信達生物(01801.HK)：創新藥管線佈局前瞻，腫瘤免疫療法行業龍頭，給予“買入”評級
機構：東吳證券
評級：買入
投資要點
信迪利單抗適應症擴大在即，奠定 PD-1 市場領先地位：信迪利單抗自獲批以來，成為國內首款納入醫保目錄的 PD-1 抑制劑。公司商業化能力得到驗證，信迪利單抗在 2019 年取得了超 10 億的銷售額，即便 2020年受疫情影響，銷售額也將超過 20 億。同時信迪利單抗積極佈局大適應症，研發進度均處於國內領先地位。其中兩項聯合化療一線治療非小細胞肺癌的適應症已提交 NDA 申請，此外尚有肝癌、胃癌以及食管癌等適應症處於臨牀 III 期階段或即將報 NDA，尤其肝癌一線聯合療法的臨牀數據達到了優效標準，有望在 2021 年獲批。我們預計，隨着信迪利單抗大適應症的進一步獲批，將為銷售額的快速增長打下堅實的基礎，預計信迪利單抗國內的銷售額將於 2020-2022 年分別達到 22.84、23.50、31.19 億元。
創新藥管線佈局寬廣，從小分子到細胞療法：信達生物積極佈局創新藥領域的開發，目前在國內腫瘤免疫療法領域保持領先地位，除了信迪利單抗上市以外，還有三款生物類似藥貝伐珠單抗、阿達木單抗、利妥昔單抗已於近兩年獲批上市，有望佔據一定的先發優勢。除已上市藥品外，信達生物也從深度及廣度兩個方面積極佈局創新藥研發。深度上積極拓寬信迪利單抗的適應症並佈局了具有前瞻性的熱門靶點如 CTLA-4（臨牀 III 期）、PCSK9（臨牀 III 期）、CD47（臨牀 II 期）、OXM3（臨牀 II期）、OX40 以及 TIGIT 等新興靶點。廣度上來講，信達生物從小分子、雙特異性抗體到細胞療法均有佈局，且其研發佈局以及臨牀進展均處於領先地位，未來成藥可期，有望為公司長期持續增長注入新鮮血液。
國際化戰略實現管線商業價值最大化：信達生物堅持國際化+持續創新戰略，與多家國際公司建立深厚的合作關係。如與禮來在多個抗體藥的研發上達成戰略合作協議。與羅氏達成戰略合作，引進其雙特異性 T 細胞抗體技術共同開發細胞治療以及雙特異性抗體。此外從 Incyte 引進三款小分子藥物積極拓展化學藥市場。在積極 License-in 的同時，信達生物也堅持“走出去”策略，將信迪利單抗的海外權益授予禮來，同時將貝伐珠單抗的海外權益授予 Coherus。尤其以信迪利單抗的海外授權為標杆，是首家將 PD-1 單抗的海外權益授予 Big-Pharma 的國內藥企，後續有望每年向信達貢獻 20~36 億人民幣的淨利潤。
盈利預測與投資建議：我們預計 2020-2022 年，信達生物的收入分別為37.12、27.50、44.76 億元，相應增長率為 254.4%、-25.9%、62.7%，並 在 2022 年實現正式盈利。考慮到公司屬於 PD-1 單抗頭部企業，PD-1單抗的海外權益將大幅增厚公司利潤，豐富的管線佈局和海外合作有望帶來持續增長，首次覆蓋給予“買入”評級。
風險提示：信迪利單抗新適應症臨牀以及獲批進度不及預期；PD-1 競爭激烈，降價幅度過大。
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