药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/01/09 – 2024/01/15

Period
2024/01/09 to 2024/01/15, 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
382
Drugs with new generic filings (by drug name, de-duplicated)
102
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

382filings, 136 of them generic

By application type

Application typeFilings
Supplement141
Generic136
New drug69
Import23
Import re-registration10
Unspecified3

By drug type

Drug typeFilings
Chemical drug286
TCM45
治疗用生物制品45
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

102 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

235 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

145 this week

AcceptedDrugApplicants
2024/01/15Generic · Class 3 盐酸羟考酮片CYHS2400213 宜昌人福药业有限责任公司
2024/01/15Generic · Class 3 盐酸羟考酮片CYHS2400212 宜昌人福药业有限责任公司
2024/01/15Generic · Class 3 注射用苯唑西林钠CYHS2400211 山东如至生物医药科技有限公司; 山东二叶制药有限公司
2024/01/15Generic · Class 3 注射用苯唑西林钠CYHS2400210 山东如至生物医药科技有限公司; 山东二叶制药有限公司
2024/01/15Generic · Class 3 硝苯地平缓释片(II)CYHS2400208 浙江京新药业股份有限公司
2024/01/15New drug · Class 2.4 醋酸阿比特龙片(Ⅱ)CXHL2400071 成都盛迪医药有限公司
2024/01/13Generic · Class 3 腺苷钴胺胶囊CYHS2400206 海南紫程众投生物科技有限公司; 天津市中央药业有限公司
2024/01/13Generic · Class 3 苯磺酸氨氯地平口崩片CYHS2400205 广东万泰科创药业有限公司; 深圳信立泰药业股份有限公司
2024/01/13Generic · Class 3 苯磺酸氨氯地平口崩片CYHS2400204 广东万泰科创药业有限公司; 深圳信立泰药业股份有限公司
2024/01/13Generic · Class 3 琥珀酸亚铁片CYHS2400200 华益药业科技(安徽)有限公司
2024/01/13Generic · Class 3 阿奇霉素颗粒CYHS2400199 重庆莱美药业股份有限公司
2024/01/13Generic · Class 3 氯化钾口服溶液CYHS2400197 苏州朗科生物技术股份有限公司; 南京海纳制药有限公司
2024/01/13Generic · Class 3 联苯苄唑溶液CYHS2400194 福元药业有限公司
2024/01/13Generic · Class 3 普瑞巴林缓释片CYHL2400019 石药集团欧意药业有限公司
2024/01/13Generic · Class 3 普瑞巴林缓释片CYHL2400018 石药集团欧意药业有限公司
2024/01/13Generic · Class 3 普瑞巴林缓释片CYHL2400017 石药集团欧意药业有限公司
2024/01/13New drug · Class 1.1 香术平胃散CXZL2400003 江苏中雍红瑞制药有限公司
2024/01/13New drug · Class 1 HB0046注射液CXSL2400029 上海华奥泰生物药业股份有限公司; 华博生物医药技术(上海)有限公司
2024/01/13New drug · Class 1 JX2105胶囊CXHL2400070 浙江京新药业股份有限公司
2024/01/13New drug · Class 1 JX2105胶囊CXHL2400069 浙江京新药业股份有限公司
2024/01/13New drug · Class 1 JX2105胶囊CXHL2400068 浙江京新药业股份有限公司
2024/01/13New drug · Class 1 JX2105胶囊CXHL2400067 浙江京新药业股份有限公司
2024/01/13New drug · Class 2.2 SL-0013片CXHL2400066 上海则正生物医药股份有限公司; 山东大学
2024/01/12Import · Class 1 Amlitelimab注射液JXSL2400018 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/01/12Import · Class 1 Amlitelimab注射液JXSL2400017 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/01/12Import · Class 1 Amlitelimab注射液JXSL2400016 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/01/12Import · Class 1 Amlitelimab注射液JXSL2400015 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/01/12Import · Class 1 Amlitelimab注射液JXSL2400014 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/01/12Import · Class 1 Amlitelimab注射液JXSL2400013 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/01/12Generic · Class 3 氯化钾颗粒CYHS2400193 福州基石医药科技有限公司

115 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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