类），新注册分类临床申请受理号4项（包括化药3类，4类），一致性评价申请7项。本周11个品种通过一致性评价（按受理号计15项），本周65个品种视同通过一致性评价（按受理号计98项）。本周无生物类似物注册申报动态。本周过评/视同过评品种主要为消化系统与代谢药物，过评/视同过评产品剂型主要为注射剂；本周艾司奥美拉唑镁肠溶胶囊过评/视同过评受理号数量最多达6个，间苯三酚注射液是本周过评/视同过评企业最多的品种达4家。截图来源：摩熵咨询周报本周石家庄四药有限公司过评/视同过评品种数最多达3种，其余各企业过评/视同过评品种数紧随其后，本周过评/视同过评企业共包括石家庄四药有限公司、宜昌人福药业有限责任公司和广东九明制药有限公司86家企业。截图来源：摩熵咨询周报本周有恩格列净二甲双胍缓释片（IV）、盐酸丙美卡因滴眼液、盐酸胍法拉辛缓释片、盐酸他喷他多片、盐酸齐拉西酮胶囊、注射用利培酮微球、吗替麦考酚酯干混悬剂7个品种首次过评/视网过评。本周首次过评/视同过评品种截图来源：摩熵咨询周报本周仅有盐酸布比卡因注射液1款过评/视同过评达7家企业的品种。本周过评/视同过评达7家企业品种截图来源：摩熵咨询周报摩熵咨询本期完整周报识别二维码领取下载往期周报回顾 51款新药IND获批！7亿+注射液，山东齐都药业过评…… 75款新药IND获批！10款重磅品种过评，涉及苏州二叶制药…… 74款新药IND获批！158个品种过评，山东新时代药业领跑…… 35款新药IND获批！79个品种过评，涉及康弘药业等药企…… END 本文为原创文章，转载请留言获取授权更多详细报告获取方式后台回复关键词“周报1”，获取2月26日-3月3日周报PDF。后台回复关键词“周报2”，获取3月4日-3月10日周报PDF。后台回复关键词“周报3”，获取3月11日-3月17日周报PDF。后台回复关键词“周报4”，获取3月18日-3月24日周报PDF。后台回复关键词“周报5”，获取3月25日-03月31日周报PDF。后台回复关键词“周报6”，获取4月1日-4月7日周报PDF版。后台回复关键词“周报7”，获取4月8日-4月14日周报PDF版。后台回复关键词“周报8”，获取4月15日-4月21日周报PDF版。近期最新周报识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作 👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

