抗体药物研发商Argenx获得欧盟委员会批准VYVGART®皮下注射与ENHANZE®联合治疗慢性炎症性脱髓鞘性多发性神经病Halozyme Announces argenx Received European Commission Approval for VYVGART® Subcutaneous Injection with ENHANZE® for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

动脉网2025-06-23

/PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:/PRNewswire/ -- Halozyme Therapeutics, Inc.（纳斯达克：) (Halozyme) today announced that argenx received European Commission (EC) approval of VYVGART® ...

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(NASDAQ:/PRNewswire/ -- Halozyme Therapeutics, Inc.（纳斯达克：) (Halozyme) today announced that argenx received European Commission (EC) approval of VYVGART® ...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN202506231504169527a13a&s=b\">网页链接</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU0320765992.SGD","symbol_name":"FTIF - Franklin Biotechnology Discovery A Acc SGD","start_time":0,"source_url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN202506231504169527a13a&s=b","article_id":"2545065467","we_media_id":null,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN202506231504169527a13a&s=b","rn_cache_url":null,"customStyle":"body{padding-top:10px;}#news_title{font-weight:bold;#titleStyle#;}#news_description span{font-size:12px;#descriptionStyle#;}.footer-note{#statement#}","selectors":".mod-LoadTzbdNews, body","filters":".relate-stock, .hot-list, .recom-box, .wx-sou","directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2545065467","pubTimestamp":1750662060,"columns":[],"sourceInfo":{"source_id":"tencent","name":"腾讯"},"weMediaInfo":null,"summary":"VYVGART is the first and only targeted IgG Fc-antibody fragment for Chronic Inflammatory Demyelinating Polyneuropathy  and the first novel mechanism of action for CIDP treatment in more than 30 years.VYVGART 是首个且唯一一个针对慢性炎性脱髓鞘性多发性神经病的靶向 IgG Fc 抗体片段，也是过去 30 多年来 CIDP 治疗中的首个全新作用机制。","collect":0,"end_time":0,"defaultTopTitle":"qq.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","BK4201":"综合性石油与天然气企业","BK4156":"煤与消费用燃料","BK4585":"ETF&股票定投概念","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","BK4505":"高瓴资本持仓","BK4139":"生物科技","ARGX":"Argenx SE","BK4588":"碎股","EC":"哥伦比亚国家石油","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)"},"translate_title":"Antibody drug developer Argenx receives European Commission approval for VYVGART ® Subcutaneous injection and ENHANZE ® Combination treatment of chronic inflammatory demyelinating polyneuropathy Halozyme Announces argenx Received European Commission Approval for VYVGART ® Subcutaneous Injection with ENHANZE ® for Chronic Inflammatory Demyelinating Polyeuropathy (CIDP)","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"EC":1,"ARGX":0.9},"content_text":"/PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:/PRNewswire/ -- Halozyme Therapeutics, Inc.（纳斯达克：) (Halozyme) today announced that argenx received European Commission (EC) approval of VYVGART® 1000mg (efgartigimod alfa) developed with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme (rHuPH20), for subcutaneous (SC) injection as a monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins..）（Halozyme）今日宣布，argenx公司开发的VYVGART® 1000mg（艾加莫德阿尔法），使用了Halozyme专有的重组人透明质酸酶（rHuPH20）技术ENHANZE®，已获得欧盟委员会（EC）批准，用于成人进行性或复发性活动性慢性炎症性脱髓鞘性多发性神经病（CIDP）的治疗，在既往使用皮质类固醇或免疫球蛋白治疗后，可作为单药通过皮下注射（SC）给药。VYVGART is the first and only targeted IgG Fc-antibody fragment for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and the first novel mechanism of action for CIDP treatment in more than 30 years.VYVGART 是首个且唯一一个针对慢性炎性脱髓鞘性多发性神经病（CIDP）的靶向 IgG Fc 抗体片段，也是过去 30 多年来 CIDP 治疗中的首个全新作用机制。'We are pleased to announce the European Commission approval of the subcutaneous injection of VYVGART, which is co-formulated with our ENHANZE drug delivery technology for use in CIDP patients. This marks another milestone in our partnership with argenx and the expansion of access to“我们很高兴地宣布，欧洲委员会已批准VYVGART的皮下注射剂型，该剂型与我们的ENHANZE药物递送技术共同配制，用于CIDP患者。这标志着我们与argenx合作的又一个里程碑，也是扩大患者获取该药物的重要一步。Europe欧洲is another catalyst supporting our growth,' said Dr.是支持我们成长的另一个催化剂，' 博士说。Helen Torley海伦·托利, president and chief executive officer of Halozyme.哈尔ozyme公司的总裁兼首席执行官。The EC decision is based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date. For more information on the study and its findings, please view argenx's press release issued on欧盟的决定基于ADHERE临床试验的积极结果，这是迄今为止针对CIDP患者规模最大的研究。有关该研究及其发现的更多信息，请查看argenx发布的新闻稿。The approval by the EC is valid in all 27 European Union (EU) Member States, as well as欧盟委员会的批准在所有27个欧盟成员国以及Iceland冰岛Norway挪威and和Liechtenstein列支敦士登About Halozyme关于HalozymeHalozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden.Halozyme是一家生物制药公司，致力于推进颠覆性解决方案，以改善患者在新兴和现有疗法中的体验与疗效。作为ENHANZE®药物递送技术的创新者，Halozyme利用其专有的rHuPH20酶开发了经过商业验证的解决方案，用于促进注射药物和液体的皮下递送，旨在通过快速皮下递送和减轻治疗负担来改善患者的体验。Having touched one million patient lives in post-marketing use in ten commercialized products in at least one major region and across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals..在至少一个主要地区和全球100多个市场中，Halozyme的十种已上市产品在上市后使用中已经惠及一百万患者的生命。Halozyme已将其ENHANZE®技术授权给领先的制药和生物技术公司，包括罗氏、武田、辉瑞、杨森、艾伯维、礼来、百时美施贵宝、argenx、ViiV Healthcare、中外制药和Acumen Pharmaceuticals。Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence.Halozyme还利用其先进的自动注射器技术，自行或与合作伙伴一起开发、生产和商业化药物-设备组合产品，这些技术旨在提供商业或功能上的优势，例如提高便利性、可靠性、耐受性，增强患者的舒适度和依从性。The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate  of Viatris Inc..公司拥有两种商业专有产品 Hylenex® 和 XYOSTED®，并与梯瓦制药和迈兰公司的附属公司麦克德莫特实验室有限公司合作开发其他商业产品及持续进行的产品开发项目。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":false,"tenantId":"TBCN","deviceId":"web-server-community-laohu8-v3","version":"4.42.0","shortVersion":"4.42.0","platform":"web","vendor":"web","appName":"laohu8","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2545065467","isCrawlerRequest":true}