This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm trials to determine the safety and efficacy of two different dose levels of SEL-212 compared to placebo. 112 and 153 patients, stratified as to the presence or absence of tophi, were randomized in a 1:1:1 allocation ratio prior to Baseline to receive treatment with one of two dose levels of SEL-212 or placebo every 28 days for approximately 6 months in each trial respectively (SEL-212/301 and SEL-212/302). Analysis of primary and key efficacy were performed at Day 28 of Treatment Period 6. Safety was monitored throughout the study.

开始日期2020-11-30

申办/合作机构

Swedish Orphan Biovitrum AB

NCT04513366

/ Completed临床3期

A Randomized Double-Blind, Placebo-Controlled Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy

This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm trials to determine the safety and efficacy of two different dose levels of SEL-212 compared to placebo. 112 and 153 patients, stratified as to the presence or absence of tophi, were randomized in a 1:1:1 allocation ratio prior to Baseline to receive treatment with one of two dose levels of SEL-212 or placebo every 28 days for approximately 6 months in each trial respectively (SEL-212/301 and SEL-212/302). Analysis of primary and key efficacy will be performed at Day 28 of Treatment Period 6. Safety was monitored throughout the study.

开始日期2020-08-18

申办/合作机构

Swedish Orphan Biovitrum AB

NCT03905512

/ Completed临床2期

A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Patients Refractory to Conventional Therapy

This is a randomized, parallel-arm, multicenter study to compare the safety and efficacy profiles of SEL-212 and KRYSTEXXA®. Participants will be randomized 1:1 to receive treatment with SEL-212 or KRYSTEXXA® for 6 months. Efficacy assessments, as measured by serum uric acid (SUA) levels, will be conducted at intervals that are appropriate to determine treatment effect differences. Safety will be monitored throughout the study.

开始日期2019-05-07

申办/合作机构

Selecta Biosciences, Inc.

100 项与 SEL-212 相关的临床结果

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100 项与 SEL-212 相关的转化医学

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100 项与 SEL-212 相关的专利（医药）

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项与 SEL-212 相关的文献（医药）

2024-04-02·Rheumatology (Oxford, England)

The COMPARE head-to-head, randomized controlled trial of SEL-212 (pegadricase plus rapamycin-containing nanoparticle, ImmTOR™) versus pegloticase for refractory gout

Article

作者: DeHaan, Wesley ; Azeem, Rehan ; Traber, Peter G ; Kivitz, Alan J ; Choi, Hyon K ; Baraf, Herbert S B ; Strand, Vibeke ; Terkeltaub, Robert ; Keenan, Robert T ; Dalbeth, Nicola ; Khanna, Puja P

Abstract:

Objectives:

Serum urate (SU) lowering with PEGylated uricases in gout can reduce flares and tophi. However, treatment-emergent anti-drug antibodies adversely affect safety and efficacy and the currently approved PEGylated uricase pegloticase requires twice-monthly infusions. Investigational SEL-212 therapy aims to promote uricase-specific tolerance via monthly sequential infusions of a proprietary rapamycin-containing nanoparticle (ImmTOR) and pegadricase.

Methods:

COMPARE was a randomized, phase 2, open-label trial of SEL-212 vs pegloticase in adults with refractory gout. SEL-212 [ImmTOR (0.15 mg/kg) and pegadricase (0.2 mg/kg)] was infused monthly or pegloticase (8 mg) twice monthly for 6 months. The primary endpoint was the proportion of participants with SU <6 mg/dl for ≥80% of the time during 3 and 6 months. Secondary outcomes were mean SU, gout flares, number of tender and/or swollen joints and safety.

Results:

During months 3 and 6 combined, numerically more participants achieved and maintained a SU <6 mg/dl for ≥80% of the time with SEL-212 vs pegloticase (53.0% vs 46.0%, P = 0.181). The percentage reductions in SU levels were statistically greater during months 3 and 6 with SEL-212 vs pegloticase (−73.79% and −47.96%, P = 0.0161). Reductions in gout flare incidence and number of tender and/or swollen joints were comparable between treatments. There were numerical differences between the most common treatment-related adverse events of interest with SEL-212 and pegloticase: gout flares (60.2% vs 50.6%), infections (25.3% vs 18.4%) and infusion-related reactions (15.7% vs 11.5%), respectively. Stomatitis (and related terms) was experienced by eight participants (9.6%) with SEL-212 and none with pegloticase. Stomatitis, a known event for rapamycin, was associated with ImmTOR only.

Conclusions:

SEL-212 efficacy and tolerability were comparable to pegloticase in refractory gout. This was associated with a substantial reduction in treatment burden with SEL-212 due to decreased infusion frequency vs pegloticase.

Clinical trial registration:

NCT03905512.

