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康希諾生物-B(6185.HK):新冠疫苗上臨牀,研發能力得驗證,維持“強烈推薦”評級
格隆匯 03-18 15:21

機構:方正證券

評級:強烈推薦

公司於 2020 年 3 月 17 日發佈公告《重組新型冠狀病毒疫苗(腺 病毒載體)遞交新藥臨牀試驗預審評申請並啟動健康志願者預 招募》,稱軍事科學院軍事醫學研究院生物工程研究所與公司合 作開發的重組新型冠狀病毒疫苗(腺病毒載體)已向監管機構 提交新藥臨牀實驗預審批。

公司重組新型冠狀病毒疫苗(腺病毒載體),可表達 COVID-19 包膜表面中的 S(Spike)蛋白。意在通過 S 蛋白作為抗原激起 機體的免疫反應。公司臨牀(註冊號:ChiCTR2000030906)與 2020 年 3 月 17 日通過審核,將在湖北省武漢市的中國人民武 裝警察部隊武漢特勤療養中心與華中科技大學同濟醫學院附屬 同濟醫院招募 3 組各 36 名的健康 18-60 歲性別不限的志願者, 通過非隨機對照試驗(開放性)分別接種高(1.511VP(病毒顆 粒)) 、中(111VP)、低(510VP)劑量一針,並檢查 7 日、28 日、 6 月的安全性指標(主要指標) 、抗 S 蛋白、抗 COVID-19、抗 Ad5 抗體水平以及特異性 T 細胞反應(次要指標) 。

國際上,目前已經進入臨牀的僅有 Moderna 一家,其採用的是 mRNA 疫苗技術,此外,BioNtech、CureVAC、Inovio 也均在採 用核酸疫苗的途徑在進行 COVID-19 的疫苗產品研發。國內目前 採取了 5 條通路,分別是減毒流感病毒載體、滅活疫苗、亞單 位疫苗、腺病毒載體疫苗、RNA/DNA 疫苗齊頭並進。目前,在 新冠疫苗研發上,軍科院和康希諾處於較為領先的狀態。

後續新冠肺炎疫苗仍有極大概率需要繼續經行臨牀 II 期、臨牀 III 期的臨牀研究方有可能上市,短期內較難給公司業績帶來 影響,但在一定程度上驗證了公司的研發實力。同時,我們認 為疫情在一定程度上促進了民眾對疫苗的認識,疫苗產品的接 受度上有望繼續上升。

我們預測公司 2019-2021 年(不考慮新冠肺炎的影響) ,營收將 分別為 40.00 百萬元、351 百萬元、1452 百萬元,淨利潤將分 別為-140 百萬元、-1 百萬元、362 百萬元。由於公司研發能力 得到驗證,後續產品可成功上市的機率加大,故維持“強烈推薦”評級。

風險提示:產品研發風險、新冠疫情風險、產品銷售風險、行 業風險、技術及專利風險。 

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