临床申请上市批准

2025-03-04

·医药观澜

8款新药在中国获批上市，3款治疗癌症！来自强生、复星医药等公司

▎药明康德内容团队报道根据中国国家药监局（NMPA）官网及公开信息，在刚刚过去的2025年2月，至少有8款新药*在中国获批上市。这些新药涵盖了单抗、双抗、小分子等药物类型，为肺癌、头颈癌、多发性骨髓瘤、丙肝、肾病等带来新的治疗选择。本文我们就一起来看看这些新药有哪些特点。（*此处的新药是指NMPA注册分类为1类、3.1类和5.1类和部分2.2类进口新药，本文仅统计首次申报上市新药，不含新适应症）神州细胞：菲诺利单抗注射液作用机制：抗PD-1单抗适应症：头颈部鳞状细胞癌、肝细胞癌 2月8日，NMPA宣布批准神州细胞的1类新药菲诺利单抗注射液上市，与含铂化疗联合用于复发性和/或转移性头颈部鳞状细胞癌（HNSCC）的一线治疗。菲诺利单抗是一款重组人源化抗PD-1 IgG4型单克隆抗体。一项3期临床研究结果表明，与单纯化疗相比，菲诺利单抗联合化疗可显著延长总生存期（OS）和无进展生存期（PFS），并提高客观缓解率（ORR）。其中，联合治疗组的中位OS达14.1个月，，在CPS≥20的人群中长达20.1个月，较化疗组（10.5个月）具有明显优势，同时中位缓解持续时间(DoR)延长至19.3个月，为患者带来更持久的获益。 2月28日，菲诺利单抗再次获NMPA批准新适应症，与贝伐珠单抗注射液（SCT510）联合用于既往未接受过系统治疗的不可切除或转移性肝细胞癌患者。一项3期临床研究结果显示，菲诺利单抗联合贝伐珠单抗治疗组和对照组的ORR分别为33%和4%；两组的中位无进展生存期（mPFS）分别为7.1个月和2.9个月，联合治疗组降低疾病进展风险50%；中位OS分别为22.1个月和14.2个月，联合治疗组降低患者死亡风险40%。东阳光药：磷酸萘坦司韦联合艾考磷布韦作用机制：NS5A抑制剂联合NS5B抑制剂适应症：慢性丙肝病毒感染 2月8日，NMPA宣布批准东阳光药业1类创新药磷酸萘坦司韦胶囊上市，该药适用于与艾考磷布韦片联用，治疗初治或干扰素经治的基因1、2、3、6型成人慢性丙型肝炎病毒（HCV）感染，可合并或不合并代偿性肝硬化。磷酸萘坦司韦为NS5A抑制剂，艾考磷布韦为NS5B抑制剂，这两款药均为东阳光药自主研发的1类新药。2024年9月，该联合疗法治疗慢性丙肝的2期临床研究成果全文在线发表于《中华肝脏病杂志》。全分析集分析结果显示总体SVR12为96.7%；按基因型总结，该方案在基因1型、2型、3型和6型受试者中SVR12分别为96.2%、100.0%、83.3%、100.0%。代偿期肝硬化和无肝硬化受试者总体SVR12分别为100%和96.2%，表明受试者肝硬化状态对疗效结果无影响。强生：埃万妥单抗作用机制：EGFR/MET双特异性抗体适应症：EGFR 20号外显子插入突变非小细胞肺癌 2月11日，强生（Johnson & Johnson）宣布EGFR/MET双特异性抗体疗法埃万妥单抗注射液已获得NMPA批准上市，用于与卡铂和培美曲塞联合给药，用于经检测确认携带表皮生长因子受体（EGFR）20号外显子插入突变的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的一线治疗。根据文献报道，EGFR 20号外显子插入突变是第三大常见的突变类型。通常由该突变驱动的非小细胞肺癌相较于EGFR常见突变驱动的肺癌患者预后更差，生存期更短。此外，这类患者对目前已获批上市的第三代EGFR-TKI靶向药物和化疗的疗效有限，患者急需更加有效的治疗方案。此次埃万妥单抗的获批是基于一项随机、开放标签、PAPILLON临床3期研究结果。该研究表明，与单独化疗相比，埃万妥单抗联合化疗可将疾病进展或死亡风险降低61%。强生：塔奎妥单抗作用机制：GPRC5D×CD3双抗适应症：多发性骨髓瘤 2月11日，强生宣布塔奎妥单抗注射液（talquetamab）已经获得NMPA批准上市，单药适用于既往接受过至少三线治疗（包括一种蛋白酶体抑制剂、一种免疫调节剂和一种抗CD38抗体）的复发或难治性多发性骨髓瘤（RRMM）成人患者。塔奎妥单抗是一款皮下注射的“first-in-class”GPRC5D×CD3双抗双特异性抗体。 GPRC5D主要在恶性浆细胞中表达，这一特性为这种异质性血液疾病提供了全新的治疗思路。临床研究显示，塔奎妥单抗通过重定向T细胞诱导杀伤带有GPRC5D表达的多发性骨髓瘤细胞，从而抑制肿瘤的形成和生长。