YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 329 drug applications between 14 April 2023 and 20 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 64, covering 51 drug names.
2023/04/14 – 2023/04/20
- New acceptances this week
- 329
- Drugs with new generic filings (by drug name, de-duplicated)
- 51
- Accepted this week, now under review
- 1
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
329filings, 64 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 176 |
| Generic | 64 |
| New drug | 62 |
| Import | 15 |
| Unspecified | 7 |
| Import re-registration | 4 |
| Drug-device combination product | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 227 |
| TCM | 58 |
| Therapeutic biologic | 37 |
| Prophylactic biologic | 3 |
| Biologic | 2 |
| 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
51 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 | Acetylcysteine Solution For Inhalation | 2 | 2 | 4 |
| 4 | Pregabalin Oral Solution | 2 | 2 | 5 |
| 5 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 2 | 2 | 23 |
| 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 | Azilsartan Medoxomil Potassium Tablets | 2 | 1 | 35 |
| 10 | Ketorolac Tromethamine 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
187 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 | Eli Lilly and Company | 5 | 1 | 0 |
| 5 | Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Henan Lan Tian Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Da Lian Tian Shan Pharma Co., Ltd. romanized | 4 | 3 | 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
107 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2023/04/20Generic · Class 3 | Esmolol Hydrochloride InjectionCYHS2301093 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/04/20New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2300279 | Jiangsu Wan Bang Sheng Hua Pharmaceuticals Group Co., Ltd. romanized |
| 2023/04/20New drug · Class 1 | JMT203注射液 · No verified English nameCXSL2300278 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2023/04/20New drug · Class 1 | 重组抗NKG2A人源化单克隆抗体注射液 · No verified English nameCXSL2300277 | Shanghai Huai Yue Bio Technology Co., Ltd. romanized |
| 2023/04/20New drug · Class 1 | TQB2928注射液 · No verified English nameCXSL2300276 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/04/20New drug · Class 1 | FT-004注射液 · No verified English nameCXSL2300275 | Fang Tuo Bio Technology (Suzhou) Co., Ltd. romanized |
| 2023/04/20New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2300274 | Hui Sheng Biopharmaceutical Co., Ltd. romanized |
| 2023/04/20New drug · Class 1 | HS-10518胶囊 · No verified English nameCXHL2300398 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/20New drug · Class 1 | 卟硒啉片 · No verified English nameCXHL2300397 | Shanghai Yuan Xi Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/20New drug · Class 1 | 卟硒啉片 · No verified English nameCXHL2300396 | Shanghai Yuan Xi Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/20New drug · Class 1 | 卟硒啉片 · No verified English nameCXHL2300395 | Shanghai Yuan Xi Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/20New drug · Class 1 | 妥拉美替尼胶囊 · No verified English nameCXHL2300394 | Shanghai Ke Zhou Drug Research and Development Co., Ltd. romanized |
| 2023/04/20New drug · Class 1 | 妥拉美替尼胶囊 · No verified English nameCXHL2300393 | Shanghai Ke Zhou Drug Research and Development Co., Ltd. romanized |
| 2023/04/20New drug · Class 1 | HRS-4357注射液 · No verified English nameCXHL2300392 | Tianjin Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/04/19Import · Class 1 | Tiragolumab注射液 · No verified English nameJXSL2300069 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd |
| 2023/04/19Generic · Class 3 | Betamethasone Sodium Phosphate InjectionCYHS2301092 | Hubei Min Kang Pharma Group Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2023/04/19Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2301089 | Hunan Xian Shi Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/04/19Generic · Class 3 | Diprophylline InjectionCYHS2301086 | Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2023/04/19Generic · Class 3 | Ketotifen Fumarate Nasal SprayCYHS2301084 | Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized; Jewim Pharmaceutical (Shandong) Co., Ltd. |
| 2023/04/19Generic · Class 3 | Pregabalin Oral SolutionCYHS2301083 | Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized |
| 2023/04/19Generic · Class 3 | Pregabalin Oral SolutionCYHS2301082 | Zhong Huan Pharmaceuticals Co., Ltd. romanized; Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized |
77 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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