An Open-Label, Multicenter Extension Study Evaluating the Patient Perspective of the Physical Impact of Multiple Sclerosis and Providing Continued Access to Ocrelizumab in Patients With Multiple Sclerosis Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study and Without Access to a Post-Trial Access Program

The study will evaluate the physical impact of MS from participant's perspective, provide continued access to ocrelizumab and assess the safety and tolerability of ocrelizumab.

开始日期2024-12-09

申办/合作机构

Hoffmann-La Roche, Inc.

NCT06677710 / Not yet recruiting临床1期

A Phase 1B Study of IDP-023 g-NK Cells Plus Ocrelizumab in Patients With Refractory Primary and Secondary Progressive Multiple Sclerosis

This is an open label, Phase 1b, multiple ascending dose, and dose-expansion study of IDP-023 administered in combination with interleukin-2 (IL-2) and ocrelizumab to evaluate the safety, tolerability, and biologic activity on autoreactive immune cells in patients with refractory progressive multiple sclerosis.

开始日期2024-11-01

申办/合作机构

Indapta Therapeutics, Inc.初创企业

NCT06495593 / Not yet recruiting临床4期IIT

Identifying Ocrelizumab-resistant Lymphocytes in Lymphoid Tissue in Multiple Sclerosis

B cell-depleting therapies, such as ocrelizumab, are among the most effective medications currently available for the treatment of multiple sclerosis (MS). This suggests that B cells play a very important role in MS. While B cells are rapidly eliminated from the blood of patients treated with medications like ocrelizumab, little is known about how effectively B cells are eliminated from lymph nodes, which are important sites of B cell activation. This study is being conducted to determine to what extent B cells are targeted in lymph nodes following ocrelizumab treatment, which may have important consequences for long-term MS outcomes.

开始日期2024-10-01

申办/合作机构

The University of California, San Francisco

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100 项与奥瑞珠单抗相关的转化医学

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100 项与奥瑞珠单抗相关的专利（医药）

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1,251

项与奥瑞珠单抗相关的文献（医药）

2025-02-01·TALANTA

A liquid chromatography - Tandem mass spectrometry method for determination of ocrelizumab in serum of patients with multiple sclerosis

Article

作者: Grundmann, Milan ; Hradilek, Pavel ; Matlak, Patrik ; Brozmanova, Hana ; Kacirova, Ivana ; Sistik, Pavel ; Moskorova, Denisa

Ocrelizumab is a second generation recombinant humanized IgG1 monoclonal antibody used for the treatment of multiple sclerosis that selectively target B cells expressing the CD20 antigen. This study aimed to develop and validate a UPLC-MS/MS method for quantification of ocrelizumab in human serum, which can be used in clinical applications for therapeutic drug monitoring. The analysis of ocrelizumab was performed using a bottom-up approach on a liquid chromatography coupled to tandem mass spectrometry detection. The method involved immunoglobulin precipitation with cold methanol followed by peptide digestion with trypsin. The resulting specific peptides were separated on an Acquity UPLC BEH C18 column at 55 °C using gradient elution. The method was validated according to European Medicines Agency (EMEA) guidelines and demonstrated intra- and inter-assay precision with coefficients of variation ranging from 1.6 % to 6.1 % and accuracies between 90.2 % and 107.2 %. Stability testing, including autosampler, long-term and freeze-thaw stability, showed no more than 15 % variation. The method was successfully applied to 169 patient samples, revealing ocrelizumab concentrations ranging from 0.5 to 21.8 mg/L in patients on 6-month dosing regimen and 20.5-65.0 mg/L in 16 patients receiving an initial two-week dose of 300 mg. The newly developed UPLC-MS/MS method met all criteria for accuracy, precision and stability, confirming its suitability for clinical use in monitoring ocrelizumab levels in multiple sclerosis patients.

2024-12-31·RENAL FAILURE

Effectiveness and safety of B cell-targeting biologics in the treatment of lupus nephritis: a systematic review and network meta‑analysis

Review

作者: Yang, Si-Qi ; Wang, Yao-Guang ; Zhao, Xi ; Li, Man

OBJECTIVES:

To evaluate the effectiveness and safety of different B cell-targeting biological agents combining with standard of care in patients with lupus nephritis (LN).

METHODS:

Comprehensive literature searches were conducted using PubMed, Embase, Web of Science, and Central in the Cochran Library, spanning from inception to May 20th, 2024. Randomized control trials (RCTs) comparing rituximab (RTX), belimumab, ocrelizumab, obinutuzumab, and anifrolumab in LN were selected. The primary outcomes of interest were related to complete renal remission (CRR), and partial renal remission (PRR). Additionally, we delved into safety outcomes, examining the occurrence of serious adverse events (SAEs), infections, and the discontinuation rates due to adverse events.

RESULTS:

A total of 6 RCTs with 1150 patients applying various B cell-targeting biological agents were included. Notably, ranking probability based on the surface under the cumulative ranking curve (SUCRA) indicated that obinutuzumab (SUCRA 85.2%) has the highest potential superiority in improving CRR, followed by belimumab, ocrelizumab. Regarding the improvement in PRR, obinutuzumab (SUCRA 83.0%) has the highest potential superiority. In terms of safety, with a focus on SAEs, infections, and the discontinuation rates due to adverse events, the results were: SUCRA-based ranking indicated that RTX (SUCRA 74.1%) had the highest probability of postponing SAEs, followed by belimumab and obinutuzumab. Concerning infection reduction, anifrolumab (SUCRA 78.7%) had the highest potential superiority. Safety events monitoring infection occurred better with RTX than with standard therapy (OR = 3.57, 95% CI 1.02, 12.66) and were statistically different. For the discontinuation rates due to adverse events, RTX (SUCRA 88.6%) demonstrated the highest potential superiority.

CONCLUSIONS:

Concerning the effectiveness and safety outcomes, obinutuzumab, belimumab, and RTX plus standard of care may be superior to the current standard therapy as treatments for LN. This study protocol has been registered with PROSPERO, with a registration number of CRD42024548522.