该产品被批准的治疗频率包括初始递增剂量后每周或每两周皮下注射（SC），为医生提供了灵活便捷的治疗方案。经临床验证，塔奎妥单抗总缓解率（ORR）超过70%且应答持久，其中有65%既往接受过T细胞重定向治疗的患者达到缓解。默沙东：注射用头孢洛生他唑巴坦钠作用机制：酶抑制剂复合制剂适应症：复杂性腹腔感染、复杂性尿路感染等 2月11日，根据NMPA官网公示，默沙东（MSD）的新型酶抑制剂复合制剂——注射用头孢洛生他唑巴坦钠在中国获批上市，适用于与甲硝唑联合治疗成人和儿童（出生至18岁以下）患者由敏感革兰阴性和革兰阳性微生物引起的复杂性腹腔感染（cIAI）；治疗成人和儿童（出生至18岁以下）患者由敏感革兰阴性微生物引起的复杂性尿路感染（cUTI）（包括肾盂肾炎）；治疗成人（18岁及以上）患者由敏感革兰阴性微生物引起的医院获得性细菌性肺炎（HABP）和呼吸机相关性细菌性肺炎(VABP)。注射用头孢洛生他唑巴坦钠包含头孢类抗生素头孢洛生（ceftolozane）和β-内酰胺酶抑制剂他唑巴坦（tazobactam）。默沙东新闻稿表示，这一新型酶抑制剂复合制剂药物能够在临床治疗中帮助医生应对日益复杂的耐药感染，为患者带来新的治疗选择。泰诺麦博：斯泰度塔单抗注射液作用机制：抗破伤风毒素单抗适应症：成人破伤风紧急预防 2月11日，泰诺麦博自主研发的重组抗破伤风毒素单克隆抗体新药——斯泰度塔单抗注射液获NMPA批准上市，该产品作为迭代升级的新“破伤风针”，用于成人破伤风紧急预防。泰诺麦博新闻稿表示，该产品通过肌内注射，快速起效，以达到紧急保护。此外，该产品无需皮试，无需留观（门诊患者），无需区分体重和伤口大小，一针一次给药，达到全程保护。研究显示，斯泰度塔单抗在给药后12小时，95.4%的患者达到保护水平，快速起效，显著高于HTIG组（53.2%）。赛生药业：注射用盐酸替拉凡星作用机制：糖肽类抗生素适应症：HABP/VABP 2月13日，赛生药业引进的注射用盐酸替拉凡星获NMPA批准上市，用于治疗由金黄色葡萄球菌敏感分离株引起的医院获得性和呼吸机相关细菌性肺炎（HABP/VABP）。注射用盐酸替拉凡星是一种能够快速杀菌的糖肽类抗生素，对MRSA在内的革兰氏阳性病原菌有杀菌活性。该产品具有独特的双重抗菌作用机制，一方面通过抑制细菌细胞壁合成，另一方面与细菌细胞膜结合，干扰膜的屏障功能——这是万古霉素不具备的一种作用机制，从而快速发挥杀菌作用。与万古霉素相比，替拉凡星的半衰期更长，每日仅需给药一次。复星医药、Ardelyx：盐酸替那帕诺片作用机制：NHE3抑制剂适应症：CKD成人透析患者 2月26日，复星医药从Ardelyx许可引入的全新机制降磷创新药盐酸替那帕诺片获NMPA批准上市，用于控制对磷结合剂疗效不充分或不耐受的慢性肾脏病（CKD）成人透析患者的血清磷水平。盐酸替那帕诺片是一款口服肠道钠/氢交换体3（NHE3）抑制剂，其通过抑制NHE3，使细胞间连接变得紧密，降低肠道磷酸盐吸收的主要途径-细胞旁途径磷酸盐的通透性，减少磷酸盐的吸收，从而降低血磷。根据复星医药新闻稿介绍，替那帕诺可与现有磷结合剂联用，进一步显著降低血磷水平、提升血磷达标率。一项随机、双盲、安慰剂对照研究纳入血液透析的高磷血症患者164例，替那帕诺与磷结合剂联用治疗8周，较单用磷结合剂治疗，血磷进一步下降0.57mmol/L。一项多中心、随机、开放标签研究纳入303例磷结合剂治疗不达标的透析患者，将磷结合剂转换为以替那帕诺为基础的降磷方案（替那帕诺30mg BID治疗，若血磷不达标，可加用磷结合剂）治疗10周，血磷达标率提升34.4%-38.2%。除了上述新药，2月还有几款新药在中国获批新适应症，比如康诺亚的IL-4Rα生物制剂司普奇拜单抗注射液获批第三个适应症，用于治疗季节性过敏性鼻炎（SAR）；强生的白介素23抑制剂古塞奇尤单抗获批新适应症，用于治疗中重度活动性克罗恩病，而这也是古塞奇尤单抗在全球范围内首次批准用于中重度活动性成人克罗恩病的治疗。期待这些获批上市的新药能尽快来到患者身边，为他们带来新的治疗选择。参考资料： [1]中国国家药监局（NMPA）官网 [2]各公司官网及公开资料本文来自药明康德内容团队，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。转载授权或其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。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。

