海正藥業(600267.SH)半年度淨利潤升254.51%至5262.65萬元
格隆匯8月19日丨海正藥業(600267.SH)發佈2019年半年度報告，實現營業收入56.66億元，同比增長6.27%；歸屬於上市公司股東的淨利潤5262.65萬元，同比增長254.51%；歸屬於上市公司股東的扣除非經常性損益的淨利潤546.10萬元；基本每股收益0.055元。
當前醫藥行業生存的宏觀環境仍然嚴峻，全球經濟仍處於低迷狀態，原材料能源價格繼續上揚，醫保控費更加嚴格，一致性評價、兩票制等政策落地加快醫藥行業洗牌等。2019年上半年，公司以增強整體盈利能力為目標，圍繞“聚焦、瘦身、優化”的戰略，全力推進改革攻堅。經過大家的共同努力，各項工作取得了較大進步。
生物藥方面：為實現生物藥的快速發展，加快證券化步伐，2019年上半年進行了生物藥單抗業務重組，成立浙江海正博鋭生物製藥有限公司，目前已完成資產評估、重組方案並委託台交所通過公開掛牌方式實施重組。
銷售方面，安佰諾銷售持續穩步增長，2019年上半年銷售突破24萬支，同比增長162%, 新患者數也繼續保持穩定增長。
臨牀及註冊方面，阿達木單抗完成臨牀現場核查和資料審評，相關上市前準備工作已啟動；完成門冬胰島素臨牀III期研究，目前處於報產資料的準備中；完成英夫利西單抗和甘精胰島素臨牀III期的入組工作；啟動了HS636、HS632和HS630的臨牀I期研究工作；其他臨牀階段產品均按照研究計劃穩步推進。
早期研發方面，繼續推進從生物類似藥到生物創新藥的轉型平台化建設，重點圍繞腫瘤免疫治療和ADC藥物佈局組合產品，目前針對10多個靶點開展了分子篩選工作，其中3個全創新抗體類分子確定候選分子，進入工藝開發及臨牀前研究。
仿製藥板塊：(1)國內板塊：有2個品種5個品規通過國家仿製藥一致性評價，7個品種完成申報；共2個品種按新註冊分類4獲得了生產批件，其中一個為國內第3家；1個品種獲得了參比製劑地位。(2)國際板塊：6個製劑品種在美國獲批，其中3個注射劑；兩個原料藥獲准進入美國。泰拉菌素原料藥在30個國家遞交申請，進入審評階段；米卡芬淨原料藥在18個國家遞交註冊文件，進入審評階段。在研發的4個原料藥完成驗證。
創新藥板塊：AD-35美國二期小規模臨牀研究已完成入組；HS234項目已啟動與CDE的IND申報溝通會議；完成HS236項目GLP毒理研究進入臨牀申報階段；GY-9項目啟動合作開發進程，兩個小分子創新藥項目進行臨牀前正式GLP毒理研究。
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