YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 347 drug applications between 22 November 2023 and 28 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 90, covering 65 drug names.
2023/11/22 – 2023/11/28
- New acceptances this week
- 347
- Drugs with new generic filings (by drug name, de-duplicated)
- 65
- 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
347filings, 90 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 166 |
| Generic | 90 |
| New drug | 54 |
| Import | 24 |
| Unspecified | 7 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 235 |
| TCM | 53 |
| Therapeutic biologic | 50 |
| Prophylactic biologic | 6 |
| 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
65 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Potassium Chloride Granules | 4 | 2 | 4 |
| 2 | Roxadustat Capsules | 4 | 2 | 17 |
| 3 | Tadalafil Tablets | 3 | 1 | 23 |
| 4 | Latamoxef Sodium for Injection | 3 | 1 | 1 |
| 5 | Iohexol Injection | 3 | 1 | 5 |
| 6 | Tafluprost Eye Drops | 2 | 2 | 3 |
| 7 | Torsemide Injection | 2 | 1 | 1 |
| 8 | Sildenafil Citrate Tablets | 2 | 1 | 12 |
| 9 | Flumazenil Injection | 2 | 1 | 2 |
| 10 | Amisulpride Injection | 2 | 1 | 1 |
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
226 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Sichuan Jin Xin Kang Da Pharmaceuticals Technology Co., Ltd. romanized | 10 | 9 | 0 |
| 2 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 7 | 2 | 0 |
| 3 | CSL Behring GmbH | 7 | 1 | 0 |
| 4 | Suzhou Erye Pharmaceutical Co., Ltd | 6 | 2 | 0 |
| 5 | GUERBET | 5 | 1 | 0 |
| 6 | Merck Sharp & Dohme LLC | 5 | 1 | 0 |
| 7 | Novo Nordisk A/S | 5 | 1 | 0 |
| 8 | Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Shandong Jing Hui Bio Technology Co., Ltd. romanized | 4 | 2 | 4 |
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
118 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/11/28Import · Class 3.1 | 注射用重组单链人凝血因子VIII · No verified English nameJXSL2300214 | CSL Behring GmbH; PAREXEL China Co. Ltd. |
| 2023/11/28Import · Class 3.1 | 注射用重组单链人凝血因子VIII · No verified English nameJXSL2300213 | CSL Behring GmbH; PAREXEL China Co. Ltd. |
| 2023/11/28Import · Class 3.1 | 注射用重组单链人凝血因子VIII · No verified English nameJXSL2300212 | CSL Behring GmbH; PAREXEL China Co. Ltd. |
| 2023/11/28Import · Class 3.1 | 注射用重组单链人凝血因子VIII · No verified English nameJXSL2300211 | CSL Behring GmbH; PAREXEL China Co. Ltd. |
| 2023/11/28Import · Class 3.1 | 注射用重组单链人凝血因子VIII · No verified English nameJXSL2300210 | CSL Behring GmbH; PAREXEL China Co. Ltd. |
| 2023/11/28Import · Class 3.1 | 注射用重组单链人凝血因子VIII · No verified English nameJXSL2300209 | CSL Behring GmbH; PAREXEL China Co. Ltd. |
| 2023/11/28Import · Class 3.1 | 注射用重组单链人凝血因子VIII · No verified English nameJXSL2300208 | CSL Behring GmbH; PAREXEL China Co. Ltd. |
| 2023/11/28Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHS2303288 | Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Guo Yao Group Guo Rui Pharma Co., Ltd. romanized |
| 2023/11/28Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2303287 | Chengdu Nuo He Cheng Hong Biopharmaceutical Co., Ltd. romanized; Sichuan Xian Tong Pharma Co., Ltd. romanized |
| 2023/11/28Generic · Class 3 | Biapenem For InjectionCYHS2303286 | Jiangsu Rui Shi Bio Technology Co., Ltd. romanized; Shandong Luo Xin Pharma Group Co., Ltd. romanized |
| 2023/11/28Generic · Class 3 | Acetylcysteine InjectionCYHS2303285 | Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/11/28Generic · Class 3 | Diprophylline InjectionCYHS2303282 | Wuhan Hua Er Bio Technology Co., Ltd. romanized; Lang Tian Pharma (Hubei) Co., Ltd. romanized |
| 2023/11/28Generic · Class 3 | 吗替麦考酚酯干混悬剂 · No verified English nameCYHS2303280 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2023/11/28Generic · Class 3 | Acetylcysteine Oral SolutionCYHS2303279 | Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/11/28Generic · Class 3 | Magnesium Sulfate InjectionCYHS2303278 | Jiangxi Bo Tai Pharma Co., Ltd. romanized; Jiangxi Dong Fu Pharmaceutical Co., Ltd. romanized |
| 2023/11/28Generic · Class 3 | Ketotifen Fumarate Oral SolutionCYHS2303277 | Zhejiang Yi Ze Da Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/11/28Generic · Class 3 | Amisulpride InjectionCYHS2303270 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2023/11/28Generic · Class 3 | Amisulpride InjectionCYHS2303269 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2023/11/28Generic · Class 3 | Relugolix TabletsCYHL2300144 | Jiangxi Shan Xiang Pharma Co., Ltd. romanized |
| 2023/11/28New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2300820 | Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized |
| 2023/11/28New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2300819 | Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized |
| 2023/11/28New drug · Class 1.3 | 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2300818 | Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2023/11/28New drug · Class 1.3 | 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2300817 | Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2023/11/28New drug · Class 1 | 重组人源抗狂犬病病毒单克隆抗体注射液 · No verified English nameCXSL2300816 | Lanzhou Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2023/11/28New drug · Class 1 | PT199 · No verified English nameCXSL2300815 | Fan En Shi Pharmaceutical (Beijing) Co., Ltd. romanized |
| 2023/11/28New drug · Class 1 | IBI389 · No verified English nameCXSL2300814 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2023/11/28New drug · Class 1 | ZL-1218注射液 · No verified English nameCXSL2300813 | Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2023/11/28New drug · Class 1 | 注射用MK-2870 · No verified English nameCXSL2300812 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2023/11/28New drug · Class 1 | ADG126注射液 · No verified English nameCXSL2300811 | Tian Yan Pharma (Suzhou) Co., Ltd. romanized |
| 2023/11/28New drug · Class 1 | TY751注射液 · No verified English nameCXHL2301314 | Tianjin Drug Research Institute Co., Ltd. romanized |
88 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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