舒泰神(300204.SZ):STSA-1001注射液用於治療癌痛取得新藥臨牀試驗通知書
格隆匯1月3日丨舒泰神(300204.SZ)公佈,近日,舒泰神(北京)生物製藥股份有限公司收到了國家藥品監督管理局簽發的STSA-1001注射液用於治療癌痛的《藥物臨牀試驗批准通知書》(通知書編號:2024LP00023),同意本品開展癌痛的臨牀試驗。
STSA-1001注射液是一種重組抗NGF的全人源IgG1單克隆抗體注射液。該抗體可以有效阻斷NGF與其受體的結合,從而在疼痛疾病中有效抑制NGF信號通路,減少因過度神經支配而引起的神經性疼痛;同時也能有效阻斷NGF對傷害性離子通道/受體的活性和傷害性基因表達水平的調節作用,減輕傷害性疼痛,從而發揮治療疼痛的作用。
公司於2023年10月向國家藥品監督管理局提交STSA-1001注射液臨牀試驗申請,於2024年01月取得臨牀試驗批准。
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