药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2023/09/05 – 2023/09/11

Period
2023/09/05 to 2023/09/11, 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
361
Drugs with new generic filings (by drug name, de-duplicated)
64
Accepted this week, now under review
0

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

361filings, 78 of them generic

By application type

Application typeFilings
Supplement185
Generic78
New drug47
Import24
Import re-registration21
Unspecified6

By drug type

Drug typeFilings
Chemical drug268
TCM62
治疗用生物制品25
预防用生物制品5
体外诊断试剂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

64 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

220 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

97 this week

AcceptedDrugApplicants
2023/09/11Import · Class 2.2 Talquetamab注射液JXSL2300168 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/09/11Import · Class 2.2 Talquetamab注射液JXSL2300167 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/09/11Import · Class 2.2 Teclistamab 注射液JXSL2300166 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/09/11Import · Class 2.2 Teclistamab 注射液JXSL2300165 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/09/11Generic · Class 3 立他司特滴眼液CYHS2302444 成都康弘药业集团股份有限公司; 成都普什制药有限公司
2023/09/11Generic · Class 3 己酮可可碱注射液CYHS2302437 华中药业股份有限公司
2023/09/11Generic · Class 3 吡非尼酮片CYHS2302435 四川依科制药有限公司
2023/09/11New drug · Class 1 注射用IAE0972CXSL2300602 盛禾(中国)生物制药有限公司
2023/09/11New drug · Class 1 GS1-144片CXHL2300977 长春金赛药业有限责任公司
2023/09/11New drug · Class 1 GS1-144片CXHL2300976 长春金赛药业有限责任公司
2023/09/11New drug · Class 1 GS1-144片CXHL2300975 长春金赛药业有限责任公司
2023/09/11New drug · Class 1 BL0020注射液CXHL2300974 上海弼领生物技术有限公司
2023/09/11New drug · Class 1 GK201胶囊CXHL2300973 苏州国匡医药科技有限公司
2023/09/11New drug · Class 1 GK201胶囊CXHL2300972 苏州国匡医药科技有限公司
2023/09/09Import · Class 1 GDC-9545JXHL2300209 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/09/09Generic · Class 3 己酮可可碱注射液CYHS2302430 海南普利制药股份有限公司
2023/09/09Generic · Class 3 复方匹可硫酸钠颗粒CYHS2302428 江西科睿药业有限公司
2023/09/09Generic · Class 3 依帕司他片CYHS2302427 河北瑞森药业有限公司
2023/09/09Generic · Class 3 吲哚布芬片CYHS2302426 北京伟林恒昌医药科技有限公司; 北京四环科宝制药股份有限公司
2023/09/09New drug · Class 3.3 西妥昔单抗注射液CXSS2300075 四川科伦博泰生物医药股份有限公司
2023/09/09New drug · Class 1 HSK36357胶囊CXHL2300971 西藏海思科制药有限公司
2023/09/09New drug · Class 1 HSK36357胶囊CXHL2300970 西藏海思科制药有限公司
2023/09/09New drug · Class 2.2 盐酸达泊西汀口溶膜CXHL2300969 上海欣峰制药有限公司
2023/09/09New drug · Class 1 注射用XCCS605BCXHL2300968 上海华禹生物科技有限公司
2023/09/08Import · Class 2.2 度伐利尤单抗注射液JXSS2300078 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd.
2023/09/08Import · Class 2.2 度伐利尤单抗注射液JXSS2300077 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd.
2023/09/08Import · Class 1 LY3502970胶囊JXHL2300208 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/09/08Import · Class 1 LY3502970胶囊JXHL2300207 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/09/08Import · Class 1 LY3502970胶囊JXHL2300206 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/09/08Import · Class 1 LY3502970胶囊JXHL2300205 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.

67 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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