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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 391 drug applications between 24 April 2025 and 30 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 90, covering 74 drug names.

2025/04/24 – 2025/04/30

Period
2025/04/24 to 2025/04/30, 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
391
Drugs with new generic filings (by drug name, de-duplicated)
74
Accepted this week, now under review
44

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

391filings, 90 of them generic

By application type

Application typeFilings
Supplement206
Generic90
New drug52
Import24
Unspecified12
Import re-registration6
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug266
TCM82
Therapeutic biologic33
Biologic5
Prophylactic biologic5

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

74 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Pemafibrate Tablets4423
2Vonoprazan Fumarate Tablets3260
3Ferrous Succinate Tablets2220
4Eperisone Hydrochloride Tablets228
5Adapalene Gel2230
6Diclofenac Sodium Sustained Release Tablets2110
7Dimethyl Fumarate Delayed-release Capsules210
8Tandospirone Citrate Tablets212
9注射用头孢唑肟钠 · No verified English name214
10Levobupivacaine Hydrochloride Injection212

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

226 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shenyang Dong Xin Pharma Co., Ltd. romanized33260
2Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized16100
3Dan Dong Hong Ye Pharmaceutical Co., Ltd. romanized880
4Eli Lilly and Company820
5Guangdong Dong Yang Guang Pharma Co., Ltd. romanized630
6Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
7Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized550
8Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized550
9Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized544
10Janssen-Cilag International NV520

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

99 this week

AcceptedDrugApplicants
2025/04/30Generic · Class 3 Multiple Electrolytes and Sodium Acetate InjectionCYHS2501623 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/04/30Generic · Class 3 Famotidine InjectionCYHS2501619 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Hangzhou Minsheng Pharmaceutical Co., Ltd
2025/04/30Generic · Class 3 Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2501617 Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized
2025/04/30New drug · Class 1 靶向CD19和CD22 的嵌合抗原受体自体T细胞注射液 · No verified English nameCXSL2500344 Shanghai Pharmaceuticals Group Bio Zhi Liao Technology Co., Ltd. romanized
2025/04/30New drug · Class 1 注射用YL242 · No verified English nameCXSL2500343 Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized
2025/04/30New drug · Class 1 DF-003胶囊 · No verified English nameCXHL2500428 Shanghai Yao Yuan Bio Technology Co., Ltd. romanized
2025/04/30New drug · Class 1 DF-003胶囊 · No verified English nameCXHL2500427 Shanghai Yao Yuan Bio Technology Co., Ltd. romanized
2025/04/30New drug · Class 1 DF-003胶囊 · No verified English nameCXHL2500426 Shanghai Yao Yuan Bio Technology Co., Ltd. romanized
2025/04/30New drug · Class 1 G201-Na胶囊 · No verified English nameCXHL2500425 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized
2025/04/30New drug · Class 1 G201-Na胶囊 · No verified English nameCXHL2500424 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized
2025/04/29Import · Class 1 Mezagitamab注射剂 · No verified English nameJXSL2500067 Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited
2025/04/29Import · Class 1 Mezagitamab注射剂 · No verified English nameJXSL2500066 Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited
2025/04/29Import · Class 1 TQJ230注射液 · No verified English nameJXHL2500103 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/04/29Generic · Class 3 Metaraminol Tartrate InjectionCYHS2501612 Shanghai Xian Dai Ha Sen (Shang Qiu) Pharma Co., Ltd. romanized
2025/04/29Generic · Class 3 Potassium Phosphates InjectionCYHS2501611 Hebei Tian Cheng Pharma Co., Ltd. romanized
2025/04/29Generic · Class 3 Bumetanide InjectionCYHS2501608 Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized
2025/04/29Generic · Class 3 Lidocaine Hydrochloride GelCYHS2501605 Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2025/04/29Generic · Class 3 Betahistine Dihydrochloride TabletsCYHS2501601 Jin Zhou Jiu Tai Pharma Co., Ltd. romanized
2025/04/29Generic · Class 3 小儿多种维生素注射液(13) · No verified English nameCYHS2501600 Hefei Shi Wei Lai Drug Kai Fa Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2025/04/29Generic · Class 3 Spironolactone Oral SuspensionCYHS2501599 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2025/04/29New drug · Class 2.1 TFA003片 · No verified English nameCXZL2500028 Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized
2025/04/29New drug · Class 1 BBT001注射液 · No verified English nameCXSL2500342 Shan Zhu Yao (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized
2025/04/29New drug · Class 1 NouvNeu004 · No verified English nameCXSL2500341 Rui Jian Yi Lian Pharmaceuticals Technology (Chengdu) Co., Ltd. romanized; Rui Jian Pharmaceuticals Technology (Wuhan) Co., Ltd. romanized
2025/04/29New drug · Class 2.2 SHR-8068注射液 · No verified English nameCXSL2500340 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/04/29New drug · Class 1 IMD101 注射液 · No verified English nameCXSL2500339 Shanghai Ying Mai De Medical Technology Co., Ltd. romanized
2025/04/29New drug · Class 1 索托克拉片 · No verified English nameCXHS2500043 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/04/28Import · Class 3.1 帕博利珠单抗注射液 · No verified English nameJXSS2500051 Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2025/04/28Import · Class 1 VHB937注射用浓溶液 · No verified English nameJXSL2500065 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/04/28Generic · Class 3 磷酸奥司他韦颗粒 · No verified English nameCYHS2501595 Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2025/04/28Generic · Class 3 富马酸氯马斯汀口服溶液 · No verified English nameCYHS2501592 Guangdong Hua Nan Pharma Group Co., Ltd. romanized; Guangdong Zhong Sheng Pharma Co., Ltd. romanized

69 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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