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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
CYSB2300230 替雷利珠单抗注射液 tislelizumab Injection Biological Products(1) Supplementary Application 2023-12-09 BeiGene Guangzhou Biologics Manufacturing Co Ltd;Boehringer Ingelheim Biopharmaceuticals (China) Ltd view
CYSB2200110 替雷利珠单抗注射液 tislelizumab Injection Biological Products(1) Supplementary Application 2022-04-27 BeiGene Guangzhou Biologics Manufacturing Co Ltd;Boehringer Ingelheim Biopharmaceuticals (China) Ltd view
CXSB2200007 替雷利珠单抗注射液 tislelizumab Injection Biological Products Supplementary Application 2022-01-21 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd 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
CYSB2400335 替雷利珠单抗注射液 tislelizumab Injection Biological Products(1) Supplementary Application 2025-01-01 BeiGene Guangzhou Biologics Manufacturing Co Ltd;Boehringer Ingelheim Biopharmaceuticals (China) Ltd view
CXSB2200104 替雷利珠单抗注射液 tislelizumab Injection Biological Products Supplementary Application 2022-12-10 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd;Boehringer Ingelheim Biopharmaceuticals (China) Ltd view
CXSL2101060 替雷利珠单抗注射液 tislelizumab Injection Biological Products(2.2) New Drug Application 2021-05-11 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd 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
CYSB2101060 替雷利珠单抗注射液 tislelizumab Injection Biological Products(2.2) Supplementary Application 2021-05-21 BeiGene Guangzhou Biologics Manufacturing Co Ltd;Baiji Shenzhou (Shanghai) Biotechnology Co Ltd view
CXSL2101005 替雷利珠单抗注射液 tislelizumab Injection Biological Products(2.2) New Drug Application 2021-03-18 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd view
CXSB1900020 替雷利珠单抗注射液 tislelizumab Injection Biological Products Supplementary Application 2019-08-28 百济神州(上海)生物科技有限公司 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd In Review 2019-08-27 view
CYSB2400093 替雷利珠单抗注射液 tislelizumab Injection Biological Products(1) Supplementary Application 2024-04-19 BeiGene Guangzhou Biologics Manufacturing Co Ltd;Boehringer Ingelheim Biopharmaceuticals (China) Ltd view
CXSL2200060 替雷利珠单抗注射液 tislelizumab Injection Biological Products(2.2) New Drug Application 2022-01-29 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd view
CXSL2101123 替雷利珠单抗注射液 tislelizumab Injection Biological Products(2.2) New Drug Application 2021-06-08 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd 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
CXSL2300042 替雷利珠单抗注射液 tislelizumab Injection Biological Products(2.2) New Drug Application 2023-01-17 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd view
CXSL2101131 替雷利珠单抗注射液 tislelizumab Injection Biological Products(2.2) New Drug Application 2021-06-11 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd 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
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