药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2021/06/22 – 2021/06/28

Period
2021/06/22 to 2021/06/28, 7 days inclusive
Data as of
2026/11/08 06:00
Cached records
94,440 acceptance records, 11,586 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
254
Drugs with new generic filings (by drug name, de-duplicated)
24
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

254filings, 35 of them generic

By application type

Application typeFilings
Supplement135
New drug44
Generic35
Import26
Unspecified9
Import re-registration5

By drug type

Drug typeFilings
Chemical drug173
治疗用生物制品42
TCM38
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

24 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

143 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

79 this week

AcceptedDrugApplicants
2021/06/28Import · Class 1 Talquetamab注射液JXSL2101051 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2021/06/28Import · Class 1 Talquetamab注射液JXSL2101050 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2021/06/28Import · Class 1 BI 1810631 片JXHL2101108 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/06/28Import · Class 1 BI 1810631 片JXHL2101107 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/06/28Import · Class 1 BI 1810631 片JXHL2101106 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/06/28Import · Class 1 Linerixibat 片JXHL2101105 GlaxoSmithKline(Ireland) Limited; GlaxoSmithKline(China) Investment Co. Ltd
2021/06/28Generic · Class 3 盐酸美金刚口服溶液CYHS2101347 山东朗诺制药有限公司
2021/06/28Generic · Class 3 奥硝唑注射液CYHS2101346 北大医药股份有限公司
2021/06/28Generic · Class 3 奥硝唑注射液CYHS2101345 北大医药股份有限公司
2021/06/28Generic · Class 3 注射用福沙匹坦双葡甲胺CYHS2101342 湖南赛隆药业有限公司
2021/06/28Generic · Class 3 地塞米松眼用植入剂(用于泪小管)CYHS2101341 北京诺康达医药科技股份有限公司; 天津金耀集团河北永光制药有限公司
2021/06/28New drug · Class 1.1 HC001颗粒CXZL2101015 北京厚成医药科技有限公司
2021/06/28New drug · Class 2.2 三七总皂苷缓释胶囊CXZL2101014 江中药业股份有限公司
2021/06/28New drug · Class 1.1 复方延麦搽剂CXZL2101013 上海活尔生物科技有限公司
2021/06/28New drug · Class 1 NBL-015注射液CXSL2101156 上海新石生物医药有限公司
2021/06/28New drug · Class 1 JS014注射液CXSL2101155 上海君实生物医药科技股份有限公司
2021/06/28New drug · Class 2.2 注射用伊尼妥单抗CXSL2101151 三生国健药业(上海)股份有限公司
2021/06/28New drug · Class 1 BEBT-109胶囊CXHL2101243 广州必贝特医药技术有限公司
2021/06/28New drug · Class 1 BEBT-109胶囊CXHL2101242 广州必贝特医药技术有限公司
2021/06/28New drug · Class 2.2 苯甲酸氨氯地平干混悬剂CXHL2101241 广州一品红制药有限公司
2021/06/28New drug · Class 2.2 SBK003注射液CXHL2101240 成都施贝康生物医药科技有限公司
2021/06/28New drug · Class 1 BPI-23314片CXHL2101239 贝达药业股份有限公司
2021/06/28New drug · Class 1 BPI-23314片CXHL2101238 贝达药业股份有限公司
2021/06/28New drug · Class 1 TL938胶囊CXHL2101225 苏州韬略生物科技股份有限公司
2021/06/28New drug · Class 1 TL938胶囊CXHL2101224 苏州韬略生物科技股份有限公司
2021/06/25Import · Class 3.1 注射用培重组人凝血因子ⅧJXSS2101012 Baxalta US Inc.; Baxalta Manufacturing Sàrl; Takeda(China) International Trading Co. Ltd
2021/06/25Import · Class 3.1 注射用培重组人凝血因子ⅧJXSS2101011 Baxalta US Inc.; Baxalta Manufacturing Sàrl; Takeda(China) International Trading Co. Ltd
2021/06/25Import · Class 3.1 注射用培重组人凝血因子ⅧJXSS2101010 Baxalta US Inc.; Baxalta Manufacturing Sàrl; Takeda(China) International Trading Co. Ltd
2021/06/25Import · Class 3.1 注射用培重组人凝血因子ⅧJXSS2101009 Baxalta US Inc.; Baxalta Manufacturing Sàrl; Takeda(China) International Trading Co. Ltd
2021/06/25Import · Class 3.1 注射用培重组人凝血因子ⅧJXSS2101008 Baxalta US Inc.; Baxalta Manufacturing Sàrl; Takeda(China) International Trading Co. Ltd

49 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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