2024-12-01·Journal of Central Nervous System Disease

Different lymphocyte counts of multiple sclerosis patients treated with ofatumumab and ocrelizumab: A retrospective observational study

Article

作者: Berger, Thomas ; Friedli, Christoph ; Zrzavy, Tobias ; Rommer, Paulus ; Marti, Stefanie ; Evangelopoulos, Maria E ; Kapsali, Ioanna ; Hoepner, Robert ; Chan, Andrew ; Krajnc, Nik ; Bsteh, Gabriel ; Hammer, Helly N

Introduction:

Patients with Multiple Sclerosis (pwMS) treated with anti-CD20 (cluster of differentiation) monoclonal antibodies (mAbs) such as ocrelizumab (OCR) and ofatumumab (OFA) show a reduction mainly of B-lymphocytes, but also other lymphocyte subsets can be affected by these treatments. There is limited data on differences between lymphocyte subset counts of pwMS after treatment initiation with OCR or OFA.

Objective:

To compare lymphocyte subset counts after treatment initiation in pwMS treated with OCR and OFA.

Methods:

We analyzed 22 pwMS initiated on OFA and 56 sex-, age- and MS course matched pwMS initiated on OCR from 2 prospectively collected observational MS databases (Bern [n: OFA 14, OCR 44] and Vienna [n: OFA 8, OCR 12]) statistically comparing lymphocyte subset counts (Mann Whitney Test).

Results:

We found that pwMS treated with OCR showed a stronger reduction of CD20 B-lymphocytes ( P = .001), and a trend towards lower counts of CD8+ T cells ( P = .056) compared to pwMS treated with OFA, whereas reduction of total lymphocyte, CD4+ lymphocyte and NK cell count was equally distributed between both treatments.

Conclusion:

Different effects on lymphocyte subpopulations appear to be present in pwMS after treatment initiation with different anti-CD20 mAbs. Further studies are needed to determine potential effects on anti-CD20 treatment efficacy as well as treatment associated risks such as failed vaccinations and infections.

381

项与奥瑞珠单抗相关的新闻（医药）

2024-11-13

·PRNewswire

75+ Key Companies Charting New Frontiers in Multiple Sclerosis Therapeutic Space | DelveInsight

