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更新于：2025-03-27

Prednisone

泼尼松

更新于：2025-03-27

概要

基本信息

简介泼尼松（Prednisone）是一种用于治疗多种炎症性疾病，如过敏、关节炎和哮喘的药物。它属于类固醇类药物，通过抑制免疫系统和减轻炎症发挥作用。泼尼松通常口服，可用于短期或长期治疗。像所有药物一样，泼尼松可能会引起副作用，如体重增加、情绪变化和感染风险增加。与医疗保健提供者合作，确定泼尼松是否是管理您特定疾病的安全有效选择是非常重要的。

药物类型

小分子化药

别名

1,2-Dehydrocortisone、1,4-Pregnadiene-17α,21-diol-3,11,20-trione、17,21-Dihydroxypregna-1,4-diene-3,11,20-trione

+ [45]

靶点

作用方式

拮抗剂

作用机制

GR拮抗剂(糖皮质激素受体拮抗剂)

治疗领域

免疫系统疾病皮肤和肌肉骨骼疾病肿瘤+ [5]

在研适应症

自身免疫性疾病非转移性前列腺癌转移性去势抵抗性前列腺癌+ [9]

非在研适应症

急性白血病腺癌前列腺腺癌+ [67]

原研机构

Merck Sharp & Dohme Corp.

在研机构

Janssen Research & Development LLC

Takeda Pharmaceutical Co., Ltd.

Janssen Biotech, Inc.

+ [6]

非在研机构

Millennium Pharmaceuticals, Inc.Horizon Therapeutics USA, Inc.

Amgen, Inc.

+ [7]

最高研发阶段批准上市

首次获批日期

美国 (1955-02-21),

炎症

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、优先审评 (中国)

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结构/序列

分子式C21H26O5

InChIKeyXOFYZVNMUHMLCC-ZPOLXVRWSA-N

CAS号53-03-2

关联

1,579

项与泼尼松相关的临床试验

NCT06833411

/ Not yet recruiting临床3期

Treatment for Giant Cell Arteritis With Tocilizumab and 8 as Compared to 26 Weeks of Prednisone: a Randomized, Multicenter, Adaptive, Blinded, Phase III Study

The GISCO study plans to determine whether 8-week therapy is just as effective as 26-week cortisone therapy for treating giant cell arteritis
* with tocilizumab,
* while using less cortisone.

开始日期2026-01-01

申办/合作机构

Insel Gruppe AG

NCT06594939

/ Not yet recruiting临床2期IIT

Multicenter Phase II Study of Mosunetuzumab and Polatuzumab Vedotin With Split-Dose CHP Chemotherapy for Elderly Patients With Diffuse Large B-Cell Lymphoma

This single-arm, interventional phase 2 study is designed to evaluate whether the inclusion of mosunetuzumab subcutaneous and polatuzumab vedotin (Mosun-Pola) to a split-dose CHP chemotherapy backbone will improve outcomes for elderly patients with a new diagnosis of diffuse large B-cell lymphoma.

开始日期2025-06-01

申办/合作机构

Medical College of Wisconsin

NCT06738368

/ Not yet recruiting临床2期IIT

Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) ± Rituximab + Recombinant Erwinia Asparaginase (JZP458; Rylaze®) for the Treatment of Newly-Diagnosed Adults With Philadelphia Chromosome-Negative Acute Lymphoblastic Lymphoma/Leukemia

This phase II trial tests how well etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin (DA-EPOCH) with or without rituximab plus recombinant Erwinia asparaginase (JZP458) works in treating patients with newly diagnosed Philadelphia chromosome (Ph) negative B-acute lymphoblastic leukemia (ALL) or T-ALL. Chemotherapy drugs, such as etoposide, vincristine, cyclophosphamide and doxorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. JZP458 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving DA-EPOCH with or without rituximab plus JZP458 may kill more cancer cells in patients with newly diagnosed Ph negative B-ALL or T-ALL.

开始日期2025-06-01

申办/合作机构

University of Washington

[+1]

100 项与泼尼松相关的临床结果

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100 项与泼尼松相关的转化医学

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100 项与泼尼松相关的专利（医药）

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46,080

项与泼尼松相关的文献（医药）

2025-12-31·Human Vaccines & Immunotherapeutics

Pembrolizumab- induced subacute cutaneous lupus erythematosus in a patient with oropharyngeal squamous cell carcinoma: A case report and literature review

Review

作者: Mayer, Beata ; Babál, Pavel ; Krivošíková, Lucia

Considering the increasing use of immune checkpoint inhibitors in cancer treatment, our aim is to report a rare cutaneous immune-related adverse event induced by PD-1 inhibitor pembrolizumab and provide a brief overview of pembrolizumab-induced subacute cutaneous lupus erythematosus (SCLE) cases in the literature. We report a 67-year-old woman with oropharyngeal squamous cell carcinoma who developed SCLE during treatment with pembrolizumab. After 18 weeks (sixth cycle) of pembrolizumab immunotherapy, a widespread pruritic erythematous rash evaluated as grade 3 immune-related adverse event appeared primarily on the patient's limbs. Histopathological examination and direct immunofluorescence showed characteristic features of SCLE. The patient was treated with oral prednisone 40 mg daily and topical corticosteroids. In 2 weeks, her rash had cleared up significantly and her pruritus had disappeared. SCLE is an infrequent but recognized immune-related adverse event linked to pembrolizumab treatment.

2025-12-31·Hematology

Sustained response off treatment after fostamatinib in refractory immune thrombocytopenia: A series of four case reports

Article

作者: Ghanima, Waleed ; Rackwitz, Stefan ; Lucas Boronat, Francisco Javier ; Carrai, Valentina

INTRODUCTION:

A goal of most primary immune thrombocytopenia (ITP) treatments is reducing or discontinuing treatment while maintaining a response including an absence of bleeding events. We present four cases describing treatment with the spleen tyrosine kinase (SYK) inhibitor, fostamatinib, that showed sustained response off treatment (SROT).

CASE PRESENTATIONS:

Case 1 was a 66-year-old male with chronic ITP. He was pre-treated with prednisone and rituximab before being in the FIT-2 clinical trial (placebo). He received fostamatinib in the FIT-3 open-label extension for seven weeks and maintained SROT for 2.5 years. Case 2 was a 54-year-old female patient with chronic, highly refractory ITP. SROT was achieved after 6 months of fostamatinib and was maintained for more than 16 months (in remission to date). Case 3 was a 60-year-old male with chronic ITP. He was successfully treated with cycles of corticosteroids for six years prior to fostamatinib. He was treated with fostamatinib plus prednisone for approximately two months. SROT was observed in this patient for one year. Case 4 was a 67-year-old male with persistent ITP. Before fostamatinib, he was unresponsive to high-dose dexamethasone, IVIG, eltrombopag and romiplostim. After 11 months of fostamatinib, his dose was tapered for three months and ultimately discontinued. SROT was observed for more than ten months (in remission to date).

DISCUSSION:

These cases emphasize that SROT is achievable with fostamatinib in complex ITP cases unresponsive to multiple previous therapies. Additional research is needed to identify the magnitude of the underlying mechanisms, and the clinical factors associated with, and potentially predictive of, SROT.

