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神州細胞(688520.SH):子公司產品阿達木單抗注射液藥品註冊申請獲得受理
格隆匯 12-15 18:25

格隆匯12月15日丨神州細胞(688520.SH)公佈,近日,公司控股子公司神州細胞工程有限公司(“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阿達木單抗注射液(產品代號:SCT630)境內生產藥品註冊上市許可申請的《受理通知書》。

SCT630產品為公司自主研發的阿達木單抗生物類似藥,擬用於治療銀屑病、類風濕關節炎及強直性脊柱炎等免疫系統疾病。TNF-α是一種導致多種自身免疫性疾病的炎症因子。過度表達的TNF-α通過降低調節性T細胞的功能使得免疫系統過度活化因而攻擊宿主正常組織。

SCT630是一種重組全人源抗TNF-α的IgG1單克隆抗體,通過與TNF-α的特異性結合,抑制TNF-α的生物活性以達到有效減輕炎症的治療效果。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SCT630的試生產。

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