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石藥集團(01093.HK):首創在研藥物JMT601(CPO107)獲美國FDA授予快速通道資格
格隆匯 01-27 17:02

格隆匯1月27日丨石藥集團(01093.HK)發佈公吿,集團開發的首創在研藥物JMT601 (CPO107)用於治療成人復發或難治瀰漫大B細胞淋巴瘤獲得美國食品藥品監督管理局(“FDA”)授予快速通道資格。

根據披露,JMT601 (CPO107)是全球首個已進入臨牀開發階段的具有協同靶向結合效應的雙特異性 SIRPα融合蛋白,其有效結合淋巴瘤細胞表面的CD20,以誘發抗體依賴性細胞介導的細胞毒作用(ADCC)及補體依賴的細胞毒作用(CDC)。其與CD20的結合進一步導致與淋巴瘤細胞上表達的CD47協同結合,從而阻斷CD47傳遞的“別吞噬”信號,並誘導抗體依賴性的巨噬細胞吞噬作用(ADCP)。

與傳統CD20靶向抗體相比,多項人類B細胞淋巴瘤模型顯示JMT601 (CPO107)的療效更為明顯。非臨牀毒理學研究顯示JMT601 (CPO107)對CD20陰性細胞無明顯結合,100 mpk劑量下未見紅細胞、血小板等CD47強陽性細胞顯着受累,安全情況理想並可支持其臨牀研究評估。授予快速通道資格表明FDA認為JMT601 (CPO107)已表現出具有治療嚴重或危及生命疾病的潛力,並會促進及加快JMT601 (CPO107)的開發和審評。

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