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Adverse consequences of systemic corticosteroids use among a broad population of US adults with asthma: a real-world analysis

Article

作者: Wu, Sandra Sze-jung ; Song, Rui ; Veeranki, Phani ; Lanz, Miguel J. ; Motawakel, Omar ; Bancroft, Tim ; Vu, Michelle ; Johnson, Karen

AIMS:

Systemic corticosteroids (SCS) are used to manage asthma exacerbations. Among the broad population of patients with asthma, SCS-related risk of adverse events (AEs), health care resource utilization (HCRU), and costs remain unclear.

MATERIALS AND METHODS:

This retrospective cohort study used the Optum Research Database claims to identify adults with asthma from 1/1/2017 to 6/30/2022. The index date was the earliest SCS claim for SCS users; non-SCS users were randomly selected and adjusted proportionally to SCS users by index year. SCS use was measured during the first 12 months of follow-up. Inverse probability of treatment weighting balanced the two cohorts for selected baseline demographic and clinical characteristics. SCS users were further stratified into low, medium, and high dose sub-cohorts. SCS-related AEs were assessed up to 48 months, while HCRU and costs were assessed during the first 12 months of follow-up. A generalized linear model (GLM) analyzed follow-up costs by SCS exposure.

RESULTS:

The 130,739 patients included 55,363 non-SCS users (42.3%), while 75,376 were SCS users stratified into 60,319 low-, 12,235 medium-, and 2,822 high-dose users. The mean age was 49.6 years; 61.8% were female and 68.9% were non-Hispanic White. SCS users had a significantly greater risk of new-onset acute and chronic SCS-related AEs, increasing incrementally with dose exposure (all p < .001) across numerous physiological systems. Follow-up HCRU and costs also rose incrementally with dose exposure (all p < .001). Compared with non-users, SCS-related costs were 1.43, 1.97, and 3.21 times higher among low-, medium-, and high-dose users, respectively. The adjusted GLM predicted a 9.9% cost increase per 100 mg of prednisone equivalents.

LIMITATIONS:

Retrospective administrative claims studies cannot randomize patients and may not capture all patient events.

CONCLUSIONS:

Among a broad population of adults with asthma, even low doses of SCS were associated with significantly increased risk of new-onset AEs, HCRU, and costs.

