YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 526 drug applications between 23 June 2026 and 29 June 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 73, covering 52 drug names.

2026/06/23 – 2026/06/29

Period
2026/06/23 to 2026/06/29, 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
526
Drugs with new generic filings (by drug name, de-duplicated)
52
Accepted this week, now under review
154

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

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
Therapeutic biologic74
Biologic4
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

52 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Nafamostat Mesilate for Injection11638
2Minoxidil Liniment3252
3Fosfomycin Sodium For Injection3116
4Ertugliflozin Tablets2213
5Methylprednisolone Sodium Succinate for injection2112
6环索奈德吸入气雾剂 · No verified English name210
7Tetracaine Hydrochloride Gel215
8Bromhexine Hydrochloride Oral Solution2122
9Terbutaline Sulfate Injection212
10马来酸左氨氯地平片 · No verified English name213

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

#Company (first applicant)FilingsDrugsGeneric
1Mu Dan Jiang Ling Tai Pharma Co., Ltd. romanized17160
2Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized1250
3Dong E E Jiao Co., Ltd. romanized10100
4Guizhou Yi Bai Nv Zi Da Pharmaceutical Factory Co., Ltd. romanized770
5AstraZeneca AB760
6Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized550
7Shenyang Dong Xin Pharma Co., Ltd. romanized550
8Janssen-Cilag International NV530
9Shanghai Shang Yao Xin Ya Pharma Co., Ltd. romanized520
10Shi Ze Bio Pharma (Shanghai) Co., Ltd. romanized520

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

117 this week

AcceptedDrugApplicants
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
2026/06/29New drug · Class 1 OX-1胶囊 · No verified English nameCXSL2600680 Wuhan Kang Fu De Bio Technology Co., Ltd. romanized; Wuhan Kang Fu De Mi Niao Xi Jie Shi Research Institute Co., Ltd. romanized
2026/06/29New drug · Class 1 OV329胶囊 · No verified English nameCXHL2600776 Di Mai Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/06/29New drug · Class 1 OV329胶囊 · No verified English nameCXHL2600775 Di Mai Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/06/29New drug · Class 1 SZJ0107片 · No verified English nameCXHL2600774 Anhui San Zhi Jian Pharmaceuticals Technology Co., Ltd. romanized
2026/06/29New drug · Class 1 BB3008片 · No verified English nameCXHL2600773 Beijing Bo Hui Bio Technology Co., Ltd. romanized
2026/06/29New drug · Class 1 BB3008片 · No verified English nameCXHL2600772 Beijing Bo Hui Bio Technology Co., Ltd. romanized
2026/06/29New drug · Class 2.2; 2.4 CZ028 · No verified English nameCXHL2600771 Zhejiang Cui Ze Biopharmaceuticals Co., Ltd. romanized
2026/06/29New drug · Class 1 HCXT-2001片 · No verified English nameCXHL2600770 Shanghai Han Chen Xing Tai Pharmaceuticals Technology Co., Ltd. romanized
2026/06/29New drug · Class 1 HCXT-2001片 · No verified English nameCXHL2600769 Shanghai Han Chen Xing Tai Pharmaceuticals Technology Co., Ltd. romanized
2026/06/26Import · Class 1 托雷奇单抗注射液 · No verified English nameJXSS2600055 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/06/26Generic · Class 3 聚普瑞锌口崩片 · No verified English nameCYHS2601515 Jilin Sheng Bo Da Wei Ye Pharmaceutical Co., Ltd. romanized
2026/06/26Generic · Class 3 比拉斯汀口崩片 · No verified English nameCYHS2601514 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2026/06/26Generic · Class 3 Terbutaline Sulfate InjectionCYHS2601511 Jiangsu Fu Bang Pharma Co., Ltd. romanized
2026/06/26Generic · Class 3 Terbutaline Sulfate InjectionCYHS2601509 Jiangsu Fu Bang Pharma Co., Ltd. romanized

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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