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貝達藥業(300558.SZ):2020年淨利升162.7%至6.06億元 擬10派3.1元
格隆匯 03-25 21:08

格隆匯3月25日丨貝達藥業(300558.SZ)披露2020年年度報吿,實現營業收入18.7億元,同比增長20.36%;歸屬於上市公司股東的淨利潤6.06億元,同比增長162.70%;歸屬於上市公司股東的扣除非經常性損益的淨利潤3.34億元,同比增長60.30%;基本每股收益1.50元,擬向全體股東每10股派發現金紅利3.1元(含税)。

2020年11月,公司第二個產品貝美納上市,正式開啟了從1到多的新徵程。作為中國首個國產ALK抑制劑,貝美納打破進口壟斷,將和凱美納一樣造福國人,並且有望成為公司第一個在境外上市的新藥。

貝達藥業是中國第一批創新生物製藥公司,創新是公司始終堅持的核心戰略,也是推動公司快速發展的動力源泉。公司已經構建了國內領先的新藥研發體系。2020年全年研發投入達到7.42億元,佔營業收入比例39.69%。報吿期內,成功推動1個產品上市(貝美納二線治療適應症)、2個候選藥物/適應症BLA/NDA(貝伐珠單抗注射液、埃克替尼術後輔助適應症)以及4個候選藥物/適應症IND(BPI-28592、BPI-23314實體瘤適應症、BPI-361175、BPI-21668)。

在不平凡的2020年,“非凡TKI”凱美納創下了不凡的成績。儘管這一年疫情爆發、主要競品價格大幅下降且競品數量激增,凱美納仍然保持穩定的增長,實現商業銷售超過18億元,較2019年增長20.72%,在一代EGFR-TKI市場中持續保持領先地位。

公司牢牢把握凱美納“非凡TKI,我們不一樣”核心策略,實施差異化競爭。凱美納是在中國患者中開展臨牀研究最多的EGFR-TKI。截至目前,與凱美納相關的臨牀研究達80多項,發表SCI論文近200篇(包含6篇影響因子超過10的論文),總計影響因子超過700分。

隨着貝美納的上市以及MIL60、BPI-D0316等品種推進上市及其他候選藥物的研發,公司一方面加強生產基地的建設,一方面鞏固與CDMO夥伴的合作。報吿期內,公司五洲路廠區新合成基地開始全面運行,承擔凱美納、貝美納以及CM082原料藥的生產任務。同時,公司與凱萊英醫藥集團簽署創新藥原料藥全面供應戰略協議,雙方將分工合作,加速新藥研發和註冊進程。

2020年全年,公司完成凱美納生產250多萬盒,較上年增長4.76%,全年產品合格率100%,充分保障了患者用藥。同時完成了BPI-43487、BPI-28592、BPI-361175等項目臨牀研究用藥的生產供應,切實為公司研發護航。生產質量體系的有效運行,為公司的發展解決了後顧之憂。

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