药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2026/01/20 – 2026/01/26

Period
2026/01/20 to 2026/01/26, 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
371
Drugs with new generic filings (by drug name, de-duplicated)
53
Accepted this week, now under review
102

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

371filings, 72 of them generic

By application type

Application typeFilings
Supplement171
New drug80
Generic72
Import34
Unspecified10
Import re-registration4

By drug type

Drug typeFilings
Chemical drug224
治疗用生物制品89
TCM54
Biologic2
体外诊断试剂1
预防用生物制品1

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

53 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

135 this week

AcceptedDrugApplicants
2026/01/26Generic · Class 3 注射用兰索拉唑CYHS2600280 山西德元堂药业有限公司
2026/01/26Generic · Class 3 小儿复方氨基酸注射液(20AA)CYHS2600276 山东齐都药业有限公司
2026/01/26New drug · Class 1 BG-A3004注射液CXSL2600129 广州百济神州生物制药有限公司
2026/01/26New drug · Class 1 EA5注射液皮下制剂CXSL2600126 山东览屹医药科技有限公司; 上海览屹医药科技有限公司
2026/01/26New drug · Class 2.1;2.2 泰它西普注射液CXSL2600125 荣昌生物制药(烟台)股份有限公司
2026/01/26New drug · Class 1 BCR-0003片CXHL2600123 浙江众神创新医药科技有限公司
2026/01/26New drug · Class 1 BCR-0003片CXHL2600122 浙江众神创新医药科技有限公司
2026/01/26New drug · Class 1 DC561043片CXHL2600121 中国科学院上海药物研究所; 临港国家实验室
2026/01/24Generic · Class 3 醋酸艾司利卡西平片CYHS2600270 上海上药中西制药有限公司; 常州制药厂有限公司
2026/01/24Generic · Class 3 醋酸艾司利卡西平片CYHS2600269 上海上药中西制药有限公司; 常州制药厂有限公司
2026/01/24Generic · Class 3 醋酸艾司利卡西平片CYHS2600268 上海上药中西制药有限公司; 常州制药厂有限公司
2026/01/24Generic · Class 3 醋酸艾司利卡西平片CYHS2600267 上海上药中西制药有限公司; 常州制药厂有限公司
2026/01/24New drug · Class 1 RSS0393乳胶CXHL2600120 瑞石生物医药有限公司
2026/01/24New drug · Class 1 RSS0393乳胶CXHL2600119 瑞石生物医药有限公司
2026/01/24New drug · Class 1 RSS0393乳胶CXHL2600118 瑞石生物医药有限公司
2026/01/24New drug · Class 1 SYH2069注射液CXHL2600117 北京抗创联生物制药技术研究有限公司; 石药集团欧意药业有限公司
2026/01/24New drug · Class 1 SYH2069注射液CXHL2600116 北京抗创联生物制药技术研究有限公司; 石药集团欧意药业有限公司
2026/01/24New drug · Class 1 SYH2069注射液CXHL2600115 北京抗创联生物制药技术研究有限公司; 石药集团欧意药业有限公司
2026/01/24New drug · Class 1 ACC085注射液CXHL2600114 江苏艾迪药业集团股份有限公司; 泸州艾迪医药技术有限公司
2026/01/24New drug · Class 1 HSK47388片(I)CXHL2600113 海思科医药集团股份有限公司
2026/01/24New drug · Class 1 HSK47388片(I)CXHL2600112 海思科医药集团股份有限公司
2026/01/23Import · Class 1 PF-08634404JXSL2600024 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/01/23Import · Class 1 PF-08634404JXSL2600023 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/01/23Import · Class 1 Bleximenib片JXHL2600029 Stichting Hemato-Oncologie voor Volwassenen Nederland; PPD Pharmaceutical Development (Beijing) Co. Ltd
2026/01/23Import · Class 1 Bleximenib片JXHL2600028 Stichting Hemato-Oncologie voor Volwassenen Nederland; PPD Pharmaceutical Development (Beijing) Co. Ltd
2026/01/23Import · Class 1 HTT227片JXHL2600027 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/01/23Generic · Class 3 吡拉西坦注射液CYHS2600266 以岭万洲国际制药有限公司
2026/01/23Generic · Class 3 盐酸去氧肾上腺素注射液CYHS2600259 绪必迪药业(沧州)有限公司; 河北凯威制药有限责任公司
2026/01/23Generic · Class 3 盐酸去氧肾上腺素注射液CYHS2600258 绪必迪药业(沧州)有限公司; 河北凯威制药有限责任公司
2026/01/23New drug · Class 1.1 丹元糖痹软膏CXZL2600012 杏林中医药科技(广州)有限公司

105 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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