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康寧傑瑞製藥-B(09966.HK):臨牀進展顯著,強強聯合共期產品落地
格隆匯 09-21 09:46

機構:興業證券

投資要點

研發支出大幅增加,資金支持充裕:公司 2020 年上半年收入較去年增加 3330 萬元至 4430 萬元,主要原因是利息收入及政府補助增加;其中利息收入佔 3520 萬元。2020 年上半年研發支出較去年同期上升 140%至1.34 億元,主要由於臨牀試驗數目增加、進度推進及規模擴大導致的CRO/CMO 等第三方成本、員工成本及原材料成本等增加。截至 2019 年年末,公司的現金及現金等價物達到 18.68 億元,資金支持充裕。

核心產品臨牀進展顯著,強強聯合最大化產品的臨牀價值:PD-L1單抗KN035 皮下給藥具有顯著優勢,相較於靜脈注射操作更便捷、有望帶來更廣的適 用 人羣、更穩定的血漿藥物濃度。目前 KN035 針 對MSI-H/dMMR 晚期實體瘤的 2 期關鍵性臨牀試驗已完成,預計 2020年下半年向 NMPA 提交上市申請。KN046 是全球首創的 PD-L1/CTLA-4雙抗,相較於 PD-1 單抗和 CLTA-4 單抗聯合療法具有潛在更佳的安全性和療效。2020 年 8 月,KN046 聯合化療治療一線治療非小細胞肺癌(NSCLC)的 3 期臨牀試驗已正式在國內開展。KN046 預計 2022 年上半年遞交首次上市申請。KN026 是公司採用具有知識產權的 Fc 異二聚體平台技術(CRIB)開發的 HER2 雙抗,可同時靶向 II 和 IV 兩個受體結構域表位,導致雙重信號阻斷,從而產生潛在的卓越療效。2020年上半年 KN026 多項 IND 申請獲 CDE 批准以及達成多項有關聯合療法的戰略合作。整體來看,公司上半年核心產品臨牀進展顯著。同時公司與國內外企業強強聯合,在臨牀開發、商業化推廣及聯合療法等多方面達成戰略合作,疊加產品自身的差異化優勢,有望最大程度在全球範圍內釋放產品的臨牀價值及在上市後充分挖掘產品的商業潛力。

為產品落地積極準備,加強人才及產能儲備:公司目前正在為產品落地積極準備,在註冊事務、質量管理等方面引進高管人才和自建商業化團隊以及增強生產能力,以助力產品成功上市及上市後的成功商業化。

我們的觀點:我們預計未來 2-3 年公司將迎來產品收穫期。憑藉公司強大的自主研發能力及產品的差異化優勢、在國際範圍內的多方面戰略性合作(聯合療法、對外授權等)以及人才及產能的儲備,產品上市後有望較快打開市場,為公司帶來業績,建議積極關注。

風險提示:研發進度不及預期,市場競爭加劇,政策風險,疫情影響超預期。

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