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神州細胞(688520.SH):神州細胞工程的貝伐珠單抗注射液註冊申請獲得受理
格隆匯 04-21 17:43

格隆匯4月21日丨神州細胞(688520.SH)公佈,近日,北京神州細胞生物技術集團股份公司控股子公司神州細胞工程有限公司(簡稱“神州細胞工程”)收到國家藥品監督管理局下發的關於公司在研產品貝伐珠單抗注射液(產品代號:SCT510)境內生產藥品註冊上市許可申請的《受理通知書》。

SCT510產品為公司自主研發的重組人源化抗VEGF單克隆抗體注射液,是貝伐珠單抗(安維汀®)的生物類似藥,本次申報的適應症包括轉移性結直腸癌、非鱗狀非小細胞肺癌、複發性膠質母細胞瘤、肝細胞癌、上皮性卵巢癌、輸卵管癌或原發性腹膜癌、宮頸癌。靶向特異的VEGF抗體藥物可以通過阻斷遊離態VEGF與VEGF受體(VEGFRs)結合降低腫瘤內部新生血管生成,從而致使腫瘤組織喪失供應生存和增生所需營養環境,提高腫瘤免疫激活環境。公司擁有完善的生物藥生產技術平台,已在商業化規模的生產線成功完成SCT510的試生產。

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