药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2023/11/07 – 2023/11/13

Period
2023/11/07 to 2023/11/13, 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
378
Drugs with new generic filings (by drug name, de-duplicated)
69
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

378filings, 104 of them generic

By application type

Application typeFilings
Supplement188
Generic104
New drug54
Import14
Unspecified11
Import re-registration7

By drug type

Drug typeFilings
Chemical drug265
TCM84
治疗用生物制品27
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

69 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

214 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

118 this week

AcceptedDrugApplicants
2023/11/13Generic · Class 3 甲硫酸新斯的明注射液CYHS2303109 杭州民生药业股份有限公司
2023/11/13Generic · Class 3 甲硫酸新斯的明注射液CYHS2303108 杭州民生药业股份有限公司
2023/11/13Generic · Class 3 甲硫酸新斯的明注射液CYHS2303107 杭州民生药业股份有限公司
2023/11/13Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液CYHS2303106 山东京卫制药有限公司
2023/11/13Generic · Class 3 盐酸苯海拉明片CYHS2303105 长春海悦药业股份有限公司
2023/11/11Import · Class 2.2 帕博利珠单抗注射液JXSL2300192 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2023/11/11Generic · Class 3 氯化钾颗粒CYHS2303100 山西皇城相府药业股份有限公司
2023/11/11Generic · Class 3 氯化钾颗粒CYHS2303099 山西皇城相府药业股份有限公司
2023/11/11New drug · Class 1 ZS805注射液CXSL2300775 四川至善唯新生物科技有限公司
2023/11/11New drug · Class 1 注射用MK-2870CXSL2300774 默沙东研发(中国)有限公司
2023/11/11New drug · Class 2.4;2.2 硫酸阿托品滴眼液CXHL2301262 乐普药业股份有限公司
2023/11/11New drug · Class 2.4;2.2 硫酸阿托品滴眼液CXHL2301261 乐普药业股份有限公司
2023/11/11New drug · Class 2.4 盐酸氨酮戊酸颗粒剂CXHL2301260 上海复旦张江生物医药股份有限公司
2023/11/11New drug · Class 1 FCN-338片CXHL2301259 上海复星医药产业发展有限公司
2023/11/11New drug · Class 1 FCN-338片CXHL2301258 上海复星医药产业发展有限公司
2023/11/11New drug · Class 2.4 硫酸阿托品滴眼液CXHL2301257 苏州欧康维视生物科技有限公司
2023/11/11New drug · Class 2.4 硫酸阿托品滴眼液CXHL2301256 苏州欧康维视生物科技有限公司
2023/11/10Import · Class 2.3 马昔腾坦他达拉非片JXHL2300281 Actelion Pharmaceuticals Ltd; Johnson & Johnson (China) Investment Ltd.
2023/11/10Import · Class 1 LNP023胶囊JXHL2300280 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2023/11/10Generic · Class 3 氯化钾口服溶液CYHS2303094 山东朗诺制药有限公司
2023/11/10Generic · Class 3 醋酸钠林格注射液CYHS2303093 浙江康吉尔药业有限公司
2023/11/10Generic · Class 3 对乙酰氨基酚布洛芬片CYHS2303092 长春澜江医药科技有限公司; 植恩生物技术股份有限公司
2023/11/10Generic · Class 3 维生素K1注射液CYHS2303088 海南倍特药业有限公司
2023/11/10Generic · Class 3 维生素K1注射液CYHS2303087 海南倍特药业有限公司
2023/11/10Generic · Class 3 吡格列酮二甲双胍片CYHS2303085 江苏安必生制药有限公司
2023/11/10Generic · Class 3 布洛芬注射液CYHL2300136 山东新华制药股份有限公司
2023/11/10New drug · Class 3.4 人凝血酶原复合物CXSS2300087 国药集团兰州生物制药有限公司
2023/11/10New drug · Class 1 重组抗IL-1β人源化单克隆抗体注射液CXSL2300773 三生国健药业(上海)股份有限公司
2023/11/10New drug · Class 1 BR115注射液CXSL2300772 浙江博锐生物制药有限公司; 海正生物制药有限公司; 成都恩沐生物科技有限公司
2023/11/10New drug · Class 1 注射用AMT-116CXSL2300771 普众发现医药科技(上海)有限公司

88 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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