药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2021/05/25 – 2021/05/31

Period
2021/05/25 to 2021/05/31, 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
231
Drugs with new generic filings (by drug name, de-duplicated)
23
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

231filings, 30 of them generic

By application type

Application typeFilings
Supplement141
Generic30
New drug27
Import23
Import re-registration7
Unspecified3

By drug type

Drug typeFilings
Chemical drug200
治疗用生物制品15
TCM12
预防用生物制品4

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

23 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

118 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

61 this week

AcceptedDrugApplicants
2021/05/31Import · Class 1 CC-220胶囊JXHL2101070 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2021/05/31Import · Class 1 CC-220胶囊JXHL2101069 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2021/05/31Import · Class 1 CC-220胶囊JXHL2101068 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2021/05/31Import · Class 1 CC-220胶囊JXHL2101067 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2021/05/31New drug · Class 1 重组抗PD-1全人源单克隆抗体注射液CXSL2101103 石药集团中奇制药技术(石家庄)有限公司
2021/05/31New drug · Class 1 重组人源化抗表皮生长因子受体单克隆抗体注射液CXSL2101102 上海津曼特生物科技有限公司
2021/05/31New drug · Class 1 注射用BD0801CXSL2101100 江苏先声药业有限公司
2021/05/31New drug · Class 1 阴道用乳杆菌二联活菌胶囊CXSL2101094 浙江欣力菲生物技术有限公司
2021/05/31New drug · Class 1 ASC40片CXHL2101167 歌礼生物科技(杭州)有限公司
2021/05/31New drug · Class 1 ASC40片CXHL2101166 歌礼生物科技(杭州)有限公司
2021/05/31New drug · Class 1 ASC40片CXHL2101165 歌礼生物科技(杭州)有限公司
2021/05/28Import · Class 1 IMGN853JXSL2101035 ImmunoGen Inc.; HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO. LTD
2021/05/28Import · Class 1 ABL001片JXHL2101066 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2021/05/28Import · Class 1 ABL001片JXHL2101065 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2021/05/28Generic · Class 3 盐酸二甲双胍口服溶液CYHS2101218 安徽新世纪药业有限公司
2021/05/28New drug · Class 1 恩沃利单抗注射液CXSL2101099 四川思路康瑞药业有限公司
2021/05/28New drug · Class 3.2 冻干ACYW135群脑膜炎球菌结合疫苗CXSL2101095 苏州微超生物科技有限公司
2021/05/28New drug · Class 2.1 注射用HR18034CXHL2101164 上海恒瑞医药有限公司
2021/05/28New drug · Class 1 RG001片CXHL2101154 上海凌济生物科技有限公司
2021/05/28New drug · Class 1 RG001片CXHL2101153 上海凌济生物科技有限公司
2021/05/27Import · Class 1 BI 456906 注射液JXHL2101064 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/05/27Import · Class 1 BI 456906 注射液JXHL2101063 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/05/27Import · Class 1 BI 456906 注射液JXHL2101062 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/05/27Import · Class 1 BI 456906 注射液JXHL2101061 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/05/27Import · Class 1 BI 456906 注射液JXHL2101060 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/05/27Import · Class 1 注射用CEND-1JXHL2101059 Cend Therapeutics Inc.; QILU PHARMACEUTICAL CO. LTD.
2021/05/27Generic · Class 3 盐酸考尼伐坦预混型葡萄糖注射液CYHS2101216 吉林省博大伟业制药有限公司
2021/05/27Generic · Class 3 二十碳五烯酸乙酯软胶囊CYHS2101205 四川国为制药有限公司
2021/05/27New drug · Class 1 PA3-17注射液CXSL2101097 博生吉医药科技(苏州)有限公司
2021/05/27New drug · Class 1 注射用重组人源化单克隆抗体MIL97CXSL2101091 北京天广实生物技术股份有限公司

31 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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