2024-01-01·Journal of molecular graphics & modelling

Theoretical investigation of asphaltene molecules in crude oil viscoelasticity enhancement

Article

作者: Cui, Peng ; Yuan, Shideng ; Zhang, Heng ; Yuan, Shiling

Understanding the mechanisms of viscosity enhancement in crude oil phases is crucial for optimizing extraction and transportation processes. The enhanced viscosity mechanism of crude oil phase can be attributed to the intricate intermolecular interactions between asphaltene molecules. However, the molecular mechanism of the viscosification of asphaltene molecules in crude oil is not yet to be fully understood. In this work, molecular dynamics simulations were employed to investigate the dynamic behavior and viscosification mechanism of asphaltene molecules in complex oil phases. Research suggests that the neutral surface of asphaltenes features abundant positive and negative electrostatic potential regions, facilitating complementary pairing between these areas. This significantly augments electrostatic interactions among asphaltene molecules. Besides, the expansive nonpolar expanse on the normal asphaltene surface facilitates interactions between asphaltenes and crude oil molecules. This leads the crude oil viscosity of the system containing normal asphaltene is higher than that of the system containing acidic asphaltene under the same mass fraction (382 μ Pa·s for AAsp and 416 μ Pa·s for NAsp). This work provides insight into the viscosity enhancement mechanisms in crude oil phases and is helpful in improving the efficiency of crude oil extraction and transportation.

2023-08-01·Rheumatology and therapy

Phase 2 Dose-Finding Study in Patients with Gout Using SEL-212, a Novel PEGylated Uricase (SEL-037) Combined with Tolerogenic Nanoparticles (SEL-110).

Article

作者: Choi, Hyon ; Kivitz, Alan ; Kishimoto, Takashi K ; Rhodes, Sheri ; Leung, Sheldon S ; DeHaan, Wesley ; Johnston, Lloyd ; Traber, Peter G ; Azeem, Rehan ; Park, Justin ; Nicolaou, Savvas ; Inshaw, Jamie ; Sands, Earl

INTRODUCTION:

SEL-212 is a developmental treatment for uncontrolled gout characterized by serum uric acid (sUA) levels ≥ 6 mg/dl despite treatment. It comprises a novel PEGylated uricase (SEL-037; also called pegadricase) co-administered with tolerogenic nanoparticles containing sirolimus (rapamycin) (SEL-110; also called ImmTOR^®), which mitigates the formation of anti-drug antibodies (ADAs) against uricase and SEL-037 (PEGylated uricase), thereby enabling sustained sUA control (sUA < 6 mg/dl). The aim of this study was to identify appropriate dosing for SEL-037 and SEL-110 for use in phase 3 clinical trials.

METHODS:

This open-label phase 2 study was conducted in adults with symptomatic gout and sUA ≥ 6 mg/dl. Participants received five monthly infusions of SEL-037 (0.2 or 0.4 mg/kg) alone or in combination with three or five monthly infusions of SEL-110 (0.05-0.15 mg/kg). Safety, tolerability, sUA, ADAs, and tophi were monitored for 6 months.

RESULTS:

A total of 152 adults completed the study. SEL-037 alone resulted in rapid sUA reductions that were not sustained beyond 30 days in most participants due to ADA formation and loss of uricase activity. Levels of ADAs decreased with increasing doses of SEL-110 up to 0.1 mg/kg, with anti-uricase titers < 1080 correlating with sustained sUA control and reductions in tophi. Overall, 66% of evaluable participants achieved sUA control at week 20 following five monthly doses of SEL-037 0.2 mg/kg + SEL-110 0.1-0.15 mg/kg, whereas only 26% achieved sUA control at week 20 when SEL-110 was withdrawn after week 12. Compared to other dose combinations, SEL-037 0.2 mg/kg + SEL-110 0.15 mg/kg achieved the greatest sUA control at week 12 and was well-tolerated with no safety concerns.

CONCLUSION:

Results provide continued support for the use of multiple monthly administrations of SEL-037 0.2 mg/kg + SEL-110 0.1-0.15 mg/kg in clinical trials for SEL-212.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier, NCT02959918.

项与 SEL-212 相关的新闻（医药）

2025-01-08

·PRNewswire

Clarivate Identifies Eleven Potential Blockbuster and Transformative Drugs in Annual Drugs to Watch Report

