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Press release
Jan 18, 2021 09:31 JST
Source:
SinoMab BioScience Limited
中國抗體SN1011之I期臨床試驗完成首例健康受試者給藥
香港, Jan 18, 2021 - (ACN Newswire) - 中國抗體製藥有限公司(「中國抗體」或「公司」,股份代號:3681.HK),一家專注研究、發展、製造及商業化免疫性疾病療法的香港生物製藥公司,欣然宣佈,其創新型第三代可逆共價布魯頓酪氨酸激酶(「BTK」)抑制劑SN1011今日(1月15日)在中國上海中醫藥大學附屬曙光醫院完成其I期臨床試驗之首例健康受試者給藥,目前受試者情況正常。
上海中醫藥大學附屬曙光醫院的醫護人員為SN1011進行首例健康受試者給藥。
SN1011是第三代可逆共價BTK,其設計在長期治療系統性紅斑狼瘡、類風濕關節炎、天皰瘡、多發性硬化及其他自身免疫性疾病方面具備更高選擇性及更卓越療效。在靶向選擇性及親和性方面,SN1011與目前市場現有的BTK抑制劑(如依魯替尼)等具有差異性優勢。是次I期臨床試驗在上海中醫藥大學附屬曙光醫院進行,旨在評估SN1011治療自身免疫性疾病的安全性、耐受性、藥代動力學、藥效動力學,以及II期臨床推薦劑量。中國抗體於2020年8月27日獲中國國家藥品監督管理局批准SN1011新藥研究申請,直到今天進入給藥階段,用時不到5個月,充分證明公司推展新藥研發項目的高效執行力。
本次臨床主要研究者上海曙光醫院元唯安主任表示:「國內批准上市的BTK抑制已有不少,但是截至目前國內還尚未批准第三代BTK抑制劑,考慮到第三代共價可逆BTK抑制劑低劑量起效及安全性優勢,因此讓第三代共價可逆BTK抑制劑在國內早日上市將給相關疾病人群帶來良好的治療預期。」
中國抗體執行董事、主席兼首席執行官梁瑞安博士表示:「SN1011順利完成首例受試者給藥,繼旗艦產品SM03後又一項主要研發資產進入臨床試驗研究階段,這是中國抗體在一系列自身免疫治療產品研發進展中的重要里程碑之一。去年我們已在澳洲啟動SN1011的一期臨床試驗。在臨床中SN1011表現出優秀的安全性,並且具有在較低劑量就能發揮效用,讓患者持續獲益的優勢,與市場上其他BTK抑制劑完全不同,我們對SN1011巨大的臨床開發前景充滿信心。未來我們將加快推進項目,為全球自身免疫患者帶來安全、有效及用得起的好藥。」
關於SN1011
Bruton 酪氨酸激酶( BTK) 是 B 細胞抗原受體( BCR) 信號轉導通路中的關鍵激酶,由於BTK缺陷主要影響B細胞,BTK是自身免疫性疾病中富有吸引力的一個治療靶點。SN1011是第三代共價可逆型BTK抑制劑,有著獨特的不同於其它同類產品的化學結構,對BTK有高度親和力,且具有優異的激酶選擇性、PK特性,以及在體內代謝穩定。臨床前研究表明該藥物與同類藥物相比,具有顯著優異的臨床前研究表明該藥物與同類共價可逆BTK抑制劑藥物相比,具有更優異的藥物安全性,同時支持自身免疫疾病的長期給藥。
關於中國抗體製藥有限公司
中國抗體專注於研究、發展、製造及商業化免疫性疾病療法。公司注重科技研發,其旗艦產品SM03為全球首項用以治療類風濕關節炎的抗CD22單抗,已在中國進入類風濕關節炎三期臨床試驗,並被列入國家十三五重大新藥創製專項重大項目。此外還有多個同類靶點首創 (First-in-target) 及同類首創 (First-in-class) 在研藥物,部分已處於臨床階段,適應症覆蓋類風濕性關節炎、系統性紅斑狼瘡、非霍奇金氏淋巴瘤、哮喘等具有重大未滿足臨床需求的疾病。
Source: SinoMab BioScience Limited
Sectors: Daily Finance, Daily News, BioTech, Healthcare & Pharm
Copyright ©2024 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.
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