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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL2400547 重组全人源抗PCSK9单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2024-08-17 view
CXSB2300075 重组全人源抗PCSK9单克隆抗体注射液 Injection Biological Products(原1) Supplementary Application 2023-07-19 view
CXSL1900102 重组全人源抗PCSK9单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2019-09-10 信立泰(成都)生物技术有限公司 Chengdu Jinkai Biotech Co Ltd In Review 2019-09-09 view
CXSL2000019 重组全人源抗PCSK9单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2020-02-14 天士力生物医药股份有限公司 Shanghai Tasly Pharmaceutical Co Ltd In Review 2020-02-13 view