亞盛醫藥-B(06855.HK)：原創1類新藥奧雷巴替尼片正式獲中國國家藥品監督管理局(NMPA)上市批准
格隆匯11月25日丨亞盛醫藥-B(06855.HK)公吿，公司全資子公司廣州順健生物醫藥科技有限公司的原創1類新藥奧雷巴替尼片(商品名：耐立克®)正式獲得中國國家藥品監督管理局(NMPA)的上市批准，用於治療任何酪氨酸激酶抑制劑(TKI)耐藥，並採用經充分驗證的檢測方法診斷為伴有T315I突變的慢性髓細胞白血病(CML)慢性期(CP)或加速期(AP)的成年患者。
耐立克®是亞盛醫藥研發的潛在同類最佳(Best-in-class)新藥，為國家"重大新藥創制"專項支持品種。該品種將由亞盛醫藥與信達生物製藥("信達生物")共同在中國開展商業化推廣，以惠及更多患者及其家庭。作為中國首個三代BCRABL靶向耐藥CML治療藥物，耐立克®的獲批將打破中國攜T315I突變耐藥患者的治療瓶頸，解決無藥可醫的困境。其獲批也標誌着亞盛醫藥正式步入商業化階段。
耐立克®獲批主要基於兩項關鍵性註冊II期臨牀研究數據，分別為HQP1351CC201研究、HQP1351CC202研究。臨牀數據顯示耐立克在伴有T315I突變的TKI耐藥的CML-CP及CML-AP患者中均具有良好的療效及耐受性，且隨着治療時間的延長，緩解率和緩解深度會進一步增加。
CML是一種與白細胞有關的惡性腫瘤。隨着靶向BCR-ABL的TKI藥物上市，針對CML的治療方式得以革新，但獲得性耐藥一直是CML治療的主要挑戰。BCRABL激酶區突變是獲得性耐藥的重要機制之一，其中T315I突變是常見的耐藥突變類型之一，在耐藥CML中的發生率高達25%左右。伴有T315I突變的CML患者對目前所有一代、二代BCR-ABL抑制劑均耐藥，因此在過去一直面臨無藥可醫的窘境。
根據2021年7月14日公司與信達生物製藥集團(1801.HK)達成的合作及授權協議，公司將與信達生物共同負責耐立克在中國市場的商業化推廣。雙方將基於各自在臨牀開發、市場覆蓋、渠道拓展等領域的優勢資源，合力打造有經驗及專注於血液腫瘤的商業團隊，助力耐立克®上市後快速完成在各級醫院和藥房的多層次覆蓋，儘早造福更多的中國患者。
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