默克对SpringWorks的收购带来了药物批准Merck's SpringWorks takeover delivers a drug approval

动脉网2025-07-21

Merck KGaA's acquisition of SpringWorks has only just closed, but has already added a new medicine to its portfolio as it gets an EU approval for rare disease therapy Ezmekly.默克公司收购SpringWorks刚刚完成，但其...

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There are approximately 135,000 people in the EU living with the condition, according to Merck, and their lifetime risk of developing PN is approximately 30% to 50%.NF1导致神经细胞覆盖层上出现肿瘤，造成毁容和其他衰弱并发症，如疼痛、运动功能障碍和恶性外周神经鞘癌。","collect":0,"end_time":0,"defaultTopTitle":"qq.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"IE00BFTCPJ56.SGD":"Janus Henderson Global Life Sciences A Acc SGD","LU1061106388.HKD":"BGF WORLD HEALTHSCIENCE \"A2\" (HKDHDG) ACC","LU2461242641.AUD":"WELLINGTON US QUALITY GROWTH \"A\" (AUDHDG) ACC","LU0208291251.USD":"FRANKLIN MUTUAL U.S. VALUE \"A\" (USD) INC","LU0070302665.USD":"FRANKLIN MUTUAL U.S. VALUE \"A\" (USD) ACC","AZN":"阿斯利康","LU0106261372.USD":"SCHRODER ISF US LARGE CAP \"A\" ACC","SG9999013999.USD":"UOB UNITED GLOBAL HEALTHCARE FUND (USDHDG) INC","LU1929549753.HKD":"FRANKLIN INCOME \"A\" (HKD) INC","IE00BBT3K403.USD":"LEGG MASON CLEARBRIDGE TACTICAL DIVIDEND INCOME \"A(USD) ACC","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","IE00B1BXHZ80.USD":"Legg Mason ClearBridge - US Appreciation A Acc USD","LU1116320901.HKD":"BGF SYSTEMATIC GLOBAL ENHANCED EQUITY YIELD \"A6\" (HKD) INC","LU1983299246.USD":"SCHRODER ISF HEALTHCARE INNOVATION \"A\" (USD) ACC","IE000M9KFDE8.USD":"NEUBERGER BERMAN US LARGE CAP VALUE \"A\" (USD) ACC","IE00BSNM7G36.USD":"NEUBERGER BERMAN SYSTEMATIC GLOBAL SUSTAINABLE VALUE \"A\" (USD) ACC","SG9999001176.SGD":"UOB UNITED GLOBAL HEALTHCARE \"SGD\" (ACC)","LU0122379950.USD":"贝莱德世界健康科学A2","BK4585":"ETF&股票定投概念","BK4534":"瑞士信贷持仓","LU0965509010.AUD":"AB LOW VOLATILITY EQUITY PORTFOLIO \"AD\" (AUDHDG) INC","LU1035773651.USD":"AB SICAV I - GLOBAL VALUE PORTFOLIO \"AD\" (USD) INC","LU0098860793.USD":"FRANKLIN INCOME \"A\" INC","LU1989772840.SGD":"CPR Invest - Climate Action A2 Acc SGD-H","LU0320765489.SGD":"FTIF - Franklin Mutual US Value A Acc SGD","IE0009355771.USD":"骏利亨德森环球生命科技A Acc","MRK":"默沙东","LU0266013472.USD":"AXA WF - Framlington Longevity Economy A Cap USD","SG9999001176.USD":"United Global Healthcare Acc USD","LU0006306889.USD":"SCHRODER ISF US LARGE CAP \"A\" (USD) INC AV","LU1941712348.USD":"ALLIANZ PET AND ANIMAL WELLBEING \"AT\" (USD) ACC","LU1066051498.USD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM2\" (USD) INC","LU1989772923.USD":"CPR Invest - Climate Action A2 Acc USD-H","LU1093756168.USD":"FRANKLIN K2 ALTERNATIVE STRATEGIES \"A\" (USD) ACC","LU1069347547.HKD":"AB SICAV I - GLOBAL VALUE PORTFOLIO \"AD\" (HKD) INC","IE00BLSP4239.USD":"Legg Mason ClearBridge - Tactical Dividend Income A Mdis USD Plus","IE00BJT1NW94.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"A2\" (SGDHDG) ACC","SG9999014575.USD":"UOB UNITED INCOME FOCUS TRUST FUND (USDHDG) INC","LU1037948541.HKD":"AB LOW VOLATILITY EQUITY PORTFOLIO \"A\" (HKD) ACC","LU0985320562.USD":"NORDEA 1 GLOBAL STARS EQUITY \"BP\" (USD) ACC","IE0002141913.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (USD) ACC","LU1699723380.USD":"ALLSPRING GLOBAL LONG/SHORT EQUITY \"AP\" (USD) ACC","BK4568":"美国抗疫概念","BK4550":"红杉资本持仓","LU1116320737.USD":"BGF SYSTEMATIC GLOBAL ENHANCED EQUITY YIELD \"A6\" (USD) INC","SG9999002224.SGD":"Allianz Global High Payout SGD","LU1934455194.USD":"AB SICAV I LOW VOLATILITY TOTAL RETURN EQUITY PORT \"A\" (USD) ACC","LU0320765646.SGD":"FTIF - Franklin Income A MDIS SGD-H1","LU2456880835.USD":"ALLIANZ GLOBAL INCOME \"AT\" (USD) ACC","LU1934455863.HKD":"AB SICAV I LOW VOLATILITY TOTAL RETURN EQUITY PORT \"A\" (HKD) ACC"},"translate_title":"Merck's SpringWorks acquisition brings drug approval Merck's SpringWorks takeover delivers a drug approval","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"AZN":0.9,"MRK":1},"content_text":"Merck KGaA's acquisition of SpringWorks has only just closed, but has already added a new medicine to its portfolio as it gets an EU approval for rare disease therapy Ezmekly.