舒泰神(300204.SZ)：治療乙型肝炎病毒感染相關疾病的基因藥物STSG-0002注射液完成首例受試者給藥
格隆匯 8 月 25日丨舒泰神(300204.SZ)公佈，公司及全資子公司北京三諾佳邑生物技術有限責任公司(“三諾佳邑”)組織開展的用於治療乙型肝炎病毒感染相關疾病的基因藥物—STSG-0002注射液近日在北京大學第一醫院完成首例受試者給藥(I期臨牀試驗)。
藥品名稱：STSG-0002注射液；試驗通俗題目：評價STSG-0002注射液安全性、耐受性及初步有效性的研究；試驗專業題目：多中心、開放性、劑量遞增評價STSG-0002注射液對無症狀慢性HBV感染者的安全性、耐受性及初步有效性Ia期臨牀試驗。
STSG-0002注射液申報臨牀試驗的適應症為：慢性乙型肝炎。乙型肝炎病毒(HBV)感染是嚴重威脅全球健康的主要問題之一。根據WHO發佈的《Globalhepatitis report, 2017》，全球有超過2.57億人慢性感染；每年有超過88.7萬人死於該病毒。中國是HBV高發國家，2006年中國HBV血清流行率調查顯示，中國1~59歲人羣的HBsAg攜帶率為7.18%。因此，估計中國約有9300萬人感染了乙肝病毒，其中2000萬為乙肝病毒慢性乙肝患者。慢性乙型肝炎給患者的生活帶來巨大的痛苦和經濟負擔。
STSG-0002注射液為攜帶靶向HBV基因組P區和X區的shRNA序列表達框的肝噬性複製缺陷重組腺相關病毒。它以重組腺相關病毒(rAAV)作為遞送載體，將目的基因序列導入細胞轉錄生成shRNA，shRNA在細胞質中剪切為單鏈siRNA，隨後通過RNAi機制，特異性地沉默HBV複製相關的pgRNA和HBV蛋白表達相關的sRNA，阻斷HBV病毒複製，降低HBsAg、HBeAg和HBc蛋白的合成和分泌。STSG-0002具有明顯嗜肝性，單次靜脈給藥可在肝細胞內長期表達siRNA。HBsAg的大幅度降低有望促進HBsAg血清轉化，從而實現HBV功能性治癒。
STSG-0002注射液項目的研發成功將有效解決現有乙型肝炎患者抗病毒治療方案不能直接降低HBsAg(乙型肝炎表面抗原)等HBV相關結構蛋白和調節蛋白的問題，有效降低HBV攜帶者肝臟HBV複製帶來的慢性炎症，從而阻止慢性乙型肝炎患者向肝硬化、肝癌等重型肝病的進展，並將對HBV感染相關重症疾病帶來新的治療手段。
公司已聘請中華醫學會感染病學分會主任委員，衞生部傳染病衞生標準委員會委員，北京大學第一醫院感染疾病科主任，兼任肝病中心主任，北京大學國際醫院感染和肝病部主任(兼)王貴強教授和中國藥理學會臨牀藥理學專業委員會候任主任委員，北京大學臨牀藥理研究所所長、北京大學第一醫院臨牀試驗中心主任崔一民教授作為STSG-0002項目I期主要研究者。
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