Multiple sclerosis (MS) is a chronic neurological disorder affecting the central nervous system (CNS), particularly the brain, spinal cord, and optic nerves. Continuous research has led to new drug developments, particularly disease-modifying therapies (DMTs) that slow MS progression. Monoclonal antibodies, oral therapies, and infusion treatments are among the most promising options and drives the multiple sclerosis market. LAS VEGAS, Nov. 13, 2024 /PRNewswire/ -- DelveInsight's ' Multiple Sclerosis Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline multiple sclerosis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the multiple sclerosis pipeline domain. Key Takeaways from the Multiple Sclerosis Pipeline Report DelveInsight's multiple sclerosis pipeline report depicts a robust space with 75+ active players working to develop 80+ pipeline therapies for multiple sclerosis treatment. Key multiple sclerosis companies such as Mapi Pharma, Novartis, Immunic, Biocad, Apimeds, Genentech (Roche), AB Science, Celltrion, Clene Nanomedicine, InnoCare Pharma, Oryzon Genomics, GeNeuro SA, AbbVie, BrainStorm Cell Therapeutics, NeuroSense Therapeutics, Denali Therapeutics Inc., Sanofi, MediciNova, Biogen, Tiziana Life Sciences, Antisense Therapeutics, RemeGen, Atara Biotherapeutics, Contineum Therapeutics, Eli Lilly and Company, Axsome Therapeutics, Accure therapeutics, Stem Cell Medicine Ltd., Ever Supreme Bio-Technology Co., Ltd., ImCyse, Lucid Psycheceuticals, Immune Response BioPharma, Guangzhou Lupeng Pharmaceutical, Kyowa Kirin, Nura Bio, Bristol-Myers Squibb, ImStem Biotechnology, Hoffmann-La Roche, LAPIX Therapeutics, Motric Bio, Immunophage Biotech, NervGen, FibroBiologics, Kyverna Therapeutics, GlaxoSmithKline, PolTREG, Cyxone, Biohaven Pharmaceuticals, HuniLife Biotechnology, GlobeStar Therapeutics, Anokion, Medsenic, ZyVersa Therapeutics, Alumis Inc., Axoltis Pharma, Barricade Therapeutics, BioNxt Solutions, Eikonoklastes Therapeutics, 4D Pharma, Gossamer Bio, Pasithea Therapeutics, Synaptogenix, Monte Rosa Therapeutics, Immix Biopharma, f5 Therapeutics, Autobahn Therapeutics, Biosenic, Polpharma Biologics, Find Therapeutics, TeraImmun, AptaTargets, Trethera, Aditxt, SetPoint Medical, Sarepta Therapeutics, Nucleome Therapeutics, Vaccinex Inc., and others are evaluating new multiple sclerosis drugs to improve the treatment landscape. Promising multiple sclerosis pipeline therapies such as GA Depot, Remibrutinib, Tolebrutinib, IMU 838, BCD-132, Apitox, Fenebrutinib, SAR 441344, CT-P53, CNM-Au8, Orelabrutinib, Vafidemstat, Temelimab, Elezanumab, NurOwn (MSC-NTF cells), PrimeC, SAR4433820, Ibudilast, BIIB091, Foralumab, ATL1102, RC18, ATA188, PIPE-307, Pirtobrutinib, LY3541860, Solriamfetol, Act-01, SCM-010, UMSC01, IMCY-0141, Lucid-MS, NeuroVax, LP-168, NB-4746, CC-97540, IMS-001, RO7121932, BMS-986196, LPX-TI641, MTR-601, IPG-11406, IPG-1094, NVG-291, CYMS-101, KYV-101, PIPE-791, GSK 3888130B, PTG-007, T 20K, BHV-8000, HuL001, Amethyst™, ANK 700, Arscimed, A-005, NX210c, Research programme: CAR-TREG, TASIN-1, Cladribine ODF, ET-101, MRx0002, GB7208, PAS-002, Bryostatin-1, MRT-6160, NXC-201, Research Program: Cytokine reduction, ABX-002, Arsenic trioxide, LL-341070, PB018, FTX 101, TI-235, TRE 515, NT-0007, NT-0002, NVG300, and others are under different phases of multiple sclerosis clinical trials. In October 2024, Immunic, Inc. reported favorable results from the non-binding interim futility analysis of its Phase 3 ENSURE trial, which is evaluating its lead candidate, vidofludimus calcium (IMU-838), a nuclear receptor-related 1 (Nurr1) activator, for the treatment of relapsing multiple sclerosis (RMS). In October 2024, Immunic, Inc. announced a positive outcome of the non-binding, interim futility analysis of its Phase III ENSURE program, investigating lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), for the treatment of relapsing multiple sclerosis (RMS). Based on the outcome of the interim futility analysis, an unblinded Independent Data Monitoring Committee (IDMC) has recommended that the trials are not futile and should continue as planned. In September 2024, Roche, secured FDA approval for an injectable form of its blockbuster multiple sclerosis treatment, Ocrevus, reducing patient treatment time and potentially helping the company stay ahead of increasing competition. In September 2024, Sanofi announced the outcomes of Phase III clinical trials of its investigational oral brain-penetrant BTK inhibitor, tolebrutinib, aimed at treating multiple sclerosis (MS). These studies, namely HERCULES, GEMINI 1, and GEMINI 2, have provided mixed results, with the HERCULES trial meeting its primary endpoint while the GEMINI trials did not. The HERCULES study focused on the efficacy and safety of tolebrutinib in individuals with non-relapsing secondary progressive MS (nrSPMS) compared to a placebo. In August 2024, Abata Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ABA-101 for the treatment of patients with progressive multiple sclerosis (MS). The FDA recently cleared ABA-101's Investigational New Drug (IND) application, and initiation of a first-in-human (FIH) Phase I study is imminent. In August 2024, TG Therapeutics announced that the FDA has cleared an investigational new drug (IND) application submitted by TG Therapeutics for azercabtagene zapreleucel (azer-cel), an investigational allogeneic chimeric antigen receptor T-cell (CAR-T) therapy, for a phase 1 clinical trial in patients with progressive multiple sclerosis (MS). In January 2024, Kyverna Therapeutics, Inc. announced it received fast-track designation by the U.S. Food and Drug Administration (FDA) for its autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell product candidate, KYV-101, to be used for the treatment of multiple sclerosis (MS). Request a sample and discover the recent advances in multiple sclerosis treatment drugs @ Multiple Sclerosis Pipeline Report The multiple sclerosis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage multiple sclerosis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the multiple sclerosis clinical trial landscape. Multiple Sclerosis Overview Multiple sclerosis is a chronic autoimmune disorder that affects the central nervous system, leading to the deterioration or permanent damage of myelin, the protective sheath surrounding nerve fibers. While the exact cause of multiple sclerosis remains unclear, it is believed to involve a combination of genetic predisposition, environmental factors, and possibly