金斯瑞生物科技(01548.HK)動態報告：中國傳奇，走向世界，維持“買入”評級
機構：國信證券
評級：買入
事項：
2019ASH會議摘要公佈，傳奇美國臨牀試驗結果優異。2019年11月6日，第61屆ASH（AmericanSocietyofHematology，美國血液學會）年會摘要線上公佈。金斯瑞子公司南京傳奇/強生公佈了JNJ-4528，CARTITUDE-1數據，此為靶向BCMA的LCAR-B38MCART療法對復發/難治性多發性骨髓瘤（RRMM）患者的美國Ib/II臨牀結果，此外也更新了中國區臨牀隨訪數據。同樣在治療RRMM的領域，Bluebird、科濟生物、馴鹿醫療等公司也公佈了BCMA-CART的I期結果，Celgene公佈了BCMA+CD3雙抗的I期結果，GSK靶向BCMA的ADC三期臨牀結果在摘要中尚未披露。
國信醫藥觀點：
1）南京傳奇BCMACAR-T療法在美國進行的一期註冊臨牀初步結果與國內臨牀多項指標相當，終結了市場對此前中國臨牀真實性的質疑。極大增強了該細胞療法產品未來1-2年在中美獲批上市的確定性。
2）BCMA靶點賽道競爭者逐漸增多，但是作為技術優勢獨特和臨牀進度領先的創新Bestinclass產品預計所受競爭影響有限。
3）呼喚創新，南京傳奇BCMACAR-T有望在未來半年到一年時間內迎來數個關鍵里程碑，公司也有望獲得來自合作伙伴美國強生公司的相應里程碑付款。
4）看好細胞治療發展前景，金斯瑞生物科技在細胞治療前沿科技賽道的稀缺性凸顯。公司已組建起全球最大的細胞治療研發隊伍，對公司的投資價值不僅應當考慮現有生命科學科研服務等現金牛業務的協同價值、目前處於中美臨牀階段細胞治療產品的價值以及公司在血液瘤和實體瘤的細胞治療領域的研發管線價值，還應考慮公司已延伸發展起來的細胞治療和生物製藥CDMO業務及其技術平台性價值。
5）投資建議：創新無價，金斯瑞生物科技安全邊際高，CAR-T療法業務彈性空間大，維持“買入”投資評級。考慮中美臨牀進度和相應研發投入以及來自美國強生的里程碑付款對業績影響較大，建議短期忽略公司利潤的波動。經調整後預計金斯瑞2019-2021年歸母淨利潤分別為-50/-32/35百萬美元，EPS為-0.03/-0.02/0.02美元。維持前期估算，即金斯瑞原有業務和細胞治療藥物LCAR-B38M從末線療法推進到二線治療的每股價值為28.83-30.08港元。進一步考慮公司業務發展和技術平台價值，上調公司合理估值為30.0~34.0港元。距當前股價18.10港元具有較大空間，維持”買入“投資評級。
6）風險提示：細胞治療臨牀進度不達市場預期；臨牀數據結果不達預期；公司工業酶及CDMO業務不達預期。
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