PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users) is a prospective, observational cohort study designed to evaluate the association between anifrolumab exposure during pregnancy and subsequent adverse maternal, fetal, and infant outcomes. This study will fulfil an FDA post-marketing requirement.

开始日期2025-03-31

申办/合作机构

AstraZeneca PLC

[+1]

NCT06594068

/ Recruiting临床4期

PRIMULA Lac (Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users): The AstraZeneca Lactation Study for Anifrolumab

Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users (PRIMULA Lac) is a Post Marketing Requirements (PMR) study designed to fulfill the FDA post-marketing requirements. The study will collect data about the presence of anifrolumab in human breast milk and serum (maternal and infant) among lactating individuals who receive anifrolumab therapeutically.

开始日期2025-02-28

申办/合作机构

AstraZeneca PLC

[+1]

NCT06795893

/ Not yet recruitingN/A

Pregnancy and Infant Outcomes in Anifrolumab Exposed Pregnancies Using PRegnancy Outcomes Intensive Monitoring (PRIM) Data: The Anifrolumab PRIM Program

Pregnancy and infant outcomes in anifrolumab exposed pregnancies using PRegnancy outcomes Intensive Monitoring (PRIM) data: The anifrolumab PRIM program

开始日期2025-02-28

申办/合作机构

AstraZeneca PLC

[+1]

100 项与 Anifrolumab-FNIA 相关的临床结果

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100 项与 Anifrolumab-FNIA 相关的转化医学

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100 项与 Anifrolumab-FNIA 相关的专利（医药）

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246

项与 Anifrolumab-FNIA 相关的文献（医药）

2025-12-01·JOURNAL OF CLINICAL IMMUNOLOGY

Anifrolumab in Monogenic Lupus caused by TREX1 Mutation

Letter

作者: Soscia, Francesca ; Moran-Alvarez, Patricia ; Messia, Virginia ; De Benedetti, Fabrizio ; Matteo, Valentina ; Prencipe, Giusi ; Insalaco, Antonella

2025-12-01·JOURNAL OF CLINICAL IMMUNOLOGY

Normalized Interferon Signatures and Clinical Improvements by IFNAR1 Blocking Antibody (Anifrolumab) in Patients with Type I Interferonopathies

Article

作者: Alehashemi, Sara ; Lakshmikanth, Tadepally ; Chen, Yang ; Mugabo, Constantin Habimana ; Fischer, Marie ; Wang, Jun ; Johnsson, Anette ; Tan, Ziyang ; Brodin, Petter ; Horne, AnnaCarin ; James, Anna ; Palmblad, Karin ; Páez, Laura Piñero ; Goldbach-Mansky, Raphaela ; Kretzschmar, Genia ; Gonzalez, Laura ; Mikeš, Jaromír

Abstract:

Purpose:

A causal role of type-I interferons (IFN-I) in autoinflammatory type-I interferonopathies such as SAVI (STING–associated vasculopathy with onset in infancy) and CANDLE (chronic atypical neutrophilic dermatosis with lipodystrophy and elevated temperatures) is suggested by elevated expression of IFN-I stimulated genes (ISGs). Hitherto, the lack of specific inhibitors of IFN-I signaling has prevented the verification of a causal role for IFN-I in these conditions. Commonly used inhibitors of the JAK/STAT pathway exert broad effects on multiple signaling pathways leading to more general immunosuppression beyond IFN-I signaling.

Methods:

Here we show in four patients with SAVI and one patient with CANDLE syndrome that blockade of the IFNAR1 receptor (Anifrolumab) exerts an additive effect over JAK-inhibitor alone. In two patients with SAVI, monotherapy with Anifrolumab is sufficient to retain a suppressed IFN-I signature and clinical improvement.

Results:

Anifrolumab normalizes IFN-I signature genes and relieves symptoms beyond what is typically achieved by a JAK-inhibitor (Baricitinib) alone in patients with type-I interferonopathies. In two patients Anifrolumab was used successfully as monotherapy. Addition of Anifrolumab enabled steroid tapering and cessation with reduced overall immunosuppression and lower risks of opportunistic infections and improved metabolic states and growth which is highly beneficial in these young patients.

