YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 279 drug applications between 3 August 2021 and 9 August 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 43, covering 32 drug names.
2021/08/03 – 2021/08/09
- New acceptances this week
- 279
- Drugs with new generic filings (by drug name, de-duplicated)
- 32
- 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
279filings, 43 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 123 |
| New drug | 65 |
| Generic | 43 |
| Import re-registration | 21 |
| Import | 19 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 189 |
| TCM | 44 |
| Therapeutic biologic | 44 |
| In vitro diagnostic reagent | 1 |
| Prophylactic 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
32 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Carbamazepine Extended-release Tablets | 3 | 1 | 0 |
| 2 | Alanyl Glutamine Injection | 2 | 1 | 4 |
| 3 | Enoxaparin Sodium Injection | 2 | 1 | 16 |
| 4 | Carbazochrome Sodium Sulfonate Injection | 2 | 1 | 1 |
| 5 | Torsemide Injection | 2 | 1 | 1 |
| 6 | Tranexamic Acid Injection | 2 | 1 | 11 |
| 7 | Trimetazidine Dihydrochloride Tablets | 2 | 1 | 0 |
| 8 | Fosphenytoin Sodium Injection | 2 | 1 | 5 |
| 9 | Oseltamivir Phosphate Capsules | 2 | 1 | 39 |
| 10 | Febuxostat Tablets | 2 | 1 | 12 |
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
154 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanxi Fu Ren Heng Feng Pharma Co., Ltd. romanized | 20 | 20 | 0 |
| 2 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 13 | 6 | 0 |
| 3 | Shandong Er Ye Pharmaceutical Co., Ltd. romanized | 11 | 3 | 0 |
| 4 | Shaanxi An Yuan Tang Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Novartis Pharma Schweiz AG | 6 | 2 | 0 |
| 6 | Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized | 6 | 2 | 0 |
| 7 | Eli Lilly and Company | 6 | 1 | 0 |
| 8 | Fresenius Kabi Deutschland GmbH | 6 | 1 | 0 |
| 9 | Shaanxi Bu Zhang Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized | 4 | 2 | 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
103 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/08/09Import · Class 1 | ES104 · No verified English nameJXSL2101090 | Elpiscience Biopharmaceuticals Co. Limited; Elpiscience (Suzhou) Biopharma Ltd. |
| 2021/08/09Import · Class 2.4 | 环硅酸锆钠散 · No verified English nameJXHL2101157 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2021/08/09Import · Class 2.4 | 环硅酸锆钠散 · No verified English nameJXHL2101156 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2021/08/09Import · Class 1 | CPI-818片 · No verified English nameJXHL2101155 | Corvus Pharmaceuticals Inc.; Angel Pharmaceuticals |
| 2021/08/09Import · Class 1 | CPI-818片 · No verified English nameJXHL2101154 | Corvus Pharmaceuticals Inc.; Angel Pharmaceuticals |
| 2021/08/09Import · Class 1 | BI 1701963片 · No verified English nameJXHL2101153 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/08/09Import · Class 1 | BI 1701963片 · No verified English nameJXHL2101152 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/08/09Import · Class 1 | TAK-981 注射液 · No verified English nameJXHL2101151 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd |
| 2021/08/09Generic · Class 3 | 非洛地平片 · No verified English nameCYHS2101538 | Hunan Jiudian Pharmaceutical Co., Ltd |
| 2021/08/09Generic · Class 3 | Torsemide InjectionCYHS2101536 | Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized |
| 2021/08/09Generic · Class 3 | Torsemide InjectionCYHS2101533 | Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized |
| 2021/08/09Generic · Class 3 | Zoledronic Acid InjectionCYHS2101520 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2021/08/09Generic · Class 3 | Lidocaine and Tetracaine CreamCYHL2101021 | Beijing Nuo Bo Te Bio Technology Co., Ltd. romanized |
| 2021/08/09Generic · Class 3 | 丙酸氟替卡松吸入粉雾剂 · No verified English nameCYHL2101020 | Run Sheng Pharma Co., Ltd. romanized |
| 2021/08/09New drug · Class 1.1 | 柏金颗粒 · No verified English nameCXZL2101022 | Zhong Nan Min Zu University romanized |
| 2021/08/09New drug · Class 1 | THZ0104注射液 · No verified English nameCXSL2101245 | Tian Jing Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2021/08/09New drug · Class 2.2 | 注射用卡瑞利珠单抗 · No verified English nameCXSL2101244 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/08/09New drug · Class 3.3 | 注射用HZBio2 · No verified English nameCXSL2101243 | Hangzhou Yuan Da Biopharmaceutical Co., Ltd. romanized |
| 2021/08/09New drug · Class 1 | 重组人源化抗表皮生长因子受体单克隆抗体注射液 · No verified English nameCXSL2101242 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2021/08/09New drug · Class 1 | CX1440胶囊 · No verified English nameCXHL2101383 | Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized |
| 2021/08/09New drug · Class 1 | CX1440胶囊 · No verified English nameCXHL2101382 | Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized |
| 2021/08/09New drug · Class 1 | CX1440胶囊 · No verified English nameCXHL2101381 | Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized |
| 2021/08/09New drug · Class 1 | CX1440胶囊 · No verified English nameCXHL2101380 | Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized |
| 2021/08/09New drug · Class 2.2 | HL231吸入溶液 · No verified English nameCXHL2101379 | Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2021/08/09New drug · Class 2.2 | HL231吸入溶液 · No verified English nameCXHL2101378 | Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2021/08/09New drug · Class 1 | HRS9531注射液 · No verified English nameCXHL2101377 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2021/08/09New drug · Class 1 | 苹果酸法米替尼胶囊 · No verified English nameCXHL2101376 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/08/09New drug · Class 1 | 苹果酸法米替尼胶囊 · No verified English nameCXHL2101375 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/08/09New drug · Class 1 | 苹果酸法米替尼胶囊 · No verified English nameCXHL2101374 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/08/09New drug · Class 1 | 注射用罗替戈汀山嵛酸酯缓释微球 · No verified English nameCXHL2101373 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
73 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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