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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 432 drug applications between 2 August 2025 and 8 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 119, covering 86 drug names.

2025/08/02 – 2025/08/08

Period
2025/08/02 to 2025/08/08, 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
432
Drugs with new generic filings (by drug name, de-duplicated)
86
Accepted this week, now under review
112

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

432filings, 119 of them generic

By application type

Application typeFilings
Supplement193
Generic119
New drug78
Import re-registration24
Import14
Unspecified4

By drug type

Drug typeFilings
Chemical drug270
TCM94
Therapeutic biologic65
Prophylactic biologic2
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

86 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets4270
2替尔泊肽注射液 · No verified English name4122
3Cefditoren Pivoxil Granules3218
4Dapagliflozin Tablets3284
5Finerenone Tablets3269
6中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English name317
7Levetiracetam Tablets316
8Trazodone Hydrochloride Sustained-release Tablets2220
9Glucosamine Sulfate Capsules2251
10Tacrolimus Ointment216

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

248 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shen Yao He Ze Pharma (Shandong) Co., Ltd. romanized1250
2Sichuan Kelun Pharmaceutical Co., Ltd.1230
3Shanxi Hua Kang Pharma Co., Ltd. romanized980
4Hunan Ke Lun Pharmaceutical Co., Ltd. romanized756
5Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized640
6Novo Nordisk A/S620
7AstraZeneca UK Limited610
8Bayer Inc.610
9Guizhou Hao Cheng Pharma Co., Ltd. romanized550
10Guizhou Yi Bai Pharmaceutical Co., Ltd. romanized550

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

129 this week

AcceptedDrugApplicants
2025/08/08Import · Class 1 MK-4280A注射液 · No verified English nameJXSL2500143 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2025/08/08Import · Class 1 MK-1084片 · No verified English nameJXHL2500210 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2025/08/08Generic · Class 3 Ketorolac Trometamol TabletsCYHS2502900 Zhejiang Hua Hai Pharmaceutical Technology Co., Ltd. romanized
2025/08/08Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2502887 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2025/08/08Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2502886 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2025/08/08Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2502885 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2025/08/08Generic · Class 3 注射用氨苄西林钠/氯化钠注射液 · No verified English nameCYHS2502884 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/08/08Generic · Class 3 注射用氨苄西林钠/氯化钠注射液 · No verified English nameCYHS2502883 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/08/08Generic · Class 3 Acetate And Glucose Electrolytes InjectionCYHS2502881 Xian Wan Long Pharmaceutical Co., Ltd. romanized
2025/08/08Generic · Class 3 Acetate And Glucose Electrolytes InjectionCYHS2502880 Xian Wan Long Pharmaceutical Co., Ltd. romanized
2025/08/08Generic · Class 3 Nedaplatin For InjectionCYHS2502879 Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized
2025/08/08Generic · Class 3 Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid Oral SolutionCYHS2502878 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/08/08Generic · Class 3 Nedaplatin For InjectionCYHS2502877 Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized
2025/08/08Generic · Class 3 Famotidine TabletsCYHS2502875 An Ruo Wei Ta Pharma Tai Zhou Co., Ltd. romanized
2025/08/08Generic · Class 3 Alendronate Sodium Oral SolutionCYHS2502869 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2025/08/08Generic · Class 3 Compound Paracetamol and Vitamin C Effervescent TabletsCYHS2502868 Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2025/08/08Generic · Class 3 Potassium Chloride Extended Release TabletsCYHS2502865 Ao Mei Pharmaceutical (Hainan) Co., Ltd. romanized
2025/08/08Generic · Class 3 西咪替丁片 · No verified English nameCYHS2502862 Hebei Xin Shi Pharmaceutical Co., Ltd. romanized; Shijiazhuang Shi Pu Li Pharmaceutical Co., Ltd. romanized
2025/08/08Generic · Class 3 Propranolol Hydrochloride TabletsCYHS2502861 Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized
2025/08/08Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2502860 Chengdu Kang Tai Yuan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Fu Rui Xi Pharma Co., Ltd. romanized
2025/08/08Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2502859 Chengdu Kang Tai Yuan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Fu Rui Xi Pharma Co., Ltd. romanized
2025/08/08New drug · Class 2.2 SHR-8068注射液 · No verified English nameCXSL2500678 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/08/08New drug · Class 1 SHR-1701注射液 · No verified English nameCXSL2500677 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/08/08New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2500676 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/08/08New drug · Class 1 SHR-7367注射液 · No verified English nameCXSL2500675 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/08New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2500674 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/08/08New drug · Class 1 注射用GenSci139 · No verified English nameCXSL2500673 Changchun Jin Sai Pharma Co., Ltd. romanized
2025/08/08New drug · Class 1 IBI363 · No verified English nameCXSL2500672 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/08/08New drug · Class 1 IBI363 · No verified English nameCXSL2500671 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/08/08New drug · Class 1 SCTC21C注射液 · No verified English nameCXSL2500670 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized

99 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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