药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2026/06/16 – 2026/06/22

Period
2026/06/16 to 2026/06/22, 7 days inclusive
Data as of
2026/11/03 06:00
Cached records
94,050 acceptance records, 11,694 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
383
Drugs with new generic filings (by drug name, de-duplicated)
37
Accepted this week, now under review
109

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

383filings, 49 of them generic

By application type

Application typeFilings
Supplement236
New drug58
Generic49
Import20
Unspecified10
Import re-registration10

By drug type

Drug typeFilings
Chemical drug168
TCM144
治疗用生物制品62
预防用生物制品6
Biologic3

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

37 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

227 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 no longer on the under-review list whose last snapshot sighting falls in this week, meaning approved or terminated, to be verified. Companies are counted by first applicant.

Class 3 and new-drug acceptances

104 this week

AcceptedDrugApplicants
2026/06/22Import · Class 2.4 甲苯磺酸他拉唑帕利胶囊JXHS2600071 Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd.
2026/06/22Import · Class 2.4 甲苯磺酸他拉唑帕利胶囊JXHS2600070 Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd.
2026/06/22Import · Class 2.4 甲苯磺酸他拉唑帕利胶囊JXHS2600069 Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd.
2026/06/22Import · Class 2.4 甲苯磺酸他拉唑帕利胶囊JXHS2600068 Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd.
2026/06/22Generic · Class 3 乙酰半胱氨酸片CYHS2601460 浙江金华康恩贝生物制药有限公司
2026/06/22Generic · Class 3 盐酸多西环素片CYHS2601459 福建海西新药创制股份有限公司
2026/06/22New drug · Class 3.1 清金化痰汤颗粒CXZS2600032 湖南九典制药股份有限公司
2026/06/22New drug · Class 1 注射用LYNC-101CXSL2600660 翎泰天润生物技术(上海)有限公司
2026/06/22New drug · Class 1 TVAX-008注射液CXSL2600659 远大赛威信生命科学(杭州)有限公司
2026/06/22New drug · Class 1.2 新型流感病毒mRNA疫苗CXSL2600658 华兰生物疫苗股份有限公司
2026/06/22New drug · Class 1 MT2004胶囊CXHL2600745 西安奥立泰医药科技有限公司
2026/06/22New drug · Class 1 MT2004胶囊CXHL2600744 西安奥立泰医药科技有限公司
2026/06/22New drug · Class 1 AHB-137注射液CXHL2600743 杭州浩博医药有限公司
2026/06/18Import · Class 1 BI 764532 输注用浓缩粉末JXSL2600146 Boehringer lngelheim International GmbH; Boehringer lngelheim (China) Investment Co. Ltd.
2026/06/18Generic · Class 3 注射用甲磺酸萘莫司他CYHS2601456 山东百诺医药股份有限公司; 吉林津升制药有限公司
2026/06/18Generic · Class 3 注射用甲磺酸萘莫司他CYHS2601455 山东百诺医药股份有限公司; 吉林津升制药有限公司
2026/06/18Generic · Class 3 富马酸依美斯汀缓释胶囊CYHS2601452 桂林华信制药有限公司
2026/06/18Generic · Class 3 富马酸依美斯汀缓释胶囊CYHS2601451 桂林华信制药有限公司
2026/06/18Generic · Class 3 对乙酰氨基酚甘露醇注射液CYHS2601450 广州南新制药有限公司; 东莞市普济药业有限公司
2026/06/18Generic · Class 3 盐酸普萘洛尔口服溶液CYHS2601449 江苏天士力帝益药业有限公司
2026/06/18Generic · Class 3 盐酸氨溴索滴剂CYHS2601448 江苏天士力帝益药业有限公司
2026/06/18New drug · Class 1 Pumitamig注射液CXSL2600657 百欧恩泰(上海)医药有限公司
2026/06/18New drug · Class 1 HEC-921注射液CXSL2600656 东莞市东阳光生物药研发有限公司; 广东东阳光药业股份有限公司
2026/06/18New drug · Class 1 YKYY033注射液CXHL2600742 北京悦康科创医药科技股份有限公司; 杭州天龙药业有限公司
2026/06/18New drug · Class 1 YKYY033注射液CXHL2600741 北京悦康科创医药科技股份有限公司; 杭州天龙药业有限公司
2026/06/18New drug · Class 2.3 TSL2402片CXHL2600740 天津天士力圣特制药有限公司; 中国药科大学
2026/06/17Import · Class 1 Lunsekimig注射液JXSL2600145 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2026/06/17Import · Class 1 HDP-101JXSL2600144 Heidelberg Pharma AG; Hangzhou Zhongmei HuaDong Pharmaceutical Co. Ltd.
2026/06/17Import · Class 1 ASP2138注射液JXSL2600143 Astellas Pharma Global Development Inc.; Astellas (Beijing) Pharmaceutical R&D Co. Ltd.
2026/06/17Generic · Class 3 氯化琥珀胆碱注射液CYHS2601444 北京远方通达医药技术有限公司; 山西威奇达光明制药有限公司

74 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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