四環醫藥(00460.HK)：首家通過一致性評價藥品重酒石酸卡巴拉汀膠囊及左乙拉西坦片獲生產批件
格隆匯2月18日丨四環醫藥(00460.HK)宣佈，集團開發的重酒石酸卡巴拉汀膠囊及左乙拉西坦片已獲得中國國家藥監局頒發的藥品生產批件，咪達唑侖口頰黏膜溶液則獲得藥品註冊批件。四環醫藥為中國首家獲得咪達唑侖口頰黏膜溶液註冊批件的企業。
重酒石酸卡巴拉汀膠囊獲批規格為1.5毫克和3.0毫克，用於輕、中度阿爾茨海默型痴呆的治療。痴呆是以認知功能損害為主要表現的一類綜合症。
左乙拉西坦片獲批規格為0.25克和0.5克，主要用於成人及4歲以上兒童癲癇患者部分性發作的加用治療。該產品作為新一代廣譜抗癲癇藥，與其他現有抗癲癇藥物的作用機制均不同，其通過影響突觸囊泡蛋白SV2A、鉀通道及N型鈣通道發揮抗癲癇用，且具有生物利用度高、線性藥動學曲線、低蛋白結合率低、無肝酶誘導作用，藥物相互作用少等優勢，從而提高患者長期用藥依從性而降低癲癇發作次數，其在國內外指南中均為一線推薦藥物。
集團近期註冊成功的咪達唑侖口頰黏膜溶液，是中國首個專門針對嬰幼兒、兒童及青少年而開發的黏膜給藥劑型，用於治療高熱或是癲癇引起的急性持續性驚厥發作。咪達唑侖通過激動苯二氮卓受體，增強抑制性神經遞質γ-氨基丁酸(GABA)的作用而發揮治療作用，對癲癇性驚厥發作及熱性驚厥發作均亦有效，在癲癇治療指南及熱性驚厥發作指南中均為推薦治療藥物。目前臨牀使用的咪達唑侖主要為口服或靜脈給藥，這對於持續性驚厥發作中的嬰幼兒及兒童用藥造成了極大不便。口頰黏膜溶液劑型與其它劑型相比，給藥方便、起效快，甚至可用於院外家庭急救。集團相信該產品的上市將大大彌補現有市場空缺，為嬰幼兒、兒童及青少年患者提供安全有效且家庭急救的治療新選擇。
以上三個產品，均屬於中樞神經系統疾病領域且有廣泛的適用患者人羣，將和集團已經上市的奧卡西平片等產品以及其他陸續上市的精神神經領域藥品為患者提供更多更優質的治療選擇，併產生協同效應進一步夯實四環醫藥在此領域的領先市場地位。
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