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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 Shenzhen Salubris Pharmaceuticals Co Ltd;Chengdu Jinkai Biotech Co Ltd;Suzhou Genemen Biotech Co Ltd 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 Shenzhen Salubris Pharmaceuticals Co Ltd;Chengdu Jinkai Biotech Co Ltd;Suzhou Genemen Biotech Co Ltd view
CXSS2300022 重组人源化抗PCSK9单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2023-04-26 Shanghai Jun Shi Biological Engineering Technology Co Ltd;Shanghai Junshi Biosciences Co Ltd view
CXSS2300024 重组人源化抗PCSK9单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2023-04-26 Shanghai Jun Shi Biological Engineering Technology Co Ltd;Shanghai Junshi Biosciences Co Ltd view
CXSS2300025 重组人源化抗PCSK9单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2023-04-26 Shanghai Jun Shi Biological Engineering Technology Co Ltd;Shanghai Junshi Biosciences Co Ltd view
CXSS2300023 重组人源化抗PCSK9单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2023-04-26 Shanghai Jun Shi Biological Engineering Technology Co Ltd;Shanghai Junshi Biosciences Co Ltd view
CXSB2101031 重组人源化抗PCSK9单克隆抗体注射液 Injection Biological Products(1) Supplementary Application 2021-08-10 Shanghai Jun Shi Biological Engineering Technology Co Ltd;Shanghai Junshi Biosciences Co Ltd view
CXSL2101227 重组人源化抗PCSK9单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2021-08-03 Shanghai Junshi Biosciences Co Ltd view
CXSB2000049 重组人源化抗PCSK9单克隆抗体注射液 Injection Biological Products(1) Supplementary Application 2020-09-05 上海君实生物医药科技股份有限公司 Shanghai Junshi Biosciences Co Ltd;Shanghai Jun Shi Biological Engineering Technology Co Ltd In Review 2020-09-04 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
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;Shenzhen Salubris Pharmaceuticals Co Ltd;Suzhou Genemen Biotech Co Ltd In Review 2019-09-09 view
CXSL1600050 重组人源化抗PCSK9单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2016-08-29 上海君实生物医药科技股份有限公司 Shanghai Junshi Biosciences Co Ltd Certificate Issued 2017-07-06 view