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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
CXSL1800094 特瑞普利单抗注射液 toripalimab Injection Biological Products(1) New Drug Application 2018-09-13 上海君实生物医药科技股份有限公司 Shanghai Junshi Biosciences Co Ltd In Review 2018-09-12 view
CXSL1900061 重组人源化抗IL-17A单克隆抗体注射液 recombinant humanized anti-IL17A monoclonal antibody Injection Biological Products(1) New Drug Application 2019-06-27 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;Suzhou Junmeng Biopharm Co Ltd;Suzhou UNION Biopharm Biosciences Co Ltd In Review 2019-06-26 view
CXSL1900129 重组人源化抗BTLA单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2019-11-13 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;Suzhou Junmeng Biopharm Co Ltd;Suzhou UNION Biopharm Biosciences Co Ltd In Review 2019-11-12 view
CXSB2000037 特瑞普利单抗注射液 toripalimab Injection Biological Products(1) Supplementary Application 2020-07-30 上海君实生物医药科技股份有限公司 Shanghai Junshi Biosciences Co Ltd;Suzhou UNION Biopharm Biosciences Co Ltd Certificate Issued 2020-10-27 view
CXSL2000219 特瑞普利单抗注射液 toripalimab Injection Biological Products(2.2) New Drug Application 2020-07-31 上海君实生物医药科技股份有限公司 Shanghai Junshi Biosciences Co Ltd In Review 2020-07-30 view
CXSL2000218 特瑞普利单抗注射液 toripalimab Injection Biological Products(2.2) New Drug Application 2020-07-31 上海君实生物医药科技股份有限公司 Shanghai Junshi Biosciences Co Ltd In Review 2020-07-30 view
CXSL2000227 特瑞普利单抗注射液 toripalimab Injection Biological Products(2.2) New Drug Application 2020-08-08 上海君实生物医药科技股份有限公司 Shanghai Junshi Biosciences Co Ltd In Review 2020-08-06 view
CXSL2000228 特瑞普利单抗注射液 toripalimab Injection Biological Products(2.2) New Drug Application 2020-08-08 上海君实生物医药科技股份有限公司 Shanghai Junshi Biosciences Co Ltd In Review 2020-08-06 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
CXSL2000259 特瑞普利单抗注射液 toripalimab Injection Biological Products(2.2) New Drug Application 2020-09-10 上海君实生物医药科技股份有限公司 Shanghai Junshi Biosciences Co Ltd In Review 2020-09-09 view
CXSL2000260 特瑞普利单抗注射液 toripalimab Injection Biological Products(2.2) New Drug Application 2020-09-10 上海君实生物医药科技股份有限公司 Shanghai Junshi Biosciences Co Ltd In Review 2020-09-09 view
CXSL2000303 特瑞普利单抗注射液 toripalimab Injection Biological Products(2.2) New Drug Application 2020-10-27 上海君实生物医药科技股份有限公司 Shanghai Junshi Biosciences Co Ltd In Review 2020-10-26 view
CXSL2000302 特瑞普利单抗注射液 toripalimab Injection Biological Products(2.2) New Drug Application 2020-10-27 上海君实生物医药科技股份有限公司 Shanghai Junshi Biosciences Co Ltd In Review 2020-10-26 view
CXSL2000308 特瑞普利单抗注射液 toripalimab Injection Biological Products(2.2) New Drug Application 2020-10-29 上海君实生物医药科技股份有限公司 Shanghai Junshi Biosciences Co Ltd In Review 2020-10-28 view
CXSL2000307 特瑞普利单抗注射液 toripalimab Injection Biological Products(2.2) New Drug Application 2020-10-29 上海君实生物医药科技股份有限公司 Shanghai Junshi Biosciences Co Ltd In Review 2020-10-28 view
CXSL2000317 特瑞普利单抗注射液 toripalimab Injection Biological Products(2.2) New Drug Application 2020-11-10 上海君实生物医药科技股份有限公司 Shanghai Junshi Biosciences Co Ltd In Review 2020-11-09 view
CXSL2000318 特瑞普利单抗注射液 toripalimab Injection Biological Products(2.2) New Drug Application 2020-11-10 上海君实生物医药科技股份有限公司 Shanghai Junshi Biosciences Co Ltd In Review 2020-11-09 view
CXSL2000331 JS006注射液 JS006 Injection Biological Products(1) New Drug Application 2020-11-25 上海君实生物医药科技股份有限公司 Shanghai Junshi Biosciences Co Ltd In Review 2020-11-24 view
CXSL2000337 特瑞普利单抗注射液 toripalimab Injection Biological Products(2.2) New Drug Application 2020-12-03 上海君实生物医药科技股份有限公司 Shanghai Junshi Biosciences Co Ltd In Review 2020-12-02 view