viral infections. Common symptoms of multiple sclerosis include fatigue, difficulty walking, numbness or tingling in the limbs, muscle weakness, and vision problems, which can vary significantly among individuals and may evolve over time. Diagnosis typically involves a combination of neurological examinations, magnetic resonance imaging (MRI) to detect lesions in the brain and spinal cord, and sometimes lumbar puncture to analyze cerebrospinal fluid for inflammatory markers. While there is no cure for multiple sclerosis, treatment options aim to manage symptoms, reduce the frequency and severity of relapses, and slow disease progression. This may include disease-modifying therapies (DMTs), corticosteroids for acute exacerbations, and symptomatic treatments such as physical therapy, pain management, and lifestyle modifications. Early diagnosis and a tailored treatment plan are crucial for improving the quality of life for those living with multiple sclerosis. Find out more about multiple sclerosis treatment drugs @ Drugs for Multiple Sclerosis Treatment A snapshot of the Multiple Sclerosis Pipeline Drugs mentioned in the report: Learn more about the emerging multiple sclerosis pipeline therapies @ Multiple Sclerosis Clinical Trials Multiple Sclerosis Therapeutics Assessment The multiple sclerosis pipeline report proffers an integral view of the multiple sclerosis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Multiple Sclerosis 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: Immunomodulators, MHC class II gene modulators, Agammaglobulinaemia tyrosine kinase inhibitors, Dihydroorotate dehydrogenase inhibitors, Nuclear receptor subfamily 4 group A member 2 agonists, CD20 antigen inhibitors, Energy metabolism stimulants; Immunomodulators, Lysine-specific demethylase 1 inhibitors, Monoamine oxidase B inhibitors, Protein-arginine deiminase inhibitors, Immunostimulants Key Multiple Sclerosis Companies: Mapi Pharma, Novartis, Immunic, Biocad, Apimeds, Genentech (Roche), AB Science, Celltrion, Clene Nanomedicine, InnoCare Pharma, Oryzon Genomics, GeNeuro SA, AbbVie, BrainStorm Cell Therapeutics, NeuroSense Therapeutics, Denali Therapeutics Inc., Sanofi, MediciNova, Biogen, Tiziana Life Sciences, Antisense Therapeutics, RemeGen, Atara Biotherapeutics, Contineum Therapeutics, Eli Lilly and Company, Axsome Therapeutics, Accure therapeutics, Stem Cell Medicine Ltd., Ever Supreme Bio-Technology Co., Ltd., ImCyse, Lucid Psycheceuticals, Immune Response BioPharma, Guangzhou Lupeng Pharmaceutical, Kyowa Kirin, Nura Bio, Bristol-Myers Squibb, ImStem Biotechnology, Hoffmann-La Roche, LAPIX Therapeutics, Motric Bio, Immunophage Biotech, NervGen, FibroBiologics, Kyverna Therapeutics, GlaxoSmithKline, PolTREG, Cyxone, Biohaven Pharmaceuticals, HuniLife Biotechnology, GlobeStar Therapeutics, Anokion, Medsenic, ZyVersa Therapeutics, Alumis Inc., Axoltis Pharma, Barricade Therapeutics, BioNxt Solutions, Eikonoklastes Therapeutics, 4D Pharma, Gossamer Bio, Pasithea Therapeutics, Synaptogenix, Monte Rosa Therapeutics, Immix Biopharma, f5 Therapeutics, Autobahn Therapeutics, Biosenic, Polpharma Biologics, Find Therapeutics, TeraImmun, AptaTargets, Trethera, Aditxt, SetPoint Medical, Sarepta Therapeutics, Nucleome Therapeutics, Vaccinex Inc., and others are evaluating new multiple sclerosis drugs to improve the treatment landscape. Key Multiple Sclerosis Pipeline Therapies:GA Depot, Remibrutinib, Tolebrutinib, IMU 838, BCD-132, Apitox, Fenebrutinib, SAR 441344, CT-P53, CNM-Au8, Orelabrutinib, Vafidemstat, Temelimab, Elezanumab, NurOwn (MSC-NTF cells), PrimeC, SAR4433820, Ibudilast, BIIB091, Foralumab, ATL1102, RC18, ATA188, PIPE-307, Pirtobrutinib, LY3541860, Solriamfetol, Act-01, SCM-010, UMSC01, IMCY-0141, Lucid-MS, NeuroVax, LP-168, NB-4746, CC-97540, IMS-001, RO7121932, BMS-986196, LPX-TI641, MTR-601, IPG-11406, IPG-1094, NVG-291, CYMS-101, KYV-101, PIPE-791, GSK 3888130B, PTG-007, T 20K, BHV-8000, HuL001, Amethyst™, ANK 700, Arscimed, A-005, NX210c, Research programme: CAR-TREG, TASIN-1, Cladribine ODF, ET-101, MRx0002, GB7208, PAS-002, Bryostatin-1, MRT-6160, NXC-201, Research Program: Cytokine reduction, ABX-002, Arsenic trioxide, LL-341070, PB018, FTX 101, TI-235, TRE 515, NT-0007, NT-0002, NVG300, and others are under different phases of multiple sclerosis clinical trials. Dive deep into rich insights for new drugs for multiple sclerosis treatment, visit @ Multiple Sclerosis Drugs Table of Contents For further information on the multiple sclerosis pipeline therapeutics, reach out @ Multiple Sclerosis Treatment Drugs Related Reports Multiple Sclerosis Market Multiple Sclerosis Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key multiple sclerosis companies including Immune Response BioPharma, Inc., Clene Nanomedicine, Genzyme, ImStem Biotechnology, Rho, Inc., Bristol-Myers Squibb, TG Therapeutics, Inc., Hoffmann-La Roche, Atara Biotherapeutics, Immunic AG, Celgene, Anokion SA, Sanofi, Actelion, Biogen, Supernus Pharmaceuticals, Inc., GeNeuro SA, HuniLife Biotechnology, Inc., Emerald Health Pharmaceuticals, RemeGen Co., Ltd., Antisense Therapeutics, Biocad, AB Science, Genentech, Novartis, Pipeline Therapeutics, ASLAN Pharmaceuticals, GlaxoSmithKline, Lucid Psycheceuticals, Voronoi, Hanmi Pharmaceutical, Mapi Pharma, f5 Therapeutics, Autobahn Therapeutics, AstraZeneca, ZyVersa Therapeutics, RedHill Biopharma, Gossamer Bio, Sarepta Therapeutics, BrainStorm Cell Limited, CytoDyn, Pear Therapeutics, Solstice Neurosciences, ProJenX, among others. Multiple Sclerosis Epidemiology Forecast Multiple Sclerosis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted multiple sclerosis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Relapsing Multiple Sclerosis Pipeline Relapsing Multiple Sclerosis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key relapsing multiple sclerosis companies, including ASLAN Pharmaceuticals, GlaxoSmithKline, Lucid Psycheceuticals, Voronoi, Hanmi Pharmaceutical, among others. Relapsing-Remitting Multiple Sclerosis Pipeline Relapsing-Remitting Multiple Sclerosis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key RRMS companies, including TG Therapeutics, Novartis, Sanofi, Cinnagen, Polpharma Biologics, Immunic, Mapi Pharma, Biocad, Apimeds, Genentech (Roche), Merck, Immune Response BioPharma, Clene Nanomedicine, InnoCare Pharma, Oryzon Genomics, GeNeuro SA, AbbVie, Emerald Health Pharmaceuticals, GlaxoSmithKline, RedHill Biopharma, 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3期临床结果快速通道细胞疗法免疫疗法

