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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYHS2502700 氨甲环酸注射液 tranexamic acid Injection Chemical Drugs(4) Generic Drug 2025-07-25 Henan Purui Pharmaceutical Co Ltd view
JYSB2500173 埃万妥单抗注射液 amivantamab Injection Biological Products(2.2) Supplementary Application 2025-07-25 Cilag AG;Janssen-Cilag International NV view
JYHB2500385 来那帕韦钠注射液 LENACAPAVIR SODIUM Injection Chemical Drugs(5.1) Supplementary Application 2025-07-25 Hikma Farmacêutica SA;Patheon Italia SpA;Gilead Sciences Ireland Uc view
CYHB2501488 大黄碳酸氢钠片 ;Sodium bicarbonate;Peppermint Tablet Chemical Drugs Supplementary Application 2025-07-25 Guangdong Sanshun Pharmaceutical Co Ltd view
CYZB2501555 黄芪生脉饮 Oral solution Chinese Herbal Medicine Supplementary Application 2025-07-25 Jiangxi Nanchang Jisheng Pharmaceutical Co Ltd view
CXSL2500624 贝莫苏拜单抗注射液 benmelstobart Injection Biological Products(2.2) New Drug Application 2025-07-25 Nanjing Shunxin Pharmaceuticals Co LTDof Chiatai Tianqing Pharmaceutical Group view
JXHB2500099 Inclisiran注射液 inclisiran sodium Injection Chemical Drugs(2.4) Supplementary Application 2025-07-25 Corden Pharma SpA;Novartis Pharmaceutical Manufacturing GmbH;Novartis Pharma Schweiz AG view
CYHS2502698 氨甲环酸注射液 tranexamic acid Injection Chemical Drugs(4) Generic Drug 2025-07-25 Henan Purui Pharmaceutical Co Ltd view
CYZB2501553 感冒灵颗粒 Granule Chinese Herbal Medicine Supplementary Application 2025-07-25 Anguo Yadong Biological Pharmaceutical Co Ltd view
CXSL2500617 注射用JS207 JS207 Lyophilized Biological Products(1) New Drug Application 2025-07-25 Shanghai Junshi Biosciences Co Ltd view
JXSL2500132 MK-7240注射液 tulisokibart Injection Biological Products(1) Import Drug Application 2025-07-25 view
CXSL2500619 注射用HLX43 HLX-43 Lyophilized Biological Products(1) New Drug Application 2025-07-25 Shanghai Fuhong Ruilin Biotechnology Co Ltd;Shanghai Henlius Biologics Co Ltd view
CYHB2501486 水合氯醛/糖浆组合包装 Chloral hydrate Oral solution Chemical Drugs(2.2) Supplementary Application 2025-07-25 Tefeng Pharmaceutical Co Ltd view
JXSL2500131 Risankizumab注射液 risankizumab Injection Biological Products(2.2) Import Drug Application 2025-07-25 AbbVie Pharmaceutical Trading (Shanghai) Co Ltd;Abbvie Inc view
JXSB2500072 Nipocalimab注射液 nipocalimab Injection Biological Products(1) Supplementary Application 2025-07-25 Vetter Pharma-Fertigung Gmbh & Co KG;Janssen Research & Development LLC view
CYZB2501545 复方仙鹤草肠炎胶囊 Capsule Chinese Herbal Medicine Supplementary Application 2025-07-25 Yunnan JINBI Pharmaceutical Co Ltd view
CYHS2502699 氨甲环酸注射液 tranexamic acid Injection Chemical Drugs(4) Generic Drug 2025-07-25 Henan Purui Pharmaceutical Co Ltd view
CXZS2500031 芍药甘草颗粒 Granule Chinese Herbal Medicine(3.1) New Drug Application 2025-07-25 China National Pharmaceutical Group Corporation Guangdong Global Pharmaceutical view
CYHS2502695 利丙双卡因乳膏 lidocaine;prilocaine Cream Chemical Drugs(4) Generic Drug 2025-07-25 Hebei Huachen Pharmaceutical Group Co Ltd view
CXSS2500077 依沃西单抗注射液 Ivonescimab Injection Biological Products(2.2) New Drug Application 2025-07-25 Akeso Pharmaceuticals Inc;Akeso-Sino Pharma Co Ltd view