普利製藥(300630.SZ):奧卡西平片通過荷蘭藥物評價委員會(CBG)技術審評
格隆匯2月14日丨普利製藥(300630.SZ)公佈,公司全資子公司浙江普利藥業有限公司(簡稱“浙江普利”)近日收到荷蘭藥物評價委員會(CBG)批准奧卡西平片的技術評審通知。
奧卡西平片是卡馬西平的衍生物,主要通過奧卡西平的代謝物單羥基衍生物發揮藥理學作用,其作用機制被認為主要是阻斷電壓敏感的鈉通道,從而穩定了過度興奮的神經元細胞膜,抑制了神經元重複放點,減少突觸衝動的傳播。適用於治療原發性強直陣攣發作和部分性發作,伴有或不伴有繼發性全面性發作,由瑞士汽巴-嘉基公司(在1996年汽巴-嘉基和山德士合併成立諾華-Novartis)開發,隨後在全球40多個國家上市。在國內,Novartis Pharma Schweiz AG的奧卡西平片獲得批准,商品名:曲萊,規格0.3g和0.15g。
浙江普利的奧卡西平片啟動研發後分別遞交了歐盟(荷蘭和德國)和中國註冊申請,屬共線生產產品,該藥品在中國目前正在審評中。近日,公司收到荷蘭藥物評價委員會(主審國)結束審評的通知,審評結論:批准。
奧卡西平片的歐洲上市許可,有利於提升產品的品牌形象,對公司的經營業績產生積極影響,同時也為公司後續開展片劑的國際化上市申請工作積累了非常寶貴的經驗。
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