YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 199 drug applications between 25 January 2021 and 31 January 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 37, covering 27 drug names.
2021/01/25 – 2021/01/31
- New acceptances this week
- 199
- Drugs with new generic filings (by drug name, de-duplicated)
- 27
- 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
199filings, 37 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 98 |
| Generic | 37 |
| New drug | 30 |
| Import | 21 |
| Unspecified | 8 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 163 |
| Therapeutic biologic | 22 |
| TCM | 10 |
| Prophylactic biologic | 3 |
| 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
27 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tranexamic Acid Injection | 3 | 1 | 11 |
| 2 | Tenofovir alafenamide Fumarate Tablets | 2 | 2 | 0 |
| 3 | Peramivir Injection | 2 | 2 | 7 |
| 4 | Sodium Valproate Concentrated Solution for Injection | 2 | 1 | 0 |
| 5 | Ipratropium Bromide Inhalation Solution | 2 | 1 | 2 |
| 6 | Carfilzomib For Injection | 2 | 1 | 0 |
| 7 | Pramipexole Dihydrochloride Prolonged-release Tablets | 2 | 1 | 0 |
| 8 | Dapagliflozin Tablets | 2 | 1 | 84 |
| 9 | Febuxostat Tablets | 2 | 1 | 12 |
| 10 | Canagliflozin Tablets | 1 | 1 | 8 |
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
124 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Suzhou Kai Tuo Pharma Co., Ltd. romanized | 9 | 2 | 0 |
| 2 | Yangtze River Pharmaceutical Group Co., Ltd | 5 | 4 | 5 |
| 3 | Hubei Yi Ban Tian Pharmaceutical Co., Ltd. romanized | 5 | 2 | 0 |
| 4 | Changzhou Heng Bang Pharma Co., Ltd. romanized | 4 | 3 | 0 |
| 5 | Roche Pharma(Schweiz)AG | 4 | 1 | 0 |
| 6 | Jiangsu Xin Yuan Su Pharmaceuticals Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 7 | Zhejiang Hai Kang Bio Zhi Pin Co., Ltd. romanized | 4 | 1 | 0 |
| 8 | Bright Future Pharmaceuticals Factory | 3 | 3 | 0 |
| 9 | Guo Yao Group Wei Qi Da Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Karyopharm Therapeutics Inc. | 3 | 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
56 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/01/30Import · Class 1 | Tiragolumab注射液 · No verified English nameJXSL2100014 | F.Hoffmann-La Roche Ltd |
| 2021/01/30Import · Class 3.3 | 阿柏西普眼内注射溶液 · No verified English nameJXSL2100013 | Affamed Therapeutics (HK) Limited |
| 2021/01/30Import · Class 1 | AMG 570 · No verified English nameJXSL2100012 | Amgen Inc. |
| 2021/01/30Import · Class 1 | ATG-019 片 · No verified English nameJXHL2100031 | Karyopharm Therapeutics Inc. |
| 2021/01/30Import · Class 1 | ATG-019 片 · No verified English nameJXHL2100030 | Karyopharm Therapeutics Inc. |
| 2021/01/30Generic · Class 3 | Sodium Valproate Concentrated Solution for InjectionCYHS2100139 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2021/01/30Generic · Class 3 | Sodium Valproate Concentrated Solution for InjectionCYHS2100138 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2021/01/30Generic · Class 3 | Peramivir InjectionCYHS2100136 | Yangtze River Pharmaceutical Group Co., Ltd |
| 2021/01/30Generic · Class 3 | Peramivir InjectionCYHS2100134 | Yang Zi Jiang Pharma Group Sichuan Hai Rong Pharma Co., Ltd. romanized |
| 2021/01/30New drug · Class 1 | HH30134片 · No verified English nameCXHL2100079 | Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized |
| 2021/01/30New drug · Class 1 | HH30134片 · No verified English nameCXHL2100078 | Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized |
| 2021/01/30New drug · Class 2.4 | 奥布替尼片 · No verified English nameCXHL2100077 | Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/01/30New drug · Class 2.4 | 奥布替尼片 · No verified English nameCXHL2100076 | Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/01/29Generic · Class 3 | Azelastine hydrochloride Fluticasone Propionate Nasal SprayCYHS2100131 | Zhang Feng Pharma Co., Ltd. romanized |
| 2021/01/29Generic · Class 3 | Memantine Hydrochloride Oral SolutionCYHS2100130 | Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2021/01/29Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHS2100128 | Yin Gu Pharmaceutical Co., Ltd. romanized |
| 2021/01/29Generic · Class 3 | Enalapril Maleate Oral SolutionCYHS2100127 | Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2021/01/29New drug · Class 1.1 | 雪蟾软坚柔肝片 · No verified English nameCXZL2100001 | Shanghai Tian Chan Bio Technology Co., Ltd. romanized |
| 2021/01/29New drug · Class 1 | 注射用SHR-A1904 · No verified English nameCXSL2100034 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/01/29New drug · Class 1 | CN401片 · No verified English nameCXHL2100075 | Tong Run Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2021/01/29New drug · Class 1 | CN401片 · No verified English nameCXHL2100074 | Tong Run Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2021/01/29New drug · Class 1 | IBI362注射液 · No verified English nameCXHL2100073 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2021/01/29New drug · Class 1 | IBI362注射液 · No verified English nameCXHL2100072 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2021/01/29New drug · Class 1 | IBI362注射液 · No verified English nameCXHL2100071 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2021/01/29New drug · Class 1 | GT20029凝胶 · No verified English nameCXHL2100070 | Suzhou Kai Tuo Pharma Co., Ltd. romanized |
| 2021/01/29New drug · Class 1 | GT20029凝胶 · No verified English nameCXHL2100069 | Suzhou Kai Tuo Pharma Co., Ltd. romanized |
| 2021/01/29New drug · Class 1 | GT20029凝胶 · No verified English nameCXHL2100068 | Suzhou Kai Tuo Pharma Co., Ltd. romanized |
| 2021/01/29New drug · Class 1 | GT20029凝胶 · No verified English nameCXHL2100067 | Suzhou Kai Tuo Pharma Co., Ltd. romanized |
| 2021/01/29New drug · Class 1 | GT20029凝胶 · No verified English nameCXHL2100066 | Suzhou Kai Tuo Pharma Co., Ltd. romanized |
| 2021/01/29New drug · Class 1 | GT20029凝胶 · No verified English nameCXHL2100065 | Suzhou Kai Tuo Pharma Co., Ltd. romanized |
26 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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