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南京力博维2.1类改良新YK-2001注射液提交上市申请|新受理(3.16-3.22)

  • 2026-03-22 23:25:55
南京力博维2.1类改良新YK-2001注射液提交上市申请|新受理(3.16-3.22)

本周药品注册受理数据，分门别类呈现，一目了然。(3.16-3.22）

新药上市申请

药品名称
企业
注册分类
受理号
YK-2001注射液
南京力博维制药有限公司
2.1
CXHS2600044
YK-2001注射液
南京力博维制药有限公司
2.1
CXHS2600043

新药临床申请

药品名称
企业
注册分类
受理号
HP-002片
上海超阳药业有限公司
1
CXHL2600354
HRS9531注射液
福建盛迪医药有限公司
1
CXHL2600353
HRS9531注射液
福建盛迪医药有限公司
1
CXHL2600352
HRS9531注射液
福建盛迪医药有限公司
1
CXHL2600351
HRS9531注射液
福建盛迪医药有限公司
1
CXHL2600350
HRS9531注射液
福建盛迪医药有限公司
1
CXHL2600349
HRS9531注射液
福建盛迪医药有限公司
1
CXHL2600348
HP-002片
上海超阳药业有限公司
1
CXHL2600356
HP-002片
上海超阳药业有限公司
1
CXHL2600355
OTR-8100片
上海翱路生物医药科技有限公司
1
CXHL2600344
OTR-8100片
上海翱路生物医药科技有限公司
1
CXHL2600343
HRS9531注射液
福建盛迪医药有限公司
1
CXHL2600347
HRS9531注射液
福建盛迪医药有限公司
1
CXHL2600346
HRS9531注射液
福建盛迪医药有限公司
1
CXHL2600345
MN-08片
广州喜鹊医药有限公司
1
CXHL2600339
替恩戈替尼片
药捷安康(南京)科技股份有限公司
1
CXHL2600338
替恩戈替尼片
药捷安康(南京)科技股份有限公司
1
CXHL2600337
替恩戈替尼片
药捷安康(南京)科技股份有限公司
1
CXHL2600336
HRS-4508片
江苏恒瑞医药股份有限公司
1
CXHL2600335
硫酸益母草碱片
依诺医药(广东)有限公司
1
CXHL2600342
HZ-A-018胶囊
杭州和正医药有限公司
1
CXHL2600341
硫酸益母草碱片
依诺医药(广东)有限公司
1
CXHL2600340
注射用DN022150
江西科睿药业有限公司
1
CXHL2600331
LNK01004软膏
凌科药业(浙江)股份有限公司
1
CXHL2600330
LNK01004软膏
凌科药业(浙江)股份有限公司
1
CXHL2600329
ASKC202片
江苏奥赛康药业有限公司
1
CXHL2600328
ASKC202片
江苏奥赛康药业有限公司
1
CXHL2600327
注射用盐酸曲拉西利
先声再明医药股份有限公司
2.4
CXHL2600334
注射用盐酸曲拉西利
先声再明医药股份有限公司
2.4
CXHL2600333
利厄替尼片
江苏奥赛康药业有限公司
2.4
CXHL2600332
流感病毒裂解疫苗(CpG佐剂)
华普石家庄医药有限公司
1.3
CXSL2600337
SHR-6914注射液
苏州盛迪亚生物医药有限公司
1
CXSL2600339
注射用YL211
苏州宜联生物医药有限公司
1
CXSL2600332
SCTB39G注射液
神州细胞工程有限公司
1
CXSL2600334
SCTB41注射液
神州细胞工程有限公司
1
CXSL2600333
注射用FG-M131
明济生物制药(北京)有限公司
1
CXSL2600338
注射用QLS5133
齐鲁制药有限公司
1
CXSL2600335
夫那奇珠单抗注射液
苏州盛迪亚生物医药有限公司
2.2
CXSL2600342
夫那奇珠单抗注射液
苏州盛迪亚生物医药有限公司
2.2
CXSL2600341
夫那奇珠单抗注射液
苏州盛迪亚生物医药有限公司
2.2
CXSL2600340
QL2107注射液
齐鲁制药有限公司
2.2
CXSL2600336