1,142

项与泼尼松相关的新闻（医药）

2025-03-27

·同写意

当ADC遇上自免：一场靶向疗法的静默革命

20世纪初，德国科学家Paul Ehrlich首次提出抗毒素（即抗体）可用于对抗细菌释放的毒素。他认为可能存在一种既能杀死病原体又不伤害宿主的“魔法子弹”，这一设想为他带来了1908年的诺贝尔医学奖。直到1960年代，研究人员才开始用抗体递送细胞毒性药物来杀死癌细胞，后来诞生的抗体药物偶联物（ADCs）成为靶向癌症治疗的“魔法子弹”。距离Ehrlich提出ADC概念过去近百年，首个ADC才在1980年代得以成功在临床前模型中开发和测试。如今，已经有15款ADC得到FDA批准，用于治疗肿瘤。图源：lifescivc 但对于ADC的想象远不止肿瘤，开发抗癌ADC的公司也在探索ADC治疗自身免疫和炎症性疾病。虽然理论上抗体可以治疗的免疫病应该适合于用ADC，稳定的ADC应该可以治疗同靶点的免疫疾病，药效可能更显著，但相应地，毒性也会更高。 ADC的稳定性还没能得到真正地解决，过早释放普遍存在，会带来系统性毒性。而免疫治疗要求的安全治疗窗口远高过癌症治疗，目前市场上还没有安全性特别好的ADC药物出现。星辰虽远，步履未停。 1 更高的安全窗口自身免疫性疾病源于异常的免疫反应，在这种反应中，身体会错误地攻击自身组织。传统疗法通常涉及全身性免疫抑制，这可能会导致严重的副作用，并增加感染的易感性。因而，识别在致病性细胞上特异性表达的特定标志物对于避免脱靶效应至关重要。使用的免疫调节性有效载荷必须在疗效和安全性之间取得平衡，以防止对更广泛的免疫系统产生意外的抑制作用。在这方面，ADC凭借其精准的靶向性，通过选择性地清除致病性免疫细胞或调节特定的信号通路，提供了一种替代方法。但免疫疾病一般是慢性疾病，需要长期治疗，要求治疗药物容易耐受，不能有严重不良事件，在这一点上与癌症不同。 “如果将一款有数十年历史的药物与一种有数十年历史的方法结合，表现出‘杂交优势’——不同亲本的后代表现出优于双亲特性的现象，那将为患者提供简单而优雅的解决方案。”Arthur Tzianabos进行了上述比喻。他担任CEO的Lifordi Immunotherapeutics，致力于开发用于治疗自身免疫和炎症性疾病ADC疗法。 Tzianabos提到的另一个主角是类固醇。 1948年，梅奥诊所的医生首次为四名类风湿性关节炎患者注射类固醇，效果堪称惊人。《英国皇家医学会杂志》如此描述：“发生了非凡的变化……疼痛缓解和功能改善是不同维度的。一位完全卧床的患者能够下床尝试跳舞。” 尽管患者在药物用尽后完全复发，但研究团队确实取得了重大突破。两年后，他们获得诺贝尔医学奖。首批类固醇（又称皮质类固醇或糖皮质激素）于数年后获FDA批准：氢化可的松（1952年）和泼尼松（1955年）。如今，类固醇被广泛用于治疗多种急慢性炎症性疾病，包括哮喘、类风湿性关节炎、血管炎、湿疹、过敏反应或过敏性休克、炎症性肠病、白血病和淋巴瘤。但问题在于：疗效伴随高昂的生理代价。这些药物具有高度毒性。当类固醇（尤其是高剂量或长期使用时）在体内停留过久，会影响靶点外的多个器官和系统。类固醇是药物相关不良事件导致住院的最常见原因之一。近期一篇医学期刊文章提出：如果糖皮质激素是今日被发现，它们能否获批临床使用？尽管如此，当前现状是：全球5000万或占比1%的成年人长期使用糖皮质激素全球糖皮质激素市场规模约50亿美元且持续增长糖皮质激素毒性占相关患者医疗成本的40% 类固醇的应用规模是毫无疑问的。如果将ADC与类固醇这两项诺奖成果结合，实现类固醇疗效而无毒性会怎样？ 2 “杂交优势” 用ADC将强效类固醇直接递送至免疫细胞，既能利用类固醇的疗效，又可避免阻碍其广泛或长期使用的脱靶毒性。尽管这一“魔法子弹”并非全新概念，但其成功关键在于找到正确靶点并建立合适剂型，为自身免疫和炎症性疾病提供有效、安全且便利的治疗。好消息是，生物制剂（如抗TNF、JAK抑制剂、IL-6抑制剂等）这类新疗法已经解决了类固醇问题。但问题的是，生物制剂的应答率不及类固醇，且部分带有黑框警告。图源：lifescivc 尽管未达到理想应答率且存在严重安全隐患，生物制剂仍在多个适应症中位列畅销药。这凸显了治疗自身免疫和炎症性疾病的巨大未满足需求。以类风湿性关节炎为例，2023年其市场规模超100亿美元。图源：lifescivc 通过让这类强效药物充分发挥作用，或许能彻底改变免疫和炎症性疾病的治疗方式。VISTA（T细胞活化的V结构域Ig抑制因子）成为了可选项。这是一种选择性高表达于免疫细胞（包括髓系细胞、T细胞和浆B细胞）表面的蛋白。其快速内化和药物载荷累积的特性使其成为理想ADC靶点。携带强效类固醇的VISTA定向ADC在免疫细胞中表现出快速摄取和短血清半衰期（仅数小时，而多数ADC的血清驻留时间为数天）。 VISTA结构及其下游信号，图源：Tumor immunotherapy: Mechanisms and clinical applications 换言之，该ADC在免疫细胞内的驻留时间远超其在血清中的暴露时间，因此几乎无需担心ADC在循环系统中停留过久导致断裂、药物全身释放和系统性毒性。由于VISTA承担了快速内化ADC的所有工作，单克隆抗体无需具备任何药理功能——将疗效完全交给类固醇。Lifordi Immunotherapeutics正在为旗下同类产品LFD-200进行IND申报研究，目标是在2025年底前获得初步数据。这种携带类固醇的VISTA定向DAR8 ADC在多种疾病和炎症临床前模型中展现出卓越疗效和无毒性，且所需剂量更低、给药频率更低。该新型ADC可将高效糖皮质激素递送至免疫细胞区室，通过靶向可高度内化的细胞表面膜蛋白来靶向髓样细胞和淋巴细胞。该疗法已在多种临床前疾病模型中证明其疗效，能在免疫细胞内持久发挥免疫抑制功能，且无相关毒性，有望用于治疗多种自身免疫和炎症性疾病。早期研究表明，这种VISTA定向ADC方法也适用于不同载荷，包括ASO、siRNA和其他核酸。当前VISTA靶向药物多聚焦于肿瘤免疫治疗，比如免疫疗法公司Kineta的KVA12123，其曾与默沙东合作研发该产品，但由于Kineta在去年的架构重组，KVA12123的1/2期临床试验已停止招募新患者，现有患者允许继续接受治疗。目前，还没有针对VISTA靶点的抑制剂获批上市。 3 步履未停 VISTA之外，一些成熟靶点也受到关注，例如TNF。艾伯维旗下的ABBV-3373，便是其中一款TNF ADC。 ABBV-3373将TNF抗体与增强糖皮质激素受体活性的化合物偶联，由于TNF是在免疫细胞表面活跃的蛋白质，这样的设计使得偶联物在被摄入细胞之前，会与过度活跃的免疫细胞上的TNF结合，释放糖皮质激素受体调节剂以平息细胞的炎症活动。在小鼠实验中，ABBV-3373可有效抑制患有接触性超敏反应或诱发关节炎的小鼠的炎症信号传导，并且单剂量即可完全抑制关节炎超过30天。对健康志愿者的1期临床试验也证实了ABBV-3373的药物代谢动力学特征，并且没有显著影响志愿者糖皮质激素的全身标记物。也有药企是通过“精准打击”作为重点开发产品。一个显著的例子是使用靶向CD19的ADC。清除B细胞是治疗系统性红斑狼疮（SLE）和类风湿关节炎（RA）等疾病的一种治疗策略。新兴的ADC，例如将抗CD19抗体与免疫抑制性有效载荷结合的药物，在临床前研究中显示出有望实现靶向清除B细胞，同时保护健康组织的效果。另一个例子是CD6 ADC，已在治疗两种自身免疫性葡萄膜炎的临床前模型以及一种人源化的移植物抗宿主病（GVHD）模型中显示出了良好的效果，这表明CD6 ADC可以进一步开发成为一种治疗药物，用于选择性地清除自身反应性T细胞，并且是治疗许多其他T细胞介导的疾病的一种有前景的方法。国内映恩生物则采用激素类似物作为paylaod，研发出BDCA2 ADC新药DB-2304（DAR值为4），用于治疗自身免疫性疾病。 BDCA2主要在pDC上表达，DB-2304结合后内吞并释放激素类似物到细胞中，促进抑制促炎细胞因子分泌的糖皮质激素反应基因的转录，抗体的结合本身也会抑制pDC活化和干扰素的产生，两种机制发挥协同效应。其临床前研究显示出卓越的免疫调控效果和良好的安全性，已于2024年11月完成全球首例健康受试者给药。图源：Sino Biological 据华经产业研究院的报告，全球自身免疫性疾病药物市场规模由2019年的1169亿美元增至2024年的1338亿美元。市场庞大，想象空间也很大。近年来，风投机构和大型药企也加大了对研发ADC治疗自免公司的投资。 Evercore ISI报告显示，2023-2025年间，私营融资交易数量和最高交易额均以肿瘤领域为首，其次是免疫炎症领域。在此期间，免疫炎症领域获得超100亿美元投资，其中近20亿美元流向ADC，涉及ADC的交易比例在过去一年得到翻倍。期待曙光终现。参考文章： 1、The Sweetest Thing；lifescivc 2、前沿 | 精准抗炎！艾伯维开发全新ADC登《科学》子刊；药明康德 3、映恩生物：自免ADC启动一期临床，靶向BDCA2；医药笔记

