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凱普生物(300639.SZ):磷酸氯喹凝膠開展II期臨牀試驗獲同意
格隆匯 02-23 18:21

格隆匯2月23日丨凱普生物(300639.SZ)公佈,近日,公司全資子公司廣州凱普生物科技有限公司收到國家藥品監督管理局藥品評審中心(CDE)的書面回覆意見,同意公司開發的藥品磷酸氯喹凝膠開展II期臨牀試驗。

“磷酸氯喹凝膠”適應症為皮膚外用治療HPV病毒感染引起的各種皮膚疣、外生殖器及肛周尖鋭濕疣,為國內外尚未批准的新適應症。通過皮膚外用給藥,減少全身藥物暴露量,提高藥品的有效性和安全性。該藥品自2014年開始研發,2018年3月獲國家藥品監督管理局頒發《藥物臨牀試驗批件》,開展I期臨牀試驗。

2019年11月22日,該藥品相關研製技術獲國家發明專利授權,專利名稱:一種氯喹凝膠及其製備方法和應用,授權號:ZL 201811474701.3。

2019年12月4日,廣州凱普生物科技有限公司正式向CDE提交II期臨牀試驗方案。2020年2月21日,公司收到CDE回覆同意本項目開展II期臨牀試驗。

截至2019年末,“磷酸氯喹凝膠”已累計投入研發費用約為人民幣2407.82萬元。

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