辰欣藥業(603367.SH):胞磷膽鹼鈉注射液及溴芬酸鈉滴眼液獲得藥品註冊證書
格隆匯4月4日丨辰欣藥業(603367.SH)公佈,近日,公司收到國家藥品監督管理局批准簽發的胞磷膽鹼鈉注射液《藥品註冊證書》(證書編號:2023S00360)及溴芬酸鈉滴眼液《藥品註冊證書》(證書編號:2023S00445)。
胞磷膽鹼是一種核苷衍生物,可增強腦幹網狀結構、尤其是與意識密切相關的上行網狀結構激動系統的機能;增強椎體系統的機能,改善運動麻痺,還能改善大腦循環,通過減少大腦血流阻力,增加大腦血流而促進大腦物質代謝,對促進大腦功能恢復和促進甦醒等具有一定作用。
胞磷膽鹼鈉注射液屬於神經系統藥物,臨牀用於治療頭部受傷相關的神經和認知障礙及治療中風急性期和亞急性期相關的神經和認知障礙。
截至目前,公司在胞磷膽鹼鈉注射液研發項目上已累計投入研發費用為人民幣482.32萬元。
溴芬酸鈉是2-氨基-3-苯甲酰基苯乙酸類衍生物,屬於新一代非甾體抗炎藥,其結構與酮洛芬和雙氯芬酸類似,能抑制環氧合酶介導的前列腺素類炎症介質的合成,是最有效的環氧合酶抑制劑之一,具有強力消炎鎮痛作用。此外,溴芬酸鈉既是一種強效抗炎藥,又是一種可滲透到眼部組織中的親脂分子,從而增加作用的持續時間。
溴芬酸鈉的作用強度較其它非甾體抗炎藥高,臨牀上用於外眼部及前眼部的炎症性疾病的對症治療:眼瞼炎、結膜炎、強膜炎(包括上強膜炎)、術後炎症等。同時,溴酚酸鈉滴眼液每天2次的給藥方案提高了患者的依從性。
截至目前,公司在溴芬酸鈉滴眼液研發項目上已累計投入研發費用為人民幣558.59萬元。
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