抗体药物偶联物

2025-03-27

·cstonepharma.com

基石药业公布2024年年度业绩及公司近期业务进展

财务表现同比大幅改善：2024年总收入为人民币4.072亿元，其中授权费及特许权使用费收入为人民币2.321亿元；年内亏损减少71.5%。舒格利单抗上市进展与国际化合作：舒格利单抗三项上市申请获批，包括在中国大陆获批一线治疗胃腺癌/胃食管结合部腺癌（GC/GEJC），以及在欧盟、英国获批一线治疗IV期非小细胞肺癌（NSCLC）；此外，治疗III期NSCLC的新适应症申请已递交至欧洲药品管理局（EMA）。基石药业已就舒格利单抗达成3项国际战略合作，涉及3个主要地区覆盖40个国家，进一步推动其在全球范围内的商业化。泰吉华®生产及商业化：泰吉华®本地化生产申请在中国获批，基石药业亦就其商业化与恒瑞医药达成战略合作，大幅提升泰吉华®在国内市场的可及性与可负担性。 CS5001（ROR1 ADC）临床开发进展：CS5001用于淋巴瘤与实体瘤的全球多中心临床试验正在美国、澳大利亚和中国入组患者，其临床进程全球前二。临床数据显示，CS5001单药治疗侵袭性和惰性晚期淋巴瘤具有优异的疗效与良好的安全性，具有快速注册上市的潜力。Ib期临床试验将探索CS5001治疗淋巴瘤与实体瘤，覆盖一线、前线、单药和联合用药等多种应用场景。 CS2009（PD-1/VEGF/CTLA-4三抗）首例患者给药：CS2009全球多中心I期临床试验已在澳大利亚完成首例患者给药。其在临床前研究中展现出优于潜在竞品的抗肿瘤活性，是潜在的同类首创/同类最佳下一代肿瘤免疫骨架产品。管线2.0创新项目驱动长远发展：基石药业正积极推动管线2.0的临床开发，包括超过9款具有全球权益和广泛适应症潜力的同类首创/同类最佳候选药物，涵盖多特异性抗体和抗体偶联药物（ADC）。基石药业已基于专有的ADC技术平台开发出多款高潜力ADC资产，该技术平台将持续助力公司创新管线的拓展。中国苏州，2025年3月27日——基石药业（股票代码：2616.HK），一家专注于抗肿瘤药物研发的创新驱动型生物医药企业，今日公布其2024年年度业绩及近期业务亮点。业务摘要截至2024年12月31日止年度及截至本公告日期，我们在注册审批、临床进展和战略合作方面均取得了重要进展，进一步夯实基石药业在创新疗法领域的领导地位。我们在此期间取得的成就包括：商业化产品择捷美®（舒格利单抗），抗PD-L1抗体 – 全球拓展与监管批准 2024年，舒格利单抗获得三项新药上市申请的批准，包括其在中国大陆的第五项适应症，用于一线治疗GC/GEJC。此外，舒格利单抗在欧盟和英国获批用于一线治疗IV期NSCLC，标志其成功地进入主要国际市场。近期，舒格利单抗治疗III期NSCLC的新适应症申请已递交至欧洲药品管理局（EMA）。 – 战略合作驱动全球商业化 2024年5月，与Ewopharma AG达成在中东欧（CEE）和瑞士地区的商业化合作。 2024年11月，与Pharmalink Store - L.L.C - O.P.C达成合作，拓展中东和北非（MENA）地区及南非市场。 2025年1月，与SteinCares签订在拉丁美洲地区（LATAM）的合作协议。预计于2025年在西欧、东南亚和加拿大建立更多合作伙伴关系。 – 坚实的临床数据凸显疗效 GEMSTONE-304研究：一线治疗食管鳞状细胞癌（ESCC）的无进展生存期（PFS）最终分析和总生存期（OS）中期分析结果发表于《Nature Medicine》(2024年2月) GEMSTONE-302研究：四年随访数据在欧洲肿瘤内科学会（ESMO）大会上公布，进一步证实了舒格利单抗治疗IV期NSCLC的长期生存获益 GEMSTONE-303研究：治疗联合阳性分数（CPS）≥5 GC/GEJC的PFS和OS最终分析结果发表于顶尖期刊《美国医学会杂志》（JAMA）(2025年2月) ESMO指南认可：舒格利单抗被《欧洲肿瘤内科学会非驱动基因阳性转移性非小细胞肺癌动态临床指南》推荐为NSCLC一线疗法，同时覆盖鳞状和非鳞状NSCLC（2025年2月）泰吉华®（阿伐替尼），KIT/PDGFRA抑制剂在中国实现本地化生产 2024年6月与8月，中国国家药品监督管理局（NMPA）先后批准了泰吉华®片剂（300 mg和100 mg）的本地化生产申请。已于2025年初实现国产供应，提升成本效益。纳入国家医保目录，提高可及性泰吉华®（阿伐替尼）已被纳入国家医保目录（NRDL），用于治疗携带血小板衍生生长因子受体α（PDGFRA）外显子18突变（包括PDGFRA D842V突变）的不可切除性或转移性胃肠道间质瘤（GIST）。更新后的医保目录自2024年1月1日起生效，将显著改善目标患者使用泰吉华®的可负担性。与恒瑞达成商业化合作 2024年7月，我们与江苏恒瑞医药股份有限公司建立新的合作伙伴关系，授予其在中国大陆的独家推广权益，以扩大泰吉华®的商业化范围并提升盈利能力。普吉华®（普拉替尼），RET抑制剂向本地化生产过渡 2024年4月，国家药品监督管理局药品审评中心（CDE）已受理普吉华®制造本地化及生物等效性（BE）研究申请，目前正在审评中。与艾力斯持续开展合作根据2023年11月签署的独家协议，普吉华®的商业运营已于2024年上半年移交至上海艾力斯医药科技股份有限公司。双方将保持紧密合作以最大化市场渗透率。临床阶段核心资产 CS5001 (ROR1 ADC) 具有注册潜力的Ib期临床试验 CS5001的全球多中心临床试验正在美国、澳大利亚和中国同步推进。CS5001单药治疗侵袭性和惰性晚期淋巴瘤队列正在有序入组中，后续有望扩展为II期单臂注册研究。CS5001联合R-CHOP（利妥昔单抗+环磷酰胺+阿霉素+长春新碱+泼尼松）一线治疗弥漫性大B细胞淋巴瘤（DLBCL），CS5001联合标准疗法（SOC）前线治疗DLBCL等队列也将陆续启动入组，以扩大CS5001针对DLBCL所有阶段的治疗潜力。此外，CS5001也正在进行单一疗法及联合PD-L1抑制剂治疗晚期实体瘤的研究，突显CS5001在肿瘤适应症方面的广泛适用性。于2024年ASCO & ASH上发布亮眼的临床数据 CS5001的Ia期数据在2024年美国临床肿瘤学会（ASCO）年会和第66届美国血液学会（ASH）年会上公布。数据表明，CS5001是目前已知的首个在实体瘤和淋巴瘤中均显示出临床抗肿瘤活性的受体酪氨酸激酶样孤儿受体1（ROR1）抗体偶联药物（ADC）。