東陽光藥(01558.HK)：降壓藥物苯磺酸氨氯地平片通過一致性評價
格隆匯11月4日丨東陽光藥(01558.HK)宣佈，公司苯磺酸氨氯地平片(5mg)已獲國家藥品監督管理局批准通過仿製藥質量和療效一致性評價。
苯磺酸氨氯地平片適用於高血壓的治療。高血壓是引起心血管疾病最常見的獨立危險因素。根據2018年中國心血管報告，推算心血管病現有病患人數2.9億，其中患有中腦卒中1300萬人，冠心病1100萬人，肺原性心臟病500萬人，心力衰竭450萬人，風濕性心臟病250萬人，先天性心臟病200萬人，高血壓2.45億人。心血管病死亡率居首位，高於腫瘤及其他疾病，心血管疾病佔居民疾病死亡因素的40%以上，而高血壓是總體疾病死亡因素的第一危險因素。
降壓藥分為五大類：鈣離子拮抗劑(CCB)、β－受體阻滯劑、利尿劑、血管緊張素轉換酶抑制劑(ACEI)及血管緊張素II受體拮抗劑(ARB)，其中CCB類市場佔有率最高。苯磺酸氨氯地平片屬於CCB類降壓藥物，為中國市場應用最廣泛的降血壓藥品。
《苯磺酸氨氯地平臨牀應用中國專家建議書》強調，苯磺酸氨氯地平片優先適用於老年人收縮期高血壓，分別患有左心室肥厚，頸動脈或冠狀動脈粥樣硬化，穩定性心絞痛，腦卒中病史，外周血管病和代謝綜合症的病人。美國2017ACC/AHA高血壓指南，歐洲2018ESH/ESC高血壓指南，中國2018高血壓防治指南，均推薦苯磺酸氨氯地平為降血壓的一綫用藥，可以與其他4類降壓藥同時聯合使用。
公司苯磺酸氨氯地平片成功通過一致性評價，是對公司研發能力、生產和藥品質量及藥品療效的權威性認可，也使該藥品在未來的市場拓展、醫保支付等層面獲得優勢。通過仿製藥一致性評價工作，集團能為提升醫藥行業發展質量、進一步推動中國醫藥產業國際化和藥品生產領域的結構性改革、實現原研藥的國產替代貢獻一份力量。本集團將繼續推動其他仿製藥一致性評價進程，為廣大患者提供質價雙優的用藥選擇。
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