YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 338 drug applications between 15 April 2023 and 21 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 69, covering 57 drug names.
2023/04/15 – 2023/04/21
- New acceptances this week
- 338
- Drugs with new generic filings (by drug name, de-duplicated)
- 57
- 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
338filings, 69 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 178 |
| Generic | 69 |
| New drug | 66 |
| Import | 11 |
| Unspecified | 8 |
| Import re-registration | 5 |
| Drug-device combination product | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 238 |
| TCM | 55 |
| Therapeutic biologic | 39 |
| Prophylactic biologic | 3 |
| 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
57 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 | Diprophylline Injection | 2 | 2 | 7 |
| 3 | Pregabalin Oral Solution | 2 | 2 | 5 |
| 4 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 2 | 2 | 23 |
| 5 | Progesterone Injection | 2 | 2 | 5 |
| 6 | Lacosamide Injection | 2 | 1 | 0 |
| 7 | 注射用头孢唑肟钠 · No verified English name | 2 | 1 | 4 |
| 8 | Lurasidone Hydrochloride Tablets | 2 | 1 | 2 |
| 9 | Ketorolac Tromethamine Injection | 2 | 1 | 4 |
| 10 | 醋酸维持液(含葡萄糖) · No verified English name | 2 | 1 | 0 |
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
190 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized | 23 | 23 | 0 |
| 2 | Changsha Ai Bei Gao Pharma Co., Ltd. romanized | 15 | 15 | 0 |
| 3 | Heilongjiang Hua Xi Biopharmaceuticals Technology Co., Ltd. romanized | 9 | 9 | 0 |
| 4 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 5 | Shandong Luo Xin Pharma Group Co., Ltd. romanized | 5 | 2 | 0 |
| 6 | Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Da Lian Tian Shan Pharma Co., Ltd. romanized | 4 | 3 | 0 |
| 8 | Shanghai Xian Bo Bio Technology Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | UCB Pharma SA | 4 | 1 | 0 |
| 10 | Shanghai Pu You Biopharmaceuticals Co., Ltd. romanized | 4 | 1 | 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
112 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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. |
| 2023/04/21Generic · Class 3 | Phenylephrine Hydrochloride InjectionCYHS2301113 | Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized |
| 2023/04/21Generic · Class 3 | Progesterone InjectionCYHS2301111 | Li Zhu Group Li Min Pharmaceutical Factory romanized |
| 2023/04/21Generic · Class 3 | 盐酸肾上腺素注射液 · No verified English nameCYHS2301110 | Shanghai Bao Long Bio Technology Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized |
| 2023/04/21Generic · Class 3 | Dexketoprofen Trometamol TabletsCYHS2301107 | Hunan Nuo Na Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2023/04/21New drug · Class 1 | 靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液 · No verified English nameCXSL2300282 | Shanghai Xian Bo Bio Technology Co., Ltd. romanized |
| 2023/04/21New drug · Class 1 | 靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液 · No verified English nameCXSL2300281 | Shanghai Xian Bo Bio Technology Co., Ltd. romanized |
| 2023/04/21New drug · Class 1 | 靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液 · No verified English nameCXSL2300280 | Shanghai Xian Bo Bio Technology Co., Ltd. romanized |
| 2023/04/21New drug · Class 1 | NH300231片 · No verified English nameCXHL2300408 | Jiangsu En Hua Pharma Co., Ltd. romanized; Shanghai Shu Jing Bio Technology Co., Ltd. romanized |
| 2023/04/21New drug · Class 1 | NH300231片 · No verified English nameCXHL2300407 | Jiangsu En Hua Pharma Co., Ltd. romanized; Shanghai Shu Jing Bio Technology Co., Ltd. romanized |
| 2023/04/21New drug · Class 1 | NH300231片 · No verified English nameCXHL2300406 | Jiangsu En Hua Pharma Co., Ltd. romanized; Shanghai Shu Jing Bio Technology Co., Ltd. romanized |
| 2023/04/21New drug · Class 2.4 | 布比卡因脂质体注射液 · No verified English nameCXHL2300405 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/04/21New drug · Class 2.4 | 布比卡因脂质体注射液 · No verified English nameCXHL2300404 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/04/21New drug · Class 1 | TY-4028胶囊 · No verified English nameCXHL2300403 | Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized |
| 2023/04/21New drug · Class 1 | TY-4028胶囊 · No verified English nameCXHL2300402 | Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized |
| 2023/04/21New drug · Class 1 | D3S-002片 · No verified English nameCXHL2300401 | Name not romanized |
| 2023/04/21New drug · Class 1 | D3S-002片 · No verified English nameCXHL2300400 | Name not romanized |
| 2023/04/21New drug · Class 1 | D3S-002片 · No verified English nameCXHL2300399 | Name not romanized |
| 2023/04/20Import · Class 2.2 | 萨特利珠单抗注射液 · No verified English nameJXSL2300071 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2023/04/20Import · Class 2.2 | 注射用戈沙妥珠单抗 · No verified English nameJXSL2300070 | Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd. |
| 2023/04/20Import · Class 1 | STC314注射液 · No verified English nameJXHL2300088 | Grand Medical Pty Ltd.; Name not romanized |
| 2023/04/20Generic · Class 3 | Oxytocin InjectionCYHS2301105 | Anhui Bai Ao Pharma Co., Ltd. romanized; Chengdu Li Er Pharma Co., Ltd. romanized |
| 2023/04/20Generic · Class 3 | 醋酸维持液(含葡萄糖) · No verified English nameCYHS2301104 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2023/04/20Generic · Class 3 | 醋酸维持液(含葡萄糖) · No verified English nameCYHS2301103 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2023/04/20Generic · Class 3 | 复方氨基酸(16AA)/葡萄糖(12.6%)电解质注射液 · No verified English nameCYHS2301098 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/04/20Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2301095 | Sichuan Nuo Fei Te Bio Pharma Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
| 2023/04/20Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2301094 | Sichuan Nuo Fei Te Bio Pharma Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
82 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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