君實生物(01877.HK):新冠中和抗體海外臨牀數據良好,上市可期,維持“買入”評級
機構:西南證券
評級:買入
事件:10 月 ]7 日,禮來公司宣佈其 SARS-CoV-2 中和抗體項目的輕中度COVID-19 患者聯合治療的中期數據。
中和抗體聯用方案(LY-CoV555 和 LY-CoV016)顯著降低病毒載量和就診率。BLAZE-1 臨牀試驗的中期數據表明,聯合使用兩種 SARS-CoV-2 中和抗體可以降低體內病毒載量,減輕相關症狀,同時降低住院和急診風險。探索性分析顯示,與安慰劑組(20.8%)相比,聯合治療組在第 7 天較高病毒載量的患者比例顯著較低(3.0%)。此外,與安慰劑組(5.8%)相比,聯合治療的患者住院或急診的就診率較低(0.9%),相對風險降低 84.5%(p=0.049)。
禮來公司預計第四季度開始生產聯合用藥中和抗體。為了儘快提供患者可及藥物,即使尚未有數據顯示這兩種抗體療法可能成為 COVID-19 有效療法,禮來仍在大規模投資生產這兩種抗體。針對單一療法,公司預計在 2020 年第四季度將提供超過 100 萬劑 700mg 的 LY-CoV555 用於單一療法,其中 10 萬劑將可 能於 10 月上市。至於聯合療法,預計 2020 年第 4 季度將可能提供 5 萬劑該抗體。從 2021 年第一季度開始,公司將可能大幅增加聯合療法藥品的供應。
公司對 LY-CoV016 的海外權益享有里程碑付款及銷售分成。禮來進行試驗的兩個中和抗體中。LY-CoV555 是禮來與 AbCellera 公司合作開發的用於預防和治療 COVID-19 的中和抗體。LY-CoV016(又稱 JS016)是禮來與君實生物、中國科學院微生物研究所合作的針對 COVID-19 的中和抗體,其海外權益授權給禮來公司,公司獲得 1000 萬美元首付款,不超過 2.45 億美元的里程碑付款,外加該產品銷售淨額兩位數百分比的銷售分成。
盈利預測與評級:預計公司 2020-2022 年 EPS 分別為人民幣-0.73/-0.37/-0.10 元。公司與中國科學院微生物研究所及禮來公司合作的新冠中和抗體在臨牀試驗中顯示出良好的效果,體現出公司研發的高效率,如該產品能成功上市,將有望增厚公司業績。維持“買入”評級。
風險提示:1)新冠中和抗體及在研管線研發進展不及預期;2)特瑞普利單抗產品降價幅度超預期;3)特瑞普利單抗以及未來上市產品不能進入醫保的風險。

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