YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 478 drug applications between 24 June 2026 and 30 June 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 64, covering 50 drug names.

2026/06/24 – 2026/06/30

Period
2026/06/24 to 2026/06/30, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
478
Drugs with new generic filings (by drug name, de-duplicated)
50
Accepted this week, now under review
137

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.

Names with a public page are linked.

New acceptances this week

By application type and drug type

478filings, 64 of them generic

By application type

Application typeFilings
Supplement315
Generic64
New drug60
Import20
Unspecified11
Import re-registration8

By drug type

Drug typeFilings
Chemical drug216
TCM193
Therapeutic biologic63
Biologic5
Prophylactic biologic1

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

50 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Nafamostat Mesilate for Injection7438
2Fosfomycin Sodium For Injection3116
3Ertugliflozin Tablets2213
4Eplerenone Tablets214
5环索奈德吸入气雾剂 · No verified English name210
6Tetracaine Hydrochloride Gel215
7Bromhexine Hydrochloride Oral Solution2122
8Terbutaline Sulfate Injection212
91.5 mmol/L钙碳酸氢钠血滤置换液 · No verified English name111
10Upadacitinib Sustained-release Tablets1143

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

297 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized1780
2Mu Dan Jiang Ling Tai Pharma Co., Ltd. romanized10100
3Yan Tai Xin Ke Si Da Pharmaceuticals Technology Co., Ltd. romanized770
4Shandong Xin Shi Dai Pharma Co., Ltd. romanized660
5Chengdu Brilliant Pharmaceutical Co., Ltd.533
6Shanghai Shang Yao Xin Ya Pharma Co., Ltd. romanized520
7Shi Ze Bio Pharma (Shanghai) Co., Ltd. romanized520
8Dong E E Jiao Co., Ltd. romanized440
9Shanxi Guang Yu Yuan Guo Yao Co., Ltd. romanized440
10AstraZeneca AB430

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

109 this week

AcceptedDrugApplicants
2026/06/30Import · Class 1 Golcadomide胶囊 · No verified English nameJXHL2600237 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2026/06/30Import · Class 1 Golcadomide胶囊 · No verified English nameJXHL2600236 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2026/06/30Import · Class 1 Golcadomide胶囊 · No verified English nameJXHL2600235 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2026/06/30Import · Class 1 Golcadomide胶囊 · No verified English nameJXHL2600234 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2026/06/30Import · Class 1 BMS-986458片 · No verified English nameJXHL2600233 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2026/06/30Import · Class 1 BMS-986458片 · No verified English nameJXHL2600232 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2026/06/30Import · Class 2.4 Rilzabrutinib片 · No verified English nameJXHL2600231 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2026/06/30Generic · Class 3 Eplerenone TabletsCYHS2601535 Chengdu Brilliant Pharmaceutical Co., Ltd.
2026/06/30Generic · Class 3 Eplerenone TabletsCYHS2601534 Chengdu Brilliant Pharmaceutical Co., Ltd.
2026/06/30Generic · Class 3 Landiolol Hydrochloride for InjectionCYHS2601533 Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized
2026/06/30New drug · Class 1 人自体多克隆调节性T细胞注射液 · No verified English nameCXSL2600685 Shanghai Sai Er Xin Bio Medical Technology Co., Ltd. romanized
2026/06/30New drug · Class 1 注射用VBC106 · No verified English nameCXSL2600684 Shanghai Cheng Fan Pharmaceuticals Co., Ltd. romanized
2026/06/30New drug · Class 2.2 醋酸阿比特龙软胶囊 · No verified English nameCXHS2600093 Jiangsu He Chen Pharma Co., Ltd. romanized
2026/06/30New drug · Class 2.4 安奈拉唑钠肠溶片 · No verified English nameCXHS2600092 Xuan Zhu (Beijing) Pharmaceuticals Technology Co., Ltd. romanized; Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized
2026/06/29Import · Class 2.4 Revumenib片 · No verified English nameJXHL2600230 Syndax Pharmaceuticals Inc.; PAREXEL China Co. Ltd.
2026/06/29Import · Class 2.4 Revumenib片 · No verified English nameJXHL2600229 Syndax Pharmaceuticals Inc.; PAREXEL China Co. Ltd.
2026/06/29Import · Class 2.4 Revumenib片 · No verified English nameJXHL2600228 Syndax Pharmaceuticals Inc.; PAREXEL China Co. Ltd.
2026/06/29Generic · Class 3 Minoxidil LinimentCYHS2601529 Anhui De Hong Sheng Pharmaceutical Co., Ltd. romanized; Zhejiang Ding Tai Pharma Co., Ltd. romanized
2026/06/29Generic · Class 3 Tetracaine Hydrochloride GelCYHS2601527 Hunan Jiudian Pharmaceutical Co., Ltd
2026/06/29Generic · Class 3 Tetracaine Hydrochloride GelCYHS2601526 Hunan Jiudian Pharmaceutical Co., Ltd
2026/06/29Generic · Class 3 Regadenoson InjectionCYHS2601525 Kang Pu Pharma Co., Ltd. romanized
2026/06/29Generic · Class 3 Acetylcysteine TabletsCYHS2601524 Huayi Pharmaceuticals (Anhui) Co., Ltd.
2026/06/29Generic · Class 3 Calcium Acetate TabletsCYHS2601522 Heilongjiang Long De Pharma Co., Ltd. romanized
2026/06/29Generic · Class 3 Piracetam InjectionCYHS2601521 Chengdu Hua Yu Pharmaceutical Co., Ltd. romanized
2026/06/29Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601519 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2026/06/29Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601518 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2026/06/29New drug · Class 2.2 注射用瑞康曲妥珠单抗 · No verified English nameCXSS2600103 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Name not romanized
2026/06/29New drug · Class 1 SHR-4610注射液 · No verified English nameCXSL2600683 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/06/29New drug · Class 1 注射用HS-20093 · No verified English nameCXSL2600682 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2026/06/29New drug · Class 1 注射用HC029 · No verified English nameCXSL2600681 Shanghai Hong Cheng Pharma Co., Ltd. romanized

79 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.