药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2023/03/21 – 2023/03/27

Period
2023/03/21 to 2023/03/27, 7 days inclusive
Data as of
2026/11/07 06:00
Cached records
94,440 acceptance records, 11,686 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
279
Drugs with new generic filings (by drug name, de-duplicated)
49
Accepted this week, now under review
1

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

279filings, 66 of them generic

By application type

Application typeFilings
Supplement133
Generic66
New drug32
Import24
Unspecified18
Import re-registration6

By drug type

Drug typeFilings
Chemical drug204
TCM35
治疗用生物制品33
Biologic5
预防用生物制品2

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

49 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

174 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

81 this week

AcceptedDrugApplicants
2023/03/27Generic · Class 3 胞磷胆碱钠注射液CYHS2300904 北京四环科宝药业有限公司; 北京四环科宝制药股份有限公司
2023/03/27Generic · Class 3 胞磷胆碱钠注射液CYHS2300903 北京四环科宝药业有限公司; 北京四环科宝制药股份有限公司
2023/03/27New drug · Class 1 APG-2575片CXHL2300333 苏州亚盛药业有限公司
2023/03/27New drug · Class 1 APG-2575片CXHL2300332 苏州亚盛药业有限公司
2023/03/27New drug · Class 2.4 奥雷巴替尼片CXHL2300331 广州顺健生物医药科技有限公司
2023/03/25Import · Class 2.2 贝利尤单抗注射液(皮下注射)JXSL2300061 GlaxoSmithKline (Ireland) Limited; GlaxoSmithKline (China) Investment Company Limited
2023/03/25Generic · Class 3 盐酸去氧肾上腺素注射液CYHS2300901 石家庄四药有限公司
2023/03/25Generic · Class 3 聚乙烯醇滴眼液CYHS2300898 浙江恒研医药科技有限公司; 浙江赛默制药有限公司
2023/03/25Generic · Class 3 聚乙烯醇滴眼液CYHS2300897 四川海梦智森生物制药有限公司; 浙江赛默制药有限公司
2023/03/25New drug · Class 1 赛立奇单抗注射液CXSS2300015 重庆智翔金泰生物制药股份有限公司
2023/03/25New drug · Class 1 SHR-3167注射液CXSL2300216 江苏恒瑞医药股份有限公司
2023/03/25New drug · Class 1 HJ178胶囊CXHL2300330 成都华健未来科技有限公司
2023/03/25New drug · Class 1 HJ178胶囊CXHL2300329 成都华健未来科技有限公司
2023/03/24Import · Class 1 注射用SAR443579JXSL2300060 Sanofi-Aventis Recherche & Développement; SANOFI (CHINA) INVESTMENT CO. LTD
2023/03/24Import · Class 3.1 Bimekizumab注射液JXSL2300059 UCB Pharma S.A.; UCB Trading (Shanghai) Co. Ltd
2023/03/24Import · Class 1 Amlitelimab注射液JXSL2300058 Sanofi-Aventis Recherche & Développement; Sanofi(China) Investment Co. LTD
2023/03/24Import · Class 1 Zibotentan胶囊JXHL2300060 Astrazeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/03/24Import · Class 1 Zibotentan胶囊JXHL2300059 Astrazeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/03/24Import · Class 1 Zibotentan胶囊JXHL2300058 Astrazeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/03/24Import · Class 2.3 注射用氨曲南阿维巴坦JXHL2300057 Pfizer Inc.; Pfizer Investment CO. Ltd.
2023/03/24Generic · Class 3 注射用左亚叶酸钙CYHS2300895 四川百利药业有限责任公司
2023/03/24Generic · Class 3 帕米膦酸二钠注射液CYHS2300894 成都欣捷高新技术开发股份有限公司; 成都市海通药业有限公司
2023/03/24Generic · Class 3 帕米膦酸二钠注射液CYHS2300892 仁合益康集团有限公司; 河北仁合益康药业有限公司
2023/03/24Generic · Class 3 重酒石酸间羟胺注射液CYHS2300889 河南蓝图制药有限公司; 江苏悦兴药业有限公司
2023/03/24Generic · Class 3 阿立哌唑口崩片CYHS2300888 澳美制药(海南)有限公司
2023/03/24Generic · Class 3 阿立哌唑口崩片CYHS2300887 澳美制药(海南)有限公司
2023/03/24Generic · Class 3 聚乙烯醇滴眼液CYHS2300885 远大医药(中国)有限公司; 湖北远大天天明制药有限公司
2023/03/24Generic · Class 3 聚乙烯醇滴眼液CYHS2300884 远大医药(中国)有限公司; 湖北远大天天明制药有限公司
2023/03/24Generic · Class 3 西咪替丁注射液CYHS2300880 温岭市创新生物医药科技股份有限公司; 万邦德制药集团有限公司
2023/03/24Generic · Class 3 水溶性黄体酮注射液CYHS2300879 长春金赛药业有限责任公司; 吉林省金派格药业有限责任公司

51 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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