药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2025/03/18 – 2025/03/24

Period
2025/03/18 to 2025/03/24, 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
308
Drugs with new generic filings (by drug name, de-duplicated)
55
Accepted this week, now under review
22

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

308filings, 71 of them generic

By application type

Application typeFilings
Supplement159
Generic71
New drug44
Import20
Unspecified9
Import re-registration5

By drug type

Drug typeFilings
Chemical drug209
TCM48
治疗用生物制品43
预防用生物制品8

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

55 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

183 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

94 this week

AcceptedDrugApplicants
2025/03/24Import · Class 1 Golcadomide胶囊JXHL2500055 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2025/03/24Import · Class 1 Golcadomide胶囊JXHL2500054 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2025/03/24Import · Class 1 Golcadomide胶囊JXHL2500053 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2025/03/24Import · Class 1 Golcadomide胶囊JXHL2500052 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2025/03/24New drug · Class 1 Alpha-0261片CXHL2500316 深圳阿尔法分子科技有限责任公司
2025/03/24New drug · Class 1 Alpha-0261片CXHL2500315 深圳阿尔法分子科技有限责任公司
2025/03/22Import · Class 2.2 利妥昔单抗注射液JXSS2500036 Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH
2025/03/22Import · Class 2.2 利妥昔单抗注射液JXSS2500035 Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH
2025/03/22Import · Class 2.2 利妥昔单抗注射液JXSS2500034 Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH
2025/03/22Import · Class 2.2 利妥昔单抗注射液JXSS2500033 Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH
2025/03/22Import · Class 2.2 利妥昔单抗注射液JXSS2500032 Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH
2025/03/22Import · Class 2.2 利妥昔单抗注射液JXSS2500031 Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH
2025/03/22Import · Class 2.2 利妥昔单抗注射液JXSS2500030 Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH
2025/03/22Import · Class 2.2 利妥昔单抗注射液JXSS2500029 Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH
2025/03/22Import · Class 3.1 度伐利尤单抗注射液JXSS2500028 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/03/22Import · Class 3.1 度伐利尤单抗注射液JXSS2500027 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/03/22Import · Class 1 MK-1084片JXHL2500051 Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2025/03/22Import · Class 1 MK-1084片JXHL2500050 Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2025/03/22Generic · Class 3 秋水仙碱片CYHS2501148 一加药业(湖北)有限公司; 浙江浙北药业有限公司
2025/03/22Generic · Class 3 重酒石酸去甲肾上腺素注射液CYHS2501147 上海炫鑫医药科技有限公司; 山东方明药业集团股份有限公司
2025/03/22Generic · Class 3 酮洛芬凝胶贴膏CYHL2500064 北京阳光诺和药物研究股份有限公司
2025/03/22New drug · Class 3.2 流感病毒裂解疫苗(BK-01佐剂)CXSL2500240 长春百克生物科技股份公司
2025/03/22New drug · Class 3.2 流感病毒裂解疫苗(BK-01佐剂)CXSL2500239 长春百克生物科技股份公司
2025/03/22New drug · Class 1 GenSci134注射液CXSL2500238 长春金赛药业有限责任公司
2025/03/22New drug · Class 1 GenSci134注射液CXSL2500237 长春金赛药业有限责任公司
2025/03/22New drug · Class 2.4 CMCY2501片CXHL2500314 杭州中美华东制药有限公司
2025/03/21Generic · Class 3 碘[131I]化钠口服溶液CYHS2501145 成都欣科医药有限公司
2025/03/21Generic · Class 3 乙酰唑胺片CYHS2501142 上海理想制药有限公司
2025/03/21New drug · Class 3.3 流感病毒裂解疫苗CXSS2500037 成大生物(本溪)有限公司
2025/03/21New drug · Class 1 BT02单克隆抗体注射液CXSL2500236 上海柏全生物科技有限公司

64 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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