海辰藥業(300584.SZ):上半年淨利同比降30.89%至3648.6萬元
格隆匯 8 月 17日丨海辰藥業(300584.SZ)發佈2020年半年度報告,上半年實現營業收入3.76億元,同比降17.55%;歸屬於上市公司股東的淨利潤3648.6萬元,同比降30.89%;基本每股收益0.3040元。
報告期內,積極響應國家仿製藥質量與療效一致性評價等政策,以體系建設為導向,繼續加大研發投入,強化科研團隊建設,堅持自主研發與合作研發相結合的模式,穩步推進仿製藥一致性評價和新仿製藥重點項目研發進度,進一步佈局多個治療領域,豐富品種組合,保證後續產品持續推出。報告期內,公司已上市產品苯磺酸氨氯地平片通過一致性評價;注射用蘭索拉唑一致性評價申請獲得CDE受理,進入審評程序;已進入審評程序的利伐沙班原料藥及片劑項目完成補充研究資料提交;阿哌沙班原料藥及片劑項目和恩替卡韋片劑項目正在審評中。公司獨家重點品種鹽酸蘭地洛爾原料及粉針項目已完成國家藥品審核查驗中心組織的生產現場檢查,預計將在年內獲批上市。
公司堅持以仿哺創、仿創結合的研發戰略,實現研發管線由仿製藥向創新藥轉型。2019年8月,公司與意大利NMS集團簽署了《許可協議》,引進NMS集團正在開發的IDH(異檸檬酸脱氫酶)抑制劑候選化合物,獲得該候選化合物在全球的臨牀開發、註冊、生產和市場銷售的獨家權利。目前,NMS集團新藥發現團隊正在全力以赴按計劃推進相關工作,力爭年內向公司交付合格的候選化合物。公司方面先期已與美迪西、締脈等知名CRO公司達成了合作意向,後續將委託其開展臨牀前研究等工作,共同推進項目進展。公司將藉助本項目的實施,加快與國際創新資源的深度對接,擴展公司創新藥研發管線,建立相應技術平台,培育創新藥研發團隊,提升公司的核心競爭力。
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