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博雅生物(300294.SZ):靜注人免疫球蛋白(10%)獲批臨牀
格隆匯 12-29 16:08

格隆匯12月29日丨博雅生物(300294.SZ)公佈,2021年12月29日,公司收到國家藥品監督管理局於2021年12月28日簽發的《藥物臨牀試驗批准通知書》(通知書編號:2021LP02122),公司申報的靜注人免疫球蛋白(10%)(受理號:CXSL2101366)臨牀試驗申請已獲批准。

靜注人免疫球蛋白(10%)適用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;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;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。

該次獲得的《藥物臨牀試驗批准通知書》的產品為靜注人免疫球蛋白(10%),公司已有5%濃度的多種規格靜注人免疫球蛋白上市。靜注人免疫球蛋白(10%)是公司在現有靜注人免疫球蛋白基礎上,對生產工藝、配方等進行改進後的產品,在質量標準、產品收率、病毒安全性等方面均有所提高。

目前,靜注人免疫球蛋白(10%)尚無國內產品上市。截至目前,公司靜注人免疫球蛋白(10%)累計研發投入1951.47萬元。公司該次獲得靜注人免疫球蛋白(10%)的《藥物臨牀試驗批准通知書》,有利於提高公司研發積極性,進一步加快公司在研產品的進度。

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