Anticipated advancements in obesity, oncology, gene therapy and other areas poised to revolutionize patient care LONDON, Jan. 8, 2025 /PRNewswire/ -- Clarivate Plc (NYSE:CLVT) a leading global provider of transformative intelligence, today announced the release of the twelfth annual Drugs to Watch™ report, a trusted guide to the therapies poised to redefine the future of healthcare. This year, the highly anticipated resource highlights 11 drugs projected to achieve blockbuster status or revolutionize treatment paradigms within five years. Since its inception, Drugs to Watch has identified over 98 transformative therapies, cementing its role as an essential resource for navigating the ever-evolving pharmaceutical landscape. This year's report, powered by insights from the Clarivate Cortellis intelligence suite of products, highlights 11 therapies that have recently launched or are set to debut in 2025. These innovations, addressing critical challenges in areas such as obesity, oncology, and gene therapy, are forecast to achieve blockbuster sales by 2030 or dramatically improve patient outcomes on a global scale. The report also explores pivotal trends shaping the industry, including the surging demand for obesity treatments, the transformative potential of gene editing, and the growing impact of regulatory innovation. The report offers an in-depth analysis of the chronic disease market in Mainland China, spotlighting five therapies expected to exceed $1 billion in annual sales over the next five years or deliver transformative outcomes for patients. It also explores critical topics shaping global healthcare, including regulatory advancements, the role of radiopharmaceutical theranostics in oncology, and the growing use of real-world data (RWD) and patient-reported outcomes (PROs) to drive health equity and enhance regulatory submissions. Henry Levy, President, Life Sciences & Healthcare, Clarivate, remarked: "Innovation in the life sciences is reaching unprecedented heights, and this year's Drugs to Watch™ report once again demonstrates the industry's ability to deliver therapies that address unmet medical needs and challenge existing paradigms of care. At Clarivate, we take pride in the precision and reliability of our predictions—last year, we identified 13 molecules as Drugs to Watch, with 12 already approved and launched and one poised for launch. This track record reflects the strength of our comprehensive data and deep expertise. By continuing to provide actionable insights, we empower the sector to navigate opportunities, overcome challenges and drive progress in advancing global health." Mike Ward, Global Head of Thought Leadership, Life Sciences & Healthcare, Clarivate, stated: "2025 represents a turning point for the life sciences sector as it embraces cutting-edge technologies such as AI and machine learning to enhance drug discovery and development. This year's report captures the dynamic forces at play, including groundbreaking progress in precision oncology, the rise of radiopharmaceuticals, and the growing focus on addressing global health disparities." The 2025 Drugs to Watch™ report highlights key trends reshaping the life sciences landscape, emphasizing the transformative impact of emerging technologies and therapeutic breakthroughs. Advances in AI and machine learning are streamlining drug discovery, clinical trials, and real-world data integration, enabling precision medicine approaches. The obesity market is undergoing a revolution driven by next-generation GLP-1 therapies, while radiopharmaceutical theranostics are redefining cancer treatment with a "see it and treat it" paradigm. Gene editing technologies are unlocking new opportunities in personalized medicine, and evolving regulatory frameworks are fostering greater emphasis on patient-reported outcomes and health equity. Together, these trends showcase the sector's resilience and its ability to navigate challenges while driving innovation to improve patient care worldwide. This year's drugs to watch exemplify the fusion of innovation and dedication to advancing patient care in an increasingly complex healthcare ecosystem. The Drugs to Watch™ 2025 list include: AWIQLI® (LAI 287; insulin icodec) developed by Novo Nordisk | Type 1 and type 2 diabetes mellitus AWIQLI®, the first once-weekly, subcutaneous insulin, has launched in Australia, Canada, the EU, Mainland China, and Japan. Its weekly dosing offers a significant advantage over daily basal insulin, potentially reducing the treatment burden for patients with type 1 or type 2 diabetes (T1DM and T2DM). CagriSema (cagrilintide + semaglutide) developed by Novo Nordisk | Obesity and type 2 diabetes mellitus CagriSema, combining cagrilintide, a long-acting amylin analog, with semaglutide, promises superior efficacy over semaglutide (OZEMPIC/WEGOVY®) and tirzepatide (MOUNJARO/ZEPBOUND®) in treating obesity and type 2 diabetes. This next-generation GLP-1 therapy leverages the benefits of GLP-1s, such as enhanced insulin secretion and appetite reduction, while incorporating amylin's effects, including slowed glucose absorption and release. If approved, CagriSema will be the first fixed-dose combination of amylin and GLP-1 receptor agonists in the obesity and T2DM markets. COBENFY™ (KarXT; xanomeline-trospium) developed by Bristol Myers Squibb | Schizophrenia and psychosis related to Alzheimer's disease Amid setbacks for emerging schizophrenia treatments, the approval of COBENFY marks a transformative milestone as the first drug in over 30 years with a novel mechanism of action for treating schizophrenia. Combining xanomeline and trospium, COBENFY selectively targets M1 and M4 receptors, rather than traditional dopamine pathways, while minimizing cholinergic side effects. While further data is needed to assess its effectiveness in Alzheimer's disease-related psychosis, COBENFY shows strong commercial potential if proven effective in treating AD-related hallucinations and delusions. EBGLYSS™ (lebrikizumab) developed by Eli Lilly and Co and Almirall | Atopic dermatitis EBGLYSS™, the third biologic targeting IL-13 for atopic dermatitis, follows DUPIXENT® (dupilumab) and ADBRY®/ADTRALZA® (tralokinumab) to market. Its less frequent dosing, more selective IL-13 inhibition, and strong efficacy and safety data position it as a likely first-line treatment for moderate-to-severe atopic dermatitis when topical corticosteroids are inadequate. Fitusiran developed by Alnylam® Pharmaceuticals Inc and Sanofi | Hemophilia A and B Fitusiran, shown to be effective in phase 3 trials for both hemophilia A and B, regardless of inhibitor status, has the potential to offer a new approach to hemophilia treatment. This small interfering RNA (siRNA) therapy works by inhibiting SerpinPC1 mRNA, reducing antithrombin levels, promoting thrombin generation, and helping to rebalance hemostasis