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醫藥:國產mRNA新冠疫苗臨牀相繼獲批,推薦上游供應鏈國產化潛在獲益標的

本文來自格隆匯專欄:中信證券研究,作者:陳竹 韓世通 宋碩 朱奕彰

多款國產mRNA疫苗進入臨牀試驗階段,上游國產供應鏈有望明顯獲益。近日,石藥集團及康希諾生物新型冠狀病毒mRNA疫苗獲批臨牀試驗。mRNA疫苗有望在抗擊omicron新冠肺炎中發揮重要的作用。

考慮到mRNA疫苗保護效果較好及已有國內眾多企業在相關領域進行佈局,我們認為隨着上述企業臨牀試驗不斷推進,上游供應鏈國產替代空間有望進一步打開,相關企業有望明顯獲益:

1)mRNA製備:mRNA原液的製備(體外轉錄)需要用到一系列酶,如mRNA T7聚合酶、加帽酶以及2′O-甲基轉移酶、無機焦磷酸酶、Rnase Inhibitor、Poly(A)聚合酶和DNAase等多種酶以及核苷酸底物。我們推測,規模放量後,1劑mRNA疫苗需要6元左右的酶和底物。相關公司有諾唯贊、義翹神州、百普賽斯、菲鵬生物(已過會)

2)遞送系統:由於mRNA單鏈結構致使其極為不穩定,易被降解,需要特殊的修飾或包裹遞送系統才能實現mRNA的胞內表達,目前常用的遞送手段是以脂質納米粒(Lipid nanoparticle,LNP)為載體遞送,主要由可電離的陽離子脂質(ionizable lipids),中性輔助脂質,膽固醇,聚乙二醇修飾的脂質(PEGylated lipid)等四種組分構成,Moderna、CureVac、BioNTech等公司均採用脂質納米技術遞送(LNP)。

諾唯贊可供應mRNA製備步驟所用的酶和底物,疫苗評價業務導流,mRNA疫苗酶原料供應值得期待。

諾唯贊是國內領先的酶、抗原、抗體等生物試劑生產企業,正持續向下遊領域延伸。作為國內首批抗原檢測試劑供應商,IVD產品正藉助新冠疫情快速放量。另外,憑藉疫苗評價業務的導流(公司已與多家mRNA疫苗企業建立業務合作),諾唯贊有望在國產mRNA疫苗原料供應中佔據優勢。

鍵凱科技可提供LNP系統主要組分,未來1-2年內伴隨國產mRNA疫苗進展,帶來潛在業績彈性。

鍵凱科技是國內領先的醫用聚乙二醇及衍生產品研發生產企業,已從大分子蛋白質藥物修飾擴展到小分子修飾給藥、LNPs遞送系統、基因藥物修飾等。公司已於2021年推出了系列新產品--LNP遞送系統輔料,其中 M-DMG-2000、ALC-0315與M-DTDAM-2000(ALC-0159)已經獲得藥用輔料登記。根據我們測算,若mRNA疫苗進入申請上市前/商業化階段,僅考慮PEG脂質體產品,預計每一億劑mRNA疫苗有望帶來2000-3000萬相應藥用輔料產品收入。參考Moderna首款mRNA疫苗“mRNA-1273”的EUA獲批節奏(2020年3月進行人體臨牀試驗,2020年12月獲得EUA),疊加國內民眾對國產mRNA新冠疫苗的迫切需求,我們預計今年Q4前後,會有相關商業化前驗證批次訂單落地於上游供應鏈公司,帶來潛在業績彈性。

風險因素:

mRNA疫苗研發進展低預期;mRNA上游產品定價低預期;新冠疫苗需求低預期。 

投資策略:

mRNA疫苗領域建議關注沃森生物、康希諾、復星醫藥等;上游建議關注諾唯贊、義翹神州、百普賽斯、菲鵬生物、鍵凱科技等。

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