諾誠健華-B(09969.HK)：奧布替尼兩項淋巴瘤適應症獲批，納入港股通期待估值修復，維持“審慎增持”評級，目標價21.49港元
機構：興業證券
評級：審慎增持
目標價：21.49 港元
投資要點
事件：近日，（1）國家藥監局批准公司的1類創新藥奧布替尼（商品名：宜諾凱）上市，用於治療既往至少接受過一種治療的成人套細胞淋巴瘤（MCL）患者和既往至少接受過一種治療的成人慢性淋巴細胞白血病（CLL）/小淋巴細胞淋巴瘤（SLL）患者。（2）公司股票調入港股通股票範圍。
奧布替尼臨牀數據優異，較已獲批BTK抑制劑有更精準的靶點選擇性：公司在美國血液學協會（ASH）年會上公佈奧布替尼治療r/rCLL/SLL和r/rMCL的臨牀數據，結果顯示優異的ORR和安全性。奧布替尼在支架中心設計為單環，而不是伊布替尼等分子的稠合雙環核心。得益於此，奧布替尼具有更精準的靶向選擇性，從而帶來更低的脱靶副作用，如房顫、大出血、腹瀉等。
奧布替尼針對多種B細胞淋巴瘤及自免疾病的試驗穩步推進：除了CLL/SLL及MCL，公司亦在推進MZL、CNSL、WM、DLBCL以及一線治療CLL/SLL等臨牀試驗。基於奧布替尼的高選擇性、良好的安全性以及可透過血腦屏障的特性，公司已在美國啟動針對復發緩解型多發性硬化症（RRMS）的國際多中心2期臨牀試驗。目前尚無BTK抑制劑獲批治療MS，進度最快的為賽諾菲、默克和羅氏，均處於3期臨牀階段。根據Frost&Sullivan，全球MS市場超過230億美元，預計2030年超過480億美元。奧布替尼針對SLE的2a期臨牀正在國內開展。SLE現有治療選擇有限，唯一獲批生物藥貝利尤單抗療效有限且需要注射給藥，存在巨大的臨牀未滿足需求。公司商業化隊伍已準備就緒，能夠覆蓋全國300家頂級醫院。預計奧布替尼明年將為公司貢獻較顯著的收入。後續多項B細胞淋巴瘤適應症的獲批以及在自身免疫性疾病領域的開拓，有望推動奧布替尼的銷售不斷跨上台階。
納入港股通提升流動性，有望實現價值重估：公司股票成功納入港股通，成為上月末港股通納入規則調整後的第一批受益標的之一。結合近期公司核心產品奧布替尼獲批上市，基本面向好，調入港股通後，有望短期內給公司帶來增量資金、提高流動性，公司股票有望實現估值修復。
盈利預測與估值：奧布替尼獲批稍早於預期，預計2021年初可正式上市銷售。我們維持此前的盈利預測，預測2020-2022年營業收入分別為1.43、203.97和459.86百萬元，同比增長15.00%、14123.08%和125.46%；淨利潤分別為-458.15、-473.41和-442.60百萬元。維持目標價21.49港元，維持“審慎增持”評級。
風險提示：奧布替尼研發進度和銷售低於預期，管線產品的競爭超過預期，研發投入過大導致資金短缺。
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