普洛藥業(000739.SZ):鹽酸安非他酮緩釋片通過美國FDA補充新藥簡略申請
格隆匯4月30日丨普洛藥業(000739.SZ)公佈,近日,公司全資子公司浙江巨泰藥業有限公司收到美國FDA的通知,公司向美國FDA申報的鹽酸安非他酮緩釋片(150mg)的補充新藥簡略申請(sANDA,即美國仿製藥補充申請)已獲得批准。鹽酸安非他酮緩釋片適用於治療中重度抑鬱症以及季節性情感障礙。
該藥物由VALEANT INTERNATIONAL BARBADOS SRL研發,於2003年8月28日在美國上市。目前,鹽酸安非他酮緩釋片在美國境內的主要生產廠商有PAR,TEVA等;國內目前未有該劑型的產品上市。根據相關市場銷售數據,2018年該劑型產品150mg規格美國仿製藥市場銷售額約為1.3億美元。
該產品為公司與美國Tulex Pharmaceutical Co. Ltd.合作開發,截至目前,公司在鹽酸安非他酮緩釋片(150mg;300mg)項目上累計已投入研發費用約167萬美元。
公司表示,其已於2019年9月獲批鹽酸安非他酮緩釋片(300mg),是公司獲得美國FDA批准的第一個仿製藥,此次鹽酸安非他酮緩釋片(150mg)的獲批標誌着該產品具備了美國市場銷售資格,對於該產品海外市場銷售具有進一步推動作用,可以更好地滿足不同的臨牀用藥需求,也有利於公司積極拓展仿製藥海外市場,符合公司製劑業務國際國內協同發展的戰略目標,對公司未來經營業績具有一定積極的影響。公司後續也將積極推進該產品新增規格的上市準備。
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