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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
CXSL2300534 替雷利珠单抗注射液(皮下注射) tislelizumab Injection Biological Products(2.1) New Drug Application 2023-08-02 BeiGene Guangzhou Biologics Manufacturing Co Ltd view
CXSB2101058 替雷利珠单抗注射液 tislelizumab Injection Biological Products(2.2) Supplementary Application 2021-11-10 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd view
CXSS2400013 替雷利珠单抗注射液 tislelizumab Injection Biological Products(2.2) New Drug Application 2024-01-19 BeiGene Guangzhou Biologics Manufacturing Co Ltd;Boehringer Ingelheim Biopharmaceuticals (China) Ltd view
CXSL2101047 替雷利珠单抗注射液 tislelizumab Injection Biological Products(2.2) New Drug Application 2021-04-28 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd view
CXSS2200095 替雷利珠单抗注射液 tislelizumab Injection Biological Products(2.2) New Drug Application 2022-12-31 BeiGene Guangzhou Biologics Manufacturing Co Ltd;Boehringer Ingelheim Biopharmaceuticals (China) Ltd view
CXSB2200084 替雷利珠单抗注射液 tislelizumab Injection Biological Products Supplementary Application 2022-10-26 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd;Boehringer Ingelheim Biopharmaceuticals (China) Ltd view
CYSB2400312 替雷利珠单抗注射液 tislelizumab Injection Biological Products(1) Supplementary Application 2024-12-04 BeiGene Guangzhou Biologics Manufacturing Co Ltd;Boehringer Ingelheim Biopharmaceuticals (China) Ltd view
CXSS2200075 替雷利珠单抗注射液 tislelizumab Injection Biological Products(2.2) New Drug Application 2022-08-23 BeiGene Guangzhou Biologics Manufacturing Co Ltd;Boehringer Ingelheim Biopharmaceuticals (China) Ltd view
CYSB2200094 替雷利珠单抗注射液 tislelizumab Injection Biological Products Supplementary Application 2022-03-21 BeiGene Guangzhou Biologics Manufacturing Co Ltd;Baiji Shenzhou (Shanghai) Biotechnology Co Ltd;Boehringer Ingelheim Biopharmaceuticals (China) Ltd view
CXSS2101021 替雷利珠单抗注射液 tislelizumab Injection Biological Products(2.2) New Drug Application 2021-08-20 BeiGene Guangzhou Biologics Manufacturing Co Ltd;Baiji Shenzhou (Shanghai) Biotechnology Co Ltd view
CXSB2300077 替雷利珠单抗注射液 tislelizumab Injection Biological Products(2.2) Supplementary Application 2023-08-01 Baiji Shenzhou (Shanghai) Biotechnology 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
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
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
CXSB2200046 替雷利珠单抗注射液 tislelizumab Injection Biological Products(2.2) Supplementary Application 2022-05-24 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd view
CYSB2400264 替雷利珠单抗注射液 tislelizumab Injection Biological Products(1) Supplementary Application 2024-09-29 BeiGene Guangzhou Biologics Manufacturing Co Ltd;Boehringer Ingelheim Biopharmaceuticals (China) Ltd view
CXSL2200360 替雷利珠单抗注射液 tislelizumab Injection Biological Products(2.2) New Drug Application 2022-08-05 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd view
CYSB2200290 替雷利珠单抗注射液 tislelizumab Injection Biological Products(1) Supplementary Application 2022-12-27 BeiGene Guangzhou Biologics Manufacturing Co Ltd;Boehringer Ingelheim Biopharmaceuticals (China) Ltd view