君實生物(01877.HK):特瑞普利維持高速增長,新品種上市值得期待,維持“買入”評級
機構:西南證券
評級:買入
業績總結:公司2020 上半年實現營業收入 5.8 億元(+85.9%);實現歸母淨利潤-5.6 億元;扣非歸母淨利潤為-6 億元。
特瑞普利單抗繼續高速增長,2 個適應症正在優先審評,超過 30 個臨牀試驗正在進行中,未來增長潛力大。公司目前收入主要來自特瑞普利單抗,該藥目前僅有黑色素瘤一個適應症獲批上市,鼻咽癌和尿路上皮癌均處於上市申請優先審評階段,有望於今年底或明年初上市。2020H1 特瑞普利單抗的重要事件包括:1)鼻咽癌和尿路上皮癌進入上市申請優先審評階段;2)新開展特瑞普利單抗與貝伐珠單抗聯合一線治療肝癌、與侖伐替尼一線治療肝癌、與阿昔替尼聯合治療腎細胞癌、單藥三線治療胃癌四項關鍵註冊臨牀;3)特瑞普利單抗注射液聯合化療作為復發或轉移性鼻咽癌患者一線治療方案的三期臨牀研究JUPITER-02 研究(NCT03581786)已完成入組;4)特瑞普利單抗與化療聯合一線治療 EGFR 陰性非小細胞肺癌的 III 期關鍵註冊臨牀已完成患者入組。此外,特瑞普利單抗正在全球開展超過 30 個單藥治療及聯合治療的臨牀試驗。隨着新增適應症的陸續上市,將有望推動收入持續高速增長。
貢獻抗疫力量,新冠中和抗體進度領先。公司與中科院微生物所嚴景華團隊合作研發新冠病毒中和抗體,國內已完成一期臨牀入組。海外權益授權給禮來,公司將獲得 1000 萬美元首付款以及最高 2.45 億美元的里程碑款,外加該產品銷售淨額兩位數百分比的銷售分成。目前海外正在進行二期臨牀,如最終能成功上市,將有望增厚公司業績。
多個項目在研,後續新產品值得期待。公司上半年研發投入 7.09 億元(+92.25%),由於多個產品處於臨牀後期階段,預計下半年將可能繼續維持較高增速。目前公司有 21 項在研產品,除了特瑞普利單抗,進度最快的項目是UBP1211(修美樂生物類似藥),其已提交 NDA 並獲受理,有望在今年下半年或明年初上市。
積極尋求外部合作,擴展研發廣度和深度。公司依託於現有研發,積極尋求外部合作,補全和增強現有產品管線。截止到 2020 年 8 月 28 日,公司今年進行了 4 項外部合作,涉及產品和領域包括新冠中和抗體、新一代 T 細胞嵌合活化腫瘤免疫療法、PARP 抑制劑、IL-2。
盈利預測與投資建議。預計 2020-2022 年收入增速分別為 45.4%、58.5%、45%,EPS 分別為-0.77 元、-0.53 元、-0.10 元。考慮到公司作為創新藥公司,正處於藥品銷售放量時期,後續產品管線豐富,增長潛力大,維持“買入”評級。
風險提示:臨牀失敗的風險,上市產品不能順利進入醫保的風險,產品降價幅度或超出預期。

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