普利製藥(300630.SZ):地氯雷他定幹混懸劑即將獲荷蘭和德國上市許可
格隆匯8月22日丨普利製藥(300630.SZ)宣佈,近日,公司收到歐盟荷蘭藥物評價委員會(CBG)審評程序結束的通知(End of Procedure),意味着公司的地氯雷他定幹混懸劑順利通過荷蘭藥物評價委員會(CBG)和德國聯邦藥物和醫療器械管理局(BfArM)的審評,不日即將獲得荷蘭和德國的上市許可。地氯雷他定幹混懸劑可用於緩解成人、12歲及以上青少年和6-11歲兒童的過敏性鼻炎和蕁麻疹的相關症狀。
地氯雷他定為非鎮靜性的長效三環類抗組膠藥,為氯雷他定的活性代謝物,可通過選擇性地阻斷外周H1受體,抑制各種過敏性致炎的化學介質的釋放,緩解過敏性鼻炎和蕁麻疹的相關症狀。地氯雷他定由Sepracor公司研製,Schering-Plough公司開發並在全球53個國家上市。
地氯雷他定幹混懸劑為公司的獨家劑型,2.5mg和5mg規格分別於2004年8月、2011年1月首次獲國家藥品監督管理局批准上市,並於2021年3月獲得國家藥品監督管理局簽發的一致性評價補充申請批准件。
此外,公司積極響應國務院和國家藥品監督管理部門號召的產業升級、提升產品質量和走出去的戰略,同時啟動了地氯雷他定幹混懸劑(2.5mg、5mg)的歐洲上市許可申請工作,在歐洲,該申請屬於劑型創新。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。
公司表示,地氯雷他定幹混懸劑的歐洲上市許可,有利於提升產品的品牌形象,對公司的國際化經營產生積極影響,同時也為公司後續開展改良型藥物的國際化上市申請工作積累了非常寶貴的經驗。
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