亞盛醫藥-B(06855.HK)耐立克藥物獲國家藥監局藥品審評中心臨床試驗許可
亞盛醫藥-B(06855.HK)公布,其核心品種奧雷巴替尼(商品名:耐立克)獲得國家藥監局(NMPA)藥品審評中心(CDE)臨床試驗許可,將開展聯合化療對比伊馬替尼聯合化療治療新診斷費城染色體陽性急性淋巴細胞白血病(Ph+ ALL)的患者的關鍵註冊性III期臨床研究,意味著耐立克有望成為內地首個用於一線治療Ph+ ALL的靶向藥物酪氨酸激(酉每)抑制劑(TKI)藥物。
耐立克是亞盛醫藥原創1類新藥,為口服第三代TKI,是中國首個且唯一獲批上市的第三代BCR-ABL抑制劑。
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