临床数据显示，CS5001作为单药治疗侵袭性和惰性晚期淋巴瘤均具有优异的疗效与良好的安全性。在初步推荐的II期剂量（RP2D）水平（125 μg/kg），CS5001针对非霍奇金淋巴瘤（NHL）和霍奇金淋巴瘤（HL）的客观缓解率（ORR）分别达到70%和100%。这些结果证明CS5001具备快速上市的潜力，有望成为前线联合疗法的骨架产品。 CS2009 (PD-1/VEGF/CTLA-4三抗) 启动全球临床I期试验 2024年12月，CS2009治疗实体瘤的全球多中心首次人体试验（FIH）在澳大利亚启动，将陆续扩展至中国和美国。2025年3月，CS2009完成首例患者给药。潜在的同类首创/同类最佳下一代肿瘤免疫骨架产品在第39届癌症免疫治疗学会（SITC）年会上公布的临床前数据突显了CS2009具有明显优于潜在竞品的同类首创或同类最优的潜力，包括PD-1/CTLA-4、PD-1/VEGF双抗和抗PD-1/抗CTLA-4联合疗法。独特的三特异性机制使CS2009成为具有广泛适用性的新一代肿瘤免疫骨架产品。临床前/IND阶段候选药物及ADC平台基石药业临床前管线有超过九款具有全球权益和广泛适应症潜力的同类首创/同类最佳候选药物，涵盖多特异性抗体、ADC和放射性核素偶联药物（RDC），覆盖肿瘤、自身免疫疾病和代谢疾病等多个治疗领域。公司致力于通过管线2.0候选药物的开发提供临床价值，并将进行全球多中心临床试验，以最大化产品组合的全球潜力。基石药业自主开发了ADC技术平台，开发专有的连接子，并对不同靶点和有效载荷进行优化。该平台支持了管线2.0多个ADC项目，包括CS5007（EGFR/HER3双特异性ADC）、CS5005（SSTR2 ADC）、CS5008（DLL3/SSTR2双特异性ADC）以及CS5006（ITGB4 ADC）。未来及愿景展望未来，我们致力于通过提升内部开发能力与持续加大研发投入来推进我们强大且差异化的管线。同时，我们将通过战略合作和本地化生产升级，最大化上市产品的全球商业化潜力。2025年的主要增长驱动因素包括：临床里程碑: 推动CS5001、CS2009进入关键性临床试验，同步寻求全球合作伙伴，加速其开发进程。推动早期研发资产如CS2011、CS5007、CS5005、CS5008、CS5006在未来两年内进入临床阶段。商业化卓越：通过战略合作和本地化生产最大化已获批产品泰吉华®（阿伐替尼）、普吉华®（普拉替尼）的价值，提升盈利能力和市场覆盖范围。通过区域合作加速舒格利单抗的海外商业化拓展。技术创新与国际影响力: 强化ADC技术平台，推动管线拓展。在AACR、ESMO、ASH等主要国际学术会议上发布关键研究数据。财务摘要国际财务报告准则计量：收入截至2024年12月31日止年度为人民币4.072亿元，其中包括药品（阿伐替尼、普拉替尼）销售收入人民币1.751亿、人民币2.04亿元的授权费收入以及人民币0.281亿元的舒格利单抗特许权使用费收入，授权费收入同比增加人民币1.083亿元，增幅达113.1%，其在很大程度上抵销了药品销售收入的减少，因而总收入同比减少人民币0.566亿元，下降了12.2%。研发开支截至2024年12月31日止年度为人民币1.347亿元，较截至2023年12月31日的5.278亿元减少了人民币3.931亿元，主要由于里程碑费用及第三方合约成本降低。行政开支截至2024年12月31日止年度为人民币0.778亿元，较截至2023年12月31日的1.827亿元减少了人民币1.049亿元，主要由于雇员成本降低。销售及市场推广开支截至2024年12月31日止年度为人民币1.338亿元，较截至2023年12月31日的1.993亿元减少了人民币0.655亿元，主要是由于雇员成本和其他费用的降低，但部分被渠道服务费的增加抵销。年内亏损截至2024年12月31日止年度为人民币0.912亿元，较截至2023年12月31日的3.672亿元减少了人民币2.76亿元，降幅达到75.2%，主要是由于经营费用的大幅减少。现金及现金等价物及定期存款截至2024年12月31日为人民币6.729亿元。非国际财务报告准则计量：研发开支截至2024年12月31日止年度，扣除以股份为基础的付款开支后为人民币1.247亿元，较截至2023年12月31日止年度的5.347亿元减少了人民币4.10亿元，主要由于里程碑费用及第三方合约成本降低。行政以及销售及市场推广开支截至2024年12月31日止年度，扣除以股份为基础的付款开支后为人民币2.244亿元，较截至2023年12月31日止年度的3.382亿元减少了人民币1.138亿元，主要由于雇员成本减少所致。年内亏损截至2024年12月31日止年度，扣除以股份为基础的付款开支后为人民币0.94亿元，较截至2023年12月31日止年度的3.302亿元减少了人民币2.362亿元，降幅达到71.5%，主要是由于经营费用的大幅减少。 2024年度业绩投资者交流会公司将于2025年3月28日星期五上午10:00（北京时间）举办2024年度业绩投资者交流会。请通过该链接参加电话会议：https://s.comein.cn/ritii3dr（密码：067784）。关于基石药业基石药业（香港联交所代码: 2616）成立于2015年底，是一家专注于前沿抗肿瘤药物研发的创新驱动型生物医药企业，致力于满足中国和全球癌症患者的殷切医疗需求。截至目前，公司已成功上市4款创新药、获批16项新药上市申请以及9项适应症。当前研发管线均衡配置了潜在同类首创或同类最佳的抗体偶联药物（ADC）、多特异性抗体、以及免疫疗法和精准治疗药物在内的16款候选药物。同时，基石药业拥有一支资深管理团队，“全链条”覆盖临床前探索、临床转化、临床开发、药物生产、商务拓展、商业运营等关键环节。如需了解有关基石药业的更多信息，请访问：www.cstonepharma.com。投资者关系: ir@cstonepharma.com 媒体关系: pr@cstonepharma.com 前瞻性声明本文所作出的前瞻性陈述仅与本文作出该陈述当日的事件或资料有关。除法律规定外，于作出前瞻性陈述当日之后，无论是否出现新资料、未来事件或其他情况，我们并无责任更新或公开修改任何前瞻性陈述及预料之外的事件。请细阅本文，并理解我们的实际未来业绩或表现可能与预期有重大差异。本文内所有陈述乃本文章刊发日期作出，可能因未来发展而出现变动。声明：仅供医疗卫生专业人士交流使用，并非用于推广目的。

