遠大醫藥(00512.HK):新型眼藥“貝美前列素滴眼液”獲頒發藥品註冊證書
格隆匯 3 月 3日丨遠大醫藥(00512.HK)發佈公吿,集團自主研發的新型眼藥“貝美前列素滴眼液”(規格:9mg)已獲中國國家藥品監督管理局頒發藥品註冊證書,為該品種在國內首個獲批的仿製藥物。
貝美前列素滴眼液用於降低原發性開角型青光眼(“POAG”)及高眼壓症患者眼壓,是目前市場上治療POAG及高眼壓症患者的首選藥物。按薈萃分析方法所得的資料顯示,目前治療POAG常見的一線藥物前列腺素類(PGA)產品中,貝美前列素較其他品種具有更強的降眼壓療效,中國、歐洲、美國、亞太等國際青光眼治療指南推薦貝美前列素滴眼液為治療POAG單藥治療首選藥物。此外,集團的貝美前列素滴眼液亦在中國大陸申請三項專利,並已全部獲批。
青光眼嚴重威脅人們的視覺健康,是中國第二大致盲眼科疾病。據弗若斯特沙利文統計,2019年中國青光眼病患接近2,000萬,其中開角型青光眼約佔43.1%,預計到2030年將青光眼患者將增長至2,300萬。目前臨牀上主要將青光眼分為原發性開角型青光眼和原發性閉角型青光眼(PACG)。POAG由於臨牀診斷較差,通常在全面眼科檢查中或在不可逆視力喪失風險較高的晚期階段才會被偶然發現。開角型青光眼的診斷和治療市場仍然有很大的空間,患者數量的快速增長加之青光眼患者長期用藥的需求,該領域具有較大的未被滿足的臨牀需求。
集團作為中國最大的眼科藥研發、生產及銷售綜合企業之一,現有產品覆蓋眼表及眼底多種疾病,具有良好的品牌知名度。為持續鞏固和加強集團在眼科領域的優勢地位,集團一直致力於眼科領域創新產品及首仿產品的開發及引進,目前已針對乾眼症、翼狀胬肉等臨牀需求未被滿足的適應症佈局多款創新產品,同時打造護眼生態圈,在眼用器械及耗材方面進行快速開發。作為集團自主研發的新型眼科用藥貝美前列素滴眼液獲批上市,再次驗證了集團在眼科藥品方面的研發實力,同時該產品進一步豐富了眼科板塊的產品線,持續奠定集團在眼科用藥的龍頭企業地位。集團一直高度重視創新產品和先進技術的研發,以患者需求為核心,持續自主研發新型產品,提升產品市場競爭力。集團將進一步增強產品整體成本優勢、技術優勢,為廣大患者提供優質優價的用藥選擇。
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