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中國抗體-B(03681.HK):SN1011新藥研究申請獲國家藥監局批准
格隆匯 04-20 18:35

格隆匯4月20日丨中國抗體-B(03681.HK)公吿,於2022年4月19日,SN1011的新藥研究申請(針對多發性硬化症)已獲中國國家藥品監督管理局批准。新藥研究申請獲批准將使公司能夠在中國開始II期臨牀試驗,以評估SN1011在中國多發性硬化症患者中的療效及安全性,計劃於2022年第四季首名患者入組。

SN1011是公司的第三代可逆共價BTK抑制劑,其設計在長期治療系統性紅斑狼瘡、尋常型天皰瘡、多發性硬化症、類風濕關節炎及其他免疫性疾病方面,具備更高選擇性、更卓越療效及更高的安全性。在作用機制、親和性、靶向選擇性及安全性方面,SN1011與目前市場上現有的BTK抑制劑(如依魯替尼)等具有差異性優勢。

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