药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2026/06/23 – 2026/06/29

Period
2026/06/23 to 2026/06/29, 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
526
Drugs with new generic filings (by drug name, de-duplicated)
52
Accepted this week, now under review
165

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

526filings, 73 of them generic

By application type

Application typeFilings
Supplement356
Generic73
New drug66
Import18
Unspecified10
Import re-registration3

By drug type

Drug typeFilings
TCM232
Chemical drug215
治疗用生物制品74
Biologic4
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

52 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

311 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

117 this week

AcceptedDrugApplicants
2026/06/29Import · Class 2.4 Revumenib片JXHL2600230 Syndax Pharmaceuticals Inc.; PAREXEL China Co. Ltd.
2026/06/29Import · Class 2.4 Revumenib片JXHL2600229 Syndax Pharmaceuticals Inc.; PAREXEL China Co. Ltd.
2026/06/29Import · Class 2.4 Revumenib片JXHL2600228 Syndax Pharmaceuticals Inc.; PAREXEL China Co. Ltd.
2026/06/29Generic · Class 3 米诺地尔搽剂CYHS2601529 安徽得宏生制药有限公司; 浙江鼎泰药业股份有限公司
2026/06/29Generic · Class 3 盐酸丁卡因凝胶CYHS2601527 湖南九典制药股份有限公司
2026/06/29Generic · Class 3 盐酸丁卡因凝胶CYHS2601526 湖南九典制药股份有限公司
2026/06/29Generic · Class 3 瑞加诺生注射液CYHS2601525 康普药业股份有限公司
2026/06/29Generic · Class 3 乙酰半胱氨酸片CYHS2601524 华益药业科技(安徽)有限公司
2026/06/29Generic · Class 3 醋酸钙片CYHS2601522 黑龙江龙德药业有限公司
2026/06/29Generic · Class 3 吡拉西坦注射液CYHS2601521 成都华宇制药有限公司
2026/06/29Generic · Class 3 注射用甲磺酸萘莫司他CYHS2601519 成都青山利康药业股份有限公司; 湖南科伦制药有限公司
2026/06/29Generic · Class 3 注射用甲磺酸萘莫司他CYHS2601518 成都青山利康药业股份有限公司; 湖南科伦制药有限公司
2026/06/29New drug · Class 2.2 注射用瑞康曲妥珠单抗CXSS2600103 苏州盛迪亚生物医药有限公司; 苏州盛迪亚生物医药有限公司(小分子SHR169106:江苏恒瑞医药股份有限公司)
2026/06/29New drug · Class 1 SHR-4610注射液CXSL2600683 上海盛迪医药有限公司
2026/06/29New drug · Class 1 注射用HS-20093CXSL2600682 上海翰森生物医药科技有限公司; 常州恒邦药业有限公司
2026/06/29New drug · Class 1 注射用HC029CXSL2600681 上海宏成药业有限公司
2026/06/29New drug · Class 1 OX-1胶囊CXSL2600680 武汉康复得生物科技股份有限公司; 武汉康复得泌尿系结石研究院有限公司
2026/06/29New drug · Class 1 OV329胶囊CXHL2600776 缔脉生物医药科技(上海)有限公司
2026/06/29New drug · Class 1 OV329胶囊CXHL2600775 缔脉生物医药科技(上海)有限公司
2026/06/29New drug · Class 1 SZJ0107片CXHL2600774 安徽三之健医药科技有限公司
2026/06/29New drug · Class 1 BB3008片CXHL2600773 北京伯汇生物技术有限公司
2026/06/29New drug · Class 1 BB3008片CXHL2600772 北京伯汇生物技术有限公司
2026/06/29New drug · Class 2.2;2.4 CZ028CXHL2600771 浙江萃泽生物医药有限公司
2026/06/29New drug · Class 1 HCXT-2001片CXHL2600770 上海瀚辰星泰医药科技有限公司
2026/06/29New drug · Class 1 HCXT-2001片CXHL2600769 上海瀚辰星泰医药科技有限公司
2026/06/26Import · Class 1 托雷奇单抗注射液JXSS2600055 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/06/26Generic · Class 3 聚普瑞锌口崩片CYHS2601515 吉林省博大伟业制药有限公司
2026/06/26Generic · Class 3 比拉斯汀口崩片CYHS2601514 山东朗诺制药有限公司
2026/06/26Generic · Class 3 硫酸特布他林注射液CYHS2601511 江苏福邦药业有限公司
2026/06/26Generic · Class 3 硫酸特布他林注射液CYHS2601509 江苏福邦药业有限公司

87 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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