药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/07/02 – 2024/07/08

Period
2024/07/02 to 2024/07/08, 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
387
Drugs with new generic filings (by drug name, de-duplicated)
78
Accepted this week, now under review
5

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

387filings, 109 of them generic

By application type

Application typeFilings
Supplement189
Generic109
New drug41
Import25
Import re-registration15
Unspecified8

By drug type

Drug typeFilings
Chemical drug284
治疗用生物制品48
TCM47
预防用生物制品8

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

78 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

234 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
2024/07/08Import · Class 1 PF-06821497片JXHL2400166 Pfizer Inc.; Pfizer Investment Co. Ltd.
2024/07/08Import · Class 1 PF-06821497片JXHL2400165 Pfizer Inc.; Pfizer Investment Co. Ltd.
2024/07/08Generic · Class 3 复合磷酸氢钾注射液CYHS2402065 石家庄迪斯凯威医药科技有限公司; 知和(山东)大药厂有限公司
2024/07/08Generic · Class 3 米诺地尔搽剂CYHS2402064 武汉华尔生物科技有限公司; 江西德成制药有限公司
2024/07/08Generic · Class 3 米诺地尔搽剂CYHS2402063 河北义海医药科技有限公司; 丽彩甘肃西峰制药有限公司
2024/07/08Generic · Class 3 米诺地尔搽剂CYHS2402062 河北义海医药科技有限公司; 丽彩甘肃西峰制药有限公司
2024/07/08Generic · Class 3 维生素B6注射液CYHS2402061 济川药业集团有限公司
2024/07/08Generic · Class 3 阿仑膦酸钠口服溶液CYHS2402058 湖南普道医药技术有限公司; 湖南九典制药股份有限公司
2024/07/08New drug · Class 1 SCTB35注射液CXSL2400435 神州细胞工程有限公司
2024/07/08New drug · Class 3.2 皮下注射人免疫球蛋白CXSL2400434 四川远大蜀阳药业有限责任公司
2024/07/08New drug · Class 1 TDI01混悬液CXHL2400663 北京泰德制药股份有限公司
2024/07/08New drug · Class 1 HBW-004285片CXHL2400662 成都海博为药业有限公司
2024/07/08New drug · Class 1 注射用NC527-XCXHL2400661 浙江海擘生物科技有限公司
2024/07/06Import · Class 1 Bleximenib片JXHL2400164 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/07/06Import · Class 1 Bleximenib片JXHL2400163 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/07/06Import · Class 1 Bleximenib片JXHL2400162 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/07/06Generic · Class 3 普瑞巴林口服溶液CYHS2402049 浙江赛默制药有限公司
2024/07/06Generic · Class 3 替比培南匹伏酯细粒剂CYHL2400135 石药集团中诺药业(石家庄)有限公司
2024/07/06Generic · Class 3 布洛芬盐酸去氧肾上腺素片CYHL2400134 北京阳光诺和药物研究股份有限公司
2024/07/06New drug · Class 1 ZL-1218注射液CXSL2400433 再鼎医药(上海)有限公司
2024/07/06New drug · Class 3.3 注射用人生长激素CXSL2400432 长春生物制品研究所有限责任公司
2024/07/06New drug · Class 3.3 冻干人用狂犬病疫苗(人二倍体细胞)CXSL2400431 复星雅立峰(大连)生物制药有限公司
2024/07/06New drug · Class 2.2 三价流感病毒裂解疫苗(MDCK细胞)CXSL2400430 成都欧林生物科技股份有限公司; 兰州百灵生物技术有限公司; 成都新诺明生物科技有限公司
2024/07/06New drug · Class 1 SDTM001注射液CXSL2400429 赛德特生物制药有限公司
2024/07/06New drug · Class 1 DX1002片CXHL2400660 广州安好医药科技有限公司
2024/07/06New drug · Class 1 DX1002片CXHL2400659 广州安好医药科技有限公司
2024/07/05Import · Class 2.4 DS-3201b片JXHL2400161 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2024/07/05Import · Class 2.4 DS-3201b片JXHL2400160 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2024/07/05Generic · Class 3 阿莫西林克拉维酸钾片(8:1)CYHS2402042 昆明源瑞制药有限公司
2024/07/05Generic · Class 3 琥珀酸亚铁片CYHS2402039 浙江华海药业股份有限公司

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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