九洲藥業(603456.SH)半年度淨利潤升15.51%至1.03億元
格隆匯8月19日丨九洲藥業(603456.SH)發佈2019年半年度報告，實現營業收入8.58億元，同比下降6.72%；歸屬於上市公司股東的淨利潤1.03億元，同比增長15.51%；歸屬於上市公司股東的扣除非經常性損益的淨利潤9189.67萬元，同比下降9.01%；基本每股收益0.13元。
隨着優先審評審批、中國加入ICH、藥品上市許可持有人制度(MAH)、仿製藥一致性評價等一系列利好政策落地實施，國內創新藥發展迅速，創新藥研發已進入快速投入期。基於對全球製藥行業和CDMO行業發展趨勢的洞察，公司以創新驅動、CDMO+API雙軌發展的總體戰略，積極佈局新市場、新業務，不斷提升公司醫藥生產、研發的綜合競爭力。
目前公司承接的CDMO項目中，已上市項目11個，處於III期臨牀的項目35個，處於I期和II期臨牀試驗的有294個。
公司自成立以來，始終堅持創新驅動，通過持續地研發投入，實現生產工藝與技術革新，完成產品轉型升級。2019年，API事業部在公司原料藥創新發展戰略的指導下，依託完整的原料藥研發體系，以及領先的綠色化學合成技術，充分利用公司在工藝設計、研發創新、申報註冊等領域的優勢，着力佈局具有公司自主知識產權以及創新工藝的特色原料藥產品。報告期內，公司利用綠色化學技術已成功完成糖尿病治療藥物、抗HIV藥物和非甾體抗炎藥物的原料藥項目技術開發，後續將加快啟動安評、環評、項目申報等投產前準備工作。其中，一例糖尿病治療藥物的驗證生產已經完成，並已完成中美歐DMF(drug master file，藥物主文件)遞交。
報告期內，公司充分利用國家仿製藥一致性評價和MAH制度帶來的良好機遇，着力擴展公司特色原料藥及中間體的市場覆蓋範圍，進一步增強產品盈利能力，實現API原有產品的價值提升。公司全力打造特色原料藥新產品線，在吸取降血糖類藥物和抗HIV藥物新項目研發經驗的基礎上，主動加強與仿製藥客户的深度合作，共同研發特色原料藥產品線，取得工藝改造、路線優化等核心專利的利潤分成，最終形成良性循環，相互促進，共同增加公司產品線的寬度，在形成產品集羣優勢的同時迅速增加公司利潤。公司已與部分核心仿製藥客户達成戰略合作協議，在若幹選定的原料藥品種中，就原料藥合成策略、驗證生產以及註冊等領域開展深入合作。
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