to prevent bleeds. Leveraging Alnylam® Pharmaceuticals' ESC-GalNAc conjugate technology, fitusiran could become the first antithrombin-lowering therapy based on a double-stranded RNA molecule, pending approval. GSK-3536819 (MenABCWY) developed by GSK plc | Meningococcus GSK plc's GSK-3536819 vaccine candidate, a 5-in-1, first-generation formulation, targets the five groups of Neisseria meningitidis (A, B, C, W, and Y) responsible for most invasive meningococcal disease (IMD) cases worldwide. It combines the antigenic components of GSK's licensed meningococcal vaccines, BEXSERO (MenB) and MENVEO (MenACWY), both of which have established efficacy and safety profiles. IMDELLTRA™ (tarlatamab-dlle) developed by Amgen | Small-cell lung cancer (SCLC) IMDELLTRA™ is a first-in-class immunotherapy for extensive-stage small cell lung cancer (ES-SCLC). Using Amgen's bispecific T cell engager (BiTE®) molecules, it targets CD3 on T cells and DLL3 on tumor cells, enabling T cells to attack and lyse the tumor. DLL3 is expressed on the surface of SCLC cells in more than 85% of patients but is minimally expressed on healthy cells making it an attractive target. This mechanism positions IMDELLTRA as a potential standard of care for previously treated ES-SCLC. mRESVIA (mRNA-1345) developed by Moderna Inc | RSV With its U.S. FDA approval in May 2024, mRESVIA® joined AREXVY and ABRYSVO, both featured in Drugs to Watch 2024, as respiratory syncytial virus (RSV) vaccines currently available for adults ages 60 years and older, helping further support the public health initiative to reduce the RSV-related disease burden. Even with available vaccines, RSV infections continue to be a public health concern, particularly for infants and older adults (65 years and older). SEL-212 developed by Sobi® and Cartesian Therapeutics Inc/Selecta Biosciences Inc | Gout SEL-212 is a novel, once-monthly treatment combining pegylated uricase (pegadricase; SEL-037) with ImmTOR™, an immune tolerance technology designed to inhibit the formation of anti-drug antibodies (ADAs). For this application, ImmTOR consists of SEL-110.36, an inhibitor of uricase-specific ADA. This approach may help overcome the limitations of reduced efficacy and tolerability seen with other biologic treatments, such as KRYSTEXXA® (pegloticase), in patients with chronic gout. Vepdegestrant (ARV-471) developed by Arvinas Inc and Pfizer Inc | Breast cancer A global collaboration between Arvinas Inc and Pfizer Inc, vepdegestrant may become the first PROteolysis Targeting Chimera (PROTAC®) protein degrader on the market. Designed to target and degrade the estrogen receptor (ER) protein, early studies suggest PROTAC-induced degradation is more complete than with oral selective estrogen receptor degraders (SERDs). This offers potential for overcoming endocrine resistance in breast cancer. Label expansions, including combination with IBRANCE® (palbociclib), are being explored. Zanzalintinib (XL092) developed by Exelixis Inc | Colorectal cancer, renal cell carcinoma and squamous cell carcinoma of head and neck Zanzalintinib is a third-generation oral tyrosine kinase inhibitor targeting VEGF receptors, MET, and TAM kinases involved in tumor growth and immunosuppression. Currently in phase 3 trials for non-clear-cell renal cell carcinoma (nccRCC), colorectal cancer (CRC) and squamous cell carcinoma of the head and neck (SCCHN), the company anticipates one potential zanzalintinib launch per year starting as early as 2026. Compared to CABOMETYX® (cabozantinib), zanzalintinib may offer benefits, including approval for nccRCC histology and a broader patient population. Access the Drugs to Watch 2025 report from Clarivate, here. For more Drugs to Watch updates and analyses throughout the year, visit the Drugs to Watch web page and follow Clarivate for Life Sciences & Healthcare on LinkedIn and X. Join the conversation, using #DrugstoWatch. To learn more about how Clarivate can help healthcare companies inform and shape the drug discovery, development and delivery process, visit here. Methodology for the Clarivate Drugs to Watch 2025 Report To identify this year's Drugs to Watch, Clarivate drew from the expertise of over 160 analysts covering hundreds of diseases, drugs and markets, along with 11 integrated data sets that span the R&D and commercialization lifecycle, including: Cortellis Competitive Intelligence™, Disease Landscape & Forecast, Epidemiology Intelligence, BioWorld™, Cortellis Regulatory Intelligence™, Drug Timeline & Success Rates, Cortellis Clinical Trials Intelligence™, Cortellis Deals Intelligence™, Access & Reimbursement payer studies, Clarivate Real-World Data and Analytics, Web of Science™, Derwent Innovation™, and other industry sources including biopharma company press releases, filings and peer-reviewed publications. Candidate drugs in phase 2 or phase 3 trials, at pre-registration or registration stage, or already launched in 2024 were selected for analysis, including both novel treatments and already-marketed drugs pursuing new indications that could be particularly impactful. Drugs launched prior to 2024 were excluded. The dataset was filtered for drugs that had total forecast sales of $1 billion or more by 2030. Clarivate experts and analysts evaluated each drug in its individual context, based on factors such as expected approval or launch dates, competitive landscape, regulatory status, trial results, market dynamics and other key factors, and added novel drugs that, while likely to fall short of blockbuster status, are poised to be therapeutic game-changers. Please note that Clarivate analysts generated the data shown in this report prior to December 31, 2024. The Drugs to Watch 2025 Report and the treatments referenced in this release are based on Clarivate's current expectations per existing data, but actual results derived from the drugs named in the report and here may differ significantly. Clarivate is committed to comprehensively supporting customers across the entire drug, device and medical technology lifecycles to advance human health. By combining patient journey data, therapeutic area expertise, artificial intelligence and analytics in ways that unlock hidden insights, data-driven decisions and accelerating innovation, Clarivate's end-to-end research intelligence is designed to enable customers to make informed evidence-based decisions. About Clarivate Clarivate™ is a leading global provider of transformative intelligence. We offer enriched data, insights & analytics, workflow solutions and expert services in the areas of Academia & Government, Intellectual Property and Life Sciences & Healthcare. For more information, please visit . Media Contact: Catherine Daniel Director, External Communications, Life Sciences & Healthcare [email protected] SOURCE Clarivate Plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

