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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL2500647 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
CXSL2500542 注射用MCLA-129 MCLA-129 Lyophilized Biological Products(1) New Drug Application 2025-07-05 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
CXHL2401263 BPI-452080片 BPI-452080 Tablet Chemical Drugs(1) New Drug Application 2024-11-21 Betta Pharmaceuticals Co Ltd view
CXHL2401264 BPI-452080片 BPI-452080 Tablet Chemical Drugs(1) New Drug Application 2024-11-21 Betta Pharmaceuticals Co Ltd view
CXHL2401265 BPI-452080片 BPI-452080 Tablet Chemical Drugs(1) New Drug Application 2024-11-21 Betta Pharmaceuticals Co Ltd view
CXSL2400603 注射用MCLA-129 MCLA-129 Lyophilized Biological Products(1) New Drug Application 2024-09-11 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
CXHL2400676 CFT8919胶囊 CFT-8919 Capsule Chemical Drugs(1) New Drug Application 2024-07-10 Betta Pharmaceuticals Co Ltd view
CXHS2400039 酒石酸泰贝西利胶囊 BPI-16350 Capsule Chemical Drugs(1) New Drug Application 2024-05-01 Betta Pharmaceuticals Co Ltd view
CXHB2400014 BPI-460372片 BPI-460372 Tablet Chemical Drugs(1) Supplementary Application 2024-01-11 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
CXHL2400011 BPI-520105片 BPI-520105 Tablet Chemical Drugs(1) New Drug Application 2024-01-05 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
CXHL2400010 BPI-520105片 BPI-520105 Tablet Chemical Drugs(1) New Drug Application 2024-01-05 Betta Pharmaceuticals Co Ltd view
CXHL2400012 BPI-520105片 BPI-520105 Tablet Chemical Drugs(1) New Drug Application 2024-01-05 Betta Pharmaceuticals Co Ltd view
CXHB2300161 BPI-452080片 BPI-452080 Tablet Chemical Drugs(1) Supplementary Application 2023-08-17 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
CXSL2300322 注射用MCLA-129 MCLA-129 Lyophilized Biological Products(1) New Drug Application 2023-05-09 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