YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 193 drug applications between 29 December 2021 and 4 January 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 52, covering 33 drug names.
2021/12/29 – 2022/01/04
- New acceptances this week
- 193
- Drugs with new generic filings (by drug name, de-duplicated)
- 33
- 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
193filings, 52 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 77 |
| Generic | 52 |
| New drug | 48 |
| Import | 8 |
| Import re-registration | 5 |
| Unspecified | 2 |
| Drug-device combination product | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 153 |
| Therapeutic biologic | 26 |
| TCM | 13 |
| Drug-device combination | 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
33 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Gabapentin Capsules | 3 | 1 | 0 |
| 2 | Enarodustat Tablets | 3 | 1 | 0 |
| 3 | Sildenafil Citrate Tablets | 3 | 1 | 12 |
| 4 | Losartan Potassium and Hydrochlorothiazide Tablets | 3 | 1 | 1 |
| 5 | Nicorandil for Injection | 3 | 1 | 1 |
| 6 | 阿普米司特片 · No verified English name | 3 | 1 | 3 |
| 7 | Ticagrelor Tablets | 2 | 1 | 10 |
| 8 | Tranexamic Acid Injection | 2 | 1 | 11 |
| 9 | 注射用盐酸头孢吡肟/氯化钠注射液 · No verified English name | 2 | 1 | 0 |
| 10 | Dobutamine Hydrochloride Injection | 2 | 1 | 3 |
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
102 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hua Run Shuang He Pharma Co., Ltd. romanized | 7 | 5 | 3 |
| 2 | Zhejiang Nord Pharmaceutical Co., Ltd | 6 | 3 | 6 |
| 3 | Shandong Run Ze Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 4 | Guangdong Ke Lun Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 5 | Guangzhou Run Er Yan Ke Bio Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | AstraZeneca AB | 4 | 2 | 0 |
| 7 | Ren He Yi Kang Group Co., Ltd. romanized | 4 | 2 | 4 |
| 8 | Beijing Rui Ye Pharmaceutical Co., Ltd. romanized | 4 | 2 | 2 |
| 9 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Shandong Luo Xin Pharma Group 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
71 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/01/04Generic · Class 3 | Enarodustat TabletsCYHS2102356 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2022/01/04Generic · Class 3 | Enarodustat TabletsCYHS2102355 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2022/01/04Generic · Class 3 | Enarodustat TabletsCYHS2102354 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2022/01/04Generic · Class 3 | Nicorandil for InjectionCYHS2102350 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2022/01/04Generic · Class 3 | Nicorandil for InjectionCYHS2102349 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2022/01/04Generic · Class 3 | Nicorandil for InjectionCYHS2102348 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2022/01/04New drug · Class 1 | KL-A167注射液 · No verified English nameCXSL2101533 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2022/01/04New drug · Class 1 | 西奥罗尼胶囊 · No verified English nameCXHL2101869 | Shenzhen Wei Xin Bio Technology Co., Ltd. romanized |
| 2022/01/04New drug · Class 1 | 西奥罗尼胶囊 · No verified English nameCXHL2101868 | Shenzhen Wei Xin Bio Technology Co., Ltd. romanized |
| 2022/01/04New drug · Class 2.2 | SHR8028滴眼液 · No verified English nameCXHL2101867 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2022/01/04New drug · Class 1 | HY1839颗粒 · No verified English nameCXHL2101866 | Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized |
| 2022/01/04New drug · Class 1 | HY1839颗粒 · No verified English nameCXHL2101865 | Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized |
| 2022/01/04New drug · Class 1 | ET0111胶囊 · No verified English nameCXHL2101864 | Shanghai Yi Tuo Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/01/04New drug · Class 1 | ET0111胶囊 · No verified English nameCXHL2101863 | Shanghai Yi Tuo Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/01/04New drug · Class 1 | HTMC0435片 · No verified English nameCXHL2101859 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2022/01/04New drug · Class 1 | HTMC0435片 · No verified English nameCXHL2101858 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2022/01/04New drug · Class 1 | HTMC0435片 · No verified English nameCXHL2101857 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2022/01/04New drug · Class 1 | LL-10 · No verified English nameCXHL2101818 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2021/12/31Generic · Class 3 | Dobutamine Hydrochloride InjectionCYHS2102338 | Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized |
| 2021/12/31Generic · Class 3 | Dobutamine Hydrochloride InjectionCYHS2102337 | Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized |
| 2021/12/31Generic · Class 3 | Digoxin InjectionCYHS2102336 | Zhong Run Pharma Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2021/12/31Generic · Class 3 | Ambroxol Hydrochloride Oral SolutionCYHS2102335 | Heilongjiang Zhen Bao Dao Pharma Co., Ltd. romanized |
| 2021/12/31Generic · Class 3 | Flurbiprofen Axetil InjectionCYHL2101059 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2021/12/31New drug · Class 2.4 | 注射用重组A型肉毒毒素 · No verified English nameCXSL2101534 | Chongqing Yu Yan Pharmaceutical Co., Ltd. romanized |
| 2021/12/31New drug · Class 1 | GC304腺相关病毒注射液 · No verified English nameCXSL2101532 | Beijing Jin Lan Ji Yin Technology Co., Ltd. romanized |
| 2021/12/31New drug · Class 1 | 靶向HLA-A*02:01/NY-ESO-1的TCR-T细胞注射液 · No verified English nameCXSL2101531 | Shenzhen Pu Rui Jin Bio Pharma Co., Ltd. romanized |
| 2021/12/31New drug · Class 1 | 靶向Survivin DC细胞注射液 · No verified English nameCXSL2101530 | Qi Chen Sheng Bio Technology (Zhuhai) Co., Ltd. romanized |
| 2021/12/31New drug · Class 1 | JMKX000623片 · No verified English nameCXHL2101856 | Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/12/31New drug · Class 1 | JMKX000623片 · No verified English nameCXHL2101855 | Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/12/31New drug · Class 2.2; 2.4 | 孟鲁司特钠凝胶 · No verified English nameCXHL2101854 | Jiang Yin Bei Rui Sen Pharmaceutical Co., Ltd. romanized |
41 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.