疫苗临床3期免疫疗法

2024-11-07

·GlobeNewswire-Health Care

Sobi to present new data across its immunology portfolio at the ACR Convergence 2024

WALTHAM, Mass., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), today announced the presentation of four abstracts that highlights data from its immunology portfolio at the ACR Convergence 2024 taking place in Washington, D.C. from November 14–19, 2024. Sobi’s commitment to delivering innovative treatments for people living with immunological diseases is seen in global studies spanning multiple disorders: Results from two Phase 3 trials evaluating the effect on patient-reported outcomes in patients with chronic refractory gout treated with SEL-212.Initial data on the effect of anti-drug antibodies on serum uric acid (sUA) reduction and safety in response to treatment with SEL-212.DISSOLVE 1 Phase 3 study: Results of a post hoc analysis of sustained sUA reduction and safety of SEL-212 in patients with chronic refractory gout living in the United States.Results from a Phase 3 Study and a pooled analysis of two prospective trials evaluating efficacy and safety of emapalumab in patients with Macrophage Activation Syndrome in Still’s disease. Key Sobi data to be presented at ACR Convergence 2024 Chronic Refractory GoutSEL-212Improvements in Patient-Reported Outcomes After Treatment with SEL-212 in Adults with Refractory Gout: Results from Two Randomized Phase 3 TrialsSession: Patient Outcomes, Preferences, & Attitudes Poster ISaturday, November 16; 10:30 AM - 12:30 PMImpact of Anti-drug Antibodies on the Efficacy of SEL-212 in Patients with Chronic Gout Refractory to Conventional TherapySafety and Efficacy of SEL-212 in the US and ex-US Subgroups: Results from the Phase 3 DISSOLVE StudiesSession: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster IIIMonday, November 18; 10:30 AM - 12:30 PM Macrophage Activation SyndromeEmapalumabEfficacy and Safety of Emapalumab in Children and Adults with Macrophage Activation Syndrome (MAS) in Still’s disease: Results from a Phase 3 Study and a Pooled Analysis of Two Prospective TrialsLate-Breaking AbstractsNovember 19; Session Time: 8:00 AM - 9:30 AM; Presentation Time: 9:00 AM - 9:15 AM All abstracts can be accessed via the official ACR Convergence website. ContactsFor details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media, click here. About SEL-212SEL-212 is being developed as a novel once-monthly combination medicine that integrates targeted immunomodulation with uricase-based therapy and is being investigated for the treatment of chronic refractory gout . SEL-212 consists of pegadricase, a proprietary pegylated uricase, co-administered with nanoencapsulated sirolimus. About Chronic Refractory GoutGout is the most common form of inflammatory arthritis with more than 8.3 million people in the United States having been diagnosed with gout, which is caused by high levels of uric acid in the body that accumulate around the joints and other tissues and can result in flares that cause intense pain. Approximately 160,000 people in the United States suffer from chronic refractory gout (CRG), where patients are resistant to conventional medicines and symptoms are more persistent. CRG is a painful and debilitating condition in people with persistent raised serum uric acid (sUA) levels, which may result in several flares per year and the development of nodular masses of uric acid crystals known as tophi. About emapalumab-lzsgEmapalumab-lzsg is a fully human, anti-IFNγ monoclonal antibody that binds free and receptor-bound IFNγ, neutralizing its biological activity. In the US, emapalumab-lzsg is indicated for pediatric (newborn and older) and adult primary hemophagocytic lymphohistiocytosis (HLH) patients with refractory, recurrent or progressive disease, or intolerance to conventional HLH therapy. Emapalumab-lzsg is the first and only medicine approved in the US for primary HLH, a rare syndrome of hyperinflammation that usually occurs within the first year of life and can rapidly become fatal unless diagnosed and treated. The FDA approval in 2018 was based on data from the phase 2/3 studies (NCT01818492 and NCT02069899).For the treatment of HLH, Emapalumab is indicated for administration through twice per week until hematopoietic stem cell transplantation (HSCT). The efficacy and safety of emapalumab are currently being evaluated. Emapalumab is currently under investigation (phase 3) in patients with MAS in Still’s disease or systemic lupus erythematosus (SLE) (EMERALD; NCT05001737). U.S. Indication for Gamifant® (emapalumab-lzsg)Gamifant® (emapalumab-lzsg) is an interferon gamma (IFNγ)–blocking antibody indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent, or progressive disease or intolerance with conventional HLH therapy. Important Safety InformationInfectionsBefore initiating Gamifant, patients should be evaluated for infection, including latent tuberculosis (TB). Prophylaxis for TB should be administered to patients who are at risk for TB or known to have a positive purified protein derivative (PPD) test result or positive IFNγ release assay. During Gamifant treatment, patients should be monitored for TB, adenovirus, Epstein-Barr virus (EBV), and cytomegalovirus (CMV) every 2 weeks and as clinically indicated. Patients should be administered prophylaxis for herpes zoster, Pneumocystis jirovecii, and fungal infections prior to Gamifant administration. Increased Risk of Infection With Use of Live VaccinesDo not administer live or live attenuated vaccines to patients receiving Gamifant and for at least 4 weeks after the last dose of Gamifant. The safety of immunization with live vaccines during or following Gamifant therapy has not been studied. Infusion-Related ReactionsInfusion-related reactions, including drug eruption, pyrexia, rash, erythema, and hyperhidrosis, were reported with Gamifant treatment in 27% of patients. In one-third of these patients, the infusion-related reaction occurred during the first infusion. Adverse ReactionsIn the pivotal trial, the most commonly reported adverse reactions (≥10%) for Gamifant included infection (56%), hypertension (41%), infusion-related reactions (27%), pyrexia (24%), hypokalemia (15%), constipation (15%), rash (12%), abdominal pain (12%), CMV infection (12%), diarrhea (12%), lymphocytosis (12%), cough (12%), irritability (12%), tachycardia (12%), and tachypnea (12%). Additional selected adverse reactions (all grades) that were reported in less than 10% of patients treated with Gamifant included vomiting, acute kidney injury, asthenia, bradycardia, dyspnea, gastrointestinal hemorrhage, epistaxis, and peripheral edema. Please see the full Prescribing Information for Gamifant. About Sobi North AmericaAs the North American affiliate of international biopharmaceutical company Sobi, the Sobi North America team is committed to Sobi’s vision of being a leader in providing innovative treatments that transform lives for individuals with rare diseases. Our product portfolio includes multiple approved treatments focused on immunology, hematology and specialty care. With U.S. headquarters in the Boston area, Canadian headquarters in the Toronto area, and field sales, medical and market access representatives spanning North America, our growing team has a proven track record of commercial excellence. More information is available at https://www.sobi.com/usa or at www.sobi.com. About Sobi®Sobi is a specialized international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of hematology, immunology and specialty care, Sobi has approximately 1,800 employees across Europe, North America, the Middle East, Asia and Australia. In 2023, revenue amounted to SEK 22.1 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com, LinkedIn and YouTube. Brian Castellibrian.castelli@sobi.com