2024-11-11

·BiG生物创新社

2024下半年自免领域最值得关注的15种药物

作者｜momo 近年来，自身免疫药物研发呈现出迅猛的发展态势。全球销售额前十的药品中，3款为自身免疫性疾病药物。沙利文数据预测，到2030年，全球自身免疫性疾病药物市场规模有望达到1760亿美元，2022—2030年复合年增长率为3.6%。这一数据充分彰显了该领域的巨大潜力。在国内，众多药企积极投身于自免药物研发，其中恒瑞医药表现突出，已有超过 10 款自免药物处于研发阶段。从药物靶点的角度而言，以 JAK、CTLA - 4、IL 等为靶点的药物如雨后春笋般不断涌现...... 在这里，我们将根据2024年上半年自身免疫药物销售统计数据，预测2024年下半年最值得关注的15种自身免疫药物。经整理，排名如下：表1：2024H1自免药物销售额TOP15 注1：由于货币汇率波动，销售额换算统一货币时略有差异。注2：表格数据为笔者手动统计，如有错误及纰漏，还请文末留言指正。 1、TOP1: Dupixent（度普利尤单抗）作为赛诺菲和再生元合作开发的核心自免药物，自上市以来一直是医药领域的焦点。这款针对自身免疫疾病的重磅药物在中重度特应性皮炎、中重度哮喘、慢性鼻炎等多种适应证中表现出卓越疗效，成为了这些领域治疗的重要选择。它是全球首个获批治疗中重度特应性皮炎的生物制剂，适应证拓展能力极强。 2024年上半年，Dupixent销售额高达66美元，其在自身免疫疾病市场占据重要地位。据赛诺菲发布的第三季度最新财报显示，Dupixent第三季度的销售收入超过37.5亿美元，同比增长23.8%。，其销售额保持稳定增长趋势，为赛诺菲和再生元带来了可观的收入。并且随着适应证进一步拓展和市场渗透率的提高，Dupixent在未来无疑将持续巩固其在自免药物领域的领先地位，销售额有望持续攀升。 2、TOP2: Stelara（乌司奴单抗） Stelara（乌司奴单抗）是治疗自身免疫性疾病的药物，对银屑病、克罗恩病等病症有着出色的疗效，通过精准调节免疫系统来减轻炎症反应。它主要是通过靶向特定的免疫相关通路发挥作用。2009年，Stelara获FDA批准上市。在欧洲，它也被广泛用于相关疾病的治疗。在全球市场，Stelara已成为众多自身免疫病患者的重要治疗选择之一。根据强生公司公告，2024年上半年Stelara在全球实现了63.36亿美元高额销售额，为强生公司在自免药物领域的营收做出了重要贡献。强生公司发布的2024年第三季度报告显示，该制药公司的销售额接近225亿美元，同比增长5.2%。其中，Stelara（乌司奴单抗）的销售额接近27亿美元，显示出其在市场上的强大竞争力。 3、TOP3: Humira（阿达木单抗） Humira（阿达木单抗）是一种全人源化抗肿瘤坏死因子 - α（TNF - α）单克隆抗体，用于治疗多种自身免疫性疾病，像类风湿关节炎、强直性脊柱炎、银屑病、克罗恩病等。它能特异性地与 TNF - α结合，从而抑制炎症反应。1998年，Humira在美国获批上市，之后在全球众多国家和地区广泛应用，极大地改善了患者的病情和生活质量。近年来，阿达木单抗多年来一直是全球销售额领先的药物之一，为艾伯维公司创造了巨大的收益，据艾伯维发布的财报显示，在2023年，Humira销售额达到144.04亿美元，在2024年前三季度，Humira的销售额超过70亿美元。 4、TOP4: Skyrizi（利生奇珠单抗） Skyrizi（利生奇珠单抗）是一种白细胞介素 - 23（IL - 23）抑制剂，主要用于治疗中重度斑块状银屑病、银屑病关节炎等自身免疫性疾病。它通过精准作用于特定靶点，有效减轻皮肤炎症和关节症状。Skyrizi已在全球多个国家和地区获批上市，包括美国、欧洲等地。在临床应用中，为众多自身免疫疾病患者带来了新的治疗选择。 2023年Skyrizi全球销售额合计77.63亿美元，2024年上半年销售额接近50亿美元，同比增长46%。Skyrizi 2024年第三季度销售额为32.05亿美元，同比增长50.8%，预计全年收入可超过110亿美元。 5、TOP5:Ocrevus（奥瑞利珠单抗） Ocrevus (奥瑞利珠单抗)是一种人源化单克隆抗体，主要用于治疗多发性硬化症（MS），包括复发型多发性硬化症和原发进展型多发性硬化症。它通过靶向作用于 CD20 阳性的 B 细胞，调节免疫系统对神经组织的攻击，从而减缓疾病的进展。Ocrevus已在多个国家和地区获批上市，为大量多发性硬化症患者提供了重要的治疗选择。在临床实践中，其疗效和安全性得到了广泛验证。根据罗氏公司公告显示，Ocrevus是罗氏制药业务前三季度销售额最高的药物，达到50.6亿瑞士法郎。 6、TOP6: Entyvio （维德力珠单抗） Entyvio（维德力珠单抗）是一种治疗炎症性肠病（包括溃疡性结肠炎和克罗恩病）的生物制剂，由武田制药研发。它通过特异性地结合肠道血管内皮细胞上的α4β7整合素，阻止白细胞向肠道炎症部位迁移，从而减轻肠道炎症。Entyvio用于对传统治疗或肿瘤坏死因子拮抗剂应答不足、失应答或不耐受的中重度活动性溃疡性结肠炎或克罗恩病成年患者。它在炎症性肠病治疗领域占据重要地位，2024年上半年，Entyvio销售额在武田制药自身免疫疾病业务收入中占比显著，销售额达到28.7亿美元，同比增长20%。 7、TOP7: Cosentyx（司库奇尤单抗） Cosentyx（司库奇尤单抗）被广泛用于治疗多种自身免疫性疾病，包括中重度斑块状银屑病、银屑病关节炎和强直性脊柱炎等。它通过特异性地阻断白细胞介素 - 17A（IL - 17A）信号通路，抑制炎症反应，从而减轻疾病症状。 2024年上半年销售额为28.52亿美元，同比增长21%；第三季度销售额增长了28%，达到17亿美元，超出共识预期7%。 8、TOP8: Rinvoq（乌帕替尼） Rinvoq（乌帕替尼）是一种口服的选择性 Janus 激酶（JAK）抑制剂，用于治疗多种自身免疫性疾病，包括类风湿关节炎、银屑病关节炎、特应性皮炎、溃疡性结肠炎等。它通过抑制 JAK 信号通路，从而减少炎症反应，缓解患者症状。据艾伯维2024年第三季度的业绩报告显示，Rinvoq第三季度销售额为16.14亿美元，同比增长45.3%，预计全年收入将超50亿美元。 9、TOP9: Jakafi（芦可替尼） Jakafi（芦可替尼）是一种口服JAK抑制剂，由Incyte公司开发，用于治疗中危或高危骨髓纤维化（MF），包括原发性骨髓纤维化、真性红细胞增多症骨髓纤维化和原发性血小板增多症骨髓纤维化。Jakafi的作用机制是通过抑制JAK1和JAK2，中断JAK-STAT信号通路，从而抑制细胞增殖和炎症反应。 2024上半年，Incyte最重要的产品JAK1/2抑制剂芦可替尼占所有产品总销售额的90%以上，总销售额达24.34亿美元，同比增长8%。 10、TOP10: Xolair（奥马珠单抗） Xolair（奥马珠单抗）是一种重组的人源化单克隆抗体，用于治疗哮喘和慢性特发性荨麻疹等过敏性疾病。其活性成分omalizumab通过特异性地结合游离IgE（免疫球蛋白E），降低游离IgE水平，从而减少IgE与肥大细胞和嗜碱性粒细胞表面的高亲和力IgE受体（FcεRI）结合，抑制炎症介质的释放，发挥抗过敏作用。 2024年上半年销售额为21亿美元，同比增长11%。 11、TOP11: Enbrel（依那西普） Enbrel（依那西普）是一种肿瘤坏死因子（TNF）抑制剂，主要用于治疗类风湿关节炎、强直性脊柱炎、银屑病关节炎和斑块状银屑病等自身免疫性疾病。它通过与TNF - α和TNF - β结合，阻断它们与细胞表面TNF受体的相互作用，从而减轻炎症反应。 2024年上半年 Enbrel 销售额为18.14亿美元，据安进最新发布的第三季度收益报告显示，Enbrel 第三季度季度销售额为 8.25 亿美元。 12、TOP12: Orencia（阿巴西普） Orencia（阿巴西普）是一种选择性T细胞共刺激调节剂，用于治疗类风湿关节炎（RA）和幼年特发性关节炎（JIA）等。它通过与抗原递呈细胞表面的CD80/CD86结合，阻断其与T细胞表面CD28的相互作用，抑制T细胞激活，从而减少炎症反应。 2024年上半年Orencia销售额为17.46亿美元，同比增长3%。 13、TOP13: Tremfya（古塞奇尤单抗） Tremfya（古塞奇尤单抗）是一种人源化单克隆抗体，用于治疗中重度斑块状银屑病。其活性成分guselkumab可特异性地结合白细胞介素 - 23（IL - 23）的p19亚基，抑制IL - 23信号传导，减轻皮肤炎症。 2024年10月16日，强生公布2024年第三季度财报。其中Tremfya销售增长13.0%至10.07亿美元。 14、TOP14: Actemra（托珠单抗） Actemra（托珠单抗）是一种人源化抗白细胞介素 - 6（IL - 6）受体单克隆抗体，主要用于治疗类风湿关节炎、全身型幼年特发性关节炎等炎症性疾病。Actemra已在全球广泛获批使用，为众多患者改善了病情，其2024年上半年在全球销售额达到14.62亿美元，在自身免疫疾病治疗领域地位显著。 15、TOP15: Simponi（戈利木单抗） Simponi（戈利木单抗）是一种全人源化抗肿瘤坏死因子 - α（TNF - α）单克隆抗体，用于治疗类风湿关节炎、强直性脊柱炎和银屑病关节炎等自身免疫性疾病。它能特异性地与TNF - α结合，抑制TNF - α的活性，减少炎症反应。 2024年上半年 Simponi销售额为14.47亿美元，同比增长2%。参考资料 [1]药智数据 [2]各公司官网、企业公开数据共建Biomedical创新生态圈！如何加入BiG会员？

