药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2025/06/24 – 2025/06/30

Period
2025/06/24 to 2025/06/30, 7 days inclusive
Data as of
2026/11/05 06:00
Cached records
94,245 acceptance records, 11,689 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
310
Drugs with new generic filings (by drug name, de-duplicated)
54
Accepted this week, now under review
55

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

310filings, 72 of them generic

By application type

Application typeFilings
Supplement168
Generic72
New drug43
Import re-registration14
Import10
Unspecified3

By drug type

Drug typeFilings
Chemical drug181
TCM84
治疗用生物制品42
预防用生物制品2
Biologic1

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

54 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

206 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

75 this week

AcceptedDrugApplicants
2025/06/30Generic · Class 3 氨溴特罗口服溶液CYHS2502325 通化万通药业股份有限公司
2025/06/30New drug · Class 1 注射用DXC014CXSL2500523 杭州多禧生物科技有限公司
2025/06/28Import · Class 1 PF-07868489JXSL2500114 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.
2025/06/28Import · Class 1 VAY736注射液JXSL2500113 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/06/28Generic · Class 3 普瑞巴林缓释片CYHS2502317 石药集团欧意药业有限公司
2025/06/28Generic · Class 3 普瑞巴林缓释片CYHS2502316 石药集团欧意药业有限公司
2025/06/28Generic · Class 3 普瑞巴林缓释片CYHS2502315 石药集团欧意药业有限公司
2025/06/28Generic · Class 3 坎地沙坦酯氢氯噻嗪片(Ⅱ)CYHS2502312 江西施美药业股份有限公司
2025/06/28Generic · Class 3 坎地沙坦酯氢氯噻嗪片(Ⅰ)CYHS2502311 江西施美药业股份有限公司
2025/06/28Generic · Class 3 利多卡因丁卡因乳膏CYHS2502305 浙江孚诺医药股份有限公司
2025/06/28Generic · Class 3 瑞卢戈利片CYHL2500122 成都倍特药业股份有限公司
2025/06/28New drug · Class 1.1 补肾痹通丸CXZL2500042 新疆维吾尔自治区中医医院
2025/06/28New drug · Class 1 重组乙型肝炎治疗性疫苗CXSL2500522 远大赛威信生命科学(南京)有限公司; 远大赛威信生命科学(杭州)有限公司
2025/06/28New drug · Class 1 重组乙型肝炎治疗性疫苗CXSL2500521 远大赛威信生命科学(南京)有限公司; 远大赛威信生命科学(杭州)有限公司
2025/06/28New drug · Class 1 注射用MHB048CCXSL2500520 明慧医药(杭州)有限公司
2025/06/28New drug · Class 1 ALK2401片CXHL2500628 艾立康(合肥)医药科技有限公司
2025/06/28New drug · Class 1 ALK2401片CXHL2500627 艾立康(合肥)医药科技有限公司
2025/06/28New drug · Class 1 64Cu-TR2205注射液CXHL2500626 通瑞生物制药(成都)有限公司
2025/06/27Generic · Class 3 注射用氢化可的松琥珀酸钠CYHS2502300 湖南醇健制药科技有限公司; 国药集团容生制药有限公司
2025/06/27Generic · Class 3 氨磺必利口服溶液CYHS2502294 江苏贝佳制药有限公司
2025/06/27Generic · Class 3 依巴斯汀口服溶液CYHS2502291 海南斯达制药有限公司
2025/06/27New drug · Class 3.3 重组人促卵泡激素注射液CXSS2500071 成都景泽生物制药有限公司
2025/06/27New drug · Class 3.3 重组人促卵泡激素注射液CXSS2500070 成都景泽生物制药有限公司
2025/06/27New drug · Class 1 注射用QLC5508CXSL2500519 齐鲁制药有限公司
2025/06/27New drug · Class 2.2 培集成干扰素α-2注射液CXSL2500518 北京凯因科技股份有限公司
2025/06/27New drug · Class 1 QLH12016胶囊CXHL2500625 齐鲁制药有限公司
2025/06/27New drug · Class 1 QLH12016胶囊CXHL2500624 齐鲁制药有限公司
2025/06/27New drug · Class 1 ICP-332片CXHL2500621 广州诺诚健华医药科技有限公司
2025/06/26Import · Class 3.1 注射用A型肉毒毒素JXSS2500098 AbbVie Limited; Allergan Pharmaceuticals Ireland; Allergan Information Consulting (Shanghai) Co. Ltd.
2025/06/26Import · Class 3.1 注射用A型肉毒毒素JXSS2500097 AbbVie Limited; Allergan Pharmaceuticals Ireland; Allergan Information Consulting (Shanghai) Co. Ltd.

45 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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