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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
CXHL2500496 TAP-1504凝胶 Chemical Drugs(2.3) New Drug Application 2025-05-22 Shanghai Zedeman Pharmaceutical Technology Co Ltd view
JXHL2500120 MC2-01乳膏 Chemical Drugs(5.1) Import Drug Application 2025-05-22 MC2 Therapeutics Pty 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
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
CXSB2500074 GV20-0251注射液 GV20-0251 Biological Products(1) Supplementary Application 2025-05-21 Shanghai Xunbaihui Biotechnology 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
CXHL2500490 YL-13027片 YL-13027 Tablet Chemical Drugs(1) New Drug Application 2025-05-21 Shanghai Yingli 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
CYZB2500987 健胃止疼五味胶囊 Capsule Chinese Herbal Medicine Supplementary Application 2025-05-21 Ulanhot China Mongolia Pharmaceutical Co Ltd view
CXHL2500492 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
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
CXHL2500491 YL-13027片 YL-13027 Tablet Chemical Drugs(1) New Drug Application 2025-05-21 Shanghai Yingli Pharmaceutical Co Ltd view
CXSB2500072 LBL-007注射液 LBL-007 Injection Biological Products(1) Supplementary Application 2025-05-20 BeiGene Guangzhou Biologics Manufacturing Co Ltd view
CXSB2500073 注射用DB-1311 DB-1311 Lyophilized Biological Products(1) Supplementary Application 2025-05-20 Yingen Biopharmaceutical (Suzhou) Co Ltd view
JXSB2500041 DS-1062a datopotamab deruxtecan Injection Biological Products(1) Supplementary Application 2025-05-17 Daiichi Sankyo Co Ltd;Baxter Oncology GmbH view
CYHS2501794 中性低钙腹膜透析液(碳酸氢盐-G2.5%) Injection Chemical Drugs(3) Generic Drug 2025-05-17 Shijiazhuang NO4 Pharmaceutical Co Ltd view