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
- 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 type | Filings |
|---|---|
| Supplement | 193 |
| Generic | 119 |
| New drug | 78 |
| Import re-registration | 24 |
| Import | 14 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 270 |
| TCM | 94 |
| Therapeutic biologic | 65 |
| Prophylactic biologic | 2 |
| Biologic | 1 |
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
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sacubitril Valsartan Sodium Tablets | 4 | 2 | 70 |
| 2 | 替尔泊肽注射液 · No verified English name | 4 | 1 | 22 |
| 3 | Cefditoren Pivoxil Granules | 3 | 2 | 18 |
| 4 | Dapagliflozin Tablets | 3 | 2 | 84 |
| 5 | Finerenone Tablets | 3 | 2 | 69 |
| 6 | 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English name | 3 | 1 | 7 |
| 7 | Levetiracetam Tablets | 3 | 1 | 6 |
| 8 | Trazodone Hydrochloride Sustained-release Tablets | 2 | 2 | 20 |
| 9 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 10 | Tacrolimus Ointment | 2 | 1 | 6 |
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) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shen Yao He Ze Pharma (Shandong) Co., Ltd. romanized | 12 | 5 | 0 |
| 2 | Sichuan Kelun Pharmaceutical Co., Ltd. | 12 | 3 | 0 |
| 3 | Shanxi Hua Kang Pharma Co., Ltd. romanized | 9 | 8 | 0 |
| 4 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 7 | 5 | 6 |
| 5 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 6 | 4 | 0 |
| 6 | Novo Nordisk A/S | 6 | 2 | 0 |
| 7 | AstraZeneca UK Limited | 6 | 1 | 0 |
| 8 | Bayer Inc. | 6 | 1 | 0 |
| 9 | Guizhou Hao Cheng Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Guizhou Yi Bai Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
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
| Accepted | Drug | Applicants |
|---|---|---|
| 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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