上市批准临床3期临床结果临床2期

2025-03-04

·PMLiVE

J&J receives three CHMP recommendations for immunology and oncology indications

Johnson & Johnson (J&J) has received recommendations from the European Medicines Agency’s human medicines committee for three separate drugs in ulcerative colitis (UC), Crohn’s disease (CD) and multiple myeloma (MM). Tremfya (guselkumab) has been recommended to treat moderately to severely active UC, a type of inflammatory bowel disease (IBD) that causes inflammation in the digestive tract, in adults who have had an inadequate response, lost response or been intolerant to either conventional therapy or a biologic treatment. The Committee for Medicinal Products for Human Use (CHMP) has also recommended J&J’s Stelara (ustekinumab) to treat paediatric patients weighing at least 40kg with moderately to severely active CD, another form of IBD, as well as its Darzalex (daratumumab) subcutaneous (SC)-based regimen for adults with newly diagnosed MM regardless of transplant eligibility. The CHMP’s decision on Tremfya was supported by positive results from the phase 3 QUASAR programme, with the drug achieving the primary endpoint of clinical remission in the induction and maintenance studies and also demonstrating statistically significant and clinically meaningful improvements in symptoms compared to placebo. Mark Graham, senior director, therapeutic area lead, immunology, J&J Innovative Medicine EMEA, described the committee’s decision on Tremfya as “a step towards being able to offer an additional treatment option for patients, ultimately enhancing their health outcomes and quality of life”. The recommendation for Stelara, which also applies to patients who have had an inadequate response to, or been intolerant to either conventional or biologic therapy, was based on data from the late-stage UNITI-Jr trial, in which 52.1% of paediatric patients achieved clinical remission after eight weeks, with clinical response observed as early as week three. Results from the REALITI real-world evidence study also supported the committee’s decision. Data from the phase 3 CEPHEUS study supported the CHMP’s positive opinion of Darzalex SC in combination with bortezomib, lenalidomide and dexamethasone (VRd), with the regimen demonstrating improved progression free survival in the frontline setting. Edmond Chan, EMEA therapeutic area lead haematology, J&J Innovative Medicine, said: “It is increasingly evident that to continue optimising outcomes in MM, we must intervene early with the most effective therapies first. “[This] positive recommendation, based on the CEPHEUS study, brings us closer to offering [Darzalex-VRd] as a treatment option for patients with newly diagnosed MM, regardless of transplant eligibility.” The European Commission will now review the CHMP’s recommendations as it makes decisions on the three drugs in these indications.

临床3期临床结果免疫疗法

100 项与古塞奇尤单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10438	古塞奇尤单抗	L04AC16	DB11834

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	Janssen-Cilag International NV	2025-02-20
活动性重度克罗恩病	中国	Janssen-Cilag International NV	2025-02-20
活动性中度溃疡性结肠炎	美国	Janssen Biotech, Inc.	2024-09-11
活动性重度溃疡性结肠炎	美国	Janssen Biotech, Inc.	2024-09-11
红皮病性银屑病	日本	Janssen Global Services LLC	2018-03-23
银屑病	日本	Janssen Global Services LLC	2018-03-23
脓疱型银屑病	日本	Janssen Global Services LLC	2018-03-23
银屑病关节炎	欧盟	Janssen-Cilag International NV	2017-11-10
银屑病关节炎	冰岛	Janssen-Cilag International NV	2017-11-10
银屑病关节炎	列支敦士登	Janssen-Cilag International NV	2017-11-10
银屑病关节炎	挪威	Janssen-Cilag International NV	2017-11-10
斑块状银屑病	美国	Janssen Biotech, Inc.	2017-07-13

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	申请上市	美国	Johnson & Johnson	2024-12-02
克罗恩病	申请上市	中国	西安杨森制药有限公司	2024-03-06
小儿克罗恩病	临床3期	美国	Janssen Research & Development LLC	2024-03-13
小儿克罗恩病	临床3期	日本	Janssen Research & Development LLC	2024-03-13
小儿克罗恩病	临床3期	奥地利	Janssen Research & Development LLC	2024-03-13
小儿克罗恩病	临床3期	比利时	Janssen Research & Development LLC	2024-03-13
小儿克罗恩病	临床3期	巴西	Janssen Research & Development LLC	2024-03-13
小儿克罗恩病	临床3期	法国	Janssen Research & Development LLC	2024-03-13
小儿克罗恩病	临床3期	以色列	Janssen Research & Development LLC	2024-03-13
小儿克罗恩病	临床3期	意大利	Janssen Research & Development LLC	2024-03-13

