廣生堂(300436.SZ)：乙肝治療創新藥HBsAg抑制劑GST-HG121獲得兩件臨牀試驗批准通知書
格隆匯 9 月 7日丨廣生堂(300436.SZ)公佈，公司於2020年9月7日收到國家藥品監督管理局(“國家藥監局”)下發的關於乙肝治療創新藥乙肝表面抗原(HBsAg)抑制劑GST-HG121的受理號為CXHL2000292、CXHL2000293的兩件《臨牀試驗批准通知書》。至此，GST-HG121項目受理號為CXHL2000290、CXHL2000291、CXHL2000292、CXHL2000293的臨牀試驗申請均已獲得批准。
乙肝治療創新藥GST-HG121系乙肝表面抗原(HBsAg)抑制劑，是公司乙肝臨牀治癒路線圖“登峯計劃”的重要組件。GST-HG121系列化合物已通過PCT途徑申請國際專利，且已獲得中國、日本、韓國、歐洲等8個國家或地區的化合物發明專利授權。
GST-HG121臨牀試驗申請已於2020年6月16日獲得國家藥監局受理，受理號：CXHL2000290、CXHL2000291、CXHL2000292、CXHL2000293，註冊分類：化學藥品1類。其中受理號為CXHL2000290、CXHL2000291的臨牀試驗申請已於2020年8月26日獲得批准。
藥品名稱：GST-HG121片；受理號：CXHL2000292、CXHL2000293；申請事項：臨牀試驗；適應症：慢性乙型肝炎；申請人：福建廣生堂藥業股份有限公司；結論：根據《中華人民共和國藥品管理法》及有關規定，經審查，2020年6月16日受理的GST-HG121片符合藥品註冊的有關要求，同意按照提交的方案開展用於慢性乙型肝炎(HBV)治療的臨牀試驗。
此次獲批臨牀試驗後，GST-HG121項目尚需開展臨牀研究並經國家藥品審評部門審批通過後方可上市，其臨牀研究進度、研究結果和審評審批結果具有不確定性。公司將嚴格按照批件要求儘快開展臨牀試驗，全面考察該藥的有效性和安全性，依法依規申請生產註冊批件。
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