药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/03/19 – 2024/03/25

Period
2024/03/19 to 2024/03/25, 7 days inclusive
Data as of
2026/11/05 06:00
Cached records
94,245 acceptance records, 11,689 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
176
Drugs with new generic filings (by drug name, de-duplicated)
36
Accepted this week, now under review
1

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Drug and company names link to detail pages; sign in to view them.

New acceptances this week

By application type and drug type

176filings, 45 of them generic

By application type

Application typeFilings
Supplement88
Generic45
New drug28
Import8
Unspecified7

By drug type

Drug typeFilings
Chemical drug103
TCM47
治疗用生物制品24
Biologic1
预防用生物制品1

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

36 drugs with new generic filings; top 10 listed

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

111 companies with new acceptances; top 10 listed

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

52 this week

AcceptedDrugApplicants
2024/03/25Generic · Class 3 氨磺必利口服溶液CYHS2400906 仁合益康集团有限公司; 河北仁合益康药业有限公司
2024/03/25Generic · Class 3 呋塞米注射液CYHS2400905 酒泉大得利制药股份有限公司
2024/03/23Import · Class 1 MK-7240注射用浓溶液JXSL2400063 Merck Sharp & Dohme LLC; 不适用
2024/03/23Import · Class 1 MK-7240注射液JXSL2400062 Merck Sharp & Dohme LLC; 不适用
2024/03/23Import · Class 1 BudigalimabJXSL2400061 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/03/23Generic · Class 3 复方醋酸钠林格注射液CYHS2400900 石家庄四药有限公司
2024/03/23Generic · Class 3 注射用尼可地尔CYHS2400899 广东海赫生物医药科技有限公司; 山西振东泰盛制药有限公司
2024/03/23Generic · Class 3 复合磷酸氢钾注射液CYHS2400897 哈尔滨誉衡制药有限公司; 浙江赛默制药有限公司
2024/03/23Generic · Class 3 盐酸尼卡地平氯化钠注射液CYHS2400895 石家庄四药有限公司
2024/03/23Generic · Class 3 利多卡因丁卡因乳膏CYHL2400063 江苏万高药业股份有限公司
2024/03/23New drug · Class 2.2 贝伐珠单抗注射液CXSL2400202 百奥泰生物制药股份有限公司
2024/03/23New drug · Class 2.2 贝伐珠单抗注射液CXSL2400201 百奥泰生物制药股份有限公司
2024/03/23New drug · Class 1 HCB101注射液CXSL2400200 广州汉科生物有限公司
2024/03/22Generic · Class 3 盐酸多巴胺注射液CYHS2400892 上海现代哈森(商丘)药业有限公司
2024/03/22Generic · Class 3 盐酸肾上腺素注射液CYHS2400890 南京臣功制药股份有限公司; 合肥亿帆生物制药有限公司
2024/03/22Generic · Class 3 注射用尼可地尔CYHS2400889 福州华为医药技术开发有限公司; 四川宏明博思药业有限公司
2024/03/22New drug · Class 3.3 四价流感病毒裂解疫苗CXSS2400027 江苏康润生物科技股份有限公司
2024/03/22New drug · Class 1 盐酸杰克替尼片CXHL2400298 苏州泽璟生物制药股份有限公司
2024/03/22New drug · Class 1 盐酸杰克替尼片CXHL2400297 苏州泽璟生物制药股份有限公司
2024/03/22New drug · Class 1 YK-051CXHL2400296 南京优科制药有限公司
2024/03/21Generic · Class 3 复合磷酸氢钾注射液CYHS2400885 苏州朗科生物技术股份有限公司; 扬州中宝药业股份有限公司
2024/03/21Generic · Class 3 氨氯地平贝那普利胶囊CYHS2400884 北京福元医药股份有限公司
2024/03/21Generic · Class 3 注射用雷替曲塞CYHS2400880 山东百诺医药股份有限公司; 哈尔滨三联药业股份有限公司
2024/03/21Generic · Class 3 盐酸异丙肾上腺素注射液CYHS2400879 远大医药(中国)有限公司
2024/03/21New drug · Class 1 GCB-001CXSL2400199 上海金珂博生物技术有限公司
2024/03/21New drug · Class 1 BAT7104注射液CXSL2400198 百奥泰生物制药股份有限公司
2024/03/21New drug · Class 1 注射用BAT8008CXSL2400197 百奥泰生物制药股份有限公司
2024/03/20Import · Class 1 LY3819469注射液JXHL2400066 Eli Lilly and Company
2024/03/20New drug · Class 1.1 柴桂解感颗粒CXZL2400016 山东中医药大学; 山东古金中医药科技有限公司
2024/03/20New drug · Class 1 注射用DB-1305CXSL2400196 映恩生物制药(苏州)有限公司

22 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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