永太科技(002326.SZ)：全資子公司“加巴噴丁”製劑產品獲美國FDA批准
格隆匯 8 月 18日丨永太科技(002326.SZ)公佈，近日，公司全資子公司浙江永太藥業有限公司(以下簡稱“永太藥業”)收到美國食品藥品監督管理局(以下簡稱“FDA”)的通知，永太藥業向美國FDA申報的加巴噴丁膠囊簡略新藥申請(ANDA，即美國仿製藥申請)獲得批准。現將相關信息公告如下：
一、藥品基本情況
1、藥品名稱：加巴噴丁
2、劑型：膠囊
3、規格：100mg,300mg,400mg
4、申請事項：ANDA(美國簡略新藥申請)
5、申請人：浙江永太藥業有限公司
6、ANDA號：213603
二、藥品相關情況
加巴噴丁膠囊適應症為：1、皰疹感染後神經痛：用於成人皰疹後神經痛的治療。2、癲癇：用於成人和12歲以上兒童伴或不伴繼發性全身發作的部分性發作的輔助治療。也可用於3～12歲兒童的部分性發作的輔助治療。經查詢IMS數據庫，加巴噴丁膠囊2018年全球銷售額約為77,538萬美元，其中美國市場銷售額約為31,007萬美元；2019年全球銷售額約為74,589萬美元，其中美國市場銷售額約為29,378萬美元。
本次加巴噴丁膠囊的ANDA獲得美國FDA的批准標誌着公司具備了在美國市場銷售該產品的資格，標誌着公司在仿製藥產品領域業務的進一步推進，加快實現醫藥板塊從醫藥中間體、原料藥到製劑生產垂直一體化產業鏈，對公司未來的經營業績具有一定的積極影響。
目前公司另一子公司浙江手心製藥有限公司具備加巴噴丁原料藥生產資質及相關生產線，具有完善、有效的原料藥生產體系和先進的管理理念，能夠穩定供應加巴噴丁原料藥，與永太藥業此次獲批的加巴噴丁膠囊構成了公司醫藥板塊首個實現“原料藥+製劑”的產品鏈。在該模式下，將進一步提升公司產品的成本優勢、一體化產業鏈供應優勢，對增強公司綜合競爭力及未來發展有着積極的推動作用。由於該產品在國外市場的銷售時間、市場規模、後續拓展進度具有不確定性，可能受到國外市場環境變化、匯率波動等因素影響，敬請廣大投資者理性投資，注意防範投資風險。
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