貝達藥業(300558.SZ):貝伐珠單抗注射液(MIL60)上市許可申請獲得受理
格隆匯6月14日丨貝達藥業(300558.SZ)公佈,近日,公司收到國家藥品監督管理局籤發的《受理通知書》(受理號:CXSS2000027),公司申報的貝伐珠單抗注射液(“MIL60”,Avastin®的生物類似藥)用於晚期、轉移性或複發性非小細胞肺癌和轉移性結直腸癌患者治療的上市許可申請已獲得國家藥品監督管理局受理。
MIL60是重組抗人血管內皮生長因子人源化單克隆抗體,屬於Avastin®的生物類似藥,該藥物可以選擇性地與人血管內皮生長因子(VEGF)結合並阻斷其生物活性,包含人類抗體的框架區以及可結合VEGF的人源化鼠抗體的抗原結合區,可抑制VEGF與其位於內皮細胞上的受體Flt-1和KDR相結合,通過使VEGF失去生物活性而減少腫瘤的血管形成,從而抑制了腫瘤的生長。
截至公告日,有兩款貝伐珠單抗注射液在中國境內上市,一是由Roche Pharma (Schweiz) Ltd.(即瑞士羅氏公司)研製的貝伐珠單抗原研藥(商品名:Avastin®),用於晚期、轉移性或複發性非小細胞肺癌和轉移性結直腸癌患者的治療;一是由齊魯製藥有限公司研製的國內獲批的首個貝伐珠單抗生物類似藥(商品名:安可達),其於2019年12月獲批。除前述已上市的Avastin®和安可達外,還有信達生物、山東綠葉、江蘇恆瑞已先後提交了相關藥品註冊申請,目前均處於在審狀態。
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