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香雪製藥(300147.SZ):治療光化性角化病新藥Klisyri在美獲批
格隆匯 12-15 21:11

格隆匯12月15日丨香雪製藥(300147.SZ)公佈,公司與ATHENEX,INC.(“Athenex”)於2019年12月簽署了《授權協議》,就Athenex在研產品口服紫杉醇、口服伊立替康和KX2-391軟膏(“Klisyri”,為美國FDA批准名稱)的研發、商業化進行合作,Athenex授予公司上述在研產品、在授權區域內及領域內獨家開展商業化(包括但不限於開發、標籤、包裝、推廣、生產、分銷、製作、使用、銷售、銷售支持、註冊、商業化或其他在約定領域對許可產品的開發等商業化行為)的權利及為該等商業化目的而享有相關知識產權的權利,截止目前,公司已按協議約定完成技術盡職調查並支付了3000萬美元的預付款。

Athenex在美國將用於治療光化性角化病(一種癌前性皮膚病)的Klisyri向美國食品和藥物管理局(FDA)遞交了新藥申請。近日,公司收到Athenex通知,FDA批准了Klisyri的新藥申請,後續Athenex將會對其開展生產。

Klisyri是Athenex開發的一種微管抑制劑,該產品的臨牀三期數據顯示其非常正面的治療效果和比較低的皮膚局部不良反應。

Athenex研發的Klisyri在美國獲得新藥批准,將積極推動其在中國的申報工作。

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