财报免疫疗法高管变更

2024-11-10

·健识局

诺和盈美团首发预约；无锡虹桥医院注销；药店售价省际联动

2024年11月5-10日，第七届中国国际进口博览会在上海开幕。本届展会上，20余家全球头部跨国药械企业参展。辉瑞带来了PARP抑制剂甲苯磺酸他拉唑帕利胶囊等24款创新药产品，罗氏制药展出了PI3Kα抑制剂伊那利塞、CD20/CD3双抗莫妥珠单抗、多发性硬化创新药物奥瑞利珠单抗等；美敦力的全球最小智能可感知、可充电脑起搏器进行了“亚太首展”；诺和诺德则携全球首个胰岛素周制剂“诺和期”、GLP-1周制剂“诺和盈”在进博会亮相…… 值得注意的是，同期“诺和盈”也即将在华上市。“诺和盈”在今年6月获批减肥适应症。据报道，11月9日凌晨，美团上已经可以搜索到首批诺和盈®的待售诊所，并提供了线上找药和到店门诊服务。更多资讯，健识局整理如下：重磅政策一览 1、国家药监局：这些药品不得委托生产 11月5日，国家药监局发布《关于加强药品受托生产监督管理工作的公告(征求意见稿)〉意见》，对强化受生产企业质量责任、加强受托生产的监督管理提出具体要求。文件特别明确，鼓励创新药、经卫生健康主管部门确定的临床急需药品、应对突发公共卫生事件急需药品和治疗罕见病药品等通过委托生产方式扩大产能。同时，对于临床价值低、同质化严重的药品，原则上不得委托生产。 2、国家医保局：开展检验项目价格治理 11月8日，国家医保局发文称已统一部署各省开展医疗服务价格规范治理，推动一些量大价高的检查检验项目合理下调价格。国家医保局指出，价格治理聚焦地区价格差异大、采购成本差异大、费用占比高的检验项目，选取了血栓弹力图试验、糖化血红蛋白测定（诊断糖尿病及其控制情况）、B型钠尿肽测定和N端B型钠尿肽前体测定（诊断心衰及其治疗效果）4个检验项目开展首批价格规范治理。截至11月，全国已发文下调项目价格，其中上海、江西、青海等省份率先执行。据初步测算，单个项目平均降价超40元。 3、湖南启动线上线下省际价格联动 11月8日，湖南省医保局发布了《关于开展2024年省际药品价格联动挂网工作的通知》，其中提到，此次联动中新增挂网的产品，需填报本企业同通用名、同剂型产品、不同规格最小制剂在全国的主要线上交易平台、湖南省内线下零售药店的平均价格。此次价格联动主要针对集采非中选药品。湖南省指出，该价格信息仅做联动参考，不直接采用。比价参考的线上平台包括京东健康、美团、支付宝等手机APP，线下零售药店则指老百姓、益丰大药房、九芝堂等连锁药店企业。湖南医保局还提出了价格纠偏规则，将依照“过评药品最小制剂单位可比价不高于参比制剂”，“未过评药品最小制剂单位可比价不高于过评药品”两条规则，对化学药品、生物制剂单位可比价超1.8倍，中成药日均费用超3倍进行价格纠偏。医药卫生大事件 1、诺和盈即将在华上市，美团全网首发预约找药诺和诺德的“明星药”诺和盈在华上市迎来最新进展。 11月9日凌晨，经实测，美团已经可以搜索到首批“诺和盈”的待售诊所，并提供了线上找药和到店门诊服务。“诺和盈”今年6月刚在中国获批，用于减重适应症。此次美团上线是“诺和盈”即将正式上市的信号。美团上的“诺和盈”相关页面，已经可以显示药品价格、诊所信息，用户可看到诊所到货时间，沟通后续问诊取药。部分区域用户还可以选择就近的门诊或体检机构，体验全流程解决方案，包含预约到店问诊—取药—用药指导—减重管理整个环节。行业人士指出，目前“诺和盈”供不应求，预约模式下的“诊所地图”可最大程度提升匹配效率，减少患者寻找药品的时间和精力。随着减重市场持续升温，司美格鲁肽已有超越K药，成为新任“药王”的势头。11月6日，诺和诺德发布2024年第三季度报，今年前9个月，明星产品司美格鲁肽（包含降糖针剂“诺和泰”，降糖片剂Rybelsus，和减肥针剂“诺和盈”）销售额达到1412.13亿丹麦克朗，约203亿美元。 2、无锡虹桥医院骗保案大结局 11月6日据媒体报道，无锡虹桥医院有限公司被无锡市医疗保障局罚款5895万余元。同时，无锡市政府官网显示，无锡市卫健委已于10月29日注销无锡虹桥医院医疗机构执业许可证。 3、四环生物实控人被判有期徒刑三年 11月5日四环生物公告：公司收到实控人陆克平的刑事判决书。根据泰州市中级人民法院的判决，陆克平犯内幕交易罪，被判处有期徒刑三年，缓刑四年，并没收涉案违法所得2.32亿元。四环生物披露，该内幕交易的违法事实主要涉及海润光伏科技股份有限公司，与公司无关。陆克平目前未在公司担任董事、监事及高管职务，上述判决不会影响公司的正常业务运作。 4、通用环球医疗集团又有人被查 11月5日“廉洁通用”公众号披露，通用技术集团通用环球医疗集团有限公司业务一部原项目经理王朝晖涉嫌严重违纪违法，目前正接受通用技术集团纪检监察组和湖北省襄阳市南漳县监委纪律审查和监察调查。 5、康缘药业收购中新医药 11月7日，康缘药业公告，将以2.7亿元的自有资金，收购中新医药100%股权。因双方同属康缘集团控股，所以此次交易仅构成关联交易，不构成重大资产重组，本次交易完成后，中新医药将成为上市公司康缘药业的全资子公司。中新医药未有商业化产品销售，自成立以来一直处于持续亏损的状态，在研项目主要包括重组人神经生长因子注射液、重组人神经生长因子滴眼液、三靶点长效减重/降糖融合蛋白、双靶点长效降糖/减重融合蛋白，大部分都处于1期临床研究。 6、GSK退出美国全球生物技术工业组织 11月8日，据行业媒体报道，GSK决定2025年不再续签BIO的会员资格。此前，艾伯维、辉瑞、优时比、药明康德均已退出这一组织。有行业观点认为，药企选择退出或因BIO的游说能力下降。一周新药盘点 1、迪哲医药舒沃替尼在美申报上市 11月8日，迪哲医药宣布，已就舒沃替尼向FDA递交新药上市申请，适应症为既往经含铂化疗治疗时或治疗后出现疾病进展，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。此次新药上市申请是基于一项国际多中心注册临床研究。该研究纳入非亚裔患者占比超过40%，已达到主要研究终点。 2、华东医药银屑病新药获批，系国内首家 11月5日，华东医药宣布：其乌司奴单抗类似药的上市许可申请获得批准，用于治疗成年中重度斑块状银屑病。华东医药指出，该药物是国内首个获批的乌司奴单抗生物类似药。 3、第二个国产KRAS G12C抑制剂获批 11月8月，国家药监局官网显示，正大天晴的KRAS G12C抑制剂格索雷塞片已获附条件批准上市，适应症为至少接受过一种系统性治疗的KRAS G12C突变型的晚期非小细胞肺癌。这是国内第二个获批的KRAS G12C抑制剂。今年8月，信达生物/劲方医药的氟泽雷塞片获批，国内迎来第一个KRAS G12C抑制剂。此外，艾力斯与加科思的戈来雷塞也已递交了上市申请。两者适应症均为非小细胞肺癌。撰稿丨杨曦霞编辑丨江芸贾亭运营｜韩瑾睿插图｜视觉中国红斑狼疮能治好吗？百万一针的CAR-T或许有用 2024进博会 | 爱施健“米库氯铵注射液”回归再上市京东健康的进博画像：与跨国药企的合作深度和广度超越以往

