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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
CXSL2500524 9MW4611注射液 Biological Products(1) New Drug Application 2025-07-01 Mabwell (Shanghai) Bioscience Co Ltd 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 Ailikang (Hefei) Pharmaceutical Technology Co Ltd view
CXHL2500628 ALK2401片 Chemical Drugs(1) New Drug Application 2025-06-28 Ailikang (Hefei) Pharmaceutical Technology Co Ltd 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
CXSL2500527 HF001脐带间充质干细胞注射液 Biological Products(1) New Drug Application 2025-07-01 Beijing Hengfeng Mingcheng Biotechnology 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
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
CXHL2500630 JAB-8263片 JAB-8263 Tablet Chemical Drugs(1) New Drug Application 2025-07-01 Beijing Jiakesi New Drug Development Co Ltd view
CXHL2500629 JAB-8263片 JAB-8263 Tablet Chemical Drugs(1) New Drug Application 2025-07-01 Beijing Jiakesi New Drug Development Co Ltd view
JXSL2500114 PF-07868489 PF-07868489 Injection Biological Products(1) Import Drug Application 2025-06-28 Pfizer (China) Research and Development Co Ltd;Pfizer Inc view
CXSB2500106 PM8002注射液 PM8002 Injection Biological Products(1) Supplementary Application 2025-06-25 Biotheus Inc view
CXHL2500625 QLH12016胶囊 QLH-12016 Capsule Chemical Drugs(1) New Drug Application 2025-06-27 QILU Pharmaceutical Co Ltd view
CXHL2500624 QLH12016胶囊 QLH-12016 Capsule Chemical Drugs(1) New Drug Application 2025-06-27 QILU Pharmaceutical Co Ltd view
CXSB2500109 SCT650C 注射液 SCT650C Injection Biological Products(1) Supplementary Application 2025-06-30 SinoCelltech Ltd view
CXHL2500622 TP1001 片 apricoxib Tablet Chemical Drugs(1) New Drug Application 2025-06-26 Shengyuan Zetong (Shanghai) Pharmaceutical Co Ltd view