舒泰神(300204.SZ):STSP-0902注射液(用於治療少弱精子症)Ia期臨牀試驗完成首例受試者給藥
格隆匯8月15日丨舒泰神(300204.SZ)公佈,公司於2024年6月收到了國家藥品監督管理局簽發的STSP-0902注射液用於治療少弱精子症的《藥物臨牀試驗批准通知書》(通知書編號2024LP01413),同意本品開展少弱精子症的臨牀試驗。近日,STSP-0902注射液在北京大學第三醫院完成了針對少弱精子症Ia期臨牀試驗的首例受試者給藥。
STSP-0902是舒泰神自主研發的對特定位點進行定向改造的重組人神經生長因子Fc融合蛋白,能夠結合並激活TrkA受體通路,發揮生物學效應,臨牀前實驗數據顯示,STSP-0902可促進神經生長、精原細胞和睾丸支持細胞增殖,提高少弱精子症小鼠模型的精子數量和精子活力,減少精子畸形率,改善睾丸生精小管變性/萎縮。同時,與野生型人神經生長因子相比,STSP-0902在臨牀前研究中表現出注射後疼痛反應減弱,體內半衰期延長的特點。
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