Key Takeaways GSK gets FDA nod for Exdensur as an add-on maintenance treatment for severe eosinophilic asthma.Exdensur cut annualized asthma exacerbations versus placebo in phase III SWIFT-1 and SWIFT-2 studies.Exdensur is the first twice-yearly biologic for asthma, while its CRSwNP FDA decision remains pending.GSK plc (GSK) announced that the FDA has approved Exdensur (depemokimab-ulaa), an ultra-long-acting IL-5–targeting biologic, as an add-on maintenance treatment of severe asthma with an eosinophilic p ...

来源：环球市场播报 葛兰素史克（GSK）周三早盘上涨1%。该公司的德莫奇单抗（Exdensur，depemokimab）获得美国FDA 批准，作为严重嗜酸性粒细胞性哮喘的每年两次附加疗法；SWIFT临床试验显示，与安慰剂相比，该药 可使年化急性发作率最多降低58%。 ...

葛兰素史克称其治疗重度哮喘的药物已获得美国批准，愈发有希望成为一款明星产品。 该公司周三在声明中称，美国食品药品监督管理局（FDA）已批准Exdensur用作12岁及以上重度哮喘患 者的附加维持治疗药物。 该药本月早些时候还获得了欧洲药品管理局的支持，英国药品监管机构也已放行。葛兰素史克表示，中 国和日本监管机构也在审批之中。 该公司股价在伦敦早盘一度上涨1.2%。该股今年截至周二收盘累计上涨了逾35%。 Exdensur，即depemokimab，是首个治疗这些呼吸道疾病的超长效生物制剂，每年只需给药两次。在临 床试验中，该药物可使严重哮喘发作减少54%，并帮助改善慢性鼻窦炎患者的鼻腔阻塞情况及缩小鼻息 肉。 此药被视为葛兰素史克的关键增长点，该公司希望在2026年至2027年间将其推出、能用于多种适应症。 葛兰素史克预计Exdensur的年销售额至多将达到30亿英镑（40亿美元）。 责任编辑：刘明亮 葛兰素史克称其治疗重度哮喘的药物已获得美国批准，愈发有希望成为一款明星产品。 该公司周三在声明中称，美国食品药品监督管理局（FDA）已批准Exdensur用作12岁及以上重度哮喘患 者的附加维持治疗药物。 该 ...

2. 截至发稿，德国DAX指数跌0.01%，英国富时100指数涨1.63%，法国CAC40指数跌0.15%，欧洲斯托克50指数涨0.12%。 | ■ 德国DAX30 | 24,085.32 | 24.193.82 | 24,037.46 | -2.01 | -0.01% | 20:37:38 0 | | --- | --- | --- | --- | --- | --- | --- | | 器 英国富时100 | 9,843.10 | 9,854.35 | 9,744.40 | +158.31 | +1.63% | 20:37:31 0 | | 法国CAC40 | 8.093.79 | 8,136.07 | 8,079.72 | -12.37 | -0.15% | 20:37:30 0 | | □ 欧洲斯托克50 | 5,724.56 | 5,746.06 | 5,715.95 | +6.73 | +0.12% | 20:37:18 0 | 3. 截至发稿，WTI原油涨1.74%，报56.09美元/桶。布伦特原油涨1.63%，报59.88美元/桶。 盘前市场动向 1.12月17日(周三)美股盘前，美股三大股指 ...

智通财经APP获悉，葛兰素史克(GSK.US)宣布，其一款治疗重度哮喘的新药已获美国监管批准，这一 进展有望为该药物成为重磅产品铺平道路。 葛兰素史克在周三发布的一份声明中表示，美国食品药品监督管理局(FDA)已批准新药 Exdensur(depemokimab)作为12岁及以上重症哮喘患者的附加维持疗法。 作为首款治疗呼吸系统疾病的超长效生物制剂，Exdensur的给药频率仅为每年两次。临床试验数据显 示，该药物可使重度哮喘急性发作风险降低54%，同时还能缓解慢性鼻窦炎患者的鼻塞症状，并缩小鼻 息肉体积。 本月早些时候，这款药物刚获得欧洲药品管理局的上市许可，英国药品监管机构也已为其亮绿灯。葛兰 素史克透露，目前该药物在中国与日本的上市申请正处于审评阶段。 据葛兰素史克估计，目前美国约有200万人患有重症哮喘，其中半数患者仍面临频繁的病情加重和住院 风险。 Exdensur被视为葛兰素史克未来增长的关键部分。公司计划在2026年至2027年间，逐步拓展该药物在多 种适应症上的应用。葛兰素史克预计，Exdensur的年销售额有望高达30亿英镑(约合40亿美元)。 ...

Core Insights - GSK plc announced FDA approval for Exdensur (depemokimab-ulaa) as an add-on maintenance treatment for severe asthma with an eosinophilic phenotype in patients aged 12 and older [1][9]. Clinical Trial Results - The FDA approval is based on the SWIFT-1 and SWIFT-2 phase III trials, where depemokimab showed a 58% and 48% reduction in annualized asthma exacerbations compared to placebo over 52 weeks [2]. - A pooled analysis indicated a 72% reduction in clinically significant exacerbations requiring hospitalization or emergency department visits for depemokimab compared to placebo [3]. Treatment Benefits - Depemokimab offers sustained protection from exacerbations with only two doses per year, potentially redefining patient care for severe asthma [4]. - The treatment is well-tolerated, with side effects similar to those of placebo [3]. Market Context - Approximately 2 million Americans suffer from severe asthma, with half experiencing frequent exacerbations that lead to increased healthcare costs [5]. - Currently, only 20% of eligible patients in the US receive biologics, indicating a significant unmet need in the market [5]. Future Prospects - Depemokimab has received a positive opinion from the CHMP in Europe, with an approval decision expected in Q1 2026, and is under review in other regions including China and Japan [7]. - GSK is expanding its pipeline for depemokimab to include other diseases with type 2 inflammation, such as chronic rhinosinusitis and chronic obstructive pulmonary disease (COPD) [18].

葛兰素史克公司周二表示，美国卫生监管机构已批准该公司用于治疗重症哮喘的附加药物，这为患者选 择一种用药频率较低的治疗方案进入市场铺平了道路。 责任编辑：王永生 葛兰素史克公司周二表示，美国卫生监管机构已批准该公司用于治疗重症哮喘的附加药物，这为患者选 择一种用药频率较低的治疗方案进入市场铺平了道路。 责任编辑：王永生 ...

The U.S. Food and Drug Administration has approved GSK's add-on drug to treat asthma and a chronic inflammatory sinus condition, the drugmaker said on Tuesday, paving the way for a less frequently dosed treatment option for patients to enter the market. ...

UK's health regulator on Monday approved GSK's twice-yearly drug for use as an add-on treatment for asthma in patients aged 12 and older, as well as for a chronic inflammatory sinus condition in adult... ...

Key Takeaways CHMP backed Nucala as an add-on therapy for COPD, with a European decision expected in early 2026.A monthly injectable Nucala targets IL-5 to help uncontrolled COPD patients reduce hospital visits.Depemokimab won CHMP support after studies showed twice-yearly efficacy in asthma and CRSwNP.GSK plc (GSK) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending the approval of Nucala as an add-on main ...