仿制药申请

药品名称
企业
注册分类
受理号
二硫化硒洗剂
山西振东安欣生物制药有限公司
3
CYHS2600687
富马酸酮替芬口服溶液
浙江杭康药业有限公司
3
CYHS2600673
苯磺酸氨氯地平口服溶液
济南景笙科技有限公司
3
CYHS2600672
伏硫西汀滴剂
湖南科伦制药有限公司
3
CYHS2600685
硫酸沙丁胺醇口服溶液
济南景笙科技有限公司
3
CYHS2600674
氨甲环酸氯化钠注射液
安徽丰原药业股份有限公司淮海药厂
3
CYHS2600670
阿达帕林过氧苯甲酰凝胶
四川明欣药业有限责任公司
4
CYHS2600695
拉米夫定多替拉韦片
海南林依生物科技有限公司
4
CYHS2600694
沙库巴曲缬沙坦钠片
四川百利药业有限责任公司
4
CYHS2600691
盐酸伐地那非片
浙江英格莱制药有限公司
4
CYHS2600690
依非米替片(I)
海南林依生物科技有限公司
4
CYHS2600689
司来帕格片
辰欣药业股份有限公司
4
CYHS2600693
司来帕格片
辰欣药业股份有限公司
4
CYHS2600692
阿法骨化醇软胶囊
山东简道制药有限公司
4
CYHS2600677
非布司他片
哈尔滨中泰医药有限公司
4
CYHS2600676
聚乙二醇钠钾散
笛卡尔药业(哈尔滨)有限公司
4
CYHS2600675
左氧氟沙星滴眼液
长春迪瑞制药有限公司
4
CYHS2600679
碳酸司维拉姆片
海南赛立克药业有限公司
4
CYHS2600686
拉西地平片
吉林省聚溪医药科技有限公司
4
CYHS2600684
拉西地平片
吉林省聚溪医药科技有限公司
4
CYHS2600683
达格列净二甲双胍缓释片(I)
烟台鲁银药业有限公司
4
CYHS2600682
注射用头孢他啶阿维巴坦钠/氯化钠注射液
海南倍特药业有限公司
4
CYHS2600678
左氧氟沙星滴眼液
长春迪瑞制药有限公司
4
CYHS2600681
左氧氟沙星滴眼液
长春迪瑞制药有限公司
4
CYHS2600680
利多卡因凝胶贴膏
湖南一格制药有限公司
4
CYHS2600671
氢溴酸替格列汀片
安徽万邦医药科技股份有限公司
4
CYHS2600669
单硝酸异山梨酯缓释片
浙江车头制药股份有限公司
4
CYHS2600668
单硝酸异山梨酯缓释片
浙江车头制药股份有限公司
4
CYHS2600667
盐酸乙哌立松片
云鹏医药集团有限公司
4
CYHS2600666
注射用阿立哌唑
齐鲁制药有限公司
4
CYHS2600626
注射用阿立哌唑
齐鲁制药有限公司
4
CYHS2600627
醋丙甲泼尼龙乳膏
重庆华邦制药有限公司
3
CYHL2600037

进口申请

药品名称
企业
注册分类
受理号
乌帕替尼缓释片
AbbVie Deutschland GmbH & Co. KG
2.4
JXHS2600032
乌帕替尼缓释片
AbbVie Deutschland GmbH & Co. KG
2.4
JXHS2600031
帕博利珠单抗注射液
MSD International Business GmbH
3.1
JXSS2600023
MK-1084片
Merck Sharp & Dohme LLC
1
JXHL2600087
MK-1084片
Merck Sharp & Dohme LLC
1
JXHL2600086
Brenipatide注射液
Eli Lillly and Company
1
JXHL2600085
Brenipatide注射液
Eli Lillly and Company
1
JXHL2600084
Brenipatide注射液
Eli Lillly and Company
1
JXHL2600083
AZD2936
AstraZeneca AB
1
JXSL2600080
JNJ-79635322
Janssen Research & Development, LLC
1
JXSL2600081
JNJ-79635322
Janssen Research & Development, LLC
1
JXSL2600082
注射用贝林妥欧单抗(皮下注射)
Amgen Inc.
2.1
JXSL2600084
注射用贝林妥欧单抗(皮下注射)
Amgen Inc.
2.1
JXSL2600083

中药相关申请

药品名称
企业
注册分类
受理号
三皮强心颗粒
为因医药科技有限公司
1.1
CXZL2600031

注：绿色字体部分为潜在首仿品种；

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  1. CONNECT:[ UseTime:0.000454s ] mysql:host=127.0.0.1;port=3306;dbname=b460;charset=utf8mb4
  2. SHOW FULL COLUMNS FROM `fenlei` [ RunTime:0.000801s ]
  3. SELECT * FROM `fenlei` WHERE `fid` = 0 [ RunTime:0.000332s ]
  4. SELECT * FROM `fenlei` WHERE `fid` = 63 [ RunTime:0.000319s ]
  5. SHOW FULL COLUMNS FROM `set` [ RunTime:0.000539s ]
  6. SELECT * FROM `set` [ RunTime:0.000236s ]
  7. SHOW FULL COLUMNS FROM `article` [ RunTime:0.000618s ]
  8. SELECT * FROM `article` WHERE `id` = 512280 LIMIT 1 [ RunTime:0.008996s ]
  9. UPDATE `article` SET `lasttime` = 1774201112 WHERE `id` = 512280 [ RunTime:0.002967s ]
  10. SELECT * FROM `fenlei` WHERE `id` = 65 LIMIT 1 [ RunTime:0.000282s ]
  11. SELECT * FROM `article` WHERE `id` < 512280 ORDER BY `id` DESC LIMIT 1 [ RunTime:0.000540s ]
  12. SELECT * FROM `article` WHERE `id` > 512280 ORDER BY `id` ASC LIMIT 1 [ RunTime:0.000444s ]
  13. SELECT * FROM `article` WHERE `id` < 512280 ORDER BY `id` DESC LIMIT 10 [ RunTime:0.007511s ]
  14. SELECT * FROM `article` WHERE `id` < 512280 ORDER BY `id` DESC LIMIT 10,10 [ RunTime:0.010772s ]
  15. SELECT * FROM `article` WHERE `id` < 512280 ORDER BY `id` DESC LIMIT 20,10 [ RunTime:0.008642s ]
0.112351s