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6-K: Gsk's Nucala (Mepolizumab) Approved in China for Treatment of Adults with Chronic Rhinosinusitis with Nasal Polyps

6-K: Gsk's Nucala (Mepolizumab) Approved in China for Treatment of Adults with Chronic Rhinosinusitis with Nasal Polyps

6-K:GSK的Nucala(美泊利單抗)在中國獲批用於治療患有鼻息肉的慢性鼻竇炎成人患者
美股SEC公告 ·  01/03 20:32

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GSK announced that Nucala (mepolizumab) has received approval in China for treating adults with chronic rhinosinusitis with nasal polyps (CRSwNP). This marks the third indication for mepolizumab in China, making it the only anti-interleukin-5 therapy approved for CRSwNP in the country. The treatment serves as an add-on therapy with intranasal corticosteroids for patients whose condition is not adequately controlled by systemic corticosteroids or surgery.The approval is based on the phase III MERIT trial results, which demonstrated significant improvements in nasal obstruction and quality of life measures over 52 weeks. The study, conducted across Japan, China, and Russia, showed consistent safety profiles with known mepolizumab data. The treatment offers a non-surgical alternative for approximately 30 million Chinese patients suffering from CRSwNP.CRSwNP affects about one-third of China's 107 million chronic sinusitis patients, causing symptoms like nasal obstruction, loss of smell, and sleep disturbance. Up to 80% of CRSwNP patients have type 2 inflammation, which Nucala specifically targets by inhibiting interleukin-5, a key inflammatory protein present in nasal polyp tissue.
GSK announced that Nucala (mepolizumab) has received approval in China for treating adults with chronic rhinosinusitis with nasal polyps (CRSwNP). This marks the third indication for mepolizumab in China, making it the only anti-interleukin-5 therapy approved for CRSwNP in the country. The treatment serves as an add-on therapy with intranasal corticosteroids for patients whose condition is not adequately controlled by systemic corticosteroids or surgery.The approval is based on the phase III MERIT trial results, which demonstrated significant improvements in nasal obstruction and quality of life measures over 52 weeks. The study, conducted across Japan, China, and Russia, showed consistent safety profiles with known mepolizumab data. The treatment offers a non-surgical alternative for approximately 30 million Chinese patients suffering from CRSwNP.CRSwNP affects about one-third of China's 107 million chronic sinusitis patients, causing symptoms like nasal obstruction, loss of smell, and sleep disturbance. Up to 80% of CRSwNP patients have type 2 inflammation, which Nucala specifically targets by inhibiting interleukin-5, a key inflammatory protein present in nasal polyp tissue.
GSk 宣佈,Nucala(美泊利單抗)已在中國獲得批准,用於治療患有鼻息肉的慢性鼻竇炎成人(CRSwNP)。這標誌着美泊利單抗在中國獲得的第三個適應症,使其成爲該國唯一獲得批准用於CRSwNP的抗白介素-5治療。該治療作爲一種輔助療法,與局部鼻用類固醇聯合治療,適用於那些用全身類固醇或手術控制不佳的患者。該批准基於第三階段 MERIt 臨牀試驗的結果,該試驗顯示在52周內,鼻塞和生活質量指標有顯著改善。該研究在日本、中國和俄羅斯進行,顯示出一致的安全性,與已知的美泊利單抗數據相符。這種治療爲大約 3000萬名患有CRSwNP的中國患者提供了一種非手術的替代方案。CRSwNP影響約三分之一中國的 1億0700萬慢性鼻竇炎患者,導致鼻塞、嗅覺喪失和睡眠障礙等症狀。高達80%的CRSwNP患者具有2型炎症,而Nucala則通過抑制白介素-5(一種存在於鼻息肉組織中的關鍵炎症蛋白)來專門針對這種炎症。
GSk 宣佈,Nucala(美泊利單抗)已在中國獲得批准,用於治療患有鼻息肉的慢性鼻竇炎成人(CRSwNP)。這標誌着美泊利單抗在中國獲得的第三個適應症,使其成爲該國唯一獲得批准用於CRSwNP的抗白介素-5治療。該治療作爲一種輔助療法,與局部鼻用類固醇聯合治療,適用於那些用全身類固醇或手術控制不佳的患者。該批准基於第三階段 MERIt 臨牀試驗的結果,該試驗顯示在52周內,鼻塞和生活質量指標有顯著改善。該研究在日本、中國和俄羅斯進行,顯示出一致的安全性,與已知的美泊利單抗數據相符。這種治療爲大約 3000萬名患有CRSwNP的中國患者提供了一種非手術的替代方案。CRSwNP影響約三分之一中國的 1億0700萬慢性鼻竇炎患者,導致鼻塞、嗅覺喪失和睡眠障礙等症狀。高達80%的CRSwNP患者具有2型炎症,而Nucala則通過抑制白介素-5(一種存在於鼻息肉組織中的關鍵炎症蛋白)來專門針對這種炎症。
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