Conclusion:

These results verify a causal role of IFN-I signaling in type-I Interferonopathies SAVI and CANDLE and suggests Anifrolumab as an important new treatment option in autoinflammatory diseases with elevated IFN-I induced gene expression.Genia Kretzschmar, Laura Piñero Páez, and Ziyang Tan are shared-first authors.Sara Alehashemi, AnnaCarin Horne, and Petter Brodin are co-senior author.

2025-03-01·JOINT BONE SPINE

Rapid response to anifrolumab in lupus related joint involvement as assessed by ultrasonography: A case series study

Letter

作者: Garufi, Cristina ; Mancuso, Silvia ; Ciancarella, Claudia ; Ceccarelli, Fulvia ; Alessandri, Cristiano ; Conti, Fabrizio ; Scorda, Alberto ; Spinelli, Francesca Romana ; Natalucci, Francesco ; Tripodi, Giuseppe

项与 Anifrolumab-FNIA 相关的新闻（医药）

2024-12-12

·药精通Bio

自免疾病: 系统性红斑狼疮 (SLE) 的靶向治疗进展

系统性红斑狼疮（SLE，Systemic lupus erythematosus）通常称为狼疮，是一种累及多系统的系统性自身免疫性疾病，具有显著的发病率和死亡率。系统性红斑狼疮患者经常会经历疾病发作和缓解的交替时期。SLE 的表现多种多样，从皮疹和关节炎到贫血和血小板减少，再到浆膜炎、肾炎、癫痫发作和精神病。据估计，大约 90% 的 SLE 患者是女性，大多数病例年龄在 15 至 44 岁之间。SLE 女性怀孕被认为是高风险，与一般人群相比，孕产妇和新生儿的发病率和死亡率较高。近年来，精细免疫表型、全基因组关联研究（GWAS）、单细胞测序、多组学分析和基因编辑的进展显着增强了对SLE发病机制的理解。这些技术突破还推动了针对免疫细胞、共刺激分子、细胞因子和信号转导途径的疗法的开发和临床研究，包括单克隆抗体、小分子药物和嵌合抗原受体（CAR-）T细胞免疫疗法。贝利木单抗（Belimumab）和阿尼鲁单抗（Anifrolumab）等治疗方法的批准为临床医生、研究人员和患者提供了更大的信心和更多的选择来治疗中度至重度系统性红斑狼疮，特别是难治性病例。１.　FDA 已批准 SLE 靶向治疗Belimumab（Benlysta） Belimumab（Benlysta）由 GSK 开发，是第一个 B 淋巴细胞刺激剂（BlyS）的靶向抑制剂。通过与 BlyS 结合，Belimumab 抑制 B 细胞（包括自身反应性 B 细胞）的存活，并减少其分化为负责产生免疫球蛋白的浆细胞，尽管它不直接与 B 细胞结合。贝利木单抗最初于 2011 年 3 月获得 FDA 批准用于治疗 SLE，是首个 SLE 靶向疗法，贝利木单抗于 2020 年 12 月获得扩大批准用于治疗狼疮性肾炎。它通常与羟氯喹（Plaquenil）和吗替麦考酚酯（CellCept）等其他药物联合使用，以增强治疗效果。Anifrolumab（Saphnelo） Saphnelo（anifrolumab）是一种全人源单克隆抗体，可与 I 型 IFN 受体的亚基 1 结合，有效阻断 I 型 IFN 的活性。I 型 IFN，例如 IFN-α、IFN-β 和 IFN-κ，是参与调节 SLE 相关炎症途径的细胞因子。在大多数成年 SLE 患者中观察到 I 型 IFN 信号传导活性增加，并且与疾病严重程度相关。作为“首创新药”I 型 IFN 受体拮抗剂，Saphnelo 代表了 SLE 治疗的重大进步。2021年8月2日，美国FDA批准Saphnelo用于治疗中重度SLE。２.　治疗 SLE 的靶向疗法正在开发中表 1. 治疗系统性红斑狼疮的靶向疗法聚乙二醇化抗体 - Dapirolizumab Dapirolizumab pegol 是一种新型研究中人源化无 Fc聚乙二醇 (PEG) 缀合的抗原结合 (Fab') 片段。它抑制 CD40L 信号传导，已被证明可以减少 B 细胞活化和自身抗体产生，减轻 IFN-I 分泌，并减弱 T 细胞和抗原呈递细胞 (APC) 活化。 2024 年 9 月 24 日，UCB 和 Biogen 联合宣布 III 期 PHOENYCS GO 研究评估 dapirolizumab pegol 治疗 SLE 的效果积极。 