临床3期临床结果上市批准免疫疗法疫苗

2024-08-22

·美通社

三生制药公布2024中期业绩：营收同比增长16%，自免管线收获在望

香港 2024年8月22日 /美通社/ -- 今天，三生制药（01530.HK）公布中期业绩。业绩公告显示，2024上半年三生制药营业收入约人民币43.89亿元，比去年同期增长16.0%；毛利约人民币37.97亿元，比去年同期增长18.6%；经调整的经营性归母净利润约人民币11.12亿元，比去年同期增长1.5%；经调整EBITDA约人民币16.64亿元，比去年同期增长17.0%。生物药板块稳健成长 2024上半年，三生制药不断探索核心生物药产品适应症拓展，加强基层市场布局，积极提升药品可及性。全球唯一商业化的重组人血小板生成素（rhTPO）产品特比澳在上半年销售收入约24.76亿元，同比增长22.6%。该产品在今年4月获批第三个适应症，用于治疗儿童或青少年的持续性或慢性原发免疫性血小板减少症。促红素双品牌益比奥和赛博尔2024上半年销售收入约5.16亿元，同比增长11.3%。2024年起，益比奥用于外科围手术期的红细胞动员获医保覆盖。用于治疗类风湿性关节炎、强直性脊柱炎及银屑病的益赛普2024上半年销售收入3.29亿元，同比增长9.5%。用于治疗HER2阳性转移性乳腺癌的赛普汀2024上半年销售收入为1.62亿元，同比提升48.9%。毛发健康产品持续丰富 2024年1月，蔓迪泡沫剂型获批上市，以自主创新技术改良溶剂成分，填补敏感人群用药空白，并相对第一代酊剂产品提升渗透速率，缩短起效时间。2024上半年，蔓迪全系列销售收入5.50亿元，同比增加约10.0%。作为首个获批的OTC米诺地尔泡沫剂型，蔓迪泡沫剂与蔓迪小白瓶、精灵瓶等规格产品一同，为国内雄脱患者提供更多选择，满足不同人群的用药习惯，进一步释放蔓迪品牌的价值，扩大米诺地尔领导者的竞争优势。自免管线成果收获在即公告显示，三生制药研发管线拥有28项在研产品，包含血液及肿瘤科12项，自身免疫及眼科10项，肾科4项，皮肤科1项，代谢科1项。截至目前，已有12款新药推进至临床III期或新药上市申请（NDA）申报阶段，2款仿制药品种处于仿制药注册申请（ANDA）申报的阶段。在研管线上市产品临床价值持续扩大。2024上半年，特比澳用于治疗儿童或青少年的持续性或慢性原发免疫性血小板减少症获CDE批准上市。此外，长效促红素（SSS06）用于慢性肾衰竭贫血治疗的III期临床研究达到主要预设终点，公司已向国家药监局递交该产品新药上市申请并获受理。赛普汀在2024ASCO大会上发布多篇报告，为临床应用扩展提供更多确证性数据。自免管线研发成果即将迎来收获。2024上半年，抗IL-17A抗体（608）治疗斑块状银屑病的III期临床试验已成功达到所有疗效终点，预计将于今年完成该适应症的生物制剂许可证（BLA）申报。用于治疗急性痛风性关节炎的抗IL-1β抗体（613）、用于治疗重度嗜酸性粒细胞哮喘的抗IL-5抗体(610)和治疗特应性皮炎的抗IL-4Rα抗体（611）均已完成III期临床试验首例患者入组。此外，公司还开发具有临床需求和创新性的新靶点和新分子，着力打造国内具有竞争力的差异化自免管线。公司分别递交了早研项目抗BDCA2单抗626治疗系统性红斑狼疮（SLE）和皮肤型红斑狼疮（CLE）适应症的中美新药临床试验申请（IND），其中中国的新药临床试验申请（IND）已获国家药监局受理。 2024上半年，三生制药各项对外合作持续深化拓宽。公司与合作伙伴Sobi合作推进的组合疗法SEL-212用于慢性难治性痛风的三期临床试验已完成，Sobi已于今年7月向美国FDA申请滚动生物制剂许可证（BLA）。