序号 | 受理号 | 药品名称 | 药品类型 | 申请类型 | 注册分类 | 企业名称 | 承办日期 |
1 | JXHS2300068 | 酒石酸伐尼克兰鼻喷雾剂 | 化药 | 进口 | 5.1 | Oyster Point Pharma, Inc.;Renaissance Lakewood, LLC;Ji Xing Pharmaceuticals (Shanghai) Co., Ltd; | 2023-7-15 |
2 | JTH2300175 | 氯法齐明软胶囊 | | 进口 | 化药 | Suheung Co., Ltd.;Dong-A ST Co., Ltd.;中诺凯琳健康产业(海南)有限公司; | 2023-7-15 |
3 | JTH2300174 | 头孢曲松钠 | | 进口 | 化药 | DSM Nutritional Products;Roche Diagnostics GmbH;上海罗氏制药有限公司; | 2023-7-15 |
4 | JTH2300173 | 6-β-四氢蒂巴因 | | 进口 | 化药 | PURISYS,LLC.  URISYS,LLC.;威海路坦制药有限公司; | 2023-7-15 |
5 | JTH2300172 | 二氢蒂巴因酮 | | 进口 | 化药 | PURISYS,LLC.  URISYS,LLC.;威海路坦制药有限公司; | 2023-7-15 |
6 | JXSL2300129 | IMG-020注射液 | 治疗用生物制品 | 进口 | 1 | INMAGENE PTE. LTD.;Inmagene Biopharmaceuticals (Hangzhou) Co., Ltd.; | 2023-7-14 |
7 | JXHS2300071 | 阿布昔替尼片 | 化药 | 进口 | 5.1 | Pfizer Manufacturing Deutschland GmbH  fizer Investment CO.,Ltd.; | 2023-7-14 |
8 | JXHS2300070 | 阿布昔替尼片 | 化药 | 进口 | 5.1 | Pfizer Manufacturing Deutschland GmbH  fizer Investment CO.,Ltd.; | 2023-7-14 |
9 | JXHL2300161 | RO7435846片 | 化药 | 进口 | 1 | F. Hoffmann-La Roche Ltd;Roche (China) Holding Ltd.; | 2023-7-14 |
10 | JXHL2300160 | RO7435846片 | 化药 | 进口 | 1 | F. Hoffmann-La Roche Ltd;Roche (China) Holding Ltd.; | 2023-7-14 |
11 | JXHL2300159 | RO7435846片 | 化药 | 进口 | 1 | F. Hoffmann-La Roche Ltd;Roche (China) Holding Ltd.; | 2023-7-14 |
12 | JYHS2300091 | 艾司奥美拉唑镁肠溶胶囊 | 化药 | 进口 | 5.2 | ALKEM LABORATORIES LIMITED;ALKEM LABORATORIES LIMITED;Sino Caring Pharmaceutical Development (Suzhou) Co., Ltd.; | 2023-7-14 |
13 | JYHS2300090 | 艾司奥美拉唑镁肠溶胶囊 | 化药 | 进口 | 5.2 | ALKEM LABORATORIES LIMITED;ALKEM LABORATORIES LIMITED;Sino Caring Pharmaceutical Development (Suzhou) Co., Ltd.; | 2023-7-14 |
14 | JXSS2300058 | 法瑞西单抗注射液 | 治疗用生物制品 | 进口 | 2.2 | Roche Pharma (Schweiz) AG;F. Hoffmann-La Roche AG;/; | 2023-7-14 |
15 | JXHS2300067 | 托夫生注射液 | 化药 | 进口 | 5.1 | Biogen MA Inc.;Biogen US Corporation;/; | 2023-7-14 |
16 | JXSL2300128 | Lu AF82422 注射液 | 治疗用生物制品 | 进口 | 1 | H. Lundbeck A/S;/; | 2023-7-13 |
17 | JYHS2300089 | 左甲状腺素钠片 | 化药 | 进口 | 5.2 | Intas Pharmaceuticals. Ltd.;Intas Pharmaceuticals. Ltd.;Chongqing Lummy Pharmaceuticals Company Limited; | 2023-7-13 |
18 | JYHS2300088 | 左甲状腺素钠片 | 化药 | 进口 | 5.2 | Intas Pharmaceuticals. Ltd.;Intas Pharmaceuticals. Ltd.;Chongqing Lummy Pharmaceuticals Company Limited; | 2023-7-13 |
19 | JYHS2300087 | 左甲状腺素钠片 | 化药 | 进口 | 5.2 | Intas Pharmaceuticals. Ltd.;Intas Pharmaceuticals. Ltd.;Chongqing Lummy Pharmaceuticals Company Limited; | 2023-7-13 |
20 | JYHS2300086 | 左甲状腺素钠片 | 化药 | 进口 | 5.2 | Intas Pharmaceuticals. Ltd.;Intas Pharmaceuticals. Ltd.;Chongqing Lummy Pharmaceuticals Company Limited; | 2023-7-13 |
21 | JYHS2300085 | 左甲状腺素钠片 | 化药 | 进口 | 5.2 | Intas Pharmaceuticals. Ltd.;Intas Pharmaceuticals. Ltd.;Chongqing Lummy Pharmaceuticals Company Limited; | 2023-7-13 |
22 | JXSS2300057 | 注射用泰朗妥昔单抗 | 治疗用生物制品 | 进口 | 3.1 | ADC Therapeutics SA;BSP Pharmaceuticals S.p.A.;Overland Pharmaceuticals (Shanghai) Co., Ltd.; | 2023-7-13 |
23 | JXHS2300066 | 注射用亚西瑞来 | 化药 | 进口 | 5.1 | Merck Sharp & Dohme B.V.;Merck Sharp & Dohme LLC;不适用; | 2023-7-12 |
24 | JXHS2300065 | 注射用亚西瑞来 | 化药 | 进口 | 5.1 | Merck Sharp & Dohme B.V.;Merck Sharp & Dohme LLC;不适用; | 2023-7-12 |
25 | JXHS2300064 | 盐酸替纳帕诺片 | 化药 | 进口 | 2.4 | Ardelyx, Inc.  atheon Pharmaceuticals Inc.;Shanghai Fosun Pharmaceutical Industrial Development Company Limited; | 2023-7-12 |
26 | JXHS2300063 | 盐酸替纳帕诺片 | 化药 | 进口 | 2.4 | Ardelyx, Inc.  atheon Pharmaceuticals Inc.;Shanghai Fosun Pharmaceutical Industrial Development Company Limited; | 2023-7-12 |
27 | JXHS2300062 | 盐酸替纳帕诺片 | 化药 | 进口 | 2.4 | Ardelyx, Inc.  atheon Pharmaceuticals Inc.;Shanghai Fosun Pharmaceutical Industrial Development Company Limited; | 2023-7-12 |
28 | JXSS2300056 | 四价人乳头瘤病毒疫苗(酿酒酵母) | 预防用生物制品 | 进口 | 3.1 | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.;Merck Sharp & Dohme Corp.;MSD R&D (China) Co., Ltd.; | 2023-7-11 |
29 | JXSS2300055 | 四价人乳头瘤病毒疫苗(酿酒酵母) | 预防用生物制品 | 进口 | 3.1 | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. ;Merck Sharp & Dohme Corp. ;MSD R&D (China) Co., Ltd.; | 2023-7-11 |
30 | JXSL2300127 | Tezepelumab注射液 | 治疗用生物制品 | 进口 | 2.2 | AstraZeneca AB;AstraZeneca Investment (China) Co., Ltd; | 2023-7-11 |