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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHB2500146 BGB-43395片 BGB-43395 Tablet Chemical Drugs(1) Supplementary Application 2025-05-24 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd view
CXHB2500147 BGB-43395片 BGB-43395 Tablet Chemical Drugs(1) Supplementary Application 2025-05-24 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd view
CXHL2500505 HKG-456 Chemical Drugs(2.2) New Drug Application 2025-05-24 Hainan Yuanying Pharmaceutical Technology Co Ltd view
CXHB2500145 BGB-43395片 BGB-43395 Tablet Chemical Drugs(1) Supplementary Application 2025-05-24 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd view
CXSL2500418 SSGJ-706注射液 SSGJ-706 Injection Biological Products(1) New Drug Application 2025-05-24 Shenyang Sunshine Pharmaceutical Co Ltd view
CYZB2501012 风湿二十五味丸(琪素-25) Pellet Chinese Herbal Medicine Supplementary Application 2025-05-24 Ulanhot China Mongolia Pharmaceutical Co Ltd view
CXSL2500419 SSGJ-706注射液 SSGJ-706 Injection Biological Products(1) New Drug Application 2025-05-24 Shenyang Sunshine Pharmaceutical Co Ltd view
CXSL2500416 SHR-7782注射液 Biological Products(1) New Drug Application 2025-05-23 Suzhou Suncadia Biopharmaceuticals Co Ltd view
CXSB2500077 SHR-4597吸入剂 SHR-4597 Inhalation Biological Products(1) Supplementary Application 2025-05-23 Guangdong Hengrui Pharmaceutical Co Ltd view
CXHL2500503 BGB-45035片 BGB-45035 Tablet Chemical Drugs(1) New Drug Application 2025-05-23 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd view
JXHL2500120 MC2-01乳膏 Chemical Drugs(5.1) Import Drug Application 2025-05-22 MC2 Therapeutics Pty Ltd view
CXHL2500496 TAP-1504凝胶 Chemical Drugs(2.3) New Drug Application 2025-05-22 Shanghai Zedeman Pharmaceutical Technology Co Ltd view
CXHL2500501 MDI-1228_mesylate滴鼻液 Chemical Drugs(1) New Drug Application 2025-05-22 Maiyinuo Pharmaceutical Technology (Zhuhai) Co Ltd view
CXHL2500502 MDI-1228_mesylate滴鼻液 Chemical Drugs(1) New Drug Application 2025-05-22 Maiyinuo Pharmaceutical Technology (Zhuhai) Co Ltd view
CXHL2500491 YL-13027片 YL-13027 Tablet Chemical Drugs(1) New Drug Application 2025-05-21 Shanghai Yingli Pharmaceutical Co Ltd view
CXHL2500490 YL-13027片 YL-13027 Tablet Chemical Drugs(1) New Drug Application 2025-05-21 Shanghai Yingli Pharmaceutical Co Ltd view
CXSB2500075 BGB-A425注射液 surzebiclimab Injection Biological Products(1) Supplementary Application 2025-05-21 BeiGene Guangzhou Biologics Manufacturing Co Ltd view
CXSL2500401 SHR-8068注射液 SHR-8068 Injection Biological Products(2.2) New Drug Application 2025-05-21 Suzhou Suncadia Biopharmaceuticals Co Ltd view
CXSL2500403 注射用SHR-A2102 SHR-A2102 Lyophilized Biological Products(1) New Drug Application 2025-05-21 Suzhou Suncadia Biopharmaceuticals Co Ltd;Shanghai Hengrui Pharmaceutical Co Ltd view
CXHL2500493 HS-10516胶囊 HS-10516 Capsule Chemical Drugs(1) New Drug Application 2025-05-21 Shanghai Hansoh BioMedical Co Ltd;Jiangsu Hansoh Pharmaceutical Group Co Ltd view