Zetomipzomib

欢迎关注凯莱英药闻 今日，云顶新耀宣布，公司在研药物EVER001在治疗原发性膜性肾病（pMN）的1b/2a期临床试验阶段性数据取得积极结果。 EVER001是新一代共价可逆布鲁顿酪氨酸激酶（BTK）抑制剂，正在全球范围内开发用于治疗肾病；该药物在保持高活性的同时具有高选择性，能够避免持续抑制带来的毒副作用，具有同类最佳的潜力。 关于1b/2a期临床试验 此项1b/2a期临床试验旨在评价EVER001在蛋白尿为特征的肾小球疾病的中国患者中的安全性、疗效、药代动力学和药效学。31名经肾脏活检证实的抗-PLA2R自身抗体阳性的原发性膜性肾病患者，分别入组低剂量组和高剂量组，接受EVER001 共36周的治疗。截至2024年9月13日， 已完成36周治疗的低剂量组患者中，81.8%（9/11）的患者实现临床缓解，高剂量组中已完成24周治疗的患者已有85.7%（6/7）实现临床缓解。 除低剂量组的1例患者外，其他所有完成36周治疗的低剂量组患者，以及所有经24周治疗的高剂量组患者分别在36周和24周都实现了免疫学完全缓解。 低剂量组的24小时蛋白尿几何平均值（最小二乘法）在36周相较于基线下降78.3%，而高剂量组在24周即出现73.8%的下降。 在数据截止日期时，抗-PLA2R自身抗体水平已达到接近100%的下降；早在低剂量组的24周和高剂量组的12周，抗-PLA2R自身抗体下降已超过90%。 未见在其他共价非可逆BTK抑制剂上观察到的有临床意义的不良事件，如出血、心律失常、严重感染、白细胞减少、血小板减少、严重肝功能损伤等。 关于EVER001 EVER001（XNW1011）是新一代共价可逆的BTK抑制剂；BTK 是B 细胞受体信号通路的重要组成部分，可调节B 淋巴细胞的存活、激活、增殖和分化。应用小分子抑制剂靶向BTK 是治疗B 细胞淋巴瘤和自身免疫性疾病的有效选择。 根据2021 年9 月与信诺维医药和中国抗体制药达成的独家许可协议，云顶新耀拥有在全球开发、生产和商业化EVER001 用于治疗肾病的权利。 在中国健康受试者中进行的I 期研究结果表明，EVER001 具有高选择性、优异的药代动力学特征、良好的安全性特征以及强大的靶点参与性。 关于BTK抑制剂 BTK 是一种非受体酪氨酸激酶，在各种细胞表面受体（主要包括BCR）的信号转导中发挥核心作用，在B 细胞癌变后，BTK 会变得异常活跃，BTK 信号传导通路的激活会发出启动B 细胞恶性肿瘤细胞生长的信号，并在生长、迁移中发挥着重要作用。 BTK 抑制剂通过作用于BCR信号通路，与BTK 特异性结合而抑制BTK 自身磷酸化，阻止BTK 激活，从而阻断信号传导并诱导细胞凋亡，达到对B 细胞肿瘤发展的控制作用。 目前，全球范围内上市的BTK 抑制剂共6 种，第一代BTK 抑制剂伊布替尼2013年获FDA 批准上市，为血液肿瘤的治疗带来新进展。不过第一代BTK抑制剂由于选择性较差，除了抑制BTK 外，还会对EGFR、TEC、BMX 等多个靶点产生抑制作用，导致脱靶效应相关不良事件发生。第二代BTK 抑制剂提高了选择性，减轻脱靶效应，目前全球有四款BTK 抑制剂属于第二代BTK 抑制剂。 目前，伊布替尼仍是全球BTK 市场中最畅销的品种，第二代BTK抑制剂阿可替尼和泽布替尼销售增长迅速。 根据Deutsche Bank Report 2022 数据，BTK 抑制剂全球市场规模仍在增长中，预测2026 年BTK 抑制剂市场规模可达到204 亿美元。 据不完全统计，目前仅近十款BTK药物正开发用于肾病相关的适应症。 关于原发性膜性肾病 PMN是一种自身免疫性肾小球疾病，主要临床表现为蛋白尿，是引起成人肾病综合征（NS）最常见的原发性原因。 作为成人肾病综合征常见的病理类型，PMN在我国的患病率呈逐年升高的趋势，是发病率仅次于IgA肾病的原发性肾小球肾炎。据统计，我国目前有约200万原发性膜性肾病患者，超过30%的患者对目前的标准治疗没有应答，约30%达到缓解的患者会复发。 目前，全球没有获批用于PMN的药物；因此，亟需研发能提高治疗缓解率、降低高复发率、减少慢性肾毒性风险的治疗药物。 关于云顶新耀 云顶新耀成立于2017 年，从成功的授权引进模式逐步发展到兼具强大的自主研发和商业化的双轮驱动模式。目前，公司在肾科疾病、感染性和传染性疾病、自身免疫性疾病、mRNA 平台等领域已建立全球同类首创或者同类最佳的药物组成的顶级的产品管线。 2024上半年，公司主营收入达3 亿元，研发开支为人民币2.53 亿元，分销及销售开支为人民币2 亿元；2024 年维持人民币7 亿元的全年营业收入指引。截至2024 年6 月30 日，公司现金及现金等价物及银行存款为人民币19 亿元。 在肾病领域，云顶新耀以肾小球类疾病为焦点建立产品管线，拳头产品耐赋康(NEFECON)是治疗IgA肾病的首款创新药，现已在美国、欧盟、中国澳门等地上市；同时，公司持续通过内部发现和授权引进扩大管线，联合泽托佐米、EVER001，打造肾病“三驾马车”。 参考资料 1、公司官网 2、华福证券、财通证券、长城证券 感谢关注、转发，转载授权、加行业交流群，请加管理员微信号“hxsjjf1618”。 “在看”点一下

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