抗体药物偶联物财报临床1期申请上市引进/卖出

2025-03-26

·PRNewswire

LUXTURNA Continues to Lead in Retinal Gene Therapy with Increased Market Penetration | DelveInsight

LUXTURNA has significant market potential due to the high unmet need for effective treatments in rare genetic conditions. With its FDA approval for specific mutations in the RPE65 gene, it offers hope to patients who previously had limited options. The growing awareness and adoption of gene therapies in ophthalmology, along with advancements in personalized medicine, are expected to expand LUXTURNA's market reach. LAS VEGAS, March 26, 2025 /PRNewswire/ -- DelveInsight's " LUXTURNA Market Size, Forecast, and Market Insight Report" highlights the details around LUXTURNA, a one-time gene therapy for the treatment of patients with vision loss due to a genetic mutation in both copies of the RPE65 gene. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of LUXTURNA. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Spark Therapeutics/Novartis' LUXTURNA (AAV2-hRPE65v2; voretigene neparvovec) Overview LUXTURNA (voretigene neparvovec-rzyl, AAV2-hRPE65v2) is a one-time gene therapy designed to treat vision loss caused by mutations in both copies of the RPE65 gene. It works by delivering a functional copy of the RPE65 gene to replace the faulty one, helping to restore vision. The therapy is administered as a single subretinal injection beneath the retina in patients with confirmed RPE65 mutations and viable retinal cells. LUXTURNA was developed and commercialized in the US by Spark Therapeutics. Outside the US, Novartis holds the rights for development, registration, and commercialization under a licensing agreement. It is approved for treating vision loss caused by Leber's congenital amaurosis or retinitis pigmentosa due to confirmed biallelic RPE65 mutations. LUXTURNA uses an adeno-associated viral type 2 (AAV2) vector to deliver the RPE65 gene. The vector includes a cytomegalovirus (CMV) enhancer and a chicken beta-actin promoter to drive the expression of the normal human RPE65 protein. The parent AAV2 virus, which serves as the template, is a non-pathogenic, single-stranded DNA virus that depends on a helper virus for replication. Once inside retinal cells, the functional RPE65 protein enables the regeneration of 11-cis-retinal, which improves light detection and restores vision. In healthy individuals, RPE65 in retinal pigment epithelial cells converts all-trans-retinol into 11-cis-retinol, which then forms 11-cis-retinal—a critical step in the visual cycle that converts light into electrical signals. Mutations in the RPE65 gene disrupt this process, leading to vision loss. LUXTURNA restores the retinoid cycle by reintroducing functional RPE65 protein. LUXTURNA Dosage and Administration The recommended dose for each eye is 1.5 × 10¹¹ vector genomes (vg) in a 0.3 mL volume, administered via subretinal injection. Each eye should be treated on different days, with at least six days between injections. Oral corticosteroids equivalent to prednisone at 1 mg/kg/day (up to 40 mg/day) should be given for seven days, starting three days before injection, followed by a tapering dose over the next 10 days. LUXTURNA Dosage Forms and Strengths LUXTURNA is provided as a suspension for subretinal injection in a 0.5 mL extractable volume within a 2 mL single-dose vial. The concentration is 5 × 10¹² vg/mL, requiring a 1:10 dilution before use. The diluent is supplied in two single-use 2 mL vials. Learn more about LUXTURNA projected market size for retinitis pigmentosa @ LUXTURNA Market Potential Retinitis pigmentosa is a group of inherited retinal disorders that cause progressive degeneration of the retina and eventual blindness. It involves the gradual bilateral deterioration of rod and cone photoreceptors, leading to night blindness and progressive loss of peripheral vision, followed by a decline in central vision due to the loss of cone function. Retinitis pigmentosa is primarily linked to genetic mutations, with over 44 associated genes identified. In 2023, approximately 113,000 people in the US were affected by retinitis pigmentosa. Currently, available treatments are mainly off-label and do not address the underlying genetic causes of retinitis pigmentosa. Patients without the RPE65 mutation rely on supportive care, such as vitamin supplements, protection from sunlight, and visual aids. LUXTURNA is the only approved therapy for retinitis pigmentosa but is limited to patients with the RPE65 mutation. Gene and cell therapies are becoming key treatment strategies, targeting genes like RHO, USH2A, and RPGR. USH2A is a major focus, with two oligonucleotide candidates advancing in the RP pipeline. Optogenetics offers a novel gene therapy approach that works independently of specific gene mutations and shows promise in treating late-stage RP with severe photoreceptor loss. Several companies have progressed optogenetic gene therapies into clinical trials. According to DelveInsight, the retinitis pigmentosa gene therapy market is expected to grow due to increasing disease prevalence, improved awareness and treatment access, and a strong pipeline of therapies across the 7MM. Discover more about the retinitis pigmentosa market in detail @ Retinitis Pigmentosa Market Report Emerging Competitors of LUXTURNA Some of the drugs in the retinitis pigmentosa pipeline include Botaretigene sparoparvovec (Johnson & Johnson Innovative Medicine/MeiraGT), AGTC-501 (Beacon Therapeutics), MCO-010 (Nanoscope Therapeutics), GS030 (Gensight Biologics), CTx PDE6B (Coave Therapeutics), OCU 400 (Ocugen), jCell (jCyte), EA-2353 (Endogena Therapeutics), Ultevursen (ProQR Therapeutics), ADX‑2191 (Aldeyra Therapeutics), and other. In January 2025, Beacon Therapeutics Holdings Limited reported that the FDA has awarded Regenerative Medicine Advanced Therapy (RMAT) designation to laru-zova (laruparetigene zovaparvovec) for treating X-linked retinitis pigmentosa (XLRP). To know more about the number of competing drugs in development, visit @ LUXTURNA Market Positioning Compared to Other Drugs Key Milestones of LUXTURNA In October 2023, SpliceBio entered an exclusive collaboration and licensing agreement with Spark Therapeutics to utilize SpliceBio's proprietary Protein Splicing platform to develop a gene therapy for an undisclosed inherited retinal disease. In June 2023, Novartis Pharma obtained manufacturing and marketing approval for LUXTURNA in Japan as a gene therapy for IRD caused by mutations in both copies of the RPE65 gene. In November 2018, Novartis announced that the European Commission (EU) approved LUXTURNA for the treatment of patients with vision loss due to a genetic mutation in both copies of the RPE65 gene and who have enough viable retinal cells. The authorization is valid in all 28 member states of the EU, as well as Iceland, Liechtenstein, and Norway. In January 2018, Novartis entered into a licensing agreement with Spark Therapeutics covering development, registration, and commercialization rights to voretigene neparvovec in markets outside the US. Spark Therapeutics retains US rights for LUXTURNA. In December 2017, the FDA approved Spark Therapeutics' LUXTURNA for patients with confirmed Bi-allelic RPE65 Mutation-associated Retinal Dystrophy. In July 2017, Spark Therapeutics announced that the Offices of Orphan Products Development and Pediatric Therapeutics of the US FDA designated LUXTURNA as a drug for a rare pediatric disease. In October 2016, LUXTURNA granted ODD for the treatment of inherited retinal dystrophy due to bi-allelic RPE65 mutation. In July 2015, LUXTURNA was designated as an orphan medicinal product for the treatment of retinitis pigmentosa. In September 2014, the US FDA granted LUXTURNA a Breakthrough Therapy Designation for Inherited retinal dystrophy. LUXTURNA Patent Details The company holds the following patents related to its AAV-based retinal gene therapy: US patent application relating to cell transfection improvements for AAV vector production. We expect that any patents issued from this application will expire in 2038, excluding any potential patent term extension or adjustment. A US patent application relating to improvements in AAV vector purification. It expects that any patent from this application will expire in 2038, excluding any potential patent term extension or adjustment. Patent for manufacturing gene therapy vector Spark Therapeutics holds exclusive licenses for three patent application families from CHOP, covering scalable methods for manufacturing high-purity gene therapy vectors. The first patent family pertains to the production of Spark's product candidates, including those under its collaboration with Pfizer. Patents from this family have been granted in the United States, Australia, and Mexico, with expiration dates in 2021, not accounting for any potential extensions or adjustments. Related patent applications are still under review in the United States, Brazil, Canada, China, Europe, Israel, India, and Japan. If granted, these patents are expected to expire in 2031, excluding any possible extensions or adjustments. Modified AAV vectors and gene delivery Spark Therapeutics is advancing technology across multiple areas to enhance and broaden its current product pipeline. This technology, exclusively licensed from CHOP, focuses on modifying gene therapy vectors, incorporating companion therapies or diagnostics, and developing new therapeutic genes. The licensed patent portfolio includes: Six US patent applications covering alternative or modified AAV vectors for gene delivery. Any resulting patents are expected to expire between 2028 and 2034, excluding possible patent term extensions or adjustments. Two pending US patent applications related to inhibiting immune responses to AAV vectors and detecting AAV-binding antibodies. Any patents granted from these applications are anticipated to expire between 2032 and 2034, excluding potential patent term extensions or adjustments. Discover how LUXTURNA is shaping the retinitis pigmentosa treatment landscape @ LUXTURNA Gene Therapy LUXTURNA Market Dynamics The market for LUXTURNA is primarily driven by the increasing prevalence of inherited retinal diseases (IRDs) and the growing acceptance of gene therapy as a viable treatment option. The high unmet medical need for effective treatments for rare genetic diseases has created a favorable environment for LUXTURNA. The therapy's ability to deliver long-term benefits from a single administration, reducing the burden of repeated treatments, has also contributed to its market acceptance. Furthermore, the strong backing from Roche, with its extensive commercialization and market access infrastructure, has helped expand LUXTURNA's reach across multiple markets. Favorable reimbursement policies in the U.S. and Europe have further supported market uptake. Despite its success, LUXTURNA faces significant market challenges. The high cost of treatment, which exceeds $850,000 for both eyes, poses a barrier to widespread adoption, even with reimbursement support. Access to treatment is also limited by the need for specialized surgical centers and trained ophthalmologists, which restricts the therapy's availability to select geographic regions. Moreover, as gene therapy technology evolves, the emergence of newer, potentially more effective or cost-efficient treatments could pose competitive pressure. Additionally, the complexity of gene therapy manufacturing and delivery, along with stringent regulatory requirements, adds to the operational challenges faced by Spark Therapeutics and Roche. The future market dynamics of LUXTURNA are expected to be influenced by ongoing advancements in gene therapy, increasing diagnostic capabilities for inherited retinal diseases, and expanding treatment infrastructure. Strategic partnerships and continued investment in patient access programs and healthcare provider training could enhance market penetration. Additionally, the successful clinical outcomes and long-term durability of LUXTURNA will play a crucial role in sustaining patient and physician confidence. As the gene therapy market matures, LUXTURNA's position as a first-mover in the inherited retinal disease space will likely provide it with a competitive edge, although it will need to navigate pricing pressures and emerging competition in the broader ophthalmology and gene therapy markets. Dive deeper to get more insight into LUXTURNA's strengths & weaknesses relative to competitors @ LUXTURNA Market Drug Report Table of Contents Related Reports Retinitis Pigmentosa Market Retinitis Pigmentosa Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key retinitis pigmentosa companies including Johnson & Johnson Innovative Medicine, MeiraGTx, Beacon Therapeutics, Nanoscope Therapeutics, Gensight Biologics, 4D Molecular Therapeutics, Coave Therapeutics, Ocugen, Bionic Sight, jCyte, Endogena Therapeutics, ProQR Therapeutics, Aldeyra Therapeutics, among others. Retinitis Pigmentosa Pipeline Retinitis Pigmentosa Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key retinitis pigmentosa companies, including Acucela Inc, Allergan Plc, Amarantus Bioscience Holdings Inc, Amgen Inc, Applied Genetic Technologies Corp, Asklepios BioPharmaceutical Inc, Astellas Pharma Inc, Caladrius Biosciences Inc, Dompe Farmaceutici SpA, GenSight Biologics SA, Grupo Ferrer Internacional SA, IDPharma Co Ltd, Janssen Pharmaceutical, MeiraGTx, Anabasis Pharma, Allegro Ophthalmics, Nacuity Pharmaceuticals, ReNeuron, jCyte, Editas Medicine, SanBio, NightstarTherapeutics, Biogen, OiDE OptoEye, among others. Cell and Gene Therapies in Rare Disorders Market Cell and Gene Therapies in Rare Disorders Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key cell and gene therapies in rare disorders companies including REGENXBIO, Coave Therapeutics, GenSight Biologics, Ultragenyx, Pfizer, Sangamo Therapeutics, Roche, 4D Molecular Therapeutics, Astellas Gene Therapie, Actus Therapeutics, Nanoscope Therapeutics, Ocugen, jCyte, Amicus Therapeutics, Capricor Therapeutics, Nippon Shinyaku, Brainstorm Cell Therapeutics, Editas Medicine, Abeona Therapeutics, Ishin Pharma, among others. Gene Therapy Competitive Landscape Gene Therapy Competitive Landscape – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key gene therapy companies, including Novartis, Johnson & Johnson, Fibrocell Technologies, Pfizer, HELIXMITH Co., Ltd., Sarepta Therapeutics, REGENXBIO, Solid Biosciences Inc., Lexeo Therapeutics, Spark Therapeutics, Xalud Therapeutics, uniQure, Ultragenyx Pharmaceutical, Nanoscope Therapeutics, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

