貝達藥業(300558.SZ)：甲磺酸貝福替尼膠囊藥品註冊申請獲受理
格隆匯 3 月 3日丨貝達藥業(300558.SZ)公佈，今日，公司收到國家藥品監督管理局簽發的《受理通知書》(受理號：CXHS2100008國、CXHS2100009國)，公司申報的甲磺酸貝福替尼(BPI-D0316)膠囊擬用於既往使用EGFR-TKI耐藥後產生T790M突變的局部晚期或轉移性非小細胞肺癌治療的上市許可申請已獲得國家藥品監督管理局受理。
甲磺酸貝福替尼膠囊是一種第三代EGFR-TKI，含有新的結構明確的、具有藥理作用的化合物，屬於“境內外均未上市的創新藥”，其註冊分類為化學藥品1類。
2018年12月，貝達藥業與益方生物科技(上海)股份公司達成合作，共同擁有BPI-D0316在中國大陸、香港和台灣地區(“合作區域”)的知識產權，並獨家擁有在合作區域研發、製造和商業化BPI-D0316的權利。貝達藥業還可以分享BPI-D0316合作區域外銷售的一定比例的經濟權利。
甲磺酸貝福替尼膠囊有望用於治療具有T790M突變及其他突變的EGFR陽性肺癌患者，其最新臨牀數據詳見公司於2021年2月8日披露的《關於BPI-D0316膠囊取得藥品註冊Ⅱ期臨牀試驗總結報吿的提示性公吿》(公吿編號：2021-021)。截至公吿日，已有兩款三代EGFR-TKI在中國獲批上市，分別是阿斯利康的泰瑞沙(一線、二線)和豪森藥業的阿美樂(二線)。
甲磺酸貝福替尼膠囊是公司在EGFR陽性非小細胞肺癌(NSCLC)治療板塊的重要佈局。在中國，NSCLC患者的EGFR突變比例高達39.8%，而耐藥性已經成為EGFR-TKI面臨的主要問題，超過半數的EGFR突變NSCLC患者在接受第一或第二代EGFR-TKI治療後發生了T790M突變，15%的EGFR突變NSCLC患者在接受第三代EGFR-TKI治療後發生C797S突變。甲磺酸貝福替尼膠囊將有望與已上市的鹽酸埃克替尼片(第一代EGFR-TKI)、在研的BPI-361175(第四代EGFR-TKI)、在研的MCLA-129(EGFR/c-Met雙特異性抗體)、在研的BPI-21668(PI3Kα抑制劑)組合發力，共同解決EGFR靶點耐藥難題，延長患者的總體生存期。
此次藥品註冊申請依據是“BPI-D0316膠囊在EGFR突變局部晚期或轉移性非小細胞肺癌患者中的II期臨牀試驗”。除前述Ⅱ期研究外，公司就甲磺酸貝福替尼開展了多項臨牀研究，其中“D-0316在既往未經治療的EGFR敏感突變局部晚期或轉移性非小細胞肺癌患者中的II/III期臨牀試驗”(一線治療)目前已經完成入組。
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