貝達藥業(300558.SZ):貝伐珠單抗注射液新增適應症獲NMPA批准
格隆匯3月4日丨貝達藥業(300558.SZ)公佈,公司收到國家藥品監督管理局(以下簡稱“NMPA”)簽發的《藥品補充申請批准通知書》,公司申報的貝伐珠單抗注射液擬新增用於複發性膠質母細胞瘤、上皮性卵巢癌、輸卵管癌或原發性腹膜癌、宮頸癌等患者治療的適應症已獲得NMPA批准。
該藥是重組抗人血管內皮生長因子人源化單克隆抗體,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。
該藥屬於安維汀®的生物類似藥,遵循生物類似藥嚴謹的研發途徑,其不僅通過了全面的質量相似性研究、非臨牀相似性研究,而且在臨牀比對試驗中表現出與安維汀®在PK特徵、臨牀有效性、安全性和免疫原性方面的高度相似。
截至本公吿披露日,除該藥外,國內獲批上市的貝伐珠單抗注射液共計8個。
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