药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2023/09/19 – 2023/09/25

Period
2023/09/19 to 2023/09/25, 7 days inclusive
Data as of
2026/11/07 06:00
Cached records
94,440 acceptance records, 11,686 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
349
Drugs with new generic filings (by drug name, de-duplicated)
75
Accepted this week, now under review
4

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

349filings, 89 of them generic

By application type

Application typeFilings
Supplement174
Generic89
New drug55
Import22
Unspecified5
Import re-registration4

By drug type

Drug typeFilings
Chemical drug255
TCM55
治疗用生物制品33
预防用生物制品4
Biologic2

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

75 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

215 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

106 this week

AcceptedDrugApplicants
2023/09/25Generic · Class 3 甲硫酸新斯的明注射液CYHS2302585 上海旭东海普药业有限公司
2023/09/25Generic · Class 3 甲硫酸新斯的明注射液CYHS2302584 上海旭东海普药业有限公司
2023/09/25New drug · Class 1.1 五味益心颗粒CXZL2300064 江苏康缘药业股份有限公司
2023/09/25New drug · Class 1 重组抗 Claudin18.2 全人源单克隆抗体注射液CXSL2300651 华兰基因工程(河南)有限公司
2023/09/25New drug · Class 1 SCT650C注射液CXSL2300650 神州细胞工程有限公司
2023/09/25New drug · Class 1 HS-10516胶囊CXHL2301032 江苏豪森药业集团有限公司; 上海翰森生物医药科技有限公司
2023/09/25New drug · Class 1 HS-10516胶囊CXHL2301031 江苏豪森药业集团有限公司; 上海翰森生物医药科技有限公司
2023/09/23Generic · Class 3 氨氯地平贝那普利胶囊CYHS2302581 地奥集团成都药业股份有限公司
2023/09/23Generic · Class 3 硫酸镁注射液CYHS2302580 云南药科院生物医药股份有限公司; 楚雄和创药业有限责任公司
2023/09/23Generic · Class 3 倍他米松磷酸钠注射液CYHS2302577 辰欣药业股份有限公司
2023/09/23Generic · Class 3 奥美拉唑碳酸氢钠胶囊(Ⅱ)CYHS2302576 宁波美诺华天康药业有限公司
2023/09/23Generic · Class 3 奥美拉唑碳酸氢钠胶囊CYHS2302575 宁波美诺华天康药业有限公司
2023/09/23Generic · Class 3 地高辛注射液CYHS2302574 安徽长江药业有限公司; 浙江赛默制药有限公司
2023/09/23Generic · Class 3 地高辛注射液CYHS2302573 安徽长江药业有限公司; 浙江赛默制药有限公司
2023/09/23New drug · Class 1 Xs02注射液CXSL2300649 北京先声祥瑞生物制品股份有限公司
2023/09/23New drug · Class 1 Xs02注射液CXSL2300648 北京先声祥瑞生物制品股份有限公司
2023/09/23New drug · Class 1 Xs02注射液CXSL2300647 北京先声祥瑞生物制品股份有限公司
2023/09/23New drug · Class 2.2 SHR-8068注射液CXSL2300646 苏州盛迪亚生物医药有限公司
2023/09/23New drug · Class 1 BPAb002注射液CXSL2300645 博品泽荣(深圳)生物医药科技有限公司
2023/09/23New drug · Class 1 斯美瑞非片CXHS2300087 苏州旺山旺水生物医药股份有限公司; 苏州特瑞药业股份有限公司
2023/09/23New drug · Class 1 斯美瑞非片CXHS2300086 苏州旺山旺水生物医药股份有限公司; 苏州特瑞药业股份有限公司
2023/09/23New drug · Class 1 斯美瑞非片CXHS2300085 苏州旺山旺水生物医药股份有限公司; 苏州特瑞药业股份有限公司
2023/09/23New drug · Class 1 KC1036片CXHL2301030 北京康辰药业股份有限公司
2023/09/23New drug · Class 1 KC1036片CXHL2301029 北京康辰药业股份有限公司
2023/09/23New drug · Class 2.1;2.2;2.4 盐酸(R)氯胺酮鼻用喷雾剂CXHL2301028 江苏恩华药业股份有限公司
2023/09/22Import · Class 1 BI 456906 注射液JXHL2300244 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/22Import · Class 1 BI 456906 注射液JXHL2300243 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/22Import · Class 1 BI 456906 注射液JXHL2300242 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/22Import · Class 1 BI 456906 注射液JXHL2300241 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/22Import · Class 1 BI 456906 注射液JXHL2300240 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.

76 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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