石藥集團(01093.HK)：JMT101在中國獲突破性治療認定用於治療結直腸癌
格隆匯6月2日丨石藥集團(01093.HK)公告，集團開發的JMT101獲中國國家藥品監督管理局藥品審評中心授予突破性治療認定，擬定適應症爲聯合伊立替康用於治療二線或以上標準治療失敗的RAS、RAF、EGFRECD和PIK3CA 20外顯子均野生型晚期結直腸癌。
結直腸癌是全球第三大常見癌症。2022年中國結直腸癌新發病和死亡病例數分別爲51.7萬例和24萬例，分別位於惡性腫瘤新發病例數和死亡病例數的第2位和第4位。對於經二線或以上標準治療失敗的晚期結直腸癌患者，當前標準治療方案的客觀緩解率(ORR)低（≤5%），中位無進展生存期(mPFS)短（約3個月），存在着巨大的未滿足的臨牀需求。
JMT101是一種具有全新分子結構的重組人源化抗表皮生長因子受體（EGFR）IgG1亞型單克隆抗體注射液，具備抗體依賴的細胞介導的細胞毒作用(ADCC)和補體依賴的細胞毒作用(CDC)。JMT101具有明顯高於同類產品的靶點親和力，並能顯著降低免疫原性和輸液反應。JMT101聯合伊立替康在二線標準治療失敗的晚期結直腸癌的隨機、對照、開放標籤、Ⅱ期研究結果顯示，JMT101聯合伊立替康組的ORR、疾病控制率(DCR)和mPFS均明顯優於對照組。其中，JMT101聯合伊立替康組的mPFS爲7.4個月，遠高於對照組的2.9個月。JMT101聯合伊立替康在既往EGFR經治和未經治人羣中均觀察到良好的獲益。該研究結果在2025年美國臨牀腫瘤學(ASCO)年會上以口頭報告形式披露。
JMT101聯合伊立替康在該適應症的臨牀研究已初步顯示出突破性療效，且安全性良好，與現有治療手段相比展現出顯著的臨牀優勢，未來有望成爲結直腸癌後線的標準治療方案。目前，集團已推進JMT101聯合伊立替康在該適應症的關鍵III期臨牀試驗。此外，JMT101亦正在中國開展用於治療一線和二線及以上肺癌、鼻咽癌、頭頸鱗癌等實體瘤的多項II期及III期臨牀研究。基於JMT101良好的療效和安全性數據，本次獲授予的突破性治療認定將有助於進一步加快其研發進程。
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