天壇生物(600161.SH):“靜注人免疫球蛋白(pH4、10%)(層析法)”即將開展III期臨牀試驗
格隆匯12月31日丨天壇生物(600161.SH)公佈,公司控股子公司成都蓉生藥業有限責任公司研製的“靜注人免疫球蛋白(pH4、10%)(層析法)”已通過中國醫學科學院血液病醫院醫學倫理委員會臨牀試驗倫理審批、完成臨牀前準備等工作,即將開展III期臨牀試驗。
適應症:1、治療原發性免疫球蛋白G缺乏症,如X聯鎖低免疫球蛋白G血癥,常見變異性免疫缺陷病,免疫球蛋白G亞類缺陷病等。2、治療繼發性免疫球蛋白G缺陷病,如重症感染,新生兒敗血症,嬰幼兒毛細支氣管炎等。3、治療自身免疫性疾病,如原發性血小板減少性紫癜,川崎病等。
上述產品在生產、上市銷售前還需履行的主要程序包括:完成臨牀試驗,提交申報生產註冊申請,通過國家藥品監督管理局審評、審批通過後,獲得生產批件。
國內尚無靜注人免疫球蛋白(pH4、10%)產品上市。
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