引进/卖出孤儿药上市批准基因疗法突破性疗法

100 项与泼尼松相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00473	泼尼松	A07EA03 H02AB07	DB00635

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
先天性肾上腺增生	美国	Horizon Therapeutics USA, Inc.	2012-07-26
肾上腺皮质功能不全	美国	Horizon Therapeutics USA, Inc.	2012-07-26
外源性变应性肺泡炎	美国	Horizon Therapeutics USA, Inc.	2012-07-26
先天性单纯性红细胞再生障碍性贫血	美国	Horizon Therapeutics USA, Inc.	2012-07-26
溶血性贫血	美国	Horizon Therapeutics USA, Inc.	2012-07-26
强直性脊柱炎	美国	Horizon Therapeutics USA, Inc.	2012-07-26
银屑病关节炎	美国	Horizon Therapeutics USA, Inc.	2012-07-26
变应性支气管肺曲霉菌病	美国	Horizon Therapeutics USA, Inc.	2012-07-26
哮喘	美国	Horizon Therapeutics USA, Inc.	2012-07-26
脑水肿	美国	Horizon Therapeutics USA, Inc.	2012-07-26
闭塞性细支气管炎	美国	Horizon Therapeutics USA, Inc.	2012-07-26
溃疡性结肠炎	美国	Horizon Therapeutics USA, Inc.	2012-07-26
克罗恩病	美国	Horizon Therapeutics USA, Inc.	2012-07-26
疱疹样皮炎	美国	Horizon Therapeutics USA, Inc.	2012-07-26
特应性皮炎	美国	Horizon Therapeutics USA, Inc.	2012-07-26
接触性皮炎	美国	Horizon Therapeutics USA, Inc.	2012-07-26
剥脱性皮炎	美国	Horizon Therapeutics USA, Inc.	2012-07-26
药物过敏反应	美国	Horizon Therapeutics USA, Inc.	2012-07-26
器官移植排斥	美国	Horizon Therapeutics USA, Inc.	2012-07-26
恶性肿瘤体液性高钙血症	美国	Horizon Therapeutics USA, Inc.	2012-07-26

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
前列腺癌	临床3期	美国	Janssen Scientific Affairs LLC	2020-04-20
非转移性前列腺癌	临床3期	美国	Janssen Research & Development LLC	2017-03-06
转移性前列腺癌	临床3期	美国	Janssen Research & Development LLC	2013-02-12
转移性前列腺癌	临床3期	中国	Janssen Research & Development LLC	2013-02-12
转移性前列腺癌	临床3期	日本	Janssen Research & Development LLC	2013-02-12
转移性前列腺癌	临床3期	阿根廷	Janssen Research & Development LLC	2013-02-12
转移性前列腺癌	临床3期	澳大利亚	Janssen Research & Development LLC	2013-02-12
转移性前列腺癌	临床3期	比利时	Janssen Research & Development LLC	2013-02-12
转移性前列腺癌	临床3期	巴西	Janssen Research & Development LLC	2013-02-12
转移性前列腺癌	临床3期	保加利亚	Janssen Research & Development LLC	2013-02-12

