药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/01/23 – 2024/01/29

Period
2024/01/23 to 2024/01/29, 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
290
Drugs with new generic filings (by drug name, de-duplicated)
72
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

290filings, 94 of them generic

By application type

Application typeFilings
Supplement108
Generic94
New drug50
Import re-registration19
Import16
Unspecified2
药械组合产品1

By drug type

Drug typeFilings
Chemical drug206
TCM45
治疗用生物制品33
预防用生物制品5
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

72 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

199 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

101 this week

AcceptedDrugApplicants
2024/01/29Generic · Class 3 帕拉米韦注射液CYHS2400380 河南润弘制药股份有限公司
2024/01/29New drug · Class 1.1 喉喑清胶囊CXZS2400007 贵州瑞和制药有限公司
2024/01/28New drug · Class 1 FHND6091胶囊CXHL2400119 江苏正大丰海制药有限公司
2024/01/28New drug · Class 1 FHND6091胶囊CXHL2400118 江苏正大丰海制药有限公司
2024/01/27Generic · Class 3 盐酸甲氧氯普胺注射液CYHS2400373 河北凯威制药有限责任公司
2024/01/27Generic · Class 3 硫酸阿托品注射液CYHS2400371 河南普瑞药业有限公司
2024/01/27Generic · Class 3 氯化钾颗粒CYHS2400365 广州森荣医药科技有限公司; 金鸿药业股份有限公司
2024/01/27Generic · Class 3 氯化钾颗粒CYHS2400364 广州森荣医药科技有限公司; 金鸿药业股份有限公司
2024/01/27Generic · Class 3 氨基己酸注射液CYHS2400362 四环医药(郑州)有限公司
2024/01/27New drug · Class 3.3 利妥昔单抗注射液CXSS2400015 山东新时代药业有限公司
2024/01/26Import · Class 2.2 埃万妥单抗注射液JXSS2400004 Janssen-Cilag International NV; Cilag AG; Johnson & Johnson Pharmaceutical Ltd.
2024/01/26Import · Class 2.4 甲磺酸兰泽替尼片JXHS2400009 Janssen-Cilag International NV; JANSSEN CILAG S.P.A.; Johnson & Johnson Pharmaceutical Ltd.
2024/01/26Generic · Class 3 盐酸氢吗啡酮注射液CYHS2400358 国药集团工业有限公司廊坊分公司
2024/01/26Generic · Class 3 聚乙二醇3350散CYHS2400355 南京明生医药有限公司; 南京白敬宇制药有限责任公司
2024/01/26Generic · Class 3 复方匹可硫酸钠颗粒CYHS2400354 成都倍特得诺药业有限公司
2024/01/26Generic · Class 3 特利加压素注射液CYHS2400353 辰欣药业股份有限公司
2024/01/26New drug · Class 1.1 牛黄小儿退热贴CXZS2400006 健民药业集团股份有限公司
2024/01/26New drug · Class 1 IBR822细胞注射液CXSL2400067 英百瑞(杭州)生物医药有限公司
2024/01/26New drug · Class 3.3 ACYW135群脑膜炎球菌多糖结合疫苗(CRM197载体)CXSL2400066 辽宁成大生物股份有限公司; 北京成大天和生物科技有限公司; 成大生物(本溪)有限公司
2024/01/26New drug · Class 1 TQC3927吸入粉雾剂CXHL2400117 正大天晴药业集团股份有限公司
2024/01/26New drug · Class 1 TQC3927吸入粉雾剂CXHL2400116 正大天晴药业集团股份有限公司
2024/01/26New drug · Class 2.2 司美格鲁肽注射液CXHL2400115 华润双鹤药业股份有限公司
2024/01/26New drug · Class 2.2 司美格鲁肽注射液CXHL2400114 华润双鹤药业股份有限公司
2024/01/26New drug · Class 1 HJ-002-03片CXHL2400113 和径医药科技(上海)有限公司
2024/01/26New drug · Class 1 HJ-002-03片CXHL2400112 和径医药科技(上海)有限公司
2024/01/25Import · Class 2.2 度普利尤单抗注射液JXSS2400003 Sanofi-aventis groupe; Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2024/01/25Import · Class 2.2 度普利尤单抗注射液JXSS2400002 Sanofi-aventis groupe; Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2024/01/25Generic · Class 3 复合磷酸氢钾注射液CYHS2400350 北京民康百草医药科技有限公司; 山东华鲁制药有限公司
2024/01/25Generic · Class 3 盐酸美金刚口崩片CYHS2400349 合肥恩瑞特药业有限公司
2024/01/25Generic · Class 3 阿伐那非片CYHS2400348 扬州市三药制药有限公司

71 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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