澤璟製藥(688266.SH):索拉非尼口服常釋劑型(規格0.2g)納入集中採購品種範圍
格隆匯 12 月 14日丨澤璟製藥(688266.SH)公佈,近日,山西省藥械集中競價採購網和四川藥械採購監管網發佈了關於報送第四批國家組織藥品集中採購品種範圍相關採購數據的通知。通知中,索拉非尼口服常釋劑型(規格0.2g)(“索拉非尼”)納入集中採購品種範圍。索拉非尼是公司產品甲苯磺酸多納非尼片(“多納非尼”)的競品之一。
索拉非尼進入本次集中採購品種範圍,可能導致晚期肝癌一線靶向藥物存量市場降低6.10%~15.24%。(以上預估是公司目前按照對相關政策及市場背景的理解進行初步測算,相關預計數據按照一定假設進行測算,實際情況可能與公司目前的測算有所不符,以上預估不構成公司對競品索拉非尼未來市場空間的結論性意見,僅供本次公告披露數據預測使用。相關假設與預測過程請見“附錄:關於晚期肝癌一線靶向藥物存量市場空間的初步預測”。)
索拉非尼進入本次集中採購品種範圍,其採購價格會出現下降。按照已完成的前三批進入集中採購品種範圍藥物的前後價格變化,進入集中採購品種範圍藥物的降價幅度通常在53-59%左右。索拉非尼進入集中採購品種範圍的中標價格以官方公告為準。
雖然公司正在上市審評審批中的產品多納非尼與索拉非尼相比為不同產品,且臨牀療效和安全性優於索拉非尼,但考慮到索拉非尼是多納非尼的競品之一,以及索拉非尼進入本次集中採購品種範圍,將帶來晚期肝癌一線靶向藥物存量市場空間下降和價格下降,多納非尼上市後,市場空間和定價均存在下降的風險。雖然晚期肝癌一線藥物增量市場存在較大空間,但因多納非尼尚未獲批上市銷售,公司對於增量市場的開拓存在不確定性。
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