康哲藥業(00867.HK)2021年營收83.37億元同比增20.0% 創新藥中國臨牀取得多項突破性進展
格隆匯3月15日丨康哲藥業(00867.HK)公佈，截至2021年12月31日止年度，營業額增長20.0%至人民幣83.372億元；若全按藥品銷售收入計算則營業額增長24.8%至人民幣92.302億元。毛利增長21.7%至人民幣62.469億元；若全按藥品銷售收入計算則毛利增長24.7%至人民幣60.392億元。年度溢利增長18.4%至人民幣30.253億元，每股基本盈利增長19.4%至人民幣1.2228元。建議末期股息每股人民幣0.2269元。
報吿期內，集團經營業績穩健增長。創新藥中國臨牀取得多項突破性進展，並開啟產業化投資、自主定製創新產品新模型；同時以皮膚專業線分拆擴張業務邊界至醫美新業務領域。新康哲開啟新徵程。
可持續的創新藥孵化平台
● 開啟對中國Biotech產業化投資新模型。集團積澱的臨牀執行力、商業化能力和資金實力等將與中國Biotech優勢互補，打造本土創新藥孵化平台；股權投資泰諾麥博並與其成立合營公司，共同開發4款全人源抗體新藥。
● 開啟自主定製創新產品模式。針對集團優勢科室，圍繞新靶點、熱門靶點委託CRO定製開發，自主推進本土創新技術和創新產品的發展；委託CRO公司定製開發主要涉及自身免疫系統、婦科、心腦血管、神經中樞疾病治療領域的4款具有知識產權的創新藥物。
創新產品中國開發進展
● 地西泮鼻噴霧劑中國橋接試驗達到預期目標，其註冊上市許可申請已於七月獲受理。
● 替瑞奇珠單抗注射液(原：替拉珠單抗注射液)中國橋接試驗取得積極結果，其註冊上市許可申請已於十月獲受理。
● 甲氨蝶呤注射液(預充式)銀屑病適應症的中國註冊上市許可申請已於十二月獲受理，並於2022年1月被授予優先審評資格。
● 甲氨蝶呤注射液(預充式)RA適應症的中國臨牀試驗申請已於八月獲批准。
● 德度司他片中國臨牀試驗申請獲批准，並已完成I期PK試驗，後於2022年1月完成中國III期橋接試驗首例受試者給藥。
● 亞甲藍腸溶緩釋片用於橋接的中國III期臨牀試驗申請已於八月獲批准，並於2022年1月完成首例受試者給藥。
皮膚醫美業務
● 收購皮膚醫美專業公司盧凱，豐富皮膚線產品並進軍醫療美容領域。
● 收購聚焦超聲技術平台公司康乃馨，開啟光電類醫美器械的研發和生產。產品FUBA5200聚焦超聲塑身儀已啟動中國關鍵臨牀試驗相關工作。
● 收購醫學美容專業公司旭俐醫療，獲得中國獲批的第四個韓國進口注射用透明質酸凝膠Vmonalisa莫娜麗莎中國獨家總經銷權，同時擴充專業醫美團隊和豐富醫美渠道資源。
● 與OVMEDI就高質量且規格齊全的埋植線產品訂立獨家合作協議，滿足中國求美者多樣化需求。
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