信立泰(002294.SZ)2020年淨利降91.49%至6086.50萬元
格隆匯3月29日丨信立泰(002294.SZ)披露2020年年度報吿,報吿期內,公司實現營業總收入27.39億元,同比減少38.74%;歸屬於上市公司股東的淨利潤6086.50萬元,同比減少91.49%;經營活動產生的現金流量淨額13.74億元,同比減少8.78%;研發費用3.71億元,佔營收比重13.55%,銷售費用8.99億元,佔營收比重32.83%。
目前,自主研發的1類新藥S086已完成I期臨牀試驗,其中高血壓適應症完成II期臨牀入組,已納入230多例高血壓受試者;心衰適應症處於Ib期臨牀階段。2類新藥阿利沙坦酯氨氯地平片(SAL0107)正處於I/III期臨牀階段,進展順利;阿利沙坦酯吲達帕胺緩釋片(SAL0108)已於2021年1月收到CDE的臨牀試驗受理通知書,正在審評中。抗心衰創新生物藥JK07中美雙報獲批開展I期臨牀,目前美國I期臨牀已完成首例受試者入組;國內遺傳辦已審批公示,公司與多家中國心腦血管專科領域的知名醫院進行了初步溝通,準備開展臨牀合作。腎性貧血小分子口服制劑恩那司他片(SAL0951)目前完成I期、正在開展III期臨牀試驗,預計將是國內第二個上市的HIF-PHI藥物。
醫療器械項目研發也已逐現成效。為了讓醫療器械板塊有更好的發展前景,已啟動分拆境內上市的前期籌備工作。報吿期內,創新器械Maurora®雷帕黴素藥物洗脱椎動脈支架系統獲批,於2021年1月開始銷售;PTCA球囊導管獲得註冊批件。左心耳封堵器已完成臨牀隨訪,進展順利;“雷帕黴素藥物塗層外周血管擴張球囊導管”完成臨牀試驗備案,啟動臨牀試驗入組;GSTREAM®雷帕黴素藥物洗脱外周血管支架系統順利完成FIM臨牀試驗入組。
而受到冠脈支架全國集採未中標影響,公司根據《企業會計準則》、《會計監管風險提示第8號——商譽減值》等規定,對蘇州桓晨計提商譽減值2.83億元。計提完成後,蘇州桓晨的商譽賬面價值為0元。
報吿期內,公司引入戰略投資者——凱雷投資集團,進一步改善公司治理,為公司注入新的活力;同時,啟動非公開發行股票事宜(目前已取得批文),為創新研發提供充裕的資金保障。
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