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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYSB2500113 人凝血因子Ⅸ Human Coagulation Factor Ⅸ Lyophilized Biological Products Supplementary Application 2025-05-20 Sichuan Yuanda Shuyang Pharmaceutical Co Ltd view
CXSL2500277 人凝血因子Ⅸ Human Coagulation Factor Ⅸ Lyophilized Biological Products(3.2) New Drug Application 2025-04-08 Sichuan Yuanda Shuyang Pharmaceutical Co Ltd view
CYSB2500044 人凝血因子Ⅸ Human Coagulation Factor Ⅸ Lyophilized Biological Products Supplementary Application 2025-02-19 Sichuan Yuanda Shuyang Pharmaceutical Co Ltd view
JYSB2500006 注射用重组人凝血因子Ⅸ Recombinant Coagulation Factor Ⅸ Lyophilized Biological Products Supplementary Application 2025-01-04 Pfizer Europe Ma Eeig;Wyeth Farma SA view
JYSB2500004 注射用重组人凝血因子Ⅸ Recombinant Coagulation Factor Ⅸ Lyophilized Biological Products Supplementary Application 2025-01-04 Pfizer Europe Ma Eeig;Wyeth Farma SA view
JYSB2500005 注射用重组人凝血因子Ⅸ Recombinant Coagulation Factor Ⅸ Lyophilized Biological Products Supplementary Application 2025-01-04 Pfizer Europe Ma Eeig;Wyeth Farma SA view
JYSB2500007 注射用重组人凝血因子Ⅸ Recombinant Coagulation Factor Ⅸ Lyophilized Biological Products Supplementary Application 2025-01-04 Pfizer Europe Ma Eeig;Wyeth Farma SA view
CYSB2400105 人凝血因子Ⅸ Human Coagulation Factor Ⅸ Lyophilized Biological Products Supplementary Application 2024-05-08 Sichuan Yuanda Shuyang Pharmaceutical Co Ltd view
CYSB2400043 人凝血因子Ⅸ Human Coagulation Factor Ⅸ Lyophilized Biological Products(原7) Supplementary Application 2024-02-20 Shandong Taibang Biological Products Co Ltd view
CXSL2400072 人凝血因子IX Human Coagulation Factor Ⅸ Lyophilized Biological Products(3.4) New Drug Application 2024-01-31 Chengdu Rongsheng Pharmaceuticals Co Ltd view
CXSL2300595 人凝血因子IX Human Coagulation Factor Ⅸ Lyophilized Biological Products(3.4) New Drug Application 2023-09-02 Hualan Biological Engineering Inc view
CXSL2300529 人凝血因子IX Human Coagulation Factor Ⅸ Lyophilized Biological Products(3.4) New Drug Application 2023-08-01 Guangdong Shuanglin Bio-Pharmacy Co Ltd view
CYSB2300147 人凝血因子Ⅸ Human Coagulation Factor Ⅸ Lyophilized Biological Products Supplementary Application 2023-07-28 Shandong Taibang Biological Products Co Ltd view
CYSB2300115 人凝血因子Ⅸ Human Coagulation Factor Ⅸ Lyophilized Biological Products(原7) Supplementary Application 2023-06-14 Shandong Taibang Biological Products Co Ltd view
CXSL2300259 注射用培重组人凝血因子IX-Fc融合蛋白 Lyophilized Biological Products(1) New Drug Application 2023-04-14 Zhengzhou Shengsi Biotechnology Co Ltd view
CXSL2300260 注射用培重组人凝血因子IX-Fc融合蛋白 Lyophilized Biological Products(1) New Drug Application 2023-04-14 Zhengzhou Shengsi Biotechnology Co Ltd view
JYSZ2200035 注射用重组人凝血因子Ⅸ Recombinant Coagulation Factor Ⅸ Lyophilized Biological Products License Renew 2022-07-21 Pfizer Europe Ma Eeig;Wyeth Farma SA;Pfizer Investment Co Ltd view
JYSZ2200036 注射用重组人凝血因子Ⅸ Recombinant Coagulation Factor Ⅸ Lyophilized Biological Products License Renew 2022-07-21 Pfizer Europe Ma Eeig;Wyeth Farma SA;Pfizer Investment Co Ltd view
JYSZ2200034 注射用重组人凝血因子Ⅸ Recombinant Coagulation Factor Ⅸ Lyophilized Biological Products License Renew 2022-07-21 Pfizer Europe Ma Eeig;Wyeth Farma SA;Pfizer Investment Co Ltd view
JYSZ2200033 注射用重组人凝血因子Ⅸ Recombinant Coagulation Factor Ⅸ Lyophilized Biological Products License Renew 2022-07-21 Pfizer Europe Ma Eeig;Wyeth Farma SA;Pfizer Investment Co Ltd view