药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2023/08/29 – 2023/09/04

Period
2023/08/29 to 2023/09/04, 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
334
Drugs with new generic filings (by drug name, de-duplicated)
66
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

334filings, 90 of them generic

By application type

Application typeFilings
Supplement172
Generic90
New drug52
Import13
Import re-registration5
Unspecified2

By drug type

Drug typeFilings
Chemical drug234
TCM58
治疗用生物制品34
预防用生物制品6
体外诊断试剂1
Biologic1

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

66 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

204 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

94 this week

AcceptedDrugApplicants
2023/09/04Generic · Class 3 己酮可可碱注射液CYHS2302369 山西惠达林曦医药科技有限公司; 山西威奇达光明制药有限公司
2023/09/02Generic · Class 3 氯化钾注射液CYHS2302366 海南欧若拉生物技术有限公司; 江苏大红鹰恒顺药业有限公司
2023/09/02Generic · Class 3 吲哚布芬片CYHS2302365 深圳市朗博生物医药股份有限公司; 亚宝药业太原制药有限公司
2023/09/02Generic · Class 3 吲哚布芬片CYHS2302364 深圳市朗博生物医药股份有限公司; 亚宝药业太原制药有限公司
2023/09/02Generic · Class 3 法莫替丁注射液CYHS2302358 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
2023/09/02Generic · Class 3 顺铂注射液CYHS2302357 吉斯美(武汉)制药有限公司
2023/09/02New drug · Class 2.1 清喉咽含片CXZS2300018 浙江康恩贝制药股份有限公司; 苏州吴淞江制药有限公司
2023/09/02New drug · Class 1.2 洋常春藤叶口服液CXZL2300058 浙江康恩贝中药有限公司
2023/09/02New drug · Class 1.2 洋常春藤叶提取物CXZL2300057 浙江康恩贝中药有限公司
2023/09/02New drug · Class 3.4 人凝血因子IXCXSL2300595 华兰生物工程股份有限公司
2023/09/02New drug · Class 2.2 大流行流感全病毒灭活疫苗(H5N1)CXSL2300594 武汉生物制品研究所有限责任公司; 兰州百灵生物技术有限公司
2023/09/02New drug · Class 3.4 人纤维蛋白原CXSL2300593 广东丹霞生物制药有限公司
2023/09/02New drug · Class 3.4 人纤维蛋白原CXSL2300592 广东丹霞生物制药有限公司
2023/09/02New drug · Class 1 177Lu-LNC1003 注射液CXHL2300945 烟台蓝纳成生物技术有限公司
2023/09/02New drug · Class 2.2 氢溴酸伏硫西汀口崩片CXHL2300944 深圳市泛谷药业股份有限公司
2023/09/02New drug · Class 2.2 氢溴酸伏硫西汀口崩片CXHL2300943 深圳市泛谷药业股份有限公司
2023/09/02New drug · Class 1 YR001软膏CXHL2300942 杭州壹瑞医药科技有限公司
2023/09/02New drug · Class 1 YR001软膏CXHL2300941 杭州壹瑞医药科技有限公司
2023/09/01Import · Class 1 BI 765049 输注用粉末JXSL2300162 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/01Import · Class 1 AUP1602-CJXSL2300161 Aurealis Therapeutics AG; Shenzhen Xbiome Biotech Co. Ltd.
2023/09/01Import · Class 2.2 Anifrolumab注射液JXSL2300160 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2023/09/01Generic · Class 3 布美他尼注射液CYHS2302349 成都赛璟生物医药科技有限公司; 成都市海通药业有限公司
2023/09/01Generic · Class 3 氯化钾注射液CYHS2302346 广州合和医药有限公司; 广东星昊药业有限公司
2023/09/01Generic · Class 3 硫酸沙丁胺醇注射液CYHS2302342 华夏生生药业(北京)有限公司
2023/09/01Generic · Class 3 吸入用雷芬那辛溶液CYHL2300111 武汉人福利康药业有限公司
2023/09/01New drug · Class 1 注射用RC108CXSL2300591 荣昌生物制药(烟台)股份有限公司
2023/09/01New drug · Class 1 HB0025注射液CXSL2300590 华博生物医药技术(上海)有限公司
2023/09/01New drug · Class 1 HB0025注射液CXSL2300589 华博生物医药技术(上海)有限公司
2023/09/01New drug · Class 2.2 布地奈德福莫特罗吸入粉雾剂(胶囊型)CXHL2300939 珠海瑞思普利医药科技有限公司
2023/09/01New drug · Class 2.4 羟乙磺酸达尔西利片CXHL2300938 江苏恒瑞医药股份有限公司

64 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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