和黃醫藥指中國藥監局已受理索凡替尼之新藥上市申請
和黃醫藥公布,中國藥監局已受理索凡替尼(surufatinib)用於治療晚期非胰腺神經內分泌瘤的新藥上市申請,是次新藥上市申請是基於成功的SANET-ep臨床研究數據。SANET-ep是一項關於索凡替尼以晚期非胰腺神經內分泌瘤為適應癥的III 期關鍵性研究,而這些患者目前尚無有效治療方法。該項研究的陽性結果早前在2019年9月29日舉行的歐洲腫瘤內科學會(ESMO)年會上以口頭報告的形式公布。
和黃醫藥首席執行官賀雋(Christian Hogg)表示,提交新藥上市申請意味著索凡替尼有望在中國獲批及上市,為治療方法選擇非常有限的眾多患者帶來一種新的治療選擇。為了盡可能在讓索凡替尼在獲批後惠及更多患者,公司目前正在組建自己的腫瘤藥物商業化團隊,並期望在索凡替尼上市之時便準備就緒,覆蓋中國所有相關的醫院及診所。
和黃醫藥現時擁有索凡替尼在全球範圍內的所有權利,索凡替尼正在中國、美國及歐洲作為單藥治療或與其他腫瘤免疫療法聯合治療開展針對多種實體瘤的研究。
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