安科生物(300009.SZ):AFN0328注射液獲得藥物臨牀試驗批准
格隆匯7月18日丨安科生物(300009.SZ)公佈,近日,安徽安科生物工程(集團)股份有限公司收到國家藥品監督管理局下發的《藥物臨牀試驗批准通知書》,公司與參股公司合肥阿法納生物科技有限公司(以下簡稱“阿法納公司”)、合肥阿法納安科生物科技有限公司聯合申報的“AFN0328注射液”治療惡性腫瘤的臨牀試驗申請已獲批准。
人乳頭瘤病毒(Human Papillomavirus, HPV)屬於乳頭瘤病毒科,為嗜上皮細胞的無包膜雙鏈環狀DNA病毒。已發現的HPV型別超過200種,其中高危型共13種,包括HPV16/18等,該類病毒的持續感染可引起子宮頸、肛門、外陰、陰道等部位的癌前病變或癌變。
本次獲批臨牀的AFN0328注射液是一款針對HPV腫瘤治療的mRNA藥物,由公司與阿法納公司共同研發。目前,針對HPV感染的腫瘤治療性mRNA藥物均處於臨牀試驗階段,國內外尚無同類產品上市。
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