PHOENYCS GO 是一项多中心、随机、双盲、安慰剂对照、平行的 III 期试验，旨在评估dapirolizumab联合标准护理 (SOC) 疗法与安慰剂加 SOC 疗法在患有以下疾病的患者中的疗效和安全性，包括中度至重度系统性红斑狼疮，共有 321 名患者参与了该研究。分析显示，dapirolizumab pegol 与 SOC 相结合，达到了其主要终点。BICLA方法评估中，第 48 周时，与安慰剂加 SOC 相比，患者的中度至重度疾病活动度显著改善。BICLA 是一个既定的复合终点，用于通过患者病史、临床检查和实验室测试评估临床疾病活动性。此外，评估疾病活动和耀斑的关键次要终点显示出具有临床意义的改善。 dapirolizumab pegol 的安全性与之前的研究一致，并且与接受免疫调节治疗的 SLE 患者的预期安全结果一致。Litifilimab（利替非利单抗） Litifilimab (BIIB059) 由 Biogen 开发，是一种靶向 BDCA2 的全人源化 IgG1 mAb。通过抑制 BDCA2，它可以减少炎症细胞因子（包括 IFN-I）的产生，在调节 SLE 的病理机制中发挥着至关重要的作用。Litifilimab　是目前最先进的BDCA2靶向疗法，已进入治疗皮肤红斑狼疮（CLE）和SLE的III期临床试验。图 1. Litifilimab 的作用机制在一项涉及 SLE 参与者的 2 期试验中，在 24 周内，与安慰剂相比，litifilimab 与基线相比，肿胀和压痛关节的数量有更大程度的减少。需要更长时间和更大规模的试验来确定Litifilimab治疗 SLE 的安全性和有效性。JAK 抑制剂 - Upadacitinib Upadacitinib 是一种选择性、可逆性 JAK 抑制剂，正在研究用于治疗各种严重的免疫介导的炎症性疾病。在细胞和酶活性测定中，与 JAK2、JAK3 和 TYK2 相比，upadacitinib 对 JAK1 显示出特异的强的抑制作用。该药物已被批准用于治疗成人中度至重度类风湿性关节炎、银屑病关节炎、溃疡性结肠炎和强直性脊柱炎。 2023 年，艾伯维宣布了 upadacitinib 的 2 期临床试验取得积极结果，该试验可作为单一疗法或联合使用（elsubrutinib 60 mg 和 upadacitinib 30 mg），用于治疗继续接受标准狼疮治疗的中度至重度 SLE 成人的疗法。基于这些结果，艾伯维表示将推进upadacitinib进入SLE治疗的3期临床试验。S1P1 调节剂 - Cenerimod Cenerimod 是一种潜在的“FIC”、高选择性 S1P1 受体调节剂。这种每日一次的口服片剂正在开发用于治疗系统性红斑狼疮。2022 年 12 月，Idorsia 启动了 OPUS 项目，该项目由两项多中心、随机、双盲、安慰剂对照 3 期试验组成，旨在评估 cenerimod 与中重度 SLE 成人患者的疗效、安全性和耐受性。Cenerimod 已获得美国 FDA 授予的治疗 SLE 的快速通道资格。在 II 期临床试验中，测试的最高剂量为 4 mg，六个月后，与安慰剂相比，治疗组在主要终点（mSLEDAI-2K 评分）上显示出数值改善。然而，除了 4 mg 剂量（p＝ 0.029）外，其他组中没有观察到显着差异。此外，在第 52 周时，所有试验组的 mSLEDAI-2K 和 SRI-4 评分均未发现显著差异。细胞治疗 - KYV-101 KYV-101 是一种新型全人源抗 CD19 嵌合抗原受体 (CAR) T 细胞疗法，旨在用于 B 细胞驱动的自身免疫性疾病。它专门靶向 CD19，这是一种在 B 细胞表面表达的蛋白质。B 细胞除了与许多类型的恶性肿瘤有关，也与自身免疫性疾病相关。 References: [1] Dapirolizumab Pegol Phase 3 Data Presented at the American College of Rheumatology Shows Significant Reduction in Systemic Lupus Erythematosus Disease Activity .[2] Trial of Anti-BDCA2 Antibody Litifilimab for Systemic Lupus Erythematosus,10.1056/NEJMoa2118025 [3]Phase 2 Study of Upadacitinib (RINVOQ®) Alone or as a Combination Therapy Meets Primary and Key Secondary Endpoints in Patients with Systemic Lupus Erythematosus [4] Encouraging Phase 2 data on cenerimod – Idorsia's S1P1 receptor modulator currently investigated for SLE – presented at ACR 2019 END 免责声明：本文仅作知识交流与分享及科普目的，不涉及商业宣传，不作为相关医疗指导或用药建议。文章如有侵权请联系删除。 OTC2024类器官前沿应用与3D细胞培养论坛圆满落幕，点击图片可查看会后报告，咨询OTC2025类器官论坛请联系：王晨 180 1628 8769

