药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2023/10/31 – 2023/11/06

Period
2023/10/31 to 2023/11/06, 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
317
Drugs with new generic filings (by drug name, de-duplicated)
57
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

317filings, 74 of them generic

By application type

Application typeFilings
Supplement149
Generic74
New drug66
Import re-registration18
Import8
Unspecified2

By drug type

Drug typeFilings
Chemical drug204
TCM67
治疗用生物制品43
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

57 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

201 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
2023/11/06Generic · Class 3 复合磷酸氢钾注射液CYHS2303010 成都米子生物医药科技有限公司; 山东华鲁制药有限公司
2023/11/06New drug · Class 1 QR056240CR片CXHL2301223 武汉朗来科技发展有限公司
2023/11/06New drug · Class 1 QR056240CR片CXHL2301222 武汉朗来科技发展有限公司
2023/11/06New drug · Class 1 BGB-43395片CXHL2301221 百济神州(苏州)生物科技有限公司
2023/11/06New drug · Class 1 BGB-43395片CXHL2301220 百济神州(苏州)生物科技有限公司
2023/11/06New drug · Class 1 BGB-43395片CXHL2301219 百济神州(苏州)生物科技有限公司
2023/11/04Generic · Class 3 复合磷酸氢钾注射液CYHS2303008 成都欣捷高新技术开发股份有限公司; 山东华鲁制药有限公司
2023/11/04Generic · Class 3 富马酸酮替芬滴眼液CYHS2303005 成都慧德医药科技有限公司; 浙江赛默制药有限公司
2023/11/04Generic · Class 3 卡络磺钠注射液CYHS2303003 河北创健药业有限公司; 河北仁合益康药业有限公司
2023/11/04Generic · Class 3 卡络磺钠注射液CYHS2303002 河北创健药业有限公司; 河北仁合益康药业有限公司
2023/11/04Generic · Class 3 酮咯酸氨丁三醇注射液CYHS2303001 广州一品红制药有限公司; 河北凯威制药有限责任公司
2023/11/04Generic · Class 3 小儿复方氨基酸注射液(20AA)CYHS2302930 石家庄四药有限公司
2023/11/04New drug · Class 2.4 BAT4706注射液CXSL2300764 百奥泰生物制药股份有限公司
2023/11/04New drug · Class 2.4 BAT4706注射液CXSL2300763 百奥泰生物制药股份有限公司
2023/11/04New drug · Class 1 BAT7104注射液CXSL2300762 百奥泰生物制药股份有限公司
2023/11/04New drug · Class 1 GMCN-508B自体造血干祖细胞注射液CXSL2300761 中吉智药(南京)生物技术有限公司
2023/11/04New drug · Class 1 注射用间充质干细胞(脐带)CXSL2300760 天津昂赛细胞基因工程有限公司
2023/11/04New drug · Class 1 SHR0302片CXHS2300097 江苏恒瑞医药股份有限公司
2023/11/04New drug · Class 1 GH2616片CXHL2301218 勤浩医药(苏州)有限公司
2023/11/04New drug · Class 1 GH2616片CXHL2301217 勤浩医药(苏州)有限公司
2023/11/04New drug · Class 2.3 SZJ-208CXHL2301216 江西施美药业股份有限公司
2023/11/04New drug · Class 1 注射用双利司他CXHL2301215 广州必贝特医药股份有限公司
2023/11/03Import · Class 1 盐酸BAY 3283142片JXHL2300271 Bayer AG; Bayer Healthcare Company Ltd.
2023/11/03Import · Class 1 盐酸BAY 3283142片JXHL2300270 Bayer AG; Bayer Healthcare Company Ltd.
2023/11/03Generic · Class 3 甘油果糖氯化钠注射液CYHS2302989 湖北美林药业有限公司; 津药和平(天津)制药有限公司
2023/11/03Generic · Class 3 草酸艾司西酞普兰口服溶液CYHS2302987 苏州朗科生物技术股份有限公司; 南京海纳制药有限公司
2023/11/03Generic · Class 3 氯化钾注射液CYHS2302986 重庆万霖生物医药科技有限公司; 江苏大红鹰恒顺药业有限公司
2023/11/03New drug · Class 1 伊基奥仑赛注射液CXSL2300759 南京驯鹿生物医药有限公司
2023/11/03New drug · Class 1 PD-1基因编辑T细胞注射液CXSL2300758 美杰赛尔(北京)生物科技有限公司
2023/11/03New drug · Class 1 YTS104细胞注射液CXSL2300757 华夏英泰(北京)生物技术有限公司

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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