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長春高新(000661.SZ):百克生物全人源抗破傷風毒素單克隆抗體A82/B86注射液組合製劑臨牀試驗申請獲得批准

格隆匯10月31日丨長春高新(000661.SZ)公佈,近日,長春高新技術產業(集團)股份有限公司子公司長春百克生物科技股份公司(簡稱“百克生物”)收到國家藥品監督管理局核准簽發的《藥物臨牀試驗批准通知書》。

破傷風是由破傷風梭狀芽孢桿菌(破傷風桿菌)侵入感染引起的一種急性創傷感染性疾病。破傷風易感人羣包括新生兒、未接種疫苗者、吸毒者以及免疫力低下者等。全球範圍內破傷風的平均病死率為30~50%,在無醫療干預的情況下,重症患者的病死率接近100%,尤其是老年人和嬰幼兒患者。

破傷風是一種可以預防的疾病,主要通過:1.破傷風疫苗的接種,使機體產生獲得性免疫力。2.注射破傷風抗毒素或破傷風人免疫球蛋白,使機體立即獲得免疫力,用於破傷風的治療和短期的應急預防。其中,單克隆抗體因其獨特優勢廣泛應用於特異性靶點藥物的開發,在腫瘤治療以及傳染病的預防與治療方面有着巨大的潛力。隨着單克隆抗體藥物開發技術的發展與迭代,已由鼠抗體向全人源單抗發展。相較於異源血清、鼠源抗體、人源化抗體和嵌合抗體,全人源抗體可以最大限度的降低宿主的異源性以保證產品安全性,同時具備優良的產能以滿足市場的需求。

截至目前,暫無抗破傷風毒素單克隆抗體在國內獲批上市。

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