香雪製藥(300147.SZ)：FDA對Athenex口服紫杉醇新藥申請的審查週期已經完成 暫未獲批准
格隆匯 3 月 2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)的研發、商業化在大中華區域(中國大陸、香港和澳門)進行合作。Athenex於2020年6月在美國將用於治療轉移性乳腺癌的口服紫杉醇向美國食品和藥物管理局(FDA)遞交了新藥申請(NDA)，於2020年8月收到FDA已完成備案審查正式受理進行實質性審查，並給予進入優先審評的認定；2021年3月1日，公司接到Athenex通知，Athenex收到了FDA對口服紫杉醇新藥申請的完整回覆函(CRL)。
公司收到Athenex通知，FDA已向Athenex發出了口服紫杉醇新藥申請的完整回覆函(CRL)，通知顯示FDA對Athenex口服紫杉醇新藥申請的審查週期已經完成，該申請以目前的形式暫未獲批准，對Athenex應採取措施使申請獲得批准提出了建議。Athenex計劃向FDA提出溝通會議申請，對口服紫杉醇新藥申請的相關建議進行溝通，為下一步的工作進行準備。
公司認為，Athenex開發的新一代口服紫杉醇通過與P-gp抑制劑聯合給藥，能夠有效提高紫杉醇的口服吸收率，降低出現耐藥機制機率；同時公司會充分評估FDA對Athenex口服紫杉醇新藥申請的審核建議和關注Athenex與FDA溝通的情況，梳理優化新藥申報方案和策略，按原計劃組織用於治療轉移性乳腺癌的口服紫杉醇按中國《藥品註冊管理辦法》在中國開展申報工作。
截止目前，與授權協議合作內容相關的用於治療光化性角化病(一種癌前性皮膚病)的Klisyri (KX2-391軟膏)已獲得FDA批准，並於2021年2月18日正式在美國上市；口服伊立替康在準備臨牀二期研究的有關工作。公司已按協議約定支付了3000萬美元的首付款和150萬美元的里程碑付款，該事項目前不會對公司生產經營與當期業績產生重大影響。
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