舒泰神(300204.SZ):STSA-1301皮下注射液取得Ia期臨牀研究總結報吿
格隆匯8月8日丨舒泰神(300204.SZ)公佈,近日,公司取得STSA-1301皮下注射液用於治療原發性免疫性血小板減少症的Ia期臨牀研究總結報吿。
I期臨牀試驗主要評價STSA-1301皮下注射液單次給藥的安全性和藥代動力學特徵,結果顯示,在方案設計的劑量範圍內,STSA-1301皮下注射液在健康受試者中單次給藥的安全性和耐受性良好,呈非線性藥代動力學特徵,能夠劑量依賴性地降低血清總IgG水平,給藥後5~14天出現最大降低幅度。在高劑量組會呈現一定的免疫原性,但未見對PK、PD及安全性的影響。在方案設計的劑量範圍內,未觀察到STSA-1301皮下注射液對IgA、IgM、IgD、IgE及細胞因子有影響。
公司本次取得STSA-1301皮下注射液用於治療原發性免疫性血小板減少症的Ia期臨牀研究總結報吿,不會對公司當前業績產生重大影響。取得Ia期臨牀研究總結報吿僅是新藥研發進展中階段性里程碑,後續臨牀試驗階段是否順利、能否獲得生產批件、具備上市資格尚存在諸多不確定。公司將積極推進上述研發項目,並按有關規定對該項目後續進展情況及時履行信息披露義務。
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