YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 295 drug applications between 25 June 2025 and 1 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 63, covering 48 drug names.
2025/06/25 – 2025/07/01
- New acceptances this week
- 295
- Drugs with new generic filings (by drug name, de-duplicated)
- 48
- Accepted this week, now under review
- 45
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
295filings, 63 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 173 |
| Generic | 63 |
| New drug | 34 |
| Import re-registration | 15 |
| Import | 7 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 166 |
| TCM | 85 |
| Therapeutic biologic | 42 |
| Biologic | 1 |
| 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
48 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Acetylcysteine Injection | 7 | 7 | 53 |
| 2 | Pregabalin Extended release Tablets | 3 | 1 | 13 |
| 3 | Oseltamivir Phosphate Capsules | 3 | 1 | 39 |
| 4 | Paracetamol and Ibuprofen Tablets | 2 | 2 | 7 |
| 5 | Sacubitril Valsartan Sodium Tablets | 2 | 2 | 70 |
| 6 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
| 7 | Procaterol Hydrochloride Granules | 2 | 1 | 2 |
| 8 | 苯磺酸左氨氯地平片 · No verified English name | 2 | 1 | 45 |
| 9 | Upadacitinib Sustained-release Tablets | 1 | 1 | 43 |
| 10 | Ibrutinib Capsules | 1 | 1 | 9 |
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
190 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Heilongjiang Jun An Pharma Group Hong Xiang Pharmaceutical Co., Ltd. romanized | 13 | 13 | 0 |
| 2 | Topfond Pharmaceutical Co., Ltd. | 6 | 5 | 1 |
| 3 | Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized | 6 | 3 | 0 |
| 4 | Shanxi Hua Kang Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Qilu Pharmaceutical Co., Ltd. | 5 | 3 | 0 |
| 6 | Da Tong Shi Li Qun Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Lanzhou Tai Bao Pharmaceutical Co., Ltd. romanized | 4 | 3 | 0 |
| 8 | Guangdong He Xiang Biopharmaceuticals Co., Ltd. romanized | 4 | 3 | 0 |
| 9 | Shen Wei Pharma Group Co., Ltd. romanized | 4 | 3 | 0 |
| 10 | Pfizer Australia Pty Ltd | 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
61 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/07/01Generic · Class 3 | 硫酸特布他林口服溶液 · No verified English nameCYHS2502326 | Zhengzhou Da Ruo Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized |
| 2025/07/01New drug · Class 1.1 | 小儿便通颗粒 · No verified English nameCXZS2500026 | Ji Chuan Pharma Group Co., Ltd. romanized |
| 2025/07/01New drug · Class 1 | HF001脐带间充质干细胞注射液 · No verified English nameCXSL2500527 | Beijing Heng Feng Ming Cheng Bio Technology Co., Ltd. romanized |
| 2025/07/01New drug · Class 2.2 | 舒格利单抗注射液 · No verified English nameCXSL2500526 | Ji Shi Pharma (Suzhou) Co., Ltd. romanized |
| 2025/07/01New drug · Class 1 | 注射用CS5001 · No verified English nameCXSL2500525 | Ji Shi Pharma (Suzhou) Co., Ltd. romanized |
| 2025/07/01New drug · Class 1 | 9MW4611注射液 · No verified English nameCXSL2500524 | Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized |
| 2025/07/01New drug · Class 1 | JAB-8263片 · No verified English nameCXHL2500630 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized |
| 2025/07/01New drug · Class 1 | JAB-8263片 · No verified English nameCXHL2500629 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized |
| 2025/06/30Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2502325 | Tong Hua Wan Tong Pharma Co., Ltd. romanized |
| 2025/06/30New drug · Class 1 | 注射用DXC014 · No verified English nameCXSL2500523 | Hangzhou Duo Xi Bio Technology Co., Ltd. romanized |
| 2025/06/28Import · Class 1 | PF-07868489 · No verified English nameJXSL2500114 | Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd. |
| 2025/06/28Import · Class 1 | VAY736注射液 · No verified English nameJXSL2500113 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/06/28Generic · Class 3 | Pregabalin Extended release TabletsCYHS2502317 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2025/06/28Generic · Class 3 | Pregabalin Extended release TabletsCYHS2502316 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2025/06/28Generic · Class 3 | Pregabalin Extended release TabletsCYHS2502315 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2025/06/28Generic · Class 3 | Candesartan Cilexetil and Hydrochlorothiazide Tablets(II)CYHS2502312 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2025/06/28Generic · Class 3 | 坎地沙坦酯氢氯噻嗪片(Ⅰ) · No verified English nameCYHS2502311 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2025/06/28Generic · Class 3 | Lidocaine and Tetracaine CreamCYHS2502305 | Zhejiang Fu Nuo Pharmaceuticals Co., Ltd. romanized |
| 2025/06/28Generic · Class 3 | Relugolix TabletsCYHL2500122 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2025/06/28New drug · Class 1.1 | 补肾痹通丸 · No verified English nameCXZL2500042 | Xinjiang Wei Wu Er Zi Zhi Qu Zhong Yi Hospital romanized |
| 2025/06/28New drug · Class 1 | 重组乙型肝炎治疗性疫苗 · No verified English nameCXSL2500522 | Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized; Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Hangzhou) Co., Ltd. romanized |
| 2025/06/28New drug · Class 1 | 重组乙型肝炎治疗性疫苗 · No verified English nameCXSL2500521 | Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized; Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Hangzhou) Co., Ltd. romanized |
| 2025/06/28New drug · Class 1 | 注射用MHB048C · No verified English nameCXSL2500520 | Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2025/06/28New drug · Class 1 | ALK2401片 · No verified English nameCXHL2500628 | Ai Li Kang (Hefei) Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/06/28New drug · Class 1 | ALK2401片 · No verified English nameCXHL2500627 | Ai Li Kang (Hefei) Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/06/28New drug · Class 1 | 64Cu-TR2205注射液 · No verified English nameCXHL2500626 | Tong Rui Biopharmaceutical (Chengdu) Co., Ltd. romanized |
| 2025/06/27Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2502300 | Hunan Chun Jian Pharmaceutical Technology Co., Ltd. romanized; Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/06/27Generic · Class 3 | Amisulpride Oral SolutionCYHS2502294 | Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized |
| 2025/06/27Generic · Class 3 | Ebastine Oral SolutionCYHS2502291 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2025/06/27New drug · Class 3.3 | 重组人促卵泡激素注射液 · No verified English nameCXSS2500071 | Chengdu Jing Ze Biopharmaceutical Co., Ltd. romanized |
31 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.