带量采购

100 项与奥瑞珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D05218	奥瑞珠单抗	L04AA36	DB11988

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
多发性硬化症	澳大利亚	Roche Holding AG	2017-07-13
复发性多发性硬化	美国	Genentech, Inc.	2017-03-28
原发性进行性多发性硬化	美国	Genentech, Inc.	2017-03-28

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
慢性进行性多发性硬化	临床3期	美国	Hoffmann-La Roche, Inc.	2018-05-28
慢性进行性多发性硬化	临床3期	波斯尼亚和黑塞哥维那	Hoffmann-La Roche, Inc.	2018-05-28
慢性进行性多发性硬化	临床3期	巴西	Hoffmann-La Roche, Inc.	2018-05-28
慢性进行性多发性硬化	临床3期	加拿大	Hoffmann-La Roche, Inc.	2018-05-28
慢性进行性多发性硬化	临床3期	哥伦比亚	Hoffmann-La Roche, Inc.	2018-05-28
慢性进行性多发性硬化	临床3期	哥斯达黎加	Hoffmann-La Roche, Inc.	2018-05-28
慢性进行性多发性硬化	临床3期	捷克	Hoffmann-La Roche, Inc.	2018-05-28
慢性进行性多发性硬化	临床3期	丹麦	Hoffmann-La Roche, Inc.	2018-05-28
慢性进行性多发性硬化	临床3期	埃及	Hoffmann-La Roche, Inc.	2018-05-28
慢性进行性多发性硬化	临床3期	法国	Hoffmann-La Roche, Inc.	2018-05-28

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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


