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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 308 drug applications between 18 March 2025 and 24 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 71, covering 55 drug names.

2025/03/18 – 2025/03/24

Period
2025/03/18 to 2025/03/24, 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
308
Drugs with new generic filings (by drug name, de-duplicated)
55
Accepted this week, now under review
21

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

308filings, 71 of them generic

By application type

Application typeFilings
Supplement159
Generic71
New drug44
Import20
Unspecified9
Import re-registration5

By drug type

Drug typeFilings
Chemical drug209
TCM48
Therapeutic biologic43
Prophylactic biologic8

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

55 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Mupirocin Ointment3130
2氧(气态) · No verified English name221
3Sodium Iodide[131I] Oral Solution222
4Canagliflozin Tablets218
5Diclofenac Diethylamine Emulgel2120
6Vonoprazan Fumarate Tablets2160
7Hydrocortisone Sodium Succinate for Injection2116
8Loxoprofen Sodium Patches2130
9Lidocaine Hydrochloride Injection216
10Bupivacaine Hydrochloride Injection214

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

183 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

94 this week

AcceptedDrugApplicants
2025/03/24Import · Class 1 Golcadomide胶囊 · No verified English nameJXHL2500055 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2025/03/24Import · Class 1 Golcadomide胶囊 · No verified English nameJXHL2500054 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2025/03/24Import · Class 1 Golcadomide胶囊 · No verified English nameJXHL2500053 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2025/03/24Import · Class 1 Golcadomide胶囊 · No verified English nameJXHL2500052 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2025/03/24New drug · Class 1 Alpha-0261片 · No verified English nameCXHL2500316 Shenzhen A Er Fa Fen Zi Technology Co., Ltd. romanized
2025/03/24New drug · Class 1 Alpha-0261片 · No verified English nameCXHL2500315 Shenzhen A Er Fa Fen Zi Technology Co., Ltd. romanized
2025/03/22Import · Class 2.2 利妥昔单抗注射液 · No verified English nameJXSS2500036 Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH
2025/03/22Import · Class 2.2 利妥昔单抗注射液 · No verified English nameJXSS2500035 Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH
2025/03/22Import · Class 2.2 利妥昔单抗注射液 · No verified English nameJXSS2500034 Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH
2025/03/22Import · Class 2.2 利妥昔单抗注射液 · No verified English nameJXSS2500033 Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH
2025/03/22Import · Class 2.2 利妥昔单抗注射液 · No verified English nameJXSS2500032 Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH
2025/03/22Import · Class 2.2 利妥昔单抗注射液 · No verified English nameJXSS2500031 Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH
2025/03/22Import · Class 2.2 利妥昔单抗注射液 · No verified English nameJXSS2500030 Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH
2025/03/22Import · Class 2.2 利妥昔单抗注射液 · No verified English nameJXSS2500029 Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH
2025/03/22Import · Class 3.1 度伐利尤单抗注射液 · No verified English nameJXSS2500028 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/03/22Import · Class 3.1 度伐利尤单抗注射液 · No verified English nameJXSS2500027 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/03/22Import · Class 1 MK-1084片 · No verified English nameJXHL2500051 Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2025/03/22Import · Class 1 MK-1084片 · No verified English nameJXHL2500050 Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2025/03/22Generic · Class 3 Colchicine TabletsCYHS2501148 Yi Jia Pharma (Hubei) Co., Ltd. romanized; Zhejiang Zhe Bei Pharma Co., Ltd. romanized
2025/03/22Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2501147 Shanghai Xuan Xin Pharmaceuticals Technology Co., Ltd. romanized; Shandong Fang Ming Pharma Group Co., Ltd. romanized
2025/03/22Generic · Class 3 酮洛芬凝胶贴膏 · No verified English nameCYHL2500064 Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized
2025/03/22New drug · Class 3.2 流感病毒裂解疫苗(BK-01佐剂) · No verified English nameCXSL2500240 Changchun Bai Ke Bio Technology Shareholding Company romanized
2025/03/22New drug · Class 3.2 流感病毒裂解疫苗(BK-01佐剂) · No verified English nameCXSL2500239 Changchun Bai Ke Bio Technology Shareholding Company romanized
2025/03/22New drug · Class 1 GenSci134注射液 · No verified English nameCXSL2500238 Changchun Jin Sai Pharma Co., Ltd. romanized
2025/03/22New drug · Class 1 GenSci134注射液 · No verified English nameCXSL2500237 Changchun Jin Sai Pharma Co., Ltd. romanized
2025/03/22New drug · Class 2.4 CMCY2501片 · No verified English nameCXHL2500314 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2025/03/21Generic · Class 3 Sodium Iodide[131I] Oral SolutionCYHS2501145 Chengdu Xin Ke Pharmaceuticals Co., Ltd. romanized
2025/03/21Generic · Class 3 Acetazolamide TabletsCYHS2501142 Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized
2025/03/21New drug · Class 3.3 流感病毒裂解疫苗 · No verified English nameCXSS2500037 Cheng Da Bio (Ben Xi) Co., Ltd. romanized
2025/03/21New drug · Class 1 BT02单克隆抗体注射液 · No verified English nameCXSL2500236 Shanghai Bai Quan Bio Technology Co., Ltd. romanized

64 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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