奧賽康(002755.SZ):賽瑞替尼膠囊新藥上市申請獲受理
格隆匯 2 月 25日丨奧賽康(002755.SZ)公佈,公司的全資子公司江蘇奧賽康藥業有限公司(“子公司”)於近日收到國家藥品監督管理局(“藥監局”)下發的賽瑞替尼膠囊新藥上市申請《受理通知書》。
塞瑞替尼為ALK、胰島素樣生長因子1受體(IGF-1R)、胰島素受體(InsR)和ROS1等多靶點激酶抑制劑,由諾華製藥公司研發。塞瑞替尼膠囊於2014年首次在美國上市,隨後分別在英國、日本和歐盟上市。2018年,塞瑞替尼膠囊進口獲NMPA批准,本品適用於間變性淋巴瘤激酶(ALK)陽性的局部晚期或轉移性非小細胞肺癌(NSCLC)患者的治療。奧賽康是首家完成生物等效性試驗提交生產註冊申請的企業。
NSCLC是最常見形式的肺癌,約佔肺癌總量的80~85%,ALK基因有突變的病例佔NSCLC病例的2~7%。一代ALK靶向藥物克唑替尼治療後通常會出現疾病進展,臨牀急需新的治療藥物。塞瑞替尼是新型、強效、高選擇性的二代ALK抑制劑,可透過血腦屏障,不僅能夠治療克唑替尼耐藥的NSCLC患者,而且對30~50%的腦轉移患者也能發揮顯著的療效。米內網數據顯示2019年中國公立醫療機構終端銷售額為1.93億元,同比增長844.78%。
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