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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL2400677 CFT8919胶囊 CFT-8919 Capsule Chemical Drugs(1) New Drug Application 2024-07-10 Betta Pharmaceuticals Co Ltd view
CYHB2101570 盐酸恩沙替尼胶囊 Ensartinib Hydrochloride Capsule Chemical Drugs(1) Supplementary Application 2021-07-13 Betta Pharmaceuticals Co Ltd view
JXSL2101030 泽弗利单抗注射液 zalifrelimab Injection Biological Products(1) Import Drug Application 2021-05-20 Betta Pharmaceuticals Co Ltd view
CXHS2300016 甲磺酸贝福替尼胶囊 Befotertinib Mesylate Capsule Chemical Drugs(1) New Drug Application 2023-01-20 Betta Pharmaceuticals Co Ltd view
CXHL2200896 甲磺酸贝福替尼胶囊 Befotertinib Mesylate Capsule Chemical Drugs(1) New Drug Application 2022-11-15 Betta Pharmaceuticals Co Ltd view
CXSL2300322 注射用MCLA-129 MCLA-129 Lyophilized Biological Products(1) New Drug Application 2023-05-09 Betta Pharmaceuticals Co Ltd view
CXHL2500646 盐酸恩沙替尼胶囊 Ensartinib Hydrochloride Capsule Chemical Drugs(2.4) New Drug Application 2025-07-05 Betta Pharmaceuticals Co Ltd view
CXHL2200061 盐酸恩沙替尼胶囊 Ensartinib Hydrochloride Capsule Chemical Drugs(2.4) New Drug Application 2022-01-28 Betta Pharmaceuticals Co Ltd view
CXHL2400011 BPI-520105片 BPI-520105 Tablet Chemical Drugs(1) New Drug Application 2024-01-05 Betta Pharmaceuticals Co Ltd view
CXSB2200001 注射用MCLA-129 MCLA-129 Lyophilized Biological Products(1) Supplementary Application 2022-01-07 Betta Pharmaceuticals Co Ltd view
CXHL2400676 CFT8919胶囊 CFT-8919 Capsule Chemical Drugs(1) New Drug Application 2024-07-10 Betta Pharmaceuticals Co Ltd view
CXHL2101018 BPI-16350 胶囊 BPI-16350 Capsule Chemical Drugs(1) New Drug Application 2021-04-07 Betta Pharmaceuticals Co Ltd view
CXHL2200963 BPI-472372片 BPI-472372 Tablet Chemical Drugs(1) New Drug Application 2022-12-29 Betta Pharmaceuticals Co Ltd view
CXHL2200865 BPI-452080 片 BPI-452080 Tablet Chemical Drugs(1) New Drug Application 2022-11-03 Betta Pharmaceuticals Co Ltd view
CXHL2300494 甲磺酸贝福替尼胶囊 Befotertinib Mesylate Capsule Chemical Drugs(1) New Drug Application 2023-05-09 Betta Pharmaceuticals Co Ltd view
CXHL2401263 BPI-452080片 BPI-452080 Tablet Chemical Drugs(1) New Drug Application 2024-11-21 Betta Pharmaceuticals Co Ltd view
CXHL2101019 BPI-16350 胶囊 BPI-16350 Capsule Chemical Drugs(1) New Drug Application 2021-04-07 Betta Pharmaceuticals Co Ltd view
CXHL2400014 BPI-221351片 BPI-221351 Tablet Chemical Drugs(1) New Drug Application 2024-01-05 Betta Pharmaceuticals Co Ltd view
CXHS2101028 盐酸恩沙替尼胶囊 Ensartinib Hydrochloride Capsule Chemical Drugs(2.4) New Drug Application 2021-07-13 Betta Pharmaceuticals Co Ltd view
CXHL2101668 BPI-442096片 BPI-442096 Tablet Chemical Drugs(1) New Drug Application 2021-11-19 Betta Pharmaceuticals Co Ltd view