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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
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
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
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
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
CXSB2300125 替雷利珠单抗注射液 tislelizumab Injection Biological Products(2.2) Supplementary Application 2023-11-09 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
CXSB2200049 替雷利珠单抗注射液 tislelizumab Injection Biological Products(2.2) Supplementary Application 2022-06-08 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd view
CYSB2400327 替雷利珠单抗注射液 tislelizumab Injection Biological Products(1) Supplementary Application 2024-12-14 BeiGene Guangzhou Biologics Manufacturing Co Ltd;Boehringer Ingelheim Biopharmaceuticals (China) Ltd view
CXSL2200599 替雷利珠单抗注射液 tislelizumab Injection Biological Products(2.2) New Drug Application 2022-12-10 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd view
CXSL2200566 替雷利珠单抗注射液 tislelizumab Injection Biological Products(2.2) New Drug Application 2022-11-09 Baiji Shenzhou (Shanghai) Biotechnology Co Ltd view