药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2025/03/25 – 2025/03/31

Period
2025/03/25 to 2025/03/31, 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
352
Drugs with new generic filings (by drug name, de-duplicated)
60
Accepted this week, now under review
29

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

352filings, 88 of them generic

By application type

Application typeFilings
Supplement186
Generic88
New drug45
Import23
Import re-registration6
Unspecified3
药械组合1

By drug type

Drug typeFilings
Chemical drug244
治疗用生物制品53
TCM51
预防用生物制品4

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

60 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

204 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

102 this week

AcceptedDrugApplicants
2025/03/31New drug · Class 1 爱可仑赛注射液CXSS2500039 北京永泰生物制品有限公司
2025/03/29Generic · Class 3 马来酸曲美布汀片CYHS2501232 浙江东亚药业股份有限公司
2025/03/29Generic · Class 3 马来酸曲美布汀片CYHS2501231 浙江东亚药业股份有限公司
2025/03/29Generic · Class 3 厄贝沙坦氨氯地平片(III)CYHS2501230 浙江昂利康制药股份有限公司
2025/03/29Generic · Class 3 维生素B6注射液CYHS2501229 湖南先施制药有限公司
2025/03/29Generic · Class 3 厄贝沙坦氨氯地平片(I)CYHS2501228 浙江昂利康制药股份有限公司
2025/03/29Generic · Class 3 重酒石酸卡巴拉汀口服溶液CYHS2501227 海南海和制药有限公司; 华益药业科技(安徽)有限公司
2025/03/29Generic · Class 3 重酒石酸卡巴拉汀口服溶液CYHS2501226 海南海和制药有限公司; 华益药业科技(安徽)有限公司
2025/03/29New drug · Class 2.2 AKZ002直服颗粒CXHL2500343 海南爱科制药有限公司
2025/03/28Import · Class 3.1 度伐利尤单抗注射液JXSS2500038 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/03/28Import · Class 3.1 度伐利尤单抗注射液JXSS2500037 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/03/28Import · Class 1 Empasiprubart注射用浓溶液JXSL2500047 argenx BV; PPD Pharmaceutical Development(Beijing)Co.,Ltd.
2025/03/28Import · Class 1 PF-07985045片JXHL2500066 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.
2025/03/28Import · Class 1 PF-07985045片JXHL2500065 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.
2025/03/28Import · Class 1 Orforglipron胶囊JXHL2500064 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/03/28Import · Class 1 Orforglipron胶囊JXHL2500063 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/03/28Import · Class 1 Orforglipron胶囊JXHL2500062 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/03/28Import · Class 1 Orforglipron胶囊JXHL2500061 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/03/28Import · Class 1 Orforglipron胶囊JXHL2500060 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/03/28Import · Class 1 Orforglipron胶囊JXHL2500059 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/03/28Generic · Class 3 盐酸依匹斯汀滴眼液CYHS2501218 参天制药(中国)有限公司
2025/03/28Generic · Class 3 法莫替丁注射液CYHS2501216 山西铭羽生物科技有限公司; 甘肃成纪生物药业有限公司
2025/03/28Generic · Class 3 法莫替丁注射液CYHS2501215 山西铭羽生物科技有限公司; 甘肃成纪生物药业有限公司
2025/03/28Generic · Class 3 盐酸达克罗宁局部溶液剂CYHL2500073 深圳珐玛易药品科技有限公司
2025/03/28Generic · Class 3 溴莫尼定凝胶CYHL2500072 深圳珐玛易药品科技有限公司
2025/03/28New drug · Class 2.2 布瑞哌唑口溶膜CXHS2500026 南通慧聚制药有限公司
2025/03/28New drug · Class 2.2 布瑞哌唑口溶膜CXHS2500025 南通慧聚制药有限公司
2025/03/28New drug · Class 1 DZD6008片CXHL2500342 迪哲(江苏)医药股份有限公司; 迪哲(上海)医药有限公司
2025/03/28New drug · Class 1 DZD6008片CXHL2500341 迪哲(江苏)医药股份有限公司; 迪哲(上海)医药有限公司
2025/03/28New drug · Class 1 DZD6008片CXHL2500340 迪哲(江苏)医药股份有限公司; 迪哲(上海)医药有限公司

72 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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