公司与COSMO合作产品1%浓度柯拉特龙乳膏剂(Winlevi®，研发代码WS204)用于治疗12岁以上患者面部寻常型痤疮的III期桥接临床试验正在入组中。三生制药旗下子公司三生蔓迪进军减重领域，与深圳翰宇药业就司美格鲁肽注射液产品达成合作，该产品已在国内获得临床试验批准。未来，三生制药将继续聚焦肾科、血液与肿瘤、自免、毛发皮肤等优势领域，持续践行自主研发和对外合作双轨并行的策略，积极发掘有潜力的创新药合作标的，强化管线布局。公司还将凭借成熟的生物药研发注册、商业化生产以及销售实力，为更多优质创新药产品的研发上市进程以及市场价值发挥提供助力。三生制药董事长兼首席执行官娄竞博士表示："2024上半年，公司核心产品表现稳健，在研管线喜报频传，对外合作加速拓展。随着多款新药临床数据读出，其潜在治疗价值逐渐展现。同时，公司核心产品的临床应用受到更加广泛的市场认可，不断焕发出新的生命力。这些成绩充分展现出了公司发展的强大韧劲和广阔前景。展望未来，三生制药将继续发挥自身优势，坚定不移地推动创新药产品研发，抓住行业整合机遇和国家政策红利，积极发掘优质合作标的，推动更多高质量创新药产品走上市场，为建设健康中国贡献民族生物药企业的一份力量。" 关于三生制药三生制药是一家集研发、生产和销售为一体的生物制药领军企业，致力于以高品质的药品提高患者生存质量，为人类健康造福。目前，公司拥有100余项国家发明专利授权，40余种上市产品，覆盖肾科、肿瘤科、自身免疫性疾病、眼科及皮肤科等多种治疗领域。公司拥有抗体药物国家工程研究中心以及生物药和化药双平台的4大研发中心，共有28种在研产品，其中25种为国家新药，并拥有符合GMP标准的5大生产基地。未来，三生制药将继续秉持"珍爱生命、关注生存、创造生活"的理念，全力打造全球领先的中国生物制药企业。请访问www.3sbio.com获取更多信息。警示说明及前瞻性陈述本新闻稿包含前瞻性陈述，例如涉及业务和产品前景,或公司的意图、计划、认知、预期及策略。该等前瞻性陈述是根据本公司现有的资料，并按本新闻稿发布时的展望陈述。该等前瞻性陈述基于若干预测、假设及前提，其中一些是主观性的或不受我们控制。该等前瞻性陈述可能被证明是不正确的，或将来可能无法实现。就任何新产品或产品的新适应症, 我们无法确保其将能成功开发或最终上市销售。该等前瞻性陈述受各种风险及不明朗因素影响。我们的其他公开披露文件可能提供该等风险及不明朗因素的更多信息。所涉及之科学信息可能只是初步的和研究性的。本公司股东及潜在投资者在买卖本公司股份时，请务必谨慎行事。

财报ASCO会议临床3期

100 项与 SEL-212 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
慢性痛风	申请上市	美国	Swedish Orphan Biovitrum AB	2024-07-02
痛风	临床3期	美国	苏庇医药（广州）有限公司	2020-11-23
高尿酸血症	临床2期	美国	Selecta Biosciences, Inc.	2016-10-01

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临床结果

适应症

分期

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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


