四環醫藥(00460.HK)："安納拉唑鈉"啟動III期臨牀試驗及 "回能®"進入醫保目錄
格隆匯2月13日丨四環醫藥(00460.HK)公告，集團在消化肝病領域的研發進展：自主研發的創新專利藥"安納拉唑鈉"啟動中華人民共和國III期臨牀試驗和上市產品"回能"進入中國《國家基本醫療保險、工傷保險和生育保險藥品目錄》乙類範圍。
安納拉唑鈉是中國唯一自主研發的質子泵抑制劑，擁有中國及國際專利。在已經完成的一項評價其治療十二指腸潰瘍的有效性和安全性的多中心、隨機、雙盲、雙模擬、陽性藥物平行對照的Ⅱ期臨牀試驗研究中，結果顯示該新藥能有效治療十二指腸潰瘍，促進潰瘍癒合，並緩解潰瘍相關症狀，胃鏡下十二指腸潰瘍癒合率與同類產品相當，其安全性、耐受性良好，從而成功進入III期臨牀試驗。該研究將在中國約30至45家臨牀中心進行，採用多中心、隨機、雙盲、雙模擬、陽性藥物平行對照的研究設計，評價安納拉唑鈉腸溶片治療十二指腸潰瘍的有效性和安全性。研究設計採取精細化分層設計，對入組的十二指腸潰瘍受試者進行分層，以期為臨牀實踐提供更精準化的治療方案和選擇。
該研究進展快速，啟動後即於2020年一月成功入組第一例受試者。根據中國國家醫療保障局、人力資源社會保障部印發的《2019年國家醫保談判准入藥品名單》的正式公佈，本集團已上市藥品–甘草酸單銨半胱氨酸氯化鈉注射液(回能?)也宣告正式進入國家醫保目錄乙類範圍。本集團相信這將給回能?的銷售帶來迅速的增長。
根據IQVIA艾昆緯中國醫院藥品統計報告(CHPA，5100張牀位醫院銷售數據)顯示，中國抑酸及消化性潰瘍類藥物市場持續增長且巨大。2019年的銷售額達到約人民幣269億元。其中PPI藥物佔據主要市場份額，抗潰瘍前十名市場份額藥物中有六個為PPI藥物。回能?所在的保肝藥物市場也保持較好增長，2019年整體銷售額達到約人民幣54億元，其中回能?以107%的快速增長速度成為甘草酸注射劑的前三產品。
隨着安納拉唑鈉臨牀試驗的快速推進，其將和本集團已上市的新一代組胺H2受體拮抗劑–注射用羅沙替丁醋酸酯(傑澳?)在抑酸劑領域形成優勢聯合。而在回能?進入國家醫保目錄加速開拓肝病領域的同時，本集團也在快速推進着該領域的其它藥物研發項目。本集團在消化肝病領域的產品管線將更加豐富和多元化。
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