中國抗體-B(03681.HK)公佈SM03臨牀結果首份簡報 預期明年底商業化
格隆匯6月8日丨中國抗體-B(03681.HK)公佈，於2020年6月5日，公司就治療類風濕關節炎的SM03II期臨牀研究報告（題為“重組抗人CD22單克隆抗體SM03對中國類風濕關節炎患者的療效及安全性：II期隨機雙盲多劑量安慰劑對照研究”），公佈SM03臨牀結果的首份簡報。
24周的ACR20應答率在高劑量組別中明顯較高(63.3%,p=0.002)，其次為低劑量組別(56.9%,p=0.024)及安慰劑(34.0%)。當p值少於0.05時，兩組患者療效被認為統計學上顯着差異，而百分比指在基線隨機入組中的反應者在24周內達到臨牀反應的比例。實際數字方面顯示在高劑量治療中的ACR反應者較低劑量治療的為多，儘管並無觀察到統計上的顯着差異。我們並無觀察到在高劑量、低劑量及安慰劑之中不良事件的重大差異（分別為35.3%、51.9%及34.6%）。該等百分比指在基線隨機入組中的反應者在24周內遇到最少一次不良事件的病例比例。在高劑量及低劑量組別中，13名(12.6%)患者據報受到治療相關感染，而5名(6.8%)接受SM03輸注的患者在抗藥抗體分析中呈陽性。該等百分比分別指在基線隨機入組中的患者在24周內受到任何治療相關感染或在血清抗藥抗體反應測試中呈陽性的病例比例。在中國患有活動性類風濕關節炎的患者中，已顯示SM03聯合甲氨蝶呤在24周的治療中產生良好的安全性及耐受性，尤其在輸注相關反應及治療相關感染方面。在研究中，並無報稱患者受到嚴重治療感染或任何惡性腫瘤病例。
在中國患有活動性類風濕關節炎的患者中，輸注2,400毫克及3,600毫克SM03累積劑量和結合MTX，在24周治療中證實有效並具有良好耐受性。此外，SM03已證實具有良好的安全性，尤其在治療相關感染、惡性腫瘤及免疫原性方面。
據公司所知，這是首個向科學界披露的關於使用抗CD22抗體用作治療類風濕關節炎的隨機對照試驗，而公司董事相信，這是摘要已獲接納在大會上作口頭陳述的主要原因之一，表明公司研究結果的重要性獲得國際認可。據公司所知，公司為少數幾家獲邀在大會上發表口頭陳述的中國生物科技公司之一。
公司的旗艦產品SM03為全球同類靶點中首個治療類風濕關節炎潛在的單抗藥物，對其他免疫性疾病亦具有潛在療效，目前在中國進行III期臨牀試驗，預期將於2021年年底商業化。
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