廣生堂(300436.SZ)乙肝治療全球創新藥GST-HG141臨試申請獲國家藥監局受理
格隆匯8月14日丨廣生堂(300436.SZ)公佈，公司歷經四年完成了GST-HG141申請臨牀試驗所需的全部數據和全套資料，已獲得pre-IND meeting預核准，於2019年8月14日收到國家藥品監督管理局下發的《受理通知書》，公司乙肝治療全球創新藥乙肝核心蛋白抑制劑GST-HG141臨牀申請獲得受理，受理號：CXHL1900280國(原料藥)、CXHL1900281國和CXHL1900282國(片劑)，申請階段：臨牀。該項目是廣生堂在眾多基礎研究科學家指導下提出的乙肝功能性治癒“登峯計劃”的最重要組成藥物之一，是與具備領先新藥研發實力的上海藥明康德新藥開發有限公司合作研發的成果，目前全球尚無該靶點藥物上市，有望成為Best-in-class項目，居世界領先水平，為全球乙肝治療提供強有力的藥物新組合。
GST-HG141是全新靶點的新型抗乙肝病毒1類新藥，基礎研究和實驗顯示三大優勢：1、針對乙肝病毒複製的多個關鍵環節起作用，強烈抑制乙肝病毒的複製，在與替諾福韋的對比及聯合試驗中，GST-HG141體現了強烈的直接抗病毒效果，且與替諾福韋聯合具有協同效應；2、同時破壞乙肝病毒cccDNA(共價閉合環狀DNA)病毒池的建立(觸及乙肝治癒的關鍵)，削減乙肝病毒庫儲備，在多個劑量組下均能顯著降低血清的HBV-DNA(乙肝病毒DNA)、HBeAg(乙型肝炎病毒E抗原)水平，並且展示了明顯的劑量依賴效應；3、與廣生堂現有不同靶點的核苷(酸)類藥物及已申報的表面抗原抑制劑GST-HG131或在研的GST-HG121有協同增效的效果。
如能按計劃如期獲得主管部門的審批，公司將在2020年開始組織多個全球乙肝治癒性臨牀組合研究，挑戰乙肝功能性治癒。GST-HG141核心化合物已申請PCT國際專利，計劃進入中國、美國、日本、歐洲等24個國家和地區。
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