NCT04596540 \| NCT04513366 (DISSOLVE II, EULAR 12024 \| EULAR 22024) 人工标引	临床3期	痛风	265	SEL-212 0.15 mg/kg (high-dose)	襯築衊襯廠齋遞願獵淵(齋窪製窪衊獵鹽築鑰選) = 鑰顧夢築鬱憲鑰鏇遞製鹽製願襯觸築簾範廠醖 (顧艱鹹遞醖夢鏇壓窪廠, 9.5) 更多	积极	2024-06-14
				SEL-212 0.1 mg/kg (low-dose)	襯築衊襯廠齋遞願獵淵(齋窪製窪衊獵鹽築鑰選) = 獵鏇鹹衊醖網襯鑰艱鑰鹽製願襯觸築簾範廠醖 (顧艱鹹遞醖夢鏇壓窪廠, 9.4) 更多
NCT04513366 (DISSOLVE I, EULAR2024)	临床3期	痛风	38	SEL-110 at 0.15 mg/kg + SEL-037 at 0.2 mg/kg	壓鏇選範膚鹽鹽觸製糧(製夢鑰鬱鹽選膚艱醖憲) = The most common adverse event of special interest across all three treatment arms was gout flare 廠積窪餘製顧獵艱餘鬱 (齋遞積醖範願餘衊製構 ) 更多	积极	2024-06-05
				SEL-110 at 0.1 mg/kg + SEL-037 at 0.2 mg/kg
NCT03905512 (COMPARE, CTgov)	临床2期	痛风	170	SEL-212 (SEL-212)	膚醖艱齋觸齋齋糧願築 = 鏇簾鏇夢簾鏇壓夢簾糧鏇觸鑰遞鑰範鏇淵鹹蓋 (積積餘繭憲糧積觸鬱製, 鏇顧膚夢築齋窪網網壓 ~ 襯鹹積衊製廠鬱獵積構) 更多	-	2023-10-17
				KRYSTEXXA® (KRYSTEXXA)	膚醖艱齋觸齋齋糧願築 = 蓋觸壓襯鹹願衊醖網願鏇觸鑰遞鑰範鏇淵鹹蓋 (積積餘繭憲糧積觸鬱製, 網構簾積糧廠觸艱遞鹹 ~ 獵範構獵艱壓襯觸廠鹹) 更多
NCT03905512 (COMPARE, Corporate Publications) 人工标引	临床2期	慢性痛风	170	SEL-212	鑰壓憲廠糧艱齋範築獵(獵鹹餘觸選糧鏇簾觸齋) = 窪築廠襯淵構衊窪膚鑰顧壓鹽製憲鑰築積鑰願 (構願鏇觸壓壓遞鏇壓齋 ) 更多	积极	2020-09-30
				Pegloticase	鑰壓憲廠糧艱齋範築獵(獵鹹餘觸選糧鏇簾觸齋) = 鏇衊膚觸繭醖積廠觸遞顧壓鹽製憲鑰築積鑰願 (構願鏇觸壓壓遞鏇壓齋 ) 更多
NCT02959918 (ACR2019) 人工标引	临床2期	痛风	152	SEL-212	襯鹽範築夢鏇網蓋繭餘(觸繭糧艱獵觸衊壓鬱膚) = 艱艱積齋願鹽窪艱鏇憲積膚鹹簾繭顧衊壓積醖 (艱壓窪繭獵膚選壓顧醖 ) 更多	积极	2019-11-11
				Pegadricase	-
SEL-212 (EULAR2019)	临床2期	痛风	152	SEL-212 (0.1 mg/kg ImmTOR + 0.2 mg/kg pegadricase)	壓夢壓鑰醖顧糧願顧遞(簾廠網鬱鏇築膚鑰顧窪) = All evaluable patients receiving 0.1 or 0.15 mg/kg ImmTOR administered with 0.2 mg/kg pegadricase who achieved three months of SUA control maintained SUA control in months four and five of combination treatment 鏇醖鬱鏇襯齋壓廠夢鹹 (襯艱壓製醖鹽獵餘廠蓋 ) 更多	-	2019-06-12
				SEL-212 (0.15 mg/kg ImmTOR + 0.2 mg/kg pegadricase)
ACR2017	临床2期	痛风	60	SEL-212 (0.4mg/kg pegsiticase + 0.08mg/kg SVP-R)	糧鏇構願顧憲餘衊淵獵(願膚鬱鹽網餘夢鏇遞淵) = Of 7 observed serious infusion reactions, 4 were associated with patients receiving pegsiticase alone or the lowest dose of SEL-212, as expected, and two were related to dosing errors 膚膚顧襯壓鏇壓繭壓築 (獵獵願願鬱蓋夢窪餘繭 )	积极	2017-11-07
				Pegsiticase alone (0.4mg/kg)
FOCIS2017	临床2期	-	38	SEL-212 (SVP-R + pegsiticase)	築夢觸醖築範襯壓糧積(繭簾簾鹹糧鹹膚憲製選) = 膚淵夢築窪廠憲觸衊製築醖廠夢製糧壓齋膚壓 (鹽鹽齋壓觸獵醖襯積顧 )	积极	2017-06-14
				Pegsiticase alone	築夢觸醖築範襯壓糧積(繭簾簾鹹糧鹹膚憲製選) = 窪鹹憲夢壓鹽壓餘觸製築醖廠夢製糧壓齋膚壓 (鹽鹽齋壓觸獵醖襯積顧 )
FOCIS2017	临床1期	高尿酸血症	5	SVP-R alone	鹽蓋壓壓鹽襯醖築積鏇(遞衊範糧顧選觸網夢艱) = 餘選網襯齋顧窪網鹽鑰餘衊餘鹹範鹹襯遞夢淵 (鬱鏇夢願顧選餘製構夢 )	积极	2017-06-14