歌禮制藥-B(01672.HK)擴大利托那韋口服片劑產能，公佈口服直接抗新冠病毒藥物研發管線
格隆匯1月3日丨歌禮制藥-B(01672.HK)發佈公吿，歌禮宣佈擴大利托那韋口服片劑產能，並公佈治療新型冠狀病毒(SARS-CoV-2)感染的口服直接抗新冠病毒研發管線。公司抗新冠肺炎藥物管線目前包括：(i)已上市的利托那韋口服片劑(100 mg)；(ii)口服聚合酶 (RdRp)抑制劑ASC10；(iii)口服蛋白酶(3CLpro)抑制劑ASC11。
公司擁有中國唯一通過生物等效性研究獲批上市的利托那韋口服片劑。公司的利托那韋口服片劑於2021年9月獲中國國家藥品監督管理局批准上市。低劑量利托那韋口服片劑(100 mg)作為多種抗病毒蛋白酶抑制劑的藥代動力學增強劑，是口服直接抗新冠病毒藥物Paxlovid(Nirmatrelvir+利托那韋)的組成之一。公司使用高端製劑技術，大幅度提高難溶性利托那韋在人體內的生物利用度，從而達到與艾伯維生產的原研口服片劑在人體中的生物等效。公司計劃在全球多個國家進行利托那韋口服片劑仿製藥藥品註冊申請。利托那韋口服片劑年產能已擴大至1億片，未來根據市場需求可以進一步快速擴大。
ASC10是靶點為聚合酶(RdRp)的口服直接抗新冠病毒候選藥物，體外數據顯示出顯著的抗新冠病毒活性。ASC10是完全自主研發的候選藥物，擁有全球知識產權和商業化權益。與已被美國食品藥品監督管理局(FDA)批准的、同靶點的口服聚合酶抑制劑Molnupiravir相比，ASC10有新的和差異化的化學結構。公司已提交多項化合物和用途的專利申請。動物試驗數據顯示ASC10與Molnupiravir相比有更好的生物利用度。公司計劃於2022年上半年向中國、美國等國家提交臨牀試驗申請。
ASC11是靶點為蛋白酶(3CLpro)的口服直接抗新冠病毒候選藥物，與公司已上市的利托那韋口服片劑聯用治療新型冠狀病毒感染。ASC11是完全自主研發的候選藥物，擁有全球知識產權和商業化權益。與已被美國FDA批准的、同靶點的口服蛋白酶抑制劑Nirmatrelvir相比，ASC11有新的和差異化的化學結構。公司已提交化合物和用途的專利申請。公司計劃於2022年下半年向中國、美國等國家提交臨牀試驗申請。公司在抗病毒蛋白酶抑制劑研發上有豐富經驗，成功開發並上市丙肝病毒蛋白酶抑制劑戈諾衞®聯合利托那韋口服片劑，用於治療慢性丙型肝炎。
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