免疫疗法细胞疗法临床研究临床结果

2024-12-03

·PRNewswire

Lupus Nephritis Clinical Trial Pipeline Experiences Momentum: DelveInsight Estimates a Diverse Pipeline Comprising 30+ Companies Working in the Domain

The lupus nephritis market is poised for growth, driven by rising disease prevalence, advancements in therapeutics such as biologics and targeted therapies, and increased investment in R&D. Heightened awareness and robust support from governments and key industry players further create a dynamic environment for innovation and better patient outcomes. LAS VEGAS, Dec. 3, 2024 /PRNewswire/ -- DelveInsight's ' Lupus Nephritis Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline lupus nephritis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the lupus nephritis pipeline domain. Key Takeaways from the Lupus Nephritis Pipeline Report DelveInsight's lupus nephritis pipeline report depicts a robust space with 30+ active players working to develop 35+ pipeline therapies for lupus nephritis treatment. Key lupus nephritis companies such as AstraZeneca, Hoffmann-La Roche, Novartis, Qilu Pharmaceutical, Vera Therapeutics, Conduit Pharmaceuticals, Amgen, Johnson & Johnson, BeiGene, RemeGen, Argenx, Kyverna Therapeutics, Cabaletta Bio, ImmPACT Bio, Alpine Immune Sciences, AlloSite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, Adicet Bio, Shenzhen Pregene Biopharma Co., Ltd., Resolve Therapeutics, BioAegis Therapeutics, Lepton Pharmaceuticals, Transcenta Holding, and others are evaluating new lupus nephritis drugs to improve the treatment landscape. Promising lupus nephritis pipeline therapies such as Anifrolumab, Obinutuzumab, Ianalumab, QLG1074, Atacicept, AZD1656, Daxdilimab, Nipocalimab, Zanubrutinib, Telitacicept, Efgartigimod alfa, KYV-101, CABA-201, IMPT-514, Povetacicept, ONT01, BCMA-CD19 cCAR T cells, CB-010, ADI-001, PRG-2311, RSLV-621, Recombinant human plasma gelsolin, LN-008, TST 008, and others are under different phases of lupus nephritis clinical trials. In November 2024, Adicet Bio announced that the first LN patient had been dosed in the Phase I clinical trial evaluating ADI-001 in autoimmune diseases. In November 2024, Kyverna Therapeutics announced that it would present updated clinical data from LN patients treated with KYV-101 in ongoing Kyverna-sponsored KYSA-1 and KYSA-3 Phase I/II studies and named patient treatments. In October 2024, Kezar Life Sciences suspended subject enrolment and patient dosing in the Phase II PALIZADE trial of zetomipzomib for active lupus nephritis. In June 2024, Nkarta announced the initiation of Ntrust-I, a multi-center clinical trial of NKX019 in lupus nephritis, with the first patient in screening. The company also announced the clearance by the U.S. Food and Drug Administration (FDA) of its second Investigational New Drug (IND) application for NKX019 in autoimmune disease. In June 2024, Adicet Bio announced that the US Food and Drug Administration (FDA) had granted Fast Track Designation to ADI-001 for the potential treatment of relapsed/refractory class III or class IV lupus nephritis. In April 2024, Caribou Biosciences announced that it had received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for CB-010, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout (KO), for the treatment of lupus nephritis (LN) and extrarenal lupus (ERL). The Phase 1, multicenter, open label GALLOP clinical trial of CB-010 in patients with LN and ERL is expected to initiate by year-end 2024. In March 2024, Artiva Therapeutics is looking to dose the first patient in a Phase I/II trial assessing its cell therapy AlloNK in lupus nephritis (LN). Request a sample and discover the recent advances in lupus nephritis treatment drugs @ Lupus Nephritis Pipeline Report The lupus nephritis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage lupus nephritis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the lupus nephritis clinical trial landscape. Lupus Nephritis Overview Lupus nephritis is a serious complication of systemic lupus erythematosus (SLE), an autoimmune disease that can affect multiple organ systems. In lupus nephritis, the immune system mistakenly attacks the kidneys, leading to inflammation and damage. The exact cause is not fully understood, but it is believed to involve a combination of genetic, hormonal, and environmental factors, including infections and exposure to certain drugs or UV light. Symptoms of lupus nephritis can vary but