药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2023/04/25 – 2023/05/01

Period
2023/04/25 to 2023/05/01, 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
367
Drugs with new generic filings (by drug name, de-duplicated)
41
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

367filings, 61 of them generic

By application type

Application typeFilings
Supplement203
Generic61
New drug55
Import29
Import re-registration12
Unspecified7

By drug type

Drug typeFilings
Chemical drug242
TCM66
治疗用生物制品53
预防用生物制品4
Biologic2

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

41 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

189 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

96 this week

AcceptedDrugApplicants
2023/04/29Import · Class 1 MK-6024注射液JXSL2300085 Merck Sharp & Dohme LLC; MSD R&D(China)Co. Ltd.
2023/04/29Import · Class 1 MK-6024注射液JXSL2300084 Merck Sharp & Dohme LLC; MSD R&D(China)Co. Ltd.
2023/04/29Import · Class 1 MK-6024注射液JXSL2300083 Merck Sharp & Dohme LLC; MSD R&D(China)Co. Ltd.
2023/04/29Import · Class 1 MK-6024注射液JXSL2300082 Merck Sharp & Dohme LLC; MSD R&D(China)Co. Ltd.
2023/04/29Import · Class 1 BBP-398胶囊JXHL2300102 LianBio Development (HK) Limited; Shanghai LianBio Development Co. Ltd.
2023/04/29Import · Class 1 BBP-398胶囊JXHL2300101 LianBio Development (HK) Limited; Shanghai LianBio Development Co. Ltd.
2023/04/29Import · Class 1 AMG 890JXHL2300100 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd.
2023/04/29Generic · Class 3 氨溴特罗口服溶液CYHS2301203 海南全星制药有限公司
2023/04/29Generic · Class 3 头孢丙烯干混悬剂CYHS2301198 广东恒健制药有限公司
2023/04/29Generic · Class 3 己酮可可碱注射液CYHS2301197 华夏生生药业(北京)有限公司
2023/04/29Generic · Class 3 盐酸甲哌卡因注射液CYHS2301195 济南辰欣医药科技有限公司; 辰欣药业股份有限公司
2023/04/29New drug · Class 3.3 水痘减毒活疫苗CXSL2300299 中逸安科生物技术股份有限公司; 辽宁茂康源生物科技有限公司
2023/04/29New drug · Class 1 重组抗PEAR1人源化单克隆抗体雾化吸入溶液CXSL2300298 上海循曜生物科技有限公司
2023/04/29New drug · Class 2.4 注射用左亚叶酸CXHL2300453 上海汇伦医药股份有限公司
2023/04/29New drug · Class 2.4 注射用左亚叶酸CXHL2300452 上海汇伦医药股份有限公司
2023/04/29New drug · Class 1 PG-011凝胶CXHL2300451 北京普祺医药科技股份有限公司
2023/04/29New drug · Class 1 PG-011凝胶CXHL2300450 北京普祺医药科技股份有限公司
2023/04/29New drug · Class 1 BPYT-01胶囊CXHL2300449 百极优棠(广东)医药科技有限公司
2023/04/29New drug · Class 1 TQB3454片CXHL2300448 正大天晴药业集团股份有限公司
2023/04/29New drug · Class 1 BPYT-01胶囊CXHL2300447 百极优棠(广东)医药科技有限公司
2023/04/29New drug · Class 1 TQB3454片CXHL2300446 正大天晴药业集团股份有限公司
2023/04/28Import · Class 2.2 TV-44749JXHL2300099 Teva Branded Pharmaceutical Products R&D Inc.
2023/04/28Generic · Class 3 氢化可的松缓释片CYHL2300068 津药药业股份有限公司
2023/04/28Generic · Class 3 氢化可的松缓释片CYHL2300067 津药药业股份有限公司
2023/04/28New drug · Class 3.1 芍药甘草颗粒CXZS2300010 神威药业集团有限公司
2023/04/28New drug · Class 1 SNP201注射液CXSL2300297 赛神(上海)医药科技有限公司
2023/04/28New drug · Class 2.2 注射用重组改构人肿瘤坏死因子CXSL2300296 上海唯科生物制药有限公司
2023/04/28New drug · Class 1 JY016注射液CXSL2300295 北京东方百泰生物科技股份有限公司; 北京精益泰翔技术发展有限公司
2023/04/28New drug · Class 1 VGM-R02bCXSL2300294 上海天泽云泰生物医药有限公司
2023/04/28New drug · Class 1 QB0208-1胶囊CXHL2300445 北京清博汇能医药科技有限公司

66 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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