YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 379 drug applications between 17 April 2023 and 23 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 80, covering 65 drug names.
2023/04/17 – 2023/04/23
- New acceptances this week
- 379
- Drugs with new generic filings (by drug name, de-duplicated)
- 65
- Accepted this week, now under review
- 0
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
379filings, 80 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 194 |
| Generic | 80 |
| New drug | 72 |
| Import | 18 |
| Unspecified | 8 |
| Import re-registration | 6 |
| Drug-device combination product | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 271 |
| TCM | 57 |
| Therapeutic biologic | 45 |
| Prophylactic biologic | 2 |
| In vitro diagnostic reagent | 1 |
| Biologic | 1 |
| Drug-device combination | 1 |
| Drug-device combination | 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
65 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Lactulose Oral Solution | 3 | 2 | 34 |
| 2 | 恩那度司他片 · No verified English name | 3 | 1 | 0 |
| 3 | Diprophylline Injection | 2 | 2 | 7 |
| 4 | Pregabalin Oral Solution | 2 | 2 | 5 |
| 5 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 2 | 2 | 23 |
| 6 | Isosorbide Dinitrate Injection | 2 | 2 | 0 |
| 7 | Progesterone Injection | 2 | 2 | 5 |
| 8 | Lacosamide Injection | 2 | 1 | 0 |
| 9 | 注射用头孢唑肟钠 · No verified English name | 2 | 1 | 4 |
| 10 | Neostigmine Methylsulfate Injection | 2 | 1 | 4 |
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
217 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized | 20 | 18 | 0 |
| 2 | Changsha Ai Bei Gao Pharma Co., Ltd. romanized | 16 | 16 | 0 |
| 3 | Heilongjiang Hua Xi Biopharmaceuticals Technology Co., Ltd. romanized | 9 | 9 | 0 |
| 4 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 7 | 3 | 0 |
| 5 | Celgene Corporation | 6 | 1 | 0 |
| 6 | Shandong Luo Xin Pharma Group Co., Ltd. romanized | 5 | 2 | 0 |
| 7 | Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 8 | Sichuan Kelun Pharmaceutical Co., Ltd. | 4 | 3 | 1 |
| 9 | Da Lian Tian Shan Pharma Co., Ltd. romanized | 4 | 3 | 0 |
| 10 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 4 | 3 | 4 |
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 |
|---|---|---|
| 2023/04/22Import · Class 1 | IMG-020注射液 · No verified English nameJXSL2300076 | INMAGENE PTE. LTD.; Inmagene Biopharmaceuticals (Hangzhou) Co. Ltd. |
| 2023/04/22Import · Class 1 | MEDI5752 · No verified English nameJXSL2300075 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/04/22Import · Class 1 | AZD2936 · No verified English nameJXSL2300074 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/04/22Import · Class 1 | ASP2138 注射液 · No verified English nameJXSL2300073 | Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd. |
| 2023/04/22Generic · Class 3 | Diprophylline InjectionCYHS2301131 | Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized |
| 2023/04/22Generic · Class 3 | Desmopressin Acetate Oral SolutionCYHS2301129 | Hefei En Rui Te Pharma Co., Ltd. romanized |
| 2023/04/22Generic · Class 3 | Salbutamol Sulfate injectionCYHS2301128 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. |
| 2023/04/22Generic · Class 3 | Potassium Chloride GranulesCYHS2301126 | Shanxi Pu De Pharma Co., Ltd. romanized |
| 2023/04/22Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2301124 | Beijing Han Mei Bio Technology Co., Ltd. romanized; Beijing Han Mei Medicines Co., Ltd. romanized |
| 2023/04/22Generic · Class 3 | Neostigmine Methylsulfate InjectionCYHS2301121 | Jiangsu Jiu Xu Pharma Co., Ltd. romanized |
| 2023/04/22Generic · Class 3 | Neostigmine Methylsulfate InjectionCYHS2301120 | Jiangsu Jiu Xu Pharma Co., Ltd. romanized |
| 2023/04/22Generic · Class 3 | Sumatriptan and Naproxen Sodium TabletsCYHS2301119 | Kang Yuan Hua Wei Pharmaceuticals Co., Ltd. romanized; Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2023/04/22Generic · Class 3 | 恩那度司他片 · No verified English nameCYHL2300062 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2023/04/22Generic · Class 3 | 恩那度司他片 · No verified English nameCYHL2300061 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2023/04/22Generic · Class 3 | 恩那度司他片 · No verified English nameCYHL2300060 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2023/04/22New drug · Class 2.3 | 脑心清片 · No verified English nameCXZL2300029 | Guangzhou Bai Yun Shan He Ji Huang Pu Zhong Yao Co., Ltd. romanized |
| 2023/04/22New drug · Class 2.3 | 杏贝止咳颗粒 · No verified English nameCXZL2300028 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2023/04/22New drug · Class 1 | SG301 SC注射液 · No verified English nameCXSL2300283 | Hangzhou Shang Jian Bio Technology Co., Ltd. romanized |
| 2023/04/22New drug · Class 1 | 注射用AST-006 · No verified English nameCXHL2300416 | Shenzhen Ai Xin Da Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/22New drug · Class 1 | BPHY-08胶囊 · No verified English nameCXHL2300415 | Bai Ji Hong Ye (Nan Tong) Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/22New drug · Class 1 | BPHY-08胶囊 · No verified English nameCXHL2300414 | Bai Ji Hong Ye (Nan Tong) Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/22New drug · Class 1 | 吡罗西尼片 · No verified English nameCXHL2300413 | Xuan Zhu Bio Technology Co., Ltd. romanized |
| 2023/04/22New drug · Class 1 | WS635片 · No verified English nameCXHL2300412 | Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized |
| 2023/04/22New drug · Class 2.2 | 盐酸鲁拉西酮口溶膜 · No verified English nameCXHL2300411 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2023/04/22New drug · Class 2.4 | 布比卡因脂质体注射液 · No verified English nameCXHL2300410 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/04/22New drug · Class 2.4 | 布比卡因脂质体注射液 · No verified English nameCXHL2300409 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/04/21Import · Class 3.4 | 达雷妥尤单抗注射液 · No verified English nameJXSL2300072 | Janssen-Cilag AG; Johnson & Johnson (China) Investment Ltd. |
| 2023/04/21Generic · Class 3 | Fudosteine oral solutionCYHS2301118 | Sichuan Yi Sheng Zhi Tong Pharmaceuticals Bio Technology Development Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
| 2023/04/21Generic · Class 3 | Pentoxifylline InjectionCYHS2301115 | Anhui Mei Lai Pharma Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized |
| 2023/04/21Generic · Class 3 | Temozolomide For InjectionCYHS2301114 | Beijing SL Pharmaceutical Co., Ltd. |
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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