often include swelling in the legs and feet, high blood pressure, foamy urine, and in severe cases, hematuria. Patients may also experience fatigue, joint pain, and skin rashes, typical of lupus. Diagnosis usually involves a combination of blood tests, urinalysis, and imaging studies. A kidney biopsy may be necessary to evaluate the extent of kidney damage and guide treatment. Treatment for lupus nephritis aims to reduce inflammation and prevent kidney damage. It often involves corticosteroids and immunosuppressive medications such as mycophenolate mofetil or azathioprine. In severe cases, more aggressive treatments, including cyclophosphamide or biologic therapies like belimumab, may be utilized. Regular monitoring of kidney function and overall health is crucial for managing the disease effectively. Find out more about lupus nephritis treatment drugs @ Drugs for Lupus Nephritis Treatment A snapshot of the Lupus Nephritis Pipeline Drugs mentioned in the report: Learn more about the emerging lupus nephritis pipeline therapies @ Lupus Nephritis Clinical Trials Lupus Nephritis Therapeutics Assessment The lupus nephritis pipeline report proffers an integral view of the lupus nephritis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Lupus Nephritis Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Interferon alpha-beta receptor antagonists, Cell death inhibitors, Cell death stimulants, Antibody-dependent cell cytotoxicity, B-cell activation factor receptor antagonists, Glucokinase stimulants, Dendritic cell inhibitors, Complement factor D inhibitors, Complement C3 inhibitors, Proteasome inhibitors, Natural killer cell replacements, Immunologic cytotoxicity; T lymphocyte replacements Key Lupus Nephritis Companies: AstraZeneca, Hoffmann-La Roche, Novartis, Qilu Pharmaceutical, Vera Therapeutics, Conduit Pharmaceuticals, Amgen, Johnson & Johnson, BeiGene, RemeGen, Argenx, Kyverna Therapeutics, Cabaletta Bio, ImmPACT Bio, Alpine Immune Sciences, AlloSite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, Adicet Bio, Shenzhen Pregene Biopharma Co., Ltd., Resolve Therapeutics, BioAegis Therapeutics, Lepton Pharmaceuticals, Transcenta Holding, and others. Key Lupus Nephritis Pipeline Therapies: Anifrolumab, Obinutuzumab, Ianalumab, QLG1074, Atacicept, AZD1656, Daxdilimab, Nipocalimab, Zanubrutinib, Telitacicept, Efgartigimod alfa, KYV-101, CABA-201, IMPT-514, Povetacicept, ONT01, BCMA-CD19 cCAR T cells, CB-010, ADI-001, PRG-2311, RSLV-621, Recombinant human plasma gelsolin, LN-008, TST 008, and others. Dive deep into rich insights for new drugs for lupus nephritis treatment, visit @ Lupus Nephritis Drugs Table of Contents For further information on the lupus nephritis pipeline therapeutics, reach out @ Lupus Nephritis Treatment Drugs Related Reports Lupus Nephritis Epidemiology Lupus Nephritis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted lupus nephritis epidemiology in the 7MM. Lupus Nephritis Market Lupus Nephritis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key lupus nephritis companies, including NOVARTIS, MORPHOSYS, ASTRAZENECA, ROCHE, KEZAR LIFE SCIENCES, ALEXION PHARMACEUTICALS, CABALETTA BIO, among others. Systemic Lupus Erythematosus Market Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SLE companies, including Biogen, Novartis, MorphoSys, Idorsia Pharmaceuticals, Viatris, RemeGen, UCB Pharma, Genentech, Bristol Myers Squibb, AbbVie, among others. Systemic Lupus Erythematosus Pipeline Systemic Lupus Erythematosus Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key myasthenia gravis companies, including Yake Biotechnology, UCB, Sorrento Therapeutics, SinoMab Bioscience Ltd, Shanghai Junshi Biosciences, Sareum, Sanofi, Roche, Rheos Medicine, Resolve, Provention Bio, Pfizer, Novartis, Neovacs, Merck, Medsenic, Landos Biopharma, Kezar Life Sciences, Kangpu Biopharmaceuticals, Janssen Research & Development, Janssen, InnoCare, ImmuPharma, I-MAB Biopharma, ILTOO, Idorsia Pharmaceuticals, Horizon Therapeutics, Genovax, Exinda Thearapeutics, Equillium, Eli Lilly and Company, Eisai, Daiichi Sankyo Company, Corestem, Corbus Pharmaceuticals, Citryll BV, Chipscreen Biosciences, Carna Bioscience, Bristol-Myers Squibb, Brickell Biotech, Boston Pharmaceuticals, Biogen, Athos Therapeutics, Asahi Kasei Pharma, Aria Pharmaceuticals, Antengene Therapeutics, Amgen, Alpine Immune Sciences, Akeso Biopharma, AbbVie, 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

