百克生物(688276.SH):天然全人源抗狂犬病毒單克隆抗體CBB1注射液獲批開展臨牀試驗
格隆匯10月10日丨百克生物(688276.SH)公佈,公司近日收到國家藥品監督管理局下發的天然全人源抗狂犬病毒單克隆抗體CBB1注射液的《藥物臨牀試驗批准通知書》。同意按照提交的方案開展用於被狂犬或其他攜帶狂犬病毒動物咬傷、抓傷患者的被動免疫的臨牀試驗。
狂犬病主要通過攜帶狂犬病病毒的動物咬、抓傷傳播。除了狂犬病疫苗外,及時給予免疫球蛋白對於狂犬病暴露後預防(post exposure prophylaxis,PEP)至關重要。正確的狂犬病預防措施可以有效保護狂犬病暴露者,但是並非所有狂犬病暴露者都能及時得到治療。其中一個重要原因是狂犬病免疫球蛋白在全球範圍內供不應求。
用於人類狂犬病PEP的傳統RIG是多克隆免疫球蛋白,來源於免疫人類供體(人狂犬病免疫球蛋白)的血漿或動物。血源性產品的高效性、流行地區的有限供應、批次間的變異性、成本和安全性,促使人們尋找預防人類狂犬病的新產品。因此,在暴露後預防治療中,用重組單克隆抗體替代血漿製劑已成為一種必要的方法。
截至目前,印度有2款抗狂犬病毒單克隆抗體藥物獲得批准上市,中國有1款抗狂犬病毒單克隆抗體藥物獲得批准上市。
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