YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 246 drug applications between 15 June 2023 and 21 June 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 54, covering 42 drug names.
2023/06/15 – 2023/06/21
- New acceptances this week
- 246
- Drugs with new generic filings (by drug name, de-duplicated)
- 42
- 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
246filings, 54 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 104 |
| Generic | 54 |
| New drug | 52 |
| Import | 24 |
| Unspecified | 8 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 176 |
| TCM | 39 |
| Therapeutic biologic | 31 |
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 | Carfilzomib For Injection | 3 | 2 | 0 |
| 2 | Acarbose Tablets | 3 | 2 | 3 |
| 3 | Ibuprofen Suspension | 2 | 2 | 14 |
| 4 | Oxacillin Sodium for Injection | 2 | 2 | 13 |
| 5 | Ibrutinib Tablets | 2 | 1 | 0 |
| 6 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 7 | Procaterol Hydrochloride Oral Solution | 2 | 1 | 12 |
| 8 | Nalbuphine Hydrochloride Injection | 2 | 1 | 11 |
| 9 | Esomeprazole Magnesium Enteric-Coated Capsules | 2 | 1 | 4 |
| 10 | Trimebutine Maleate Tablets | 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
159 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | An Guo Ya Dong Biopharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 2 | Changsha Ai Bei Gao Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 3 | Hangzhou An Dao Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 4 | Huang Shi Yan Wu Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 5 | Novartis Pharma Schweiz AG | 4 | 3 | 0 |
| 6 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized | 4 | 3 | 0 |
| 7 | Hetero Labs Limited | 4 | 2 | 0 |
| 8 | Hangzhou Ji Tai Pharmaceuticals Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Janssen Research & Development LLC | 3 | 3 | 0 |
| 10 | Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized | 3 | 3 | 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
95 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/06/21Import · Class 1 | LEO 138559 注射液 · No verified English nameJXSL2300113 | LEO Pharma A/S; LEO Pharma Consultancy (Shanghai) Company Limited |
| 2023/06/21Import · Class 1 | Sisunatovir 胶囊 · No verified English nameJXHL2300145 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2023/06/21Generic · Class 3 | Pentoxifylline InjectionCYHS2301677 | Hebei Yi Pin Biopharmaceuticals Co., Ltd. romanized; Hebei Yi Pin Pharmaceutical Co., Ltd. romanized |
| 2023/06/21Generic · Class 3 | Potassium Phosphates InjectionCYHS2301676 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2023/06/21Generic · Class 3 | Formoterol Fumarate Inhalation SolutionCYHS2301674 | Shanghai Xin Yi Jin Zhu Pharma Co., Ltd. romanized |
| 2023/06/21Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2301673 | Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2023/06/21Generic · Class 3 | Acetylcysteine InjectionCYHS2301671 | Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized |
| 2023/06/21Generic · Class 3 | Carbocisteine Oral SolutionCYHS2301670 | Beijing Wo Bang Pharmaceuticals Technology Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized |
| 2023/06/21Generic · Class 3 | Nalbuphine Hydrochloride InjectionCYHL2300080 | Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized |
| 2023/06/21Generic · Class 3 | Nalbuphine Hydrochloride InjectionCYHL2300079 | Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized |
| 2023/06/21New drug · Class 3.3 | 注射用奥马珠单抗 · No verified English nameCXSS2300047 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2023/06/21New drug · Class 1 | 注射用瑞卡西单抗 · No verified English nameCXSS2300046 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized; Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2023/06/21New drug · Class 1 | 注射用重组人凝血因子Ⅷ-Fc融合蛋白 · No verified English nameCXSS2300045 | Jiangsu Cheng Si Biopharmaceutical Co., Ltd. romanized; Ao Si Kang Bio (Nan Tong) Co., Ltd. romanized |
| 2023/06/21New drug · Class 1 | 注射用重组人凝血因子Ⅷ-Fc融合蛋白 · No verified English nameCXSS2300044 | Jiangsu Cheng Si Biopharmaceutical Co., Ltd. romanized; Ao Si Kang Bio (Nan Tong) Co., Ltd. romanized |
| 2023/06/21New drug · Class 1 | SHR-2005注射液 · No verified English nameCXSL2300425 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/06/21New drug · Class 2.4 | 泽布替尼胶囊 · No verified English nameCXHS2300057 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/06/21New drug · Class 1 | LP-168片 · No verified English nameCXHL2300679 | Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized |
| 2023/06/21New drug · Class 1 | LP-168片 · No verified English nameCXHL2300678 | Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized |
| 2023/06/21New drug · Class 1 | TLL-041 缓释片 · No verified English nameCXHL2300677 | Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized |
| 2023/06/21New drug · Class 1 | TLL-041 缓释片 · No verified English nameCXHL2300676 | Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized |
| 2023/06/21New drug · Class 1 | HTD1801胶囊 · No verified English nameCXHL2300675 | Shenzhen Jun Sheng Tai Bio Technology Co., Ltd. romanized |
| 2023/06/21New drug · Class 1 | HRS-7085片 · No verified English nameCXHL2300674 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2023/06/21New drug · Class 1 | HRS-7085片 · No verified English nameCXHL2300673 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2023/06/20Import · Class 2.2 | 注射用A型肉毒毒素 · No verified English nameJXSS2300048 | AbbVie Limited; Allergan Pharmaceuticals Ireland; Allergan Information Consulting (Shanghai) Co. Ltd. |
| 2023/06/20Import · Class 2.2 | 注射用A型肉毒毒素 · No verified English nameJXSS2300047 | AbbVie Limited; Allergan Pharmaceuticals Ireland; Allergan Information Consulting (Shanghai) Co. Ltd. |
| 2023/06/20Import · Class 2.2 | 注射用A型肉毒毒素 · No verified English nameJXSS2300046 | AbbVie Limited; Allergan Pharmaceuticals Ireland; Allergan Information Consulting (Shanghai) Co. Ltd. |
| 2023/06/20Import · Class 1 | IcoSema 注射液 · No verified English nameJXSL2300112 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2023/06/20Import · Class 2.2 | 眼用贝伐珠单抗注射液 · No verified English nameJXSL2300111 | Outlook Therapeutics Inc.; Beijing Syntone Biopharma Ltd. |
| 2023/06/20Import · Class 1 | Imlunestrant 片 · No verified English nameJXHL2300144 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/06/20Generic · Class 3 | Nicergoline TabletsCYHS2301664 | Hainan Si Da Pharmaceutical Co., Ltd. romanized; Hainan Sai Li Ke Pharma Co., Ltd. romanized |
65 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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