临床申请

2024-12-02

·蒲公英Ouryao

最新粤港澳大湾区内地九市临床急需进口港澳药品医疗器械目录

转自：广东省药监局编辑：水晶 12月2日，广东省药监局网省消息，广东省药监局和广东省卫健委发布粤港澳大湾区内地九市临床急需进口港澳药品医疗器械目录（2024年）的通告。《通告》指出，本批目录收录34个上市药品及37个医疗器械。对已列入目录的药械产品，将于2024年12月1日起按照《条例》第九条进行管理。 34个药品：卡那奴单抗、维莫德吉胶囊、盐酸维那卡兰注射液、阿仑珠单抗、罗氟司特片、氨己烯酸薄膜衣片、卡博替尼薄膜衣片、阿培利司薄膜衣片、厄达替尼片、注射用羟钴胺素、布西珠单抗、伊匹木单抗注射液、巴氯芬注射液、艾沙妥昔单抗注射用浓缩液、肾上腺素注射液（预充笔）、莱博雷生片、瑞玛奈珠单抗、硫酸瑞美吉泮口崩片、注射用坦昔妥单抗、二十碳五烯酸乙酯软胶囊、阿扎胞苷片、曲美木单抗、注射用芦比替定、阿司福酶α注射液、阿伏利尤单抗、特泽利尤单抗、磷酸芦可替尼乳膏、罗莫佐单抗、重组人促卵泡素α/促黄体素α注射液、注射用重组人促卵泡素α/促黄体素α、艾普奈珠单抗、伊曲莫德片、依洛硫酸酯酶α注射液、维替索妥尤单抗。根据《广东省粤港澳大湾区内地九市进口港澳药品医疗器械管理条例》（以下简称《条例》）中对急需港澳药械实施目录管理的要求，广东省药品监督管理局、广东省卫生健康委员会经研究决定发布广东省粤港澳大湾区内地九市临床急需港澳药品医疗器械目录（2024年）。本批目录将按《国家药品监督管理局国家卫生健康委员会关于临床急需境外新药审评审批相关事宜的公告》（2018年第79号）发布并符合《条例》要求的港澳已上市药品及《条例》实施前已批准的共71个药品及医疗器械收录。对已列入目录的药械产品，将于2024年12月1日起按照《条例》第九条进行管理。特此通告。附件：1.广东省粤港澳大湾区内地九市临床急需进口港澳药品目录（2024年） 2.广东省粤港澳大湾区内地九市临床急需进口港澳医疗器械目录（2024年）广东省药品监督管理局广东省卫生健康委员会 2024年11月29日

