YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 368 drug applications between 2 February 2023 and 8 February 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 121, covering 85 drug names.
2023/02/02 – 2023/02/08
- New acceptances this week
- 368
- Drugs with new generic filings (by drug name, de-duplicated)
- 85
- 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
368filings, 121 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 160 |
| Generic | 121 |
| New drug | 59 |
| Import | 14 |
| Unspecified | 9 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 280 |
| Therapeutic biologic | 47 |
| TCM | 40 |
| 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
85 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 5 | 2 | 23 |
| 2 | Lactulose Oral Solution | 4 | 2 | 34 |
| 3 | Phenylephrine Hydrochloride Injection | 4 | 2 | 5 |
| 4 | Calcium Levofolinate Injection | 4 | 1 | 0 |
| 5 | Oxaliplatin Injection | 3 | 2 | 4 |
| 6 | Peramivir Injection | 3 | 2 | 7 |
| 7 | Amoxicillin Sodium for Injection | 3 | 1 | 0 |
| 8 | Indobufen Tablets | 2 | 2 | 6 |
| 9 | Potassium Chloride Granules | 2 | 2 | 4 |
| 10 | Mecobalamin Tablets | 2 | 2 | 16 |
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
232 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Yunnan Shen Wei Shi Pu Rui Pharma Co., Ltd. romanized | 15 | 15 | 0 |
| 2 | Anhui Pioneer Pharmaceutical Co., Ltd | 8 | 3 | 0 |
| 3 | Ping Guang Pharmaceutical Co., Ltd. romanized | 7 | 6 | 0 |
| 4 | Tianjin Bai Te Medical Yong Pin Co., Ltd. romanized | 6 | 6 | 6 |
| 5 | Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized | 4 | 2 | 2 |
| 8 | Astellas Pharma Europe B.V. | 4 | 1 | 0 |
| 9 | Patheon Inc. | 4 | 1 | 0 |
| 10 | Roche Pharma(Schweiz)AG | 4 | 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
127 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/02/08Import · Class 1 | Nipocalimab注射液 · No verified English nameJXSL2300034 | Janssen Research &Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/02/08Import · Class 1 | 注射用Abelacimab · No verified English nameJXSL2300033 | Anthos Therapeutics Inc.; IQVIA RDS (Shanghai) Co. Ltd. |
| 2023/02/08Generic · Class 3 | Potassium Chloride GranulesCYHS2300403 | Guangdong Jiu Ming Pharmaceutical Co., Ltd. romanized |
| 2023/02/08Generic · Class 3 | Levofloxacin InjectionCYHS2300402 | Hebei Tian Cheng Pharma Co., Ltd. romanized |
| 2023/02/08Generic · Class 3 | Levofloxacin InjectionCYHS2300401 | Hebei Tian Cheng Pharma Co., Ltd. romanized |
| 2023/02/08Generic · Class 3 | Aripiprazole Orally Disintegrating tabletsCYHS2300395 | Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized; Beijing Xing Hao Ying Sheng Pharma Co., Ltd. romanized |
| 2023/02/08Generic · Class 3 | Aripiprazole Orally Disintegrating tabletsCYHS2300394 | Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized; Beijing Xing Hao Ying Sheng Pharma Co., Ltd. romanized |
| 2023/02/08Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2300393 | Changzhou Si Yao Pharmaceutical Co., Ltd. romanized |
| 2023/02/08Generic · Class 3 | Oxaliplatin InjectionCYHS2300391 | Jian Jin Pharmaceutical Co., Ltd. romanized |
| 2023/02/08Generic · Class 3 | Oxaliplatin InjectionCYHS2300390 | Jian Jin Pharmaceutical Co., Ltd. romanized |
| 2023/02/08Generic · Class 3 | Potassium Chloride GranulesCYHS2300386 | Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2023/02/08Generic · Class 3 | 溴吡斯的明缓释片 · No verified English nameCYHL2300017 | Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized |
| 2023/02/08New drug · Class 2.2 | 瑞基奥仑赛注射液 · No verified English nameCXSL2300097 | Shanghai Yao Ming Ju Nuo Bio Technology Co., Ltd. romanized |
| 2023/02/08New drug · Class 1 | 阿得贝利单抗注射液 · No verified English nameCXSL2300096 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2023/02/08New drug · Class 1 | 注射用XNW27011 · No verified English nameCXSL2300095 | Shanghai Xin Nuo Wei Biopharmaceuticals Co., Ltd. romanized |
| 2023/02/08New drug · Class 1 | SYS6010 · No verified English nameCXSL2300094 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2023/02/08New drug · Class 1 | KD6005注射液 · No verified English nameCXSL2300093 | Shanghai Kang Dai Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Sai Jin Biopharmaceuticals Co., Ltd. romanized |
| 2023/02/08New drug · Class 3.3 | 德谷胰岛素利拉鲁肽注射液 · No verified English nameCXSL2300092 | Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized |
| 2023/02/08New drug · Class 1 | PB-718注射液 · No verified English nameCXHL2300181 | Pai Ge Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2023/02/08New drug · Class 1 | AL2846胶囊 · No verified English nameCXHL2300180 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/02/08New drug · Class 2.2 | 布立西坦缓释片 · No verified English nameCXHL2300179 | Jiangsu Ai Li Kang Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/02/08New drug · Class 2.2 | 布立西坦缓释片 · No verified English nameCXHL2300178 | Jiangsu Ai Li Kang Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/02/07Import · Class 2.2 | 索安非托片 · No verified English nameJXHL2300020 | Axsome Malta Ltd.; Ignis Therapeutics (Suzhou) Limited |
| 2023/02/07Generic · Class 3 | Trimebutine Maleate TabletsCYHS2300384 | Shanxi Zhen Dong An Xin Biopharmaceutical Co., Ltd. romanized |
| 2023/02/07Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300383 | Zhejiang Kang Run Pharmaceutical Co., Ltd. romanized |
| 2023/02/07Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300382 | Zhejiang Kang Run Pharmaceutical Co., Ltd. romanized |
| 2023/02/07Generic · Class 3 | Potassium Aspartate InjectionCYHS2300373 | Jilin Si Zhang Pharmaceutical Co., Ltd. romanized |
| 2023/02/07Generic · Class 3 | Methocarbamol InjectionCYHS2300368 | Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2023/02/07Generic · Class 3 | Penicillin G Sodium For InjectionCYHS2300364 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD |
| 2023/02/07New drug · Class 3.3 | 托珠单抗注射液 · No verified English nameCXSS2300005 | Hangzhou Bo Zhi Rui Biopharmaceutical Co., Ltd. romanized |
97 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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