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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


NCT05528510 (ASTRO, Company_Website 1 \| Company_Website 2) 人工标引	临床3期	溃疡性结肠炎	418	TREMFYA® 400 mg SC induction	鹹築鹽壓觸築構繭蓋網(繭鹽壓糧衊鬱鹽鏇遞襯) = 鹹鑰壓積鑰鹽衊築夢壓艱築艱蓋積鬱願獵艱廠 (鏇艱餘糧選鏇構餘選遞 ) 达到更多	积极	2025-02-21
				Placebo	鹹築鹽壓觸築構繭蓋網(繭鹽壓糧衊鬱鹽鏇遞襯) = 蓋膚鑰襯觸醖製膚蓋餘艱築艱蓋積鬱願獵艱廠 (鏇艱餘糧選鏇構餘選遞 ) 达到更多
NCT05197049 (GRAVITI, CTgov)	临床3期	克罗恩病	350	placebo+guselkumab (Placebo)	窪選醖衊蓋鹹獵鑰願築(範醖範鬱憲壓衊淵蓋夢) = 獵顧夢憲觸廠簾鑰餘簾鹹廠願艱鏇夢積醖膚廠 (餘鑰鬱夢淵網觸襯窪廠, 蓋簾憲積蓋襯窪壓糧艱 ~ 製衊繭壓積網衊製廠構) 更多	-	2025-02-21
				Guselkumab (Combined: Guselkumab 400 mg)	窪選醖衊蓋鹹獵鑰願築(範醖範鬱憲壓衊淵蓋夢) = 構糧齋顧鹹繭膚醖艱製鹹廠願艱鏇夢積醖膚廠 (餘鑰鬱夢淵網觸襯窪廠, 範觸積淵壓築壓餘蓋積 ~ 製願夢鏇觸簾夢膚鹽觸) 更多
NCT05125679 (G-CARE, CTgov)	临床4期	斑块状银屑病	15	Guselkumab (Guselkumab 100 mg: Nicotine Users)	範鬱衊構鑰範鹽齋顧醖(簾餘鹽選繭範襯繭憲獵) = 獵遞糧顧遞膚蓋壓網醖築糧製廠壓憲壓觸鹹蓋 (壓夢積製構網醖範憲鏇, 積膚齋獵膚遞網繭蓋憲 ~ 蓋夢鹽艱窪艱積淵鹹鹽) 更多	-	2025-01-27
				Guselkumab (Guselkumab 100 mg: Non-Nicotine Users)	範鬱衊構鑰範鹽齋顧醖(簾餘鹽選繭範襯繭憲獵) = 簾窪鹽繭構選鑰製膚積築糧製廠壓憲壓觸鹹蓋 (壓夢積製構網醖範憲鏇, 顧壓窪鑰夢齋壓鏇顧簾 ~ 簾鏇壓齋醖廠鑰獵淵壓) 更多
NCT04033445 (QUASAR, Pubmed) 人工标引	临床3期	活动性中度溃疡性结肠炎 \| 活动性重度溃疡性结肠炎诱导 \| 维持	-	guselkumab 200 mg (induction study)	壓膚衊繭鏇膚壓糧憲鏇(願鬱淵餘遞糧顧壓廠鬱) = 鹹鏇觸鏇夢築獵夢鏇襯糧鏇網襯選鏇製衊餘衊 (選選築衊窪餘醖齋糧餘 ) 更多	积极	2024-12-17
				Placebo (induction study)	壓膚衊繭鏇膚壓糧憲鏇(願鬱淵餘遞糧顧壓廠鬱) = 築鏇範構遞製蓋觸襯築糧鏇網襯選鏇製衊餘衊 (選選築衊窪餘醖齋糧餘 ) 更多
NCT06039189 (SPECTREM, NEWS) 人工标引	临床3期	斑块状银屑病	-	Tremfya (guselkumab)	觸選網醖網衊衊簾壓膚(鏇齋壓膚製鹽夢醖顧窪) = 鏇觸鬱鏇廠憲網範鏇夢構衊壓獵餘網鬱網築淵 (餘選積繭鏇膚糧鑰膚膚 ) 更多	积极	2024-10-31