NCT04075266 (OPERETTA 1, CTgov)	临床2期	复发-缓解型多发性硬化	23	ocrelizumab (Body Weight < 40 kg)	醖願築夢鬱繭夢淵鹹鑰(淵積觸網齋艱網鏇願觸) = 觸醖淵簾憲繭糧製餘齋蓋鹹獵築衊繭夢築繭糧 (齋膚顧製鏇窪膚壓淵築, 蓋壓網艱壓壓齋蓋積憲 ~ 鏇製觸壓夢糧遞廠鏇鑰) 更多	-	2024-11-08
				ocrelizumab (Body Weight ≥ 40 kg)	醖願築夢鬱繭夢淵鹹鑰(淵積觸網齋艱網鏇願觸) = 網廠製窪鏇繭鏇簾顧窪蓋鹹獵築衊繭夢築繭糧 (齋膚顧製鏇窪膚壓淵築, 範餘積艱壓願獵築餘窪 ~ 醖網衊鑰選餘鏇顧襯鬱) 更多
NCT04966338 (Pubmed) 人工标引	临床3期	复发性多发性硬化	170	Xacrel	選簾廠觸簾餘鏇獵糧艱(糧鏇築鏇膚襯蓋範觸獵) = equivalent 選衊衊獵餘鑰網顧觸顧 (鹽願衊餘鏇積窪廠窪壓 ) 更多	相似	2024-10-22
				Ocrevus
NCT04877457 (CELLO, CTgov)	临床4期	放射学孤立综合征	3	ocrelizumab (Ocrelizumab)	壓獵積糧鹽鹽鑰醖淵構(餘構觸鏇顧鹹膚齋鑰鬱) = 鹽範夢衊鹽簾範糧壓積廠醖網膚齋糧衊構鏇艱 (繭憲鹽觸鹹壓淵憲願製, 鹹遞築窪醖餘窪鹽積繭 ~ 選鬱廠網齋壓積獵構壓) 更多	-	2024-10-09
				Placebo (Placebo)	壓獵積糧鹽鹽鑰醖淵構(餘構觸鏇顧鹹膚齋鑰鬱) = 鏇蓋廠鏇餘願選遞夢淵廠醖網膚齋糧衊構鏇艱 (繭憲鹽觸鹹壓淵憲願製, 鹽觸淵餘鏇齋衊築鹽範 ~ 夢襯顧網糧鹽願遞壓築) 更多
EAN	N/A	-	-	ocrelizumab (Treatment-naive patients (TN))	鬱糧繭蓋淵憲鑰製淵製(築繭願鹽遞鹹醖憲繭窪) = Adverse events (AEs) occurred in 56.7/100 patient years (PY) in TN-patients (88.7/100PY in pwPMST â‰¥3); 22.9/100PY were classified as System Organ Class (SOC) âInfections and infestationsâ (32.3/100PY in pwPMST â‰¥3) 廠製遞積觸壓夢選餘淵 (網膚窪蓋窪選膚獵製窪 ) 更多	-	2024-06-28
				ocrelizumab (Patients with â‰¥1 prior MS-specific therapies (pwPMST))
NCT02688985 (CTgov)	临床3期	原发性进行性多发性硬化 \| 复发性多发性硬化	131	Antihistamine+Methyloprednisolone+ocrelizumab (RMS Cohort Arm 1: Ocrelizumab + LP)	觸範範糧獵艱糧齋積顧(廠衊襯壓鹹壓醖糧顧鹹) = 鬱襯壓鏇構鹹鏇製窪壓鹹築蓋蓋選襯膚顧鬱憲 (廠窪製簾繭獵積憲膚鏇, 願鏇鑰衊淵觸構製淵遞 ~ 積窪壓壓觸構壓鏇鑰艱) 更多	-	2024-06-04
				Antihistamine+Methyloprednisolone+ocrelizumab (RMS Cohort Arm 2: Ocrelizumab + LP)	觸範範糧獵艱糧齋積顧(廠衊襯壓鹹壓醖糧顧鹹) = 憲構艱積餘鑰獵艱夢獵鹹築蓋蓋選襯膚顧鬱憲 (廠窪製簾繭獵積憲膚鏇, 餘壓廠積鹹壓窪壓遞鹹 ~ 鬱構鹹顧鑰網襯衊簾鬱) 更多
NCT03085810 (ENSEMBLE, AAN2024)	临床3期	复发-缓解型多发性硬化	301	Ocrelizumab	糧鏇範願齋鹽範壓築網(顧艱獵鏇齋範顧遞獵膚) = 糧遞鬱廠鹽艱鬱簾壓範範餘醖築糧範壓繭淵鑰 (憲壓齋齋製鹽獵齋膚網 )	积极	2024-04-09
				Interferon β-1a/-1b, Glatiramer Acetate, Dimethyl Fumarate, Teriflunomide	糧鏇範願齋鹽範壓築網(顧艱獵鏇齋範顧遞獵膚) = 襯獵顧廠鹹觸範廠選膚範餘醖築糧範壓繭淵鑰 (憲壓齋齋製鹽獵齋膚網 )
NCT04377555 (CHIMES, AAN2024)	临床4期	复发性多发性硬化	182	Ocrelizumab (Black/African American people with relapsing multiple sclerosis (BpwRMS))	醖艱製鬱夢糧繭製鹽鏇(網廠範鹽廠膚餘夢獵構) = 餘鏇鏇齋構製顧醖艱襯廠鏇壓獵蓋選壓構餘鹽 (獵遞衊繭鏇鑰簾糧膚簾 ) 更多	积极	2024-04-09
				Ocrelizumab (Hispanic/Latino people with relapsing multiple sclerosis (HpwRMS))	醖艱製鬱夢糧繭製鹽鏇(網廠範鹽廠膚餘夢獵構) = 網齋衊網簾網膚繭願鏇廠鏇壓獵蓋選壓構餘鹽 (獵遞衊繭鏇鑰簾糧膚簾 ) 更多
NCT03972306 (OCARINA I, AAN2024)	临床1期	多发性硬化症	131	Ocrelizumab SC 920mg	鬱鏇窪鏇鑰鹹鬱繭繭簾(襯觸願蓋選蓋鏇遞醖觸) = 糧壓遞構鑰積艱顧鑰膚憲願鑰鹽簾顧齋構鏇構 (範製築築觸醖範築鏇鹹 ) 更多	积极	2024-04-09
				Ocrelizumab IV 600mg	鬱鏇窪鏇鑰鹹鬱繭繭簾(襯觸願蓋選蓋鏇遞醖觸) = 齋鹽蓋遞簾繭鑰製壓鏇憲願鑰鹽簾顧齋構鏇構 (範製築築觸醖範築鏇鹹 ) 更多
AAN2024	N/A	多发性硬化症	-	Ocrelizumab	齋糧願衊廠壓憲繭願選(艱製鹹簾遞簾獵願鑰顧) = (serious) adverse event rates were consistent with the controlled treatment period, treatment withdrawal was infrequent and malignancy rates remained within epidemiologic background 範網網壓夢衊鹹範願窪 (齋遞糧艱選廠蓋願鑰憲 ) 更多	-	2024-04-09
NCT03085810 (ENSEMBLE, AAN2024)	临床3期	复发-缓解型多发性硬化	678	Ocrelizumab 600 mg	範構壓鏇願網鏇顧憲齋(觸網夢衊憲膚憲獵獵壓) = 鑰鹹選襯顧鑰夢餘觸鹽範鹽築選鬱廠襯襯構繭 (範網襯獵積鬱醖鹹鑰積 )	积极	2024-04-09