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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


NCT03742258 (CTgov)	临床1期	高级别B细胞淋巴瘤伴 MYC 和 BCL2 和/或 BCL6 重排 \| T细胞/组织细胞丰富的大B细胞淋巴瘤	12	cyclophosphamide+Prednisone+doxorubicin hydrochloride+Spleen Tyrosine Kinase Inhibitor+Rituximab+Vincristine Sulfate+TAK-659 (TAK-659 60mg + R-CHOP)	襯繭鏇夢廠糧憲憲構鹽(鏇顧廠鏇範憲襯壓膚獵) = 醖築壓醖獵淵膚襯窪願蓋鹹憲選遞艱遞遞製壓 (遞構構餘淵選鏇鏇餘襯, 齋廠築淵鹹淵繭餘餘選 ~ 願遞顧糧糧壓憲鑰醖齋) 更多	-	2025-03-25
				Doxorubicin Hydrochloride+cyclophosphamide+Prednisone+Spleen Tyrosine Kinase Inhibitor+Rituximab+Vincristine Sulfate+TAK-659 (TAK-659 80mg + R-CHOP)	襯繭鏇夢廠糧憲憲構鹽(鏇顧廠鏇範憲襯壓膚獵) = 淵衊積鑰壓憲築觸製壓蓋鹹憲選遞艱遞遞製壓 (遞構構餘淵選鏇鏇餘襯, 選糧鹽網製齋獵製鹹構 ~ 繭積壓蓋獵鑰積夢餘遞) 更多
Pubmed \| Blood Adv 人工标引	N/A	滤泡性淋巴瘤	220	initially treated with bendamustine-rituximab, rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) second-line	遞範鹹範鑰製構鹹獵膚(窪網鹹襯積選觸醖憲窪) = 獵窪繭窪餘簾簾鏇衊願壓衊壓廠顧艱鑰蓋遞鹹 (構顧廠顧願製範遞顧衊, 56 ~ 70) 更多	积极	2025-03-11
NCT02921555 (CECUM, CTgov)	临床4期	溃疡性结肠炎	75	Methylprednisolone+Prednisone (Methylprednisolone & Prednisone)	範鑰積夢願鹽膚鑰鏇製 = 鹹築遞衊鏇網繭夢餘廠鹽襯製獵遞窪簾餘鏇願 (選選顧範鏇衊壓繭淵齋, 憲選獵簾構願鏇膚餘繭 ~ 鹽鹹鹽夢淵壓糧網淵遞) 更多	-	2025-02-21
				Prednisone (Prednisone)	範鑰積夢願鹽膚鑰鏇製 = 鏇廠壓製構繭窪鏇繭築鹽襯製獵遞窪簾餘鏇願 (選選顧範鏇衊壓繭淵齋, 鑰夢範醖鑰觸蓋壓遞糧 ~ 簾衊窪觸顧繭製構艱夢) 更多
STAMPEDE (ASCO_GU2025)	N/A	局限性前列腺癌	104	Abiraterone acetate/prednisone (AAP) + ADT + RT	獵鹹選簾壓獵鑰廠鬱艱(鹹繭鏇憲製簾範築築網) = 築廠積蓋憲觸構簾繭糧構範鏇積範壓獵製鹹繭 (鬱餘鬱襯艱糧獵鹹選夢 ) 更多	积极	2025-02-13
NCT01254864 (CTgov)	临床2期	前列腺癌	190	Prednisone+Abiraterone Acetate	膚糧觸鏇獵憲餘醖艱製(淵顧艱構鹹糧鑰遞築積) = 顧顧構鹽獵構繭鑰窪簾糧蓋獵觸顧鬱選獵窪築 (遞壓簾網齋觸齋廠憲餘, 願願積觸窪範廠網糧衊 ~ 遞繭艱壓鑰願網繭鬱製) 更多	-	2025-01-27
NCT03223610 (ASH2024) 人工标引	临床1/2期	套细胞淋巴瘤	36	Venetoclax 2IbrutinibPrednisoneObinutuzumabLenalidomide	鹽艱願淵顧構積淵糧衊(膚鬱積鏇衊鬱簾築醖範) = thrombocytopenia (14%), neutropenia (13%), and anemia (10%) 鑰餘窪鬱蓋積蓋繭願獵 (鏇衊蓋選遞鹽廠積壓膚 ) 更多	积极	2024-12-09
				Venetoclax 4IbrutinibPrednisoneObinutuzumabLenalidomide
NCT03274492 (POLARIX, ASH2024) 人工标引	临床3期	弥漫性大B细胞淋巴瘤	879	Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP)Prednisone (Pola-R-CHP)	鏇襯觸構膚願製鑰襯淵(顧糧壓簾襯淵遞選膚簾) = 觸餘鹽鹹築鏇構憲顧鏇觸膚構繭淵遞鬱觸鏇積 (淵窪築糧獵顧觸膚膚餘, 65.46 ~ 77.05) 更多	积极	2024-12-08
				Rituximab + Cyclophosphamide + Doxorubicin + Vincristine +Prednisone (R-CHOP)	鏇襯觸構膚願製鑰襯淵(顧糧壓簾襯淵遞選膚簾) = 蓋鑰範廠窪網繭範鬱鬱觸膚構繭淵遞鬱觸鏇積 (淵窪築糧獵顧觸膚膚餘, 59.45 ~ 71.45) 更多
USTMA TTP Retrospective Registry (ASH2024)	N/A	血栓性血小板减少性紫癜 ADAMTS13 deficiency	645	Prednisone and Rituximab	鹽蓋膚齋願齋衊築鏇繭(膚齋夢繭鑰繭醖觸艱繭): HR = 2.7 (95% CI, 1.6 ~ 4.5), P-Value = 0.002	积极	2024-12-07
				Non-Rituximab regimens
ASH2024	N/A	弥漫性大B细胞淋巴瘤	-	Nivolumab	顧範選壓襯製廠夢襯醖(鹹範獵製醖蓋積網膚構) = occurred in 9 (16%) pts 鑰顧鹹鹽繭願簾廠網窪 (糧鹹夢獵鹹淵簾顧襯淵 ) 更多	-	2024-12-07
NCT03508440 (CTgov)	临床2/3期	Bell麻痹	10	Prednisone (Standard of Care)	襯鏇遞積艱鬱鬱淵鏇餘(鏇憲顧積淵艱鏇網簾鬱) = 壓壓糧齋齋醖築餘醖觸觸鹽鹽艱齋觸鏇觸憲鹹 (積襯淵窪襯遞鬱夢艱構, 0) 更多	-	2024-11-05
				Intratympanic injection+Prednisone (SOC + Injection)	襯鏇遞積艱鬱鬱淵鏇餘(鏇憲顧積淵艱鏇網簾鬱) = 遞壓艱餘顧壓廠糧鬱廠觸鹽鹽艱齋觸鏇觸憲鹹 (積襯淵窪襯遞鬱夢艱構, 47.671) 更多