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6-K: Depemokimab Applications Accepted for Review in China and Japan for Asthma with Type 2 Inflammation and Crswnp

6-K: Depemokimab Applications Accepted for Review in China and Japan for Asthma with Type 2 Inflammation and Crswnp

6-K:中國和日本已接受Depemokimab治療伴有2型炎症和CRSwNP的哮喘的申請審查
美股SEC公告 ·  01/28 11:24

牛牛AI助理已提取核心訊息

GSK announced that regulatory authorities in China and Japan have accepted applications for depemokimab, the first ultra-long-acting biologic with 6-month dosing intervals. The submissions target two indications: asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps (CRSwNP). The applications are supported by positive results from SWIFT and ANCHOR trials.The SWIFT trials demonstrated depemokimab's effectiveness in reducing exacerbation and hospitalization rates in asthma patients, while ANCHOR trials showed significant reduction in nasal polyp size and obstruction compared to placebo. The drug's extended half-life and high-binding affinity enable a convenient twice-yearly dosing schedule, potentially improving patient adherence.The submissions address significant medical needs in both markets. In China, an estimated 46 million adults suffer from asthma, with 15.5% requiring hospital visits due to exacerbations. Additionally, approximately 107 million Chinese patients have chronic sinusitis, with one-third developing nasal polyps. In Japan, about 2 million people have chronic sinusitis, with 200,000 requiring surgery for nasal polyps.
GSK announced that regulatory authorities in China and Japan have accepted applications for depemokimab, the first ultra-long-acting biologic with 6-month dosing intervals. The submissions target two indications: asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps (CRSwNP). The applications are supported by positive results from SWIFT and ANCHOR trials.The SWIFT trials demonstrated depemokimab's effectiveness in reducing exacerbation and hospitalization rates in asthma patients, while ANCHOR trials showed significant reduction in nasal polyp size and obstruction compared to placebo. The drug's extended half-life and high-binding affinity enable a convenient twice-yearly dosing schedule, potentially improving patient adherence.The submissions address significant medical needs in both markets. In China, an estimated 46 million adults suffer from asthma, with 15.5% requiring hospital visits due to exacerbations. Additionally, approximately 107 million Chinese patients have chronic sinusitis, with one-third developing nasal polyps. In Japan, about 2 million people have chronic sinusitis, with 200,000 requiring surgery for nasal polyps.
GSK宣佈,中國和日本的監管機構已接受depemokimab的申請,這是首個具有6個月給藥間隔的超長效生物製藥。這些申請針對兩個適應症:伴有2型炎症的哮喘和伴有鼻息肉的慢性鼻竇炎(CRSwNP)。這些申請得到了SWIFT和ANCHOR試驗的積極結果的支持。SWIFT試驗表明,depemokimab在減少哮喘患者的加重和住院率方面的有效性,而ANCHOR試驗則顯示,與安慰劑相比,該藥物顯著減少了鼻息肉的大小和阻塞。該藥物的延長半衰期和高結合親和力使得每年兩次的給藥計劃變得方便,可能改善患者的依從性。這些申請解決了兩個市場上重大的醫療需求。在中國,估計有4600萬成年人患有哮喘,其中15.5%因爲加重需要就醫。此外,約有10700萬中國患者患有慢性鼻竇炎,三分之一發展爲鼻息肉。在日本,約有200萬人患有慢性鼻竇炎,其中20萬人需要進行鼻息肉手術。
GSK宣佈,中國和日本的監管機構已接受depemokimab的申請,這是首個具有6個月給藥間隔的超長效生物製藥。這些申請針對兩個適應症:伴有2型炎症的哮喘和伴有鼻息肉的慢性鼻竇炎(CRSwNP)。這些申請得到了SWIFT和ANCHOR試驗的積極結果的支持。SWIFT試驗表明,depemokimab在減少哮喘患者的加重和住院率方面的有效性,而ANCHOR試驗則顯示,與安慰劑相比,該藥物顯著減少了鼻息肉的大小和阻塞。該藥物的延長半衰期和高結合親和力使得每年兩次的給藥計劃變得方便,可能改善患者的依從性。這些申請解決了兩個市場上重大的醫療需求。在中國,估計有4600萬成年人患有哮喘,其中15.5%因爲加重需要就醫。此外,約有10700萬中國患者患有慢性鼻竇炎,三分之一發展爲鼻息肉。在日本,約有200萬人患有慢性鼻竇炎,其中20萬人需要進行鼻息肉手術。

譯文內容由第三人軟體翻譯。


牛牛AI助手部分由第三方人工智慧模型基於資訊內容自動產生。


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