中國抗體-B(03681.HK):SN1011新藥研究申請獲國家藥監局藥品審評中心受理
格隆匯2月7日丨中國抗體-B(03681.HK)發佈公吿,2022年1月21日,一項SN1011的新藥研究申請(“新藥研究申請”,針對多發性硬化症)已提交予中國國家藥品監督管理局藥品審評中心,並於2022年1月28日獲受理。公司計劃於當前新藥研究申請獲批後,立即在中國開始II期臨牀試驗,並後續開展和多發性硬化症適應症相關的臨牀研發項目。
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、更卓越療效及更高安全性。在作用機理、親和性、靶向選擇性及安全性方面,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。
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