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聖諾醫藥-B(02257.HK):RNAi候選藥物STP705用於治療肝癌的I期臨牀研究IND申請獲TMHW批准
格隆匯 07-26 06:41

格隆匯7月26日丨聖諾醫藥-B(02257.HK)發佈公吿,公司已獲中國台灣衞生福利部(TMHW)對其新藥研究申請(IND)的監管許可,以啟動RNAi治療藥物STP705用於治療肝腫瘤晚期患者的I期臨牀研究。

本次於中國台灣開展的多中心、開放標籤、劑量爬坡的I期臨牀研究為STP705作為全球多中心臨牀試驗的一部分,旨在評估其安全性、耐受性、藥代藥動及抗腫瘤活性。STP705將通過瘤內注射給藥,用以治療患有膽管癌、肝細胞癌或肝轉移的晚期、轉移性或手術無法切除實體瘤且對標準療法無效的患者。該研究已於2021年3月在美國啟動,本次於中國台灣進行的臨牀試驗將於未來幾個月內開始招募受試者。

Sirnaomics創始人、董事會主席、執行董事、總裁兼首席執行官陸陽博士表示:“Sirnaomics抗腫瘤候選藥物STP705在中國台灣獲得IND批准是公司將臨牀研究擴展至亞洲的重要里程碑。我們相信該臨牀研究的結果將加強整個全球多中心臨牀試驗的數據體系,包括未來位於中國內地的研究。Sirnaomics目前處於開發RNAi新型抗腫瘤療法領域的全球領先地位。”

“本次臨牀研究的IND獲批將使公司有更多機會以治療在該地區有龐大醫療需求的適應症,例如肝癌。”Sirnaomics首席開發官龍志峯博士説,“中國台灣的監管機構與臨牀試驗醫院以符合國際標準而備受認可。我們期望在未來幾年可以將更多的腫瘤臨牀研究延伸至亞太地區。”

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