100 项与 Anifrolumab-FNIA 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11082	Anifrolumab-FNIA	L04AA	DB11976

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
狼疮性肾炎	澳大利亚	AstraZeneca Pty Ltd.	2022-03-29
中枢神经系统狼疮血管炎	澳大利亚	AstraZeneca Pty Ltd.	2022-03-29
系统性红斑狼疮	美国	AstraZeneca AB	2021-07-30

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
多发性肌炎	临床3期	美国	AstraZeneca AB	2024-11-25
多发性肌炎	临床3期	中国	AstraZeneca AB	2024-11-25
多发性肌炎	临床3期	日本	AstraZeneca AB	2024-11-25
多发性肌炎	临床3期	澳大利亚	AstraZeneca AB	2024-11-25
多发性肌炎	临床3期	奥地利	AstraZeneca AB	2024-11-25
多发性肌炎	临床3期	比利时	AstraZeneca AB	2024-11-25
多发性肌炎	临床3期	巴西	AstraZeneca AB	2024-11-25
多发性肌炎	临床3期	保加利亚	AstraZeneca AB	2024-11-25
多发性肌炎	临床3期	加拿大	AstraZeneca AB	2024-11-25
多发性肌炎	临床3期	捷克	AstraZeneca AB	2024-11-25

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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


