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海正藥業(600267.SH):全資子公司獲氨氯地平阿託伐他汀鈣片補充申請批件
格隆匯 07-15 17:22

格隆匯7月15日丨海正藥業(600267.SH)公佈,近日,公司全資子公司瀚暉製藥有限公司(“瀚暉製藥”)收到國家藥品監督管理局核准簽發的關於氨氯地平阿託伐他汀鈣片(商品名“多達一”)的《藥品補充申請批准通知書》。

多達一為國內上市的原研藥品,適用於高血壓或心絞痛患者合併高膽固醇血癥或混合型高脂血症的治療,可用於下列情況:1.高血壓或心絞痛患者合併高膽固醇血癥或混合型高脂血症的初始治療;2.該類患者的治療劑量調整。如可以先給予患者含有兩種成分常規起始治療劑量的氨氯地平阿託伐他汀鈣片,然後根據其抗心絞痛﹑降壓或降脂效果增加氨氯地平或阿託伐他汀的劑量;3.用於原來使用其中一種單藥成分需要增加另一種藥物的患者。

氨氯地平阿託伐他汀鈣片原研技術廠家為PFPrismCV。經查詢IMS數據庫,氨氯地平阿託伐他汀鈣片2020年全球銷售額約為2.09億美元,其中中國銷售額約為1.098億美元;2021年1-3月全球銷售額約為5257.53萬美元,其中中國銷售額約為3277.15萬美元。2020年瀚暉製藥多達一銷售額約為5.05億元人民幣。

此次多達一兩個規格獲得藥品生產技術轉讓批件,進一步提升了公司的產品價值鏈。

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