振東製藥(300158.SZ):鹽酸氟桂利嗪膠囊通過一致性評價
格隆匯1月14日丨振東製藥(300158.SZ)公佈,近日,公司全資子公司山西振東安欣生物製藥有限公司(簡稱“安欣生物”)收到國家藥監局簽發的《藥品補充申請批准通知書》(通知書編號:2021B04926),鹽酸氟桂利嗪膠囊已通過仿製藥質量和療效一致性評價。該藥品通過仿製藥質量和療效一致性評價,同時同意該藥品處方工藝、質量標準及有效期變更。
鹽酸氟桂利嗪為選擇性鈣拮抗劑,可阻滯過量的鈣離子跨膜進入細胞內,防止細胞內鈣負荷過量,也可防止缺血缺氧時大量鈣進入神經元,改善腦微循環及神經元代謝,抑制腦血管痙攣、血小板凝結及血液粘滯度增高等,此外還有細胞膜穩定作用。本品脂溶性高,易透過血腦屏障。可用於典型(有先兆)或非典型(無先兆)偏頭痛的預防性治療及由前庭功能紊亂引起的眩暈的對症治療。
根據米內網數據顯示,2021年1-6月,鹽酸氟桂利嗪膠囊的公立醫院和基層終端銷售額分別約為1.65億元和1.75億元;2021年1-12月,鹽酸氟桂利嗪膠囊的藥店終端銷售額為1.24億元。目前共有5家鹽酸氟桂利嗪膠囊企業通過一致性評價,包括山東方明藥業集團股份有限公司、江蘇平光製藥(焦作)有限公司、石家莊市華新藥業有限公司、正大青春寶藥業有限公司和安欣生物。
公司表示,鹽酸氟桂利嗪膠囊通過仿製藥一致性評價,有利於擴大產品的市場份額,提升市場競爭力。
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