YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 235 drug applications between 9 August 2023 and 15 August 2023 (data as of 14 November 2026 06:00). Of these, generic applications numbered 59, covering 42 drug names.
2023/08/09 – 2023/08/15
- New acceptances this week
- 235
- Drugs with new generic filings (by drug name, de-duplicated)
- 42
- 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
235filings, 59 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 113 |
| Generic | 59 |
| New drug | 35 |
| Import re-registration | 18 |
| Import | 6 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 151 |
| TCM | 54 |
| Therapeutic biologic | 27 |
| 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
42 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Aminophylline Injection | 3 | 2 | 3 |
| 2 | Peramivir Injection | 2 | 2 | 7 |
| 3 | 氧 · No verified English name | 2 | 2 | 15 |
| 4 | Lactulose Oral Solution | 2 | 1 | 34 |
| 5 | Tacrolimus Sustained-release Capsules | 2 | 1 | 6 |
| 6 | Piracetam Injection | 2 | 1 | 9 |
| 7 | Procaterol Hydrochloride Solution for Inhalation | 2 | 1 | 2 |
| 8 | Brivaracetam Tablets | 2 | 1 | 19 |
| 9 | 昂丹司琼口溶膜 · No verified English name | 2 | 1 | 2 |
| 10 | Pegaspargase For Injection | 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
138 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | GE Healthcare AS | 14 | 1 | 0 |
| 2 | Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized | 9 | 9 | 0 |
| 3 | Shenyang Qing Gong Pharma Group Co., Ltd. romanized | 9 | 9 | 0 |
| 4 | Changsha Ai Bei Gao Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Jiangsu Vanguard Pharmaceutical Co., Ltd. | 4 | 3 | 4 |
| 6 | Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 7 | An Guo Ya Dong Biopharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 8 | Ren He Yi Kang Group Co., Ltd. romanized | 3 | 2 | 3 |
| 9 | Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized | 3 | 2 | 0 |
| 10 | Nichi-Iko Pharmaceutical Co. Ltd. | 3 | 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
66 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/08/15Import · Class 2.2 | 注射用tisotumab vedotin · No verified English nameJXSL2300151 | Seagen Inc.; Zai Lab (Shanghai) CO. Ltd |
| 2023/08/15Import · Class 1 | MEDI3506注射液 · No verified English nameJXSL2300150 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/08/15Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2302133 | Liao Cheng Gao Xin Bio Technology Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized |
| 2023/08/15Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2302132 | Liao Cheng Gao Xin Bio Technology Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized |
| 2023/08/15Generic · Class 3 | 头孢克肟颗粒 · No verified English nameCYHS2302131 | Chongqing Ji Si Rui Pharmaceutical Co., Ltd. romanized; Sichuan He Xin Pharma Co., Ltd. romanized |
| 2023/08/15Generic · Class 3 | Aminophylline InjectionCYHS2302129 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/08/15Generic · Class 3 | Potassium Phosphates InjectionCYHS2302126 | Hubei Ke Lun Pharma Co., Ltd. romanized |
| 2023/08/15Generic · Class 3 | Acetylcysteine InjectionCYHS2302124 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2023/08/15Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2302123 | Hai Men Pu Shi Pharmaceuticals Co., Ltd. romanized |
| 2023/08/15Generic · Class 3 | Peramivir InjectionCYHS2302122 | Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized; Hainan Ai Ke Pharmaceutical Co., Ltd. romanized |
| 2023/08/15Generic · Class 3 | Nitroglycerin InjectionCYHS2302118 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2023/08/15Generic · Class 3 | Nitroglycerin InjectionCYHS2302117 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2023/08/15Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2302115 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/08/15Generic · Class 3 | Famotidine InjectionCYHS2302113 | Suzhou Hai Jing Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Shen Long Pharma Co., Ltd. romanized |
| 2023/08/15Generic · Class 3 | Procaterol Hydrochloride Solution for InhalationCYHS2302111 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2023/08/15Generic · Class 3 | Procaterol Hydrochloride Solution for InhalationCYHS2302110 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2023/08/15Generic · Class 3 | Brivaracetam TabletsCYHL2300098 | Chengdu Ao Bang Pharma Co., Ltd. romanized |
| 2023/08/15Generic · Class 3 | Brivaracetam TabletsCYHL2300097 | Chengdu Ao Bang Pharma Co., Ltd. romanized |
| 2023/08/15New drug · Class 1 | FT-002注射液 · No verified English nameCXSL2300545 | Fang Tuo Bio Technology (Suzhou) Co., Ltd. romanized |
| 2023/08/15New drug · Class 1 | BA2101注射液 · No verified English nameCXSL2300544 | Shandong Bo An Bio Technology Co., Ltd. romanized |
| 2023/08/15New drug · Class 1 | VG2062 · No verified English nameCXSL2300543 | Shanghai Fu Nuo Jian Bio Technology Co., Ltd. romanized; Shenzhen Fu Nuo Jian Bio Technology Co., Ltd. romanized; Fu Nuo Jian Bio Technology (Nan Tong) Co., Ltd. romanized |
| 2023/08/15New drug · Class 1 | 注射用LM-108 · No verified English nameCXSL2300542 | Shanghai Li Xin Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2023/08/15New drug · Class 1 | JS015注射液 · No verified English nameCXSL2300541 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/08/15New drug · Class 1 | 英强布韦片 · No verified English nameCXHS2300069 | Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized |
| 2023/08/15New drug · Class 1 | TGRX-814片 · No verified English nameCXHL2300876 | Shenzhen Shi Ta Ji Rui Biopharmaceuticals Co., Ltd. romanized |
| 2023/08/15New drug · Class 1 | TGRX-814片 · No verified English nameCXHL2300875 | Shenzhen Shi Ta Ji Rui Biopharmaceuticals Co., Ltd. romanized |
| 2023/08/15New drug · Class 1 | TGRX-814片 · No verified English nameCXHL2300874 | Shenzhen Shi Ta Ji Rui Biopharmaceuticals Co., Ltd. romanized |
| 2023/08/15New drug · Class 1 | XY0206片 · No verified English nameCXHL2300873 | Shijiazhuang Yi Ling Pharma Co., Ltd. romanized |
| 2023/08/15New drug · Class 1 | XY0206片 · No verified English nameCXHL2300872 | Shijiazhuang Yi Ling Pharma Co., Ltd. romanized |
| 2023/08/15New drug · Class 1 | XY0206片 · No verified English nameCXHL2300871 | Shijiazhuang Yi Ling Pharma Co., Ltd. romanized |
36 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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