恆瑞醫藥(600276.SH):醋酸阿比特龍片(I)獲批臨牀試驗
格隆匯3月24日丨恆瑞醫藥(600276.SH)公佈,公司近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的《臨牀試驗通知書》,並將於近期開展臨牀試驗。藥品名稱為醋酸阿比特龍片(I)。
2019年12月13日,公司向國家局提交的一項醋酸阿比特龍片的臨牀試驗申請獲得受理,適應症為本品與潑尼鬆或潑尼鬆龍合用,治療:轉移性去勢抵抗性前列腺癌(mCRPC);新診斷的高危轉移性內分泌治療敏感性前列腺癌(mHSPC),包括未接受過內分泌治療或接受內分泌治療最長不超過3個月。
阿比特龍最早由Janssen-Cilag International N.V.公司開發,商品名為Zytiga®,於2011年4月在美國獲批上市,目前已在加拿大、歐盟、日本等多個國家上市銷售。2015年,Janssen-Cilag International N.V.公司開發的阿比特龍在中國獲批,商品名為澤珂®。2019年7月,公司的子公司成都盛迪醫藥有限公司申報的醋酸阿比特龍片首仿獲批上市。除此外,國內另有正大天晴、江西山香兩家仿製藥獲批上市,另有齊魯製藥、印度瑞迪、連雲港傑瑞3家審評審批中。經查詢IQVIA數據,2019年阿比特龍全球銷售額約32.33億美元,美國銷售額約10.89億美元,國內銷售額約1.15億美元。
截至目前,該項目已投入研發費用約592萬元人民幣。
根據我國藥品註冊相關的法律法規要求,藥物在獲得臨牀試驗通知書後,尚需開展臨牀試驗並經國家藥監局審評、審批通過後方可生產上市。
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