药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2023/11/21 – 2023/11/27

Period
2023/11/21 to 2023/11/27, 7 days inclusive
Data as of
2026/11/06 06:00
Cached records
94,364 acceptance records, 11,708 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
331
Drugs with new generic filings (by drug name, de-duplicated)
67
Accepted this week, now under review
1

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

331filings, 95 of them generic

By application type

Application typeFilings
Supplement153
Generic95
New drug46
Import19
Unspecified12
Import re-registration6

By drug type

Drug typeFilings
Chemical drug235
TCM51
治疗用生物制品36
Biologic6
预防用生物制品3

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

67 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

216 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

102 this week

AcceptedDrugApplicants
2023/11/27Import · Class 1 MK-6194 注射液JXSL2300207 Merck Sharp & Dohme LLC; 不适用
2023/11/27Import · Class 1 MK-6194 注射液JXSL2300206 Merck Sharp & Dohme LLC; 不适用
2023/11/27Import · Class 1 MK-6194 注射液JXSL2300205 Merck Sharp & Dohme LLC; 不适用
2023/11/27Import · Class 1 MK-6194 注射液JXSL2300204 Merck Sharp & Dohme LLC; 不适用
2023/11/27Import · Class 1 MK-6194 注射液JXSL2300203 Merck Sharp & Dohme LLC; 不适用
2023/11/27New drug · Class 1 ADG126注射液CXSL2300810 天演药业(苏州)有限公司
2023/11/25Generic · Class 3 盐酸昂丹司琼片CYHS2303264 杭州沐源生物医药科技有限公司; 宁波美诺华天康药业有限公司
2023/11/25Generic · Class 3 盐酸昂丹司琼片CYHS2303263 杭州沐源生物医药科技有限公司; 宁波美诺华天康药业有限公司
2023/11/25Generic · Class 3 托拉塞米注射液CYHS2303262 湖南赛隆药业(长沙)有限公司; 湖南赛隆药业有限公司
2023/11/25Generic · Class 3 托拉塞米注射液CYHS2303261 湖南赛隆药业(长沙)有限公司; 湖南赛隆药业有限公司
2023/11/25Generic · Class 3 盐酸左西替利嗪口服溶液CYHS2303260 山东致泰医药技术有限公司; 华益泰康药业股份有限公司
2023/11/25Generic · Class 3 盐酸左西替利嗪口服溶液CYHS2303259 山东致泰医药技术有限公司; 华益泰康药业股份有限公司
2023/11/25Generic · Class 3 注射用硫酸多黏菌素BCYHS2303257 江苏利泰尔药业有限公司
2023/11/25Generic · Class 3 法莫替丁注射液CYHS2303256 国仁健康制药(北京)有限公司; 内蒙古白医制药股份有限公司
2023/11/25New drug · Class 1 WG1025CXSL2300809 北京唯源立康生物科技股份有限公司
2023/11/25New drug · Class 1 aT19注射液CXSL2300808 北京永泰瑞科生物科技有限公司
2023/11/25New drug · Class 1 GP681片CXHS2300106 江西青峰药业有限公司; 江西科睿药业有限公司
2023/11/24Generic · Class 3 福多司坦口服溶液CYHS2303253 江苏开元药业有限公司; 南京海纳制药有限公司
2023/11/24Generic · Class 3 氯化钾注射液CYHS2303251 北京布霖生物科技有限公司; 华夏生生药业(北京)有限公司
2023/11/24Generic · Class 3 腺苷钴胺胶囊CYHS2303246 河北东圣科宇医药科技有限公司; 石家庄市华新药业有限责任公司
2023/11/24Generic · Class 3 氯化钾颗粒CYHS2303245 贵州瑞和制药有限公司; 天津汉瑞药业有限公司
2023/11/24Generic · Class 3 氯化钾颗粒CYHS2303244 贵州瑞和制药有限公司; 天津汉瑞药业有限公司
2023/11/24Generic · Class 3 复方匹可硫酸钠颗粒CYHS2303242 北京柏雅联合药物研究所有限公司; 石家庄宇惠制药有限公司
2023/11/24Generic · Class 3 氟马西尼注射液CYHS2303241 上海旭东海普药业有限公司
2023/11/24Generic · Class 3 氟马西尼注射液CYHS2303240 上海旭东海普药业有限公司
2023/11/24Generic · Class 3 聚乙二醇3350散CYHS2303239 舒泰神(北京)生物制药股份有限公司
2023/11/24New drug · Class 1.1 辛芪通鼻片CXZS2300024 北京以岭药业有限公司; 石家庄以岭药业股份有限公司
2023/11/24New drug · Class 1 B013注射液CXSL2300807 上海上药交联医药科技有限公司
2023/11/24New drug · Class 1 GR2102注射液CXSL2300806 智翔(上海)医药科技有限公司; 重庆智翔金泰生物制药股份有限公司
2023/11/24New drug · Class 1 GR1802注射液CXSL2300805 重庆智翔金泰生物制药股份有限公司

72 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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