麗珠醫藥(01513.HK)2021年度淨利潤升3.54%至17.76億元 擬10派13元
格隆匯3月28日丨麗珠醫藥(01513.HK)公佈,截至2021年12月31日止年度,實現營業收入120.64億元(人民幣,下同),同比增長14.67%;歸屬於公司股東的淨利潤17.76億元,同比增長3.54%;剔除非經常性損益項目收益,公司2021年主營業務實現的歸屬於公司股東的淨利潤16.27億元,同比增長13.66%;基本每股收益1.9元,擬每10股派發現金股利13元(含税)。
集團視研發創新為可持續發展的基礎,打造豐富在研管線,重點品種研發取得的突破性進展。注射用醋酸曲普瑞林微球(1個月緩釋)完成III期臨牀研究並進行生產註冊申報;重磅產品注射用阿立哌唑微球正在進行I期臨牀試驗,市場前景廣闊;注射用醋酸西曲瑞克已在中國和美國註冊申報,並於2021年12月在國內獲批上市;注射用重組人絨促性素作為國內首仿品種獲批上市銷售;重組人源化抗人IL-6R單克隆抗體注射液(託珠單抗注射液)已正式報產並獲受理;重磅產品重組抗人IL-17A/F人源化單克隆抗體注射液正在進行Ib/II期臨牀試驗。另外,一致性評價項目獲批件4項,繼續鞏固市場地位。
生物藥另一個重磅產品是集團與中國科學院生物物理研究所合作研發的重組新型冠狀病毒融合蛋白疫苗(“V-01”),V-01的I/II期臨牀結果顯示其具有優異的安全性及免疫原性,並已在全球多國開展III期臨牀試驗,V-01的序貫加強III期臨牀試驗的關鍵數據顯示V-01序貫加強絕對保護力已滿足世界衞生組織(WHO)標準,並對奧密克戎(Omicron)感染導致的COVID-19可產生良好的保護力。同時,針對全球新冠疫情趨勢及新冠變異株流行情況,集團開發了多種變異株疫苗,開展了相關的加強免疫╱序貫免疫動物、臨牀試驗相關研究。V-01作為集團首個在全球範圍內開展III期多中心臨牀試驗的產品,其III期臨牀試驗的順利推進,也為後續集團創新藥國際化以及更多藥物開展全球多中心臨牀試驗積累了更豐富的組織管理、合作伙伴、團隊能力和註冊申請等方面的資源與經驗。
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