默克公司收购SpringWorks刚刚完成，但其罕见病疗法Ezmekly已获得欧盟批准，为公司的产品组合新增了一种药物。The oral MEK inhibitor – already approved in the US as口服MEK抑制剂——已在美国获批Gomekli哥贝克利(mirdametinib) – has been cleared by the European Commission as a treatment for adults and children aged two and over with neurofibromatosis type 1 who have plexiform neurofibromas (NF1-PN) that cannot be treated with surgery.（米达梅替尼）——已被欧盟委员会批准用于治疗无法通过手术治疗的2岁及以上的成人和儿童神经纤维瘤病1型患者，这些患者患有丛状神经纤维瘤（NF1-PN）。NF1 causes tumours to develop on the covering of nerve cells, leading to disfigurement and other debilitating complications like pain, motor dysfunction, and malignant peripheral nerve sheath cancers. There are approximately 135,000 people in the EU living with the condition, according to Merck, and their lifetime risk of developing PN is approximately 30% to 50%.NF1导致神经细胞覆盖层上出现肿瘤，造成毁容和其他衰弱并发症，如疼痛、运动功能障碍和恶性外周神经鞘癌。据默克公司称，欧盟大约有135,000人患有此病，他们一生中患PN的风险约为30%至50%。Surgical removal of PN tumours can be challenging due to the tumour growing along nerve fibres..由于肿瘤沿神经纤维生长，PN肿瘤的手术切除可能具有挑战性。Ezmekly is the first drug to be approved for children and adults with the genetic disorder in the EU, and the second in the US after AstraZeneca's MEK1/2 inhibitorEzmekly是首个在欧盟获批用于治疗儿童和成人遗传病的药物，也是美国继阿斯利康的MEK1/2抑制剂之后的第二种药物。Koselgo/Koselugo科塞戈/科塞鲁戈(selumetinib), co-marketed by MSD (known as Merck & Co in the US and Canada).（司卢美替尼），由默沙东（在美国和加拿大称为默克公司）共同销售。In Europe, Koselugo – which had global sales of $631 million last year – is cleared for use in children aged three and over only.在欧洲，Koselugo——去年全球销售额达 6.31 亿美元——仅被批准用于三岁及以上的儿童。The new approval will help Merck make a return on its新的批准将帮助默克公司获得回报$3.9 billion investment39亿美元投资in acquiring SpringWorks, which has operated as a wholly owned subsidiary since the takeover was completed on 1st July. Some analysts have suggested that peak sales of Gomekli/Ezmekly could top $1 billion.在收购SpringWorks后，该公司自7月1日完成收购以来一直作为全资子公司运营。一些分析师表示，Gomekli/Ezmekly的销售峰值可能超过10亿美元。'Patients with NF1-PN often face physical and mental health challenges and impaired quality of life given the limited treatment options available for this lifelong and debilitating disease,' said Ignacio Blanco, chairman of the National Reference Centre for Adult Patients with Neurofibromatosis at Hospital Universitari Germans Trias i Pujol in Spain..“鉴于NF1-PN这种终身且致残的疾病可用的治疗方案有限，患者常常面临身体和心理健康方面的挑战，生活质量也受到损害，”西班牙Hospital Universitari Germans Trias i Pujol医院国家成人神经纤维瘤病参考中心主任伊格纳西奥·布兰科表示。'This approval represents an important advance, especially for adults who previously did not have an approved treatment,' he added. 'Importantly, [it] is available in a tablet that dissolves easily in water for people who are unable to swallow a pill and could therefore not previously receive therapy.' In contrast, Koselugo is formulated as a hard capsule..“这一批准代表了重要的进展，特别是对于以前没有获批治疗方案的成年人来说，”他补充道。“重要的是，[它]是一种易于溶于水的片剂，适合无法吞咽药丸的人群，因此他们以前无法接受治疗。”相比之下，Koselugo则被制成硬胶囊。In the phase 2b ReNeu trial, mirdametinib showed an overall response rate (ORR) of 41% in adults and 52% in children, with 'deep and durable' reduction in the volume of PN lesions as well as 'clinically meaningful' improvements in pain and quality-of-life scores.在2b期ReNeu试验中，米达美替尼在成人中的总体缓解率（ORR）为41%，在儿童中为52%，并且PN病灶体积出现“显著且持久”的减少，同时疼痛和生活质量评分也得到了“具有临床意义的”改善。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":false,"editions":null,"column":"","sentiment":"1","news_tag":"corporation,productRelease,merge","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,"isLaohu8Offline":false,"tenantId":"TBCN","deviceId":"web-server-community-laohu8-v3","version":"4.44.0","shortVersion":"4.44.0","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/2553647102","isCrawlerRequest":true}