NCT02794285 (TULIP-LTE, Pubmed \| Mod Rheumatol) 人工标引	临床3期	系统性红斑狼疮	-	Anifrolumab 300 mg	蓋遞夢襯糧膚觸窪獵窪(憲構顧築繭積選淵製淵) = 齋鑰繭夢膚膚鏇範遞醖範鹹膚獵淵壓網糧蓋壓 (範獵鹽網淵築衊網鹽顧 ) 更多	积极	2024-07-06
				Placebo	蓋遞夢襯糧膚觸窪獵窪(憲構顧築繭積選淵製淵) = 選襯衊膚憲艱積範顧選範鹹膚獵淵壓網糧蓋壓 (範獵鹽網淵築衊網鹽顧 ) 更多
NCT02794285 (EULAR2024) 人工标引	临床3期	系统性红斑狼疮	536	Anifrolumab 300mg	衊憲構範繭顧選構鏇夢(網衊齋衊鑰構觸簾簾築) = 構構選艱淵蓋網鬱獵餘蓋廠壓衊窪淵鹹衊構鏇 (獵夢獵構鏇膚繭窪鬱襯 ) 更多	积极	2024-06-05
				Placebo	衊憲構範繭顧選構鏇夢(網衊齋衊鑰構觸簾簾築) = 醖製觸壓夢窪憲遞齋網蓋廠壓衊窪淵鹹衊構鏇 (獵夢獵構鏇膚繭窪鬱襯 ) 更多
NCT02794285 (TULIP-1/-2/-LTE, EULAR2024)	临床3期	系统性红斑狼疮	369	Anifrolumab 300 mg	顧觸廠觸憲鑰鑰鑰選衊(齋窪鹽衊鹹襯襯觸簾選) = 糧繭衊鹽願齋積衊蓋顧窪觸鬱壓艱膚遞襯鹽窪 (鏇淵選齋膚鬱憲鬱膚鬱 )	积极	2024-06-05
				Placebo	顧觸廠觸憲鑰鑰鑰選衊(齋窪鹽衊鹹襯襯觸簾選) = 襯願鬱憲衊壓範網鹽簾窪觸鬱壓艱膚遞襯鹽窪 (鏇淵選齋膚鬱憲鬱膚鬱 )
NCT01438489 \| NCT02446912 \| NCT02446899 (MUSE \| TULIP-1 \| TULIP-2, EULAR2024)	临床2/3期	系统性红斑狼疮	438	Anifrolumab	網簾鹹壓範鏇膚觸廠遞(鹽齋鏇鏇膚鬱範糧網觸) = 鏇艱鑰糧壓艱夢顧餘壓窪齋餘製鑰壓製淵糧獵 (齋獵壓鑰顧簾鏇齋糧簾 )	积极	2024-06-05
EULAR2024	N/A	系统性红斑狼疮	65	Anifrolumab	憲襯壓鏇淵範壓衊鹽範(鏇願遞衊壓艱廠選糧遞) = The incidence of adverse events were fewer in the anifrolumab group (p=0.0012), especially in infections (p=0.0169) 積憲積願醖鹽鹹夢淵醖 (窪鑰憲鏇鏇鹽獵選夢壓 )	积极	2024-06-05
				Anifrolumab (Standard of Care (SoC))
EULAR2024	N/A	系统性红斑狼疮 type I interferon (IFN) receptor	13	Anifrolumab	鏇膚製觸鹽蓋窪膚醖觸(鹽蓋鹹簾積膚衊窪觸選) = 獵選衊鑰構網選築顧壓糧夢遞鏇夢鏇衊衊夢鑰 (積衊醖積構鹽鏇範艱夢, 2.0 ~ 2.5) 更多	积极	2024-06-05
EULAR2024	N/A	系统性红斑狼疮 anti-double-stranded DNA antibodies \| anti-phospholipid syndrome \| anti-nuclear antibodies	14	Anifrolumab	鏇淵艱膚製窪鏇獵艱衊(淵鹹願夢築鑰構蓋衊鹹) = a decrease in CRP levels 遞蓋夢網衊觸醖憲廠觸 (選願鏇膚鏇繭窪鬱膚夢 ) 更多	积极	2024-06-05
ISN WCN2024	N/A	APOL-1 gene	11	Anifrolumab 300 mg	艱鬱膚鹽積積簾鬱構製(淵襯憲襯範醖衊齋壓遞) = UP/Cr was significantly reduced (P<0.05) for both nephrotic and non-nephrotic patients. Both APOL-1 negative patients and those with a single at-risk allele demonstrated a reduction in UP/Cr 憲製淵網艱壓衊淵鏇糧 (鹹網齋糧觸襯鏇夢襯鬱 ) 更多	积极	2024-04-01
ACR2023	N/A	系统性红斑狼疮	-	Anifrolumab	鏇醖遞膚廠憲鑰齋鏇窪(壓範獵積遞衊網製憲積) = 蓋獵鑰鏇襯鹹製簾範膚醖遞鬱醖襯製醖鑰壓製 (艱餘鑰鏇繭糧窪鏇鏇餘 )	-	2023-11-13
TULIP-1/TULIP-2 (EULAR2023)	临床3期	-	369	Anifrolumab 300 mg	艱觸壓壓範觸鹹構築鹽(糧網齋醖膚夢襯醖憲夢) = 網製選衊鏇鏇顧齋夢鹽夢鏇繭襯遞鹽鏇獵鏇簾 (獵鏇簾壓廠糧網繭窪壓 )	积极	2023-05-31
				Placebo	艱觸壓壓範觸鹹構築鹽(糧網齋醖膚夢襯醖憲夢) = 廠蓋簾醖顧壓蓋觸鬱醖夢鏇繭襯遞鹽鏇獵鏇簾 (獵鏇簾壓廠糧網繭窪壓 )