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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL2400603 注射用MCLA-129 MCLA-129 Lyophilized Biological Products(1) New Drug Application 2024-09-11 Betta Pharmaceuticals Co Ltd view
CXHB2101064 BPI-421286胶囊 BPI-421286 Capsule Chemical Drugs(1) Supplementary Application 2021-07-06 Betta Pharmaceuticals Co Ltd view
CXHL2101650 BPI-371153胶囊 BPI-371153 Capsule Chemical Drugs(1) New Drug Application 2021-11-12 Betta Pharmaceuticals Co Ltd view
CXHS2300015 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
CXHL2101019 BPI-16350 胶囊 BPI-16350 Capsule Chemical Drugs(1) New Drug Application 2021-04-07 Betta Pharmaceuticals Co Ltd view
CXHL2200864 BPI-452080 片 BPI-452080 Tablet Chemical Drugs(1) New Drug Application 2022-11-03 Betta Pharmaceuticals Co Ltd view
CXHL2300495 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
CXHL2400013 BPI-221351片 BPI-221351 Tablet Chemical Drugs(1) New Drug Application 2024-01-05 Betta Pharmaceuticals Co Ltd view
CXHL2200060 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
CXHL2400677 CFT8919胶囊 CFT-8919 Capsule Chemical Drugs(1) New Drug Application 2024-07-10 Betta Pharmaceuticals Co Ltd view
CXHL2101238 BPI-23314片 BPI-23314 Tablet Chemical Drugs(1) New Drug Application 2021-06-28 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
CYHB2101569 盐酸恩沙替尼胶囊 Ensartinib Hydrochloride Capsule Chemical Drugs(1) Supplementary Application 2021-07-13 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
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
CXSB2200001 注射用MCLA-129 MCLA-129 Lyophilized Biological Products(1) Supplementary Application 2022-01-07 Betta Pharmaceuticals Co Ltd view
CXHL2101239 BPI-23314片 BPI-23314 Tablet Chemical Drugs(1) New Drug Application 2021-06-28 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