YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 216 drug applications between 31 January 2021 and 6 February 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 36, covering 27 drug names.
2021/01/31 – 2021/02/06
- New acceptances this week
- 216
- Drugs with new generic filings (by drug name, de-duplicated)
- 27
- Accepted this week, now under review
- 5
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
216filings, 36 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 80 |
| Generic | 36 |
| Import | 36 |
| New drug | 29 |
| Unspecified | 23 |
| Import re-registration | 12 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 172 |
| Therapeutic biologic | 23 |
| TCM | 12 |
| Biologic | 6 |
| Prophylactic biologic | 3 |
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 | Duloxetine Hydrochloride Enteric Capsules | 3 | 1 | 4 |
| 2 | Metaraminol Tartrate Injection | 2 | 2 | 2 |
| 3 | Irbesartan Tablets | 2 | 1 | 4 |
| 4 | Vortioxetine Hydrobromide Tablets | 2 | 1 | 10 |
| 5 | Tranexamic Acid Injection | 2 | 1 | 11 |
| 6 | Tirofiban Hydrochloride And Sodium Chloride Injection | 2 | 1 | 2 |
| 7 | Eldecalcitol Soft Capsules | 2 | 1 | 8 |
| 8 | 莫米松福莫特罗吸入气雾剂 · No verified English name | 2 | 1 | 0 |
| 9 | Edaravone Injection | 1 | 1 | 0 |
| 10 | Lidocaine and Prilocaine Cream | 1 | 1 | 24 |
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
141 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AstraZeneca AB | 5 | 3 | 0 |
| 2 | AbbVie Inc. | 4 | 2 | 0 |
| 3 | Actelion Pharmaceuticals Ltd | 4 | 2 | 0 |
| 4 | Pfizer Europe MA EEIG | 4 | 2 | 0 |
| 5 | Dr. Reddy's Laboratories Limited | 4 | 1 | 0 |
| 6 | Amgen Inc. | 3 | 1 | 0 |
| 7 | Aspen Pharma Trading Limited | 3 | 1 | 0 |
| 8 | GLAXOSMITHKLINE S.A. | 3 | 1 | 0 |
| 9 | Laboratoire GlaxoSmithKline | 3 | 1 | 0 |
| 10 | Sandoz Private Limited | 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 |
|---|---|---|
| 2021/02/06Import · Class 3.1 | 注射用罗特西普 · No verified English nameJXSS2100011 | Celgene Corporation; Patheon Italia S.p.A. |
| 2021/02/06Import · Class 3.1 | 注射用罗特西普 · No verified English nameJXSS2100010 | Celgene Corporation; Patheon Italia S.p.A. |
| 2021/02/06New drug · Class 1 | EMB-02注射液 · No verified English nameCXSL2100047 | Shanghai An Mai Bio Technology Co., Ltd. romanized |
| 2021/02/06New drug · Class 1 | GR1802注射液 · No verified English nameCXSL2100045 | Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/02/06New drug · Class 1 | GR1802注射液 · No verified English nameCXSL2100044 | Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/02/06New drug · Class 2.4 | 环泊酚注射液 · No verified English nameCXHS2100003 | Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2021/02/06New drug · Class 1 | SHR1459片 · No verified English nameCXHL2100094 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/02/06New drug · Class 1 | SHR1459片 · No verified English nameCXHL2100093 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/02/06New drug · Class 1 | SHR1459片 · No verified English nameCXHL2100092 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/02/06New drug · Class 1 | YY-20394片 · No verified English nameCXHL2100091 | Shanghai Ying Li Pharma Co., Ltd. romanized |
| 2021/02/05Import · Class 2.2 | Benralizumab注射液 · No verified English nameJXSL2100018 | AstraZeneca AB |
| 2021/02/05Import · Class 1 | TK216注射液 · No verified English nameJXHL2100045 | Shanghai Pharmaceutical (USA) Inc. |
| 2021/02/05Generic · Class 3 | Tranexamic Acid InjectionCYHS2100168 | Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2021/02/05Generic · Class 3 | Tranexamic Acid InjectionCYHS2100167 | Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2021/02/05Generic · Class 3 | 对乙酰氨基酚泡腾片 · No verified English nameCYHS2100164 | Shenyang Ao Ji Na Pharma Co., Ltd. romanized |
| 2021/02/05Generic · Class 3 | Compound Paracetamol and Vitamin C Effervescent TabletsCYHS2100162 | Hainan Tao Sheng Pharmaceuticals Technology Research Institute Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2021/02/05Generic · Class 3 | Peramivir InjectionCYHS2100161 | Zhong Run Pharma Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2021/02/05Generic · Class 3 | Metaraminol Tartrate InjectionCYHS2100160 | Chengdu Giantech Hi-technology Development Co., Ltd.; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2021/02/05Generic · Class 3 | 醋酸艾司利卡西平片 · No verified English nameCYHS2100147 | Yang Zi Jiang Pharma Group Beijing Hai Yan Pharma Co., Ltd. romanized; Yangtze River Pharmaceutical Group Co., Ltd |
| 2021/02/05New drug · Class 2.2 | 注射用利培酮微球(4W) · No verified English nameCXHL2100090 | Guangzhou Di Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/02/05New drug · Class 2.2 | 注射用利培酮微球(4W) · No verified English nameCXHL2100089 | Guangzhou Di Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/02/05New drug · Class 2.2 | 注射用利培酮微球(4W) · No verified English nameCXHL2100088 | Guangzhou Di Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/02/03Import · Class 1 | PF-06480605注射液 · No verified English nameJXSL2100017 | Pfizer Inc. |
| 2021/02/03Import · Class 1 | RO7030816 · No verified English nameJXSL2100016 | F. Hoffmann-La Roche Ltd |
| 2021/02/03Import · Class 1 | RO7030816 · No verified English nameJXSL2100015 | F. Hoffmann-La Roche Ltd |
| 2021/02/03Import · Class 1 | Finerenone薄膜衣片 · No verified English nameJXHS2100018 | Bayer AG |
| 2021/02/03Import · Class 1 | Finerenone薄膜衣片 · No verified English nameJXHS2100017 | Bayer AG |
| 2021/02/03Import · Class 2.4 | 阿贝西利片 · No verified English nameJXHL2100044 | Eli Lilly and Company |
| 2021/02/03Import · Class 2.4 | 环硅酸锆钠散 · No verified English nameJXHL2100042 | AstraZeneca AB |
| 2021/02/03Import · Class 2.4 | 环硅酸锆钠散 · No verified English nameJXHL2100041 | AstraZeneca AB |
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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.