药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2025/03/11 – 2025/03/17

Period
2025/03/11 to 2025/03/17, 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
376
Drugs with new generic filings (by drug name, de-duplicated)
64
Accepted this week, now under review
27

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

376filings, 95 of them generic

By application type

Application typeFilings
Supplement169
Generic95
New drug49
Import re-registration23
Import21
Unspecified19

By drug type

Drug typeFilings
Chemical drug286
TCM45
治疗用生物制品41
Biologic2
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

64 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

211 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

100 this week

AcceptedDrugApplicants
2025/03/17Import · Class 1 [225Ac]Ac-PSMA-617注射液JXHL2500047 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/03/15Import · Class 2.2 度普利尤单抗注射液JXSS2500026 Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2025/03/15Import · Class 2.2 度普利尤单抗注射液JXSS2500025 Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2025/03/15Import · Class 1 ADI-001JXSL2500038 Adicet Therapeutics Inc.; Shanghai Adicet Biotechnology Co. Ltd.
2025/03/15Import · Class 1 VSA001注射液JXHL2500045 Arrowhead Pharmaceuticals Inc.; Sanofi (China) Investment Co. Ltd.
2025/03/15Generic · Class 3 碳酸镧颗粒CYHS2501085 江西施美药业股份有限公司
2025/03/15Generic · Class 3 碳酸镧颗粒CYHS2501084 江西施美药业股份有限公司
2025/03/15Generic · Class 3 聚乙二醇3350散CYHS2501080 嘉实(湖南)医药科技有限公司; 湖南天济草堂制药股份有限公司
2025/03/15Generic · Class 3 腺苷钴胺胶囊CYHS2501078 湖南方盛制药股份有限公司
2025/03/15Generic · Class 3 尼莫地平口服溶液CYHS2501074 石家庄四药有限公司; 浙江国镜药业有限公司
2025/03/15New drug · Class 1.2 SOC201胶囊CXZL2500017 中国科学院上海药物研究所; 芷江润甜甜茶生物技术有限公司
2025/03/15New drug · Class 1.2 SOC201提取物CXZL2500016 中国科学院上海药物研究所; 芷江润甜甜茶生物技术有限公司
2025/03/15New drug · Class 1.1 小儿热立清颗粒CXZL2500015 奇正(珠海市横琴)国际医药有限公司; 甘肃奇正藏药有限公司
2025/03/15New drug · Class 1 注射用AK146D1CXSL2500227 中山康方生物医药有限公司
2025/03/15New drug · Class 1 JWK002注射液CXSL2500225 武汉金唯科生物科技有限公司; 成都金唯科生物科技有限公司
2025/03/15New drug · Class 1 GLS-W1100胶囊CXSL2500224 杭州远大生物制药有限公司
2025/03/15New drug · Class 1 玛氘诺沙韦片CXHS2500022 嘉兴安帝康生物科技有限公司; 上海合全医药有限公司
2025/03/15New drug · Class 1 塞拉维诺片CXHL2500291 中国科学院上海药物研究所; 首都医科大学附属北京天坛医院
2025/03/15New drug · Class 1 塞拉维诺片CXHL2500290 中国科学院上海药物研究所; 首都医科大学附属北京天坛医院
2025/03/15New drug · Class 2.2 PDX-04CXHL2500289 湖南九典制药股份有限公司
2025/03/15New drug · Class 2.2 PDX-04CXHL2500288 湖南九典制药股份有限公司
2025/03/15New drug · Class 1 伊匹乌肽散剂CXHL2500287 益承康泰(厦门)生物科技有限公司
2025/03/15New drug · Class 1 ZYS-1肠溶片CXHL2500286 北京科佑爱科技有限责任公司
2025/03/15New drug · Class 2.2 KEM2414直服颗粒CXHL2500285 深圳珐玛易药品科技有限公司
2025/03/15New drug · Class 1 PLB1004胶囊CXHL2500284 鞍石药业(宁波)有限责任公司
2025/03/15New drug · Class 1 PLB1004胶囊CXHL2500283 鞍石药业(宁波)有限责任公司
2025/03/14Import · Class 1 TQJ230注射液JXHL2500044 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/03/14Import · Class 1 ELVN-001胶囊JXHL2500043 Enliven Therapeutics Inc.; R&G PharmaStudies Co. Ltd.
2025/03/14Generic · Class 3 腺苷钴胺胶囊CYHS2501064 山东益康药业股份有限公司
2025/03/14Generic · Class 3 法莫替丁注射液CYHS2501060 安徽美来药业股份有限公司; 裕松源药业有限公司

70 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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