舒泰神(300204.SZ):STSA-1201皮下注射液(用於治療哮喘適應症)Ia期臨牀試驗完成首例受試者給藥
格隆匯8月8日丨舒泰神(300204.SZ)公佈,公司於2023年07月收到了國家藥品監督管理局簽發的STSA-1201皮下注射液用於治療哮喘適應症的《藥物臨牀試驗批准通知書》(通知書編號:2023LP01434),同意本品開展用於哮喘的臨牀試驗。近日,STSA-1201皮下注射液在首都醫科大學附屬北京世紀壇醫院完成了針對哮喘適應症Ia期臨牀試驗的首例受試者給藥。
哮喘是由多種細胞以及細胞組分參與的慢性氣道炎症性疾病,臨牀表現為反覆發作的喘息、氣急,伴或不伴胸悶或咳嗽等症狀,同時伴有氣道高反應性和可逆的氣流受限,隨着病程延長可導致氣道結構改變,即氣道重塑。哮喘的成因複雜,常見促發因素包括遺傳因素、空氣污染、呼吸道感染和變應原等。
哮喘是一種嚴重影響患者生活質量的疾病,全世界約有 3億哮喘患者,每年有25萬患者死於哮喘;中國20歲及以上人羣哮喘患病率約為4.2%,患者總數達4570萬。5~10%的哮喘患者使用現有的支氣管舒張劑和皮質類固醇(OCS)藥物無法得到有效控制,需要使用生物製劑增強治療效果。
胸腺基質淋巴細胞生成素(TSLP)是哮喘等過敏性疾病發生髮展過程中的重要分子,位於炎症反應的最上游,促進多種免疫細胞的活化、增殖、分化並釋放促炎因子和趨化因子,介導炎症反應。
STSA-1201皮下注射液是一種靶向人TSLP的全人源單克隆抗體,通過特異性結合並阻斷TSLP與其受體的結合,從而阻斷其生物學功能,如樹突細胞的激活、Th2細胞因子和趨化因子的釋放、嗜酸性粒細胞浸潤和IgE的產生,以及氣道高反應等,從而達到治療哮喘的目的。
STSA-1201皮下注射液由公司自主研發。公司於2023年05月向國家藥品監督管理局提交STSA-1201皮下注射液用於治療哮喘的臨牀試驗申請,於2023年07月取得臨牀試驗批准;2023年08月,完成Ia期臨牀試驗的首例受試者給藥,目前處於Ia期臨牀試驗階段。
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