				Placebo	觸選網醖網衊衊簾壓膚(鏇齋壓膚製鹽夢醖顧窪) = 觸窪衊網餘構鏇衊積積構衊壓獵餘網鬱網築淵 (餘選積繭鏇膚糧鑰膚膚 ) 更多
NCT05197049 (GRAVITI, Company_Website) 人工标引	临床3期	克罗恩病	-	TREMFYA® 400 mg SC q4w	鹽願獵醖範鏇繭餘鏇製(願製衊壓構鹽衊衊鏇獵) = 餘鹽鬱選廠繭觸獵願築廠衊製簾鬱鏇範簾蓋衊 (衊築膚蓋夢襯鏇築觸醖 ) 更多	积极	2024-10-28
				TREMFYA® 100 mg SC q8w	鹽願獵醖範鏇繭餘鏇製(積築簾範鹹鏇襯繭窪網) = 願觸衊膚獵廠鑰夢鬱簾簾糧窪願醖積鑰夢顧衊 (願繭範繭蓋憲淵壓網鏇 ) 更多
NCT05784129 (PROGRESS, CTgov)	临床3期	克罗恩病	4	Guselkumab (Guselkumab 200 mg + Guselkumab 100 mg)	鬱壓醖構鬱醖蓋簾鬱鏇(網鑰顧壓積醖窪觸憲膚) = 鏇選簾衊製構築鏇獵築襯艱糧憲艱顧鏇鏇壓願 (顧繭淵衊鬱鏇顧鏇選選, 醖鑰鏇衊鹽醖壓壓醖廠 ~ 艱壓壓淵艱鹽夢鬱獵製) 更多	-	2024-10-28
				placebo+guselkumab (Placebo)	鬱壓醖構鬱醖蓋簾鬱鏇(網鑰顧壓積醖窪觸憲膚) = 觸顧鏇糧膚淵窪壓鏇選襯艱糧憲艱顧鏇鏇壓願 (顧繭淵衊鬱鏇顧鏇選選, 鬱膚鬱餘艱製繭顧衊積 ~ 願鑰築壓衊廠廠顧鬱膚) 更多
NCT04033445 (QUASAR, UEGW2024)	临床3期	溃疡性结肠炎维持	203	Guselkumab 200 mg	築鏇製鑰憲觸齋製製觸(衊繭願鹹壓鹽憲醖醖構) = Adverse events (AEs) were reported for 78.0% of GUS Week I-24 responders, serious AEs for 5.7%, and serious infections for 1.6%. No opportunistic infections or deaths occurred. No new safety concerns were identified. 膚簾鑰觸艱鑰夢鹹簾鏇 (衊鑰鑰衊蓋願淵廠築構 )	积极	2024-10-13
UEGW2024	N/A	活动性中度溃疡性结肠炎	-	Guselkumab 200mg q4w	獵糧築範願憲鹽選鬱鬱(淵願選鏇膚齋繭獵蓋積) = 11.2% vs 14.1% in the combined GUS group vs withdrawal group 憲選憲鬱艱膚獵願選鏇 (糧廠艱鹽餘壓簾齋選蓋 ) 更多	-	2024-10-13
				Guselkumab 100mg q8w
NCT04033445 (QUASAR Maintenance Study, UEGW2024)	临床3期	活动性重度溃疡性结肠炎维持	568	Guselkumab 200 mg SC q4w	夢網鏇構製鬱遞夢鏇醖(鑰鹹遞構鬱夢範廠製積) = 夢範壓選艱膚遞壓顧鬱積積鹹壓簾構願襯艱網 (衊淵壓廠衊範醖鬱鑰願 ) 更多	积极	2024-10-13
				Guselkumab 100 mg SC q8w	夢網鏇構製鬱遞夢鏇醖(鑰鹹遞構鬱夢範廠製積) = 選顧憲繭獵鑰繭獵糧壓積積鹹壓簾構願襯艱網 (衊淵壓廠衊範醖鬱鑰願 ) 更多