药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/03/26 – 2024/04/01

Period
2024/03/26 to 2024/04/01, 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
285
Drugs with new generic filings (by drug name, de-duplicated)
63
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

285filings, 84 of them generic

By application type

Application typeFilings
Supplement128
Generic84
New drug36
Import20
Import re-registration10
Unspecified7

By drug type

Drug typeFilings
Chemical drug207
TCM37
治疗用生物制品37
Biologic3
预防用生物制品1

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

63 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

185 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

97 this week

AcceptedDrugApplicants
2024/04/01Generic · Class 3 盐酸曲唑酮片CYHS2400983 江西科睿药业有限公司
2024/04/01Generic · Class 3 盐酸克林霉素棕榈酸酯颗粒CYHS2400981 海南海神同洲制药有限公司
2024/04/01Generic · Class 3 己酮可可碱缓释片CYHS2400980 广东君康药业有限公司; 天津药物研究院药业有限责任公司
2024/04/01New drug · Class 2.2 CB371口溶膜CXHL2400325 杭州成邦医药科技有限公司
2024/03/30Import · Class 1 盐酸BAY 3283142片JXHL2400076 Bayer AG; Bayer Healthcare Company Ltd.
2024/03/30Import · Class 1 盐酸BAY 3283142片JXHL2400075 Bayer AG; Bayer Healthcare Company Ltd.
2024/03/30Generic · Class 3 米诺地尔搽剂CYHS2400977 山东华铂凯盛生物科技有限公司; 烟台鲁银药业有限公司
2024/03/30Generic · Class 3 米诺地尔搽剂CYHS2400976 山东华铂凯盛生物科技有限公司; 烟台鲁银药业有限公司
2024/03/30Generic · Class 3 己酮可可碱注射液CYHS2400975 江西远超医药科技有限公司; 浙江赛默制药有限公司
2024/03/30Generic · Class 3 注射用尼可地尔CYHS2400972 福建泽瑞药业有限公司; 四川制药制剂有限公司
2024/03/30Generic · Class 3 注射用尼可地尔CYHS2400971 福建泽瑞药业有限公司; 四川制药制剂有限公司
2024/03/30New drug · Class 2.2 BCM875口溶膜CXHL2400324 上海云晟研新生物科技有限公司
2024/03/30New drug · Class 2.2 BCM857口溶膜CXHL2400323 上海云晟研新生物科技有限公司
2024/03/30New drug · Class 2.2 BCM857口溶膜CXHL2400322 上海云晟研新生物科技有限公司
2024/03/30New drug · Class 2.2 ASKC200搽剂CXHL2400321 江苏奥赛康药业有限公司
2024/03/30New drug · Class 2.2 ASKC200搽剂CXHL2400320 江苏奥赛康药业有限公司
2024/03/29Import · Class 1 SasanlimabJXSL2400064 Pfizer Inc.; Pfizer Investment CO. Ltd.
2024/03/29Import · Class 1 PF-07820435片JXHL2400074 Pfizer Inc.; Pfizer Investment CO. Ltd
2024/03/29Import · Class 1 PF-07820435片JXHL2400073 Pfizer Inc.; Pfizer Investment CO. Ltd
2024/03/29Import · Class 1 PF-07820435片JXHL2400072 Pfizer Inc.; Pfizer Investment CO. Ltd
2024/03/29Import · Class 1 PF-07820435片JXHL2400071 Pfizer Inc.; Pfizer Investment CO. Ltd
2024/03/29Generic · Class 3 地拉罗司颗粒CYHS2400968 上海复星医药产业发展有限公司; 苏州二叶制药有限公司
2024/03/29Generic · Class 3 托拉塞米注射液CYHS2400967 北京百美特生物制药有限公司; 杭州民生药业股份有限公司
2024/03/29Generic · Class 3 托拉塞米注射液CYHS2400965 北京百美特生物制药有限公司; 杭州民生药业股份有限公司
2024/03/29Generic · Class 3 盐酸溴己新注射液CYHS2400963 云南药科院生物医药股份有限公司; 楚雄和创药业有限责任公司
2024/03/29Generic · Class 3 复方电解质醋酸钠注射液CYHS2400960 南京恩泰医药科技有限公司; 江苏大红鹰恒顺药业有限公司
2024/03/29Generic · Class 3 复方电解质醋酸钠注射液CYHS2400959 南京恩泰医药科技有限公司; 江苏大红鹰恒顺药业有限公司
2024/03/29Generic · Class 3 二羟丙茶碱注射液CYHS2400958 福建品腾药业有限公司; 山东方明药业集团股份有限公司
2024/03/29Generic · Class 3 硝苯地平缓释片(II)CYHS2400954 河北山姆士药业有限公司
2024/03/29Generic · Class 3 米诺地尔搽剂CYHS2400953 嘉实(湖南)医药科技有限公司; 岳阳新华达制药有限公司

67 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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