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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL2500626 64Cu-TR2205注射液 Chemical Drugs(1) New Drug Application 2025-06-28 C-Ray Therapeutics (Chengdu) Ltd Co view
JXHB2500080 Acalabrutinib胶囊 acalabrutinib Capsule Chemical Drugs(2.4) Supplementary Application 2025-06-28 AstraZeneca AB view
CXHL2500627 ALK2401片 Chemical Drugs(1) New Drug Application 2025-06-28 view
CXHL2500628 ALK2401片 Chemical Drugs(1) New Drug Application 2025-06-28 view
CXSL2500510 ALMB-0166注射液 ALMB-0166 Injection Biological Products(1) New Drug Application 2025-06-24 Shanghai Enlemai Biotechnology Co Ltd view
JXSL2500110 ALPN-303注射液 povetacicept Injection Biological Products(1) Import Drug Application 2025-06-24 Vertex Pharmaceuticals Inc view
CXHL2500618 AXT-1003胶囊 AXT-1003 Capsule Chemical Drugs(1) New Drug Application 2025-06-25 AXTER THERAPEUTICS (BEIJING) Co Ltd view
CXSB2500107 BNT323 BNT-323 Biological Products(1) Supplementary Application 2025-06-25 BioNTech (Shanghai) Pharmaceuticals Co Ltd;Yingen Biopharmaceutical (Suzhou) Co Ltd view
CXHL2500611 BT01001滴眼液 Chemical Drugs(1) New Drug Application 2025-06-24 Beyang Therapeutics Co Ltd view
CXHL2500612 BT01001滴眼液 Chemical Drugs(1) New Drug Application 2025-06-24 Beyang Therapeutics Co Ltd view
CXHL2500613 BT01001滴眼液 Chemical Drugs(1) New Drug Application 2025-06-24 Beyang Therapeutics Co Ltd view
CXSL2500512 GR2303注射液 Biological Products(1) New Drug Application 2025-06-24 Chongqing Genrix Biopharmaceutical Co Ltd;Zhixiang (Shanghai) Medical Technology Co Ltd view
CXHL2500607 HS-10241片 HS-10241 Tablet Chemical Drugs(1) New Drug Application 2025-06-23 Shanghai Hansoh BioMedical Co Ltd;Jiangsu Hansoh Pharmaceutical Group Co Ltd view
CXHL2500608 HS-10241片 HS-10241 Tablet Chemical Drugs(1) New Drug Application 2025-06-23 Shanghai Hansoh BioMedical Co Ltd;Jiangsu Hansoh Pharmaceutical Group Co Ltd view
CXSB2500108 HS-20137注射液 QX-004-N Injection Biological Products(1) Supplementary Application 2025-06-26 Shanghai Hansoh BioMedical Co Ltd;Changzhou Humon Pharmaceutical Co Ltd view
CXHL2500610 ICP-248片 ICP-248 Tablet Chemical Drugs(1) New Drug Application 2025-06-24 Beijing InnoCare Pharma Tech Co Ltd view
CXHL2500609 ICP-248片 ICP-248 Tablet Chemical Drugs(1) New Drug Application 2025-06-24 Beijing InnoCare Pharma Tech Co Ltd view
CXHL2500621 ICP-332片 ICP-332 Tablet Chemical Drugs(1) New Drug Application 2025-06-27 Guangzhou InnoCare Pharma Tech Co Ltd view
CXSL2500515 IM96嵌合抗原受体T细胞注射液(IM96 CAR-T细胞注射液) IM96 CAR-T cells Injection Biological Products(1) New Drug Application 2025-06-26 Shandong Jinsai Biotechnology Co Ltd view
CXSL2500514 IMS001注射液 IMS-001 Injection Biological Products(1) New Drug Application 2025-06-25 Zhuhai Hengqin Imstem BIOTECH Ltd view