药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/05/07 – 2024/05/13

Period
2024/05/07 to 2024/05/13, 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
417
Drugs with new generic filings (by drug name, de-duplicated)
89
Accepted this week, now under review
4

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

417filings, 120 of them generic

By application type

Application typeFilings
Supplement172
Generic120
New drug79
Import30
Import re-registration11
Unspecified5

By drug type

Drug typeFilings
Chemical drug297
TCM61
治疗用生物制品57
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

89 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

239 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

149 this week

AcceptedDrugApplicants
2024/05/13Import · Class 2.4 Upadacitinib片JXHL2400112 AbbVie Inc.
2024/05/13Import · Class 2.4 Upadacitinib片JXHL2400111 AbbVie Inc.
2024/05/13Import · Class 2.4 Upadacitinib片JXHL2400110 AbbVie Inc.
2024/05/13Import · Class 2.4 镥(177Lu)vipivotide tetraxetan注射液JXHL2400109 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/05/13Import · Class 2.4 镥(177Lu)vipivotide tetraxetan注射液JXHL2400108 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/05/13Generic · Class 3 法莫替丁注射液CYHS2401441 成都倍特药业股份有限公司
2024/05/13Generic · Class 3 坎地氢噻片CYHS2401435 北京福元医药股份有限公司
2024/05/13Generic · Class 3 甘露醇山梨醇注射液CYHL2400092 湖北欣泽霏药业有限公司
2024/05/13New drug · Class 1 APH01727片CXHL2400473 广州一品红制药有限公司
2024/05/13New drug · Class 1 D3S-001胶囊CXHL2400472 德昇济医药(无锡)有限公司
2024/05/13New drug · Class 1 D3S-001胶囊CXHL2400471 德昇济医药(无锡)有限公司
2024/05/12Import · Class 2.2 马昔腾坦分散片JXHL2400107 Actelion Pharmaceuticals Ltd; Johnson & Johnson (China) Investment Ltd.
2024/05/12Generic · Class 3 盐酸多巴胺注射液CYHS2401431 海南普利制药股份有限公司
2024/05/12New drug · Class 1 塔戈利单抗注射液CXSS2400049 四川科伦博泰生物医药股份有限公司
2024/05/12New drug · Class 1 CM512注射液CXSL2400309 康诺亚生物医药科技(成都)有限公司
2024/05/12New drug · Class 1 重组I型单纯疱疹病毒R130注射液(Vero细胞)CXSL2400308 上海允英生物医药科技有限公司
2024/05/12New drug · Class 2.4 枸橼酸舒芬太尼注射液CXHL2400470 宜昌人福药业有限责任公司
2024/05/12New drug · Class 2.4 枸橼酸舒芬太尼注射液CXHL2400469 宜昌人福药业有限责任公司
2024/05/12New drug · Class 2.4 枸橼酸舒芬太尼注射液CXHL2400468 宜昌人福药业有限责任公司
2024/05/12New drug · Class 2.4 枸橼酸舒芬太尼注射液CXHL2400467 宜昌人福药业有限责任公司
2024/05/12New drug · Class 2.4 枸橼酸舒芬太尼注射液CXHL2400466 宜昌人福药业有限责任公司
2024/05/12New drug · Class 1 HRS-4508片CXHL2400465 江苏恒瑞医药股份有限公司
2024/05/12New drug · Class 1 HRS-4508片CXHL2400464 江苏恒瑞医药股份有限公司
2024/05/11Import · Class 2.2 古塞奇尤单抗注射液JXSL2400091 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/05/11Import · Class 2.2 古塞奇尤单抗注射液JXSL2400090 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/05/11Import · Class 2.2 古塞奇尤单抗注射液JXSL2400089 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/05/11Import · Class 2.2;2.4 盐酸氨酮戊酸己酯软膏光动力治疗系统JXHS2400035 ASIERIS MEDITECH (Hong Kong) CO. LIMITED; Bioglan AB; Jiangsu Yahong Meditech Co. Ltd.
2024/05/11Import · Class 1 BI 690517片JXHL2400106 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/05/11Generic · Class 3 盐酸多西环素片CYHS2401422 浙江赛默制药有限公司
2024/05/11Generic · Class 3 盐酸多西环素片CYHS2401421 浙江赛默制药有限公司

119 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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