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中國生物製藥(01177.HK)TQC3302"ICS/LAMA/LABA軟霧吸入製劑"臨牀試驗申請獲NMPA批準

格隆匯8月5日丨中國生物製藥(01177.HK)公告,集團自主研發的2.3類改良型新藥TQC3302"ICS/LAMA/LABA軟霧吸入製劑"吸入噴霧劑已獲得中國國家藥品監督管理局(NMPA)的臨牀試驗批準,擬用於慢性阻塞性肺疾病(COPD)的維持治療。

TQC3302是依託集團軟霧吸入技術平臺開發的一款ICS(吸入性糖皮質激素)╱LAMA(長效抗膽礆能藥物)╱LABA(長效β2受體激動劑)三聯複方製劑,已通過臨牀前研究證實了其三聯組方的安全性。

軟霧吸入劑是新一代吸入劑型,利用機械動力以緩慢的細霧形式向患者遞送藥物。相較於傳統的霧化、乾粉等劑型,軟霧吸入劑能使氣溶膠釋放時間更長、速度更慢,並減少藥物在口咽部的損失,使得藥物的肺部沉積率更高,同時對患者的手口協調性要求較低,對於兒童、老人等給藥困難人羣同樣適用。

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