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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSS2100030 替雷利珠单抗注射液 tislelizumab Injection Biological Products(2.2) New Drug Application 2021-03-05 百济神州(上海)生物科技有限公司,勃林格殷格翰生物药业(中国)有限公司 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd;Boehringer Ingelheim Biopharmaceuticals (China) Ltd Certificate Issued 2022-01-07 view
CXSL2100061 替雷利珠单抗注射液 tislelizumab Injection Biological Products(2.2) New Drug Application 2021-02-22 百济神州(上海)生物科技有限公司 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd In Review 2021-02-22 view
CXSL2100053 替雷利珠单抗注射液 tislelizumab Injection Biological Products(2.2) New Drug Application 2021-02-09 百济神州(上海)生物科技有限公司 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd In Review 2021-02-09 view
CXSL2100051 替雷利珠单抗注射液 tislelizumab Injection Biological Products(2.2) New Drug Application 2021-02-09 百济神州(上海)生物科技有限公司 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd In Review 2021-02-08 view
CXSS2000014 替雷利珠单抗注射液 tislelizumab Injection Biological Products(1) New Drug Application 2020-04-23 勃林格殷格翰生物药业(中国)有限公司 Boehringer Ingelheim Biopharmaceuticals (China) Ltd;Baiji Shenzhou (Shanghai) Biotechnology Co Ltd Certificate Issued 2021-01-21 view
CYSB2000288 替雷利珠单抗注射液 tislelizumab Injection Biological Products(1) Supplementary Application 2020-11-14 百济神州(上海)生物科技有限公司 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd;Boehringer Ingelheim Biopharmaceuticals (China) Ltd Certificate Issued 2021-01-21 view
CXSB2100007 替雷利珠单抗注射液 tislelizumab Injection Biological Products Supplementary Application 2021-01-19 百济神州(上海)生物科技有限公司 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd In Review 2021-01-19 view
CXSL2100004 替雷利珠单抗注射液 tislelizumab Injection Biological Products(2.2) New Drug Application 2021-01-06 百济神州(上海)生物科技有限公司 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd In Review 2021-01-06 view
CYSB2000223 替雷利珠单抗注射液 tislelizumab Injection Biological Products(1) Supplementary Application 2020-09-30 百济神州(上海)生物科技有限公司 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd;BeiGene Guangzhou Biologics Manufacturing Co Ltd In Review 2020-09-30 view
CXSB2000052 替雷利珠单抗注射液 tislelizumab Injection Biological Products(1) Supplementary Application 2020-09-12 百济神州(上海)生物科技有限公司 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd In Review 2020-09-30 view
CXSB2000024 替雷利珠单抗注射液 tislelizumab Injection Biological Products Supplementary Application 2020-06-30 百济神州(上海)生物科技有限公司 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd In Review 2020-06-29 view
CXSS2000033 替雷利珠单抗注射液 tislelizumab Injection Biological Products(1) New Drug Application 2020-06-29 勃林格殷格翰生物药业(中国)有限公司 Boehringer Ingelheim Biopharmaceuticals (China) Ltd;Baiji Shenzhou (Shanghai) Biotechnology Co Ltd In Review 2020-06-28 view
CXSS2000032 替雷利珠单抗注射液 tislelizumab Injection Biological Products(1) New Drug Application 2020-06-24 勃林格殷格翰生物药业(中国)有限公司 Boehringer Ingelheim Biopharmaceuticals (China) Ltd;Baiji Shenzhou (Shanghai) Biotechnology Co Ltd In Review 2020-06-23 view
CXSB2000018 替雷利珠单抗注射液 tislelizumab Injection Biological Products Supplementary Application 2020-06-13 百济神州(上海)生物科技有限公司 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd In Review 2020-06-12 view
CXSB2000014 替雷利珠单抗注射液 tislelizumab Injection Biological Products Supplementary Application 2020-05-19 百济神州(上海)生物科技有限公司 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd In Review 2020-05-18 view
CXSB2000015 替雷利珠单抗注射液 tislelizumab Injection Biological Products Supplementary Application 2020-05-19 百济神州(上海)生物科技有限公司 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd In Review 2020-05-18 view
CXSB2000008 替雷利珠单抗注射液 tislelizumab Injection Biological Products Supplementary Application 2020-04-22 百济神州(上海)生物科技有限公司 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd In Review 2020-04-21 view
CXSS1900025 替雷利珠单抗注射液 tislelizumab Injection Biological Products(1) New Drug Application 2019-06-03 勃林格殷格翰生物药业(中国)有限公司 Boehringer Ingelheim Biopharmaceuticals (China) Ltd;Baiji Shenzhou (Shanghai) Biotechnology Co Ltd Certificate Issued 2020-04-14 view
CXSS1800019 替雷利珠单抗注射液 tislelizumab Injection Biological Products(1) New Drug Application 2018-09-06 勃林格殷格翰生物药业(中国)有限公司 Boehringer Ingelheim Biopharmaceuticals (China) Ltd;Baiji Shenzhou (Shanghai) Biotechnology Co Ltd Certificate Issued 2020-01-06 view
CXSL1900146 替雷利珠单抗注射液 tislelizumab Injection Biological Products(1) New Drug Application 2019-12-21 百济神州(上海)生物科技有限公司 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd In Review 2019-12-19 view