YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 526 drug applications between 23 June 2026 and 29 June 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 73, covering 52 drug names.
2026/06/23 – 2026/06/29
- New acceptances this week
- 526
- Drugs with new generic filings (by drug name, de-duplicated)
- 52
- Accepted this week, now under review
- 154
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
526filings, 73 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 356 |
| Generic | 73 |
| New drug | 66 |
| Import | 18 |
| Unspecified | 10 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| TCM | 232 |
| Chemical drug | 215 |
| Therapeutic biologic | 74 |
| Biologic | 4 |
| 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
52 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Nafamostat Mesilate for Injection | 11 | 6 | 38 |
| 2 | Minoxidil Liniment | 3 | 2 | 52 |
| 3 | Fosfomycin Sodium For Injection | 3 | 1 | 16 |
| 4 | Ertugliflozin Tablets | 2 | 2 | 13 |
| 5 | Methylprednisolone Sodium Succinate for injection | 2 | 1 | 12 |
| 6 | 环索奈德吸入气雾剂 · No verified English name | 2 | 1 | 0 |
| 7 | Tetracaine Hydrochloride Gel | 2 | 1 | 5 |
| 8 | Bromhexine Hydrochloride Oral Solution | 2 | 1 | 22 |
| 9 | Terbutaline Sulfate Injection | 2 | 1 | 2 |
| 10 | 马来酸左氨氯地平片 · No verified English name | 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
311 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Mu Dan Jiang Ling Tai Pharma Co., Ltd. romanized | 17 | 16 | 0 |
| 2 | Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized | 12 | 5 | 0 |
| 3 | Dong E E Jiao Co., Ltd. romanized | 10 | 10 | 0 |
| 4 | Guizhou Yi Bai Nv Zi Da Pharmaceutical Factory Co., Ltd. romanized | 7 | 7 | 0 |
| 5 | AstraZeneca AB | 7 | 6 | 0 |
| 6 | Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Shenyang Dong Xin Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Janssen-Cilag International NV | 5 | 3 | 0 |
| 9 | Shanghai Shang Yao Xin Ya Pharma Co., Ltd. romanized | 5 | 2 | 0 |
| 10 | Shi Ze Bio Pharma (Shanghai) Co., Ltd. romanized | 5 | 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
117 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/06/29Import · Class 2.4 | Revumenib片 · No verified English nameJXHL2600230 | Syndax Pharmaceuticals Inc.; PAREXEL China Co. Ltd. |
| 2026/06/29Import · Class 2.4 | Revumenib片 · No verified English nameJXHL2600229 | Syndax Pharmaceuticals Inc.; PAREXEL China Co. Ltd. |
| 2026/06/29Import · Class 2.4 | Revumenib片 · No verified English nameJXHL2600228 | Syndax Pharmaceuticals Inc.; PAREXEL China Co. Ltd. |
| 2026/06/29Generic · Class 3 | Minoxidil LinimentCYHS2601529 | Anhui De Hong Sheng Pharmaceutical Co., Ltd. romanized; Zhejiang Ding Tai Pharma Co., Ltd. romanized |
| 2026/06/29Generic · Class 3 | Tetracaine Hydrochloride GelCYHS2601527 | Hunan Jiudian Pharmaceutical Co., Ltd |
| 2026/06/29Generic · Class 3 | Tetracaine Hydrochloride GelCYHS2601526 | Hunan Jiudian Pharmaceutical Co., Ltd |
| 2026/06/29Generic · Class 3 | Regadenoson InjectionCYHS2601525 | Kang Pu Pharma Co., Ltd. romanized |
| 2026/06/29Generic · Class 3 | Acetylcysteine TabletsCYHS2601524 | Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2026/06/29Generic · Class 3 | Calcium Acetate TabletsCYHS2601522 | Heilongjiang Long De Pharma Co., Ltd. romanized |
| 2026/06/29Generic · Class 3 | Piracetam InjectionCYHS2601521 | Chengdu Hua Yu Pharmaceutical Co., Ltd. romanized |
| 2026/06/29Generic · Class 3 | Nafamostat Mesilate for InjectionCYHS2601519 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2026/06/29Generic · Class 3 | Nafamostat Mesilate for InjectionCYHS2601518 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2026/06/29New drug · Class 2.2 | 注射用瑞康曲妥珠单抗 · No verified English nameCXSS2600103 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Name not romanized |
| 2026/06/29New drug · Class 1 | SHR-4610注射液 · No verified English nameCXSL2600683 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/06/29New drug · Class 1 | 注射用HS-20093 · No verified English nameCXSL2600682 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2026/06/29New drug · Class 1 | 注射用HC029 · No verified English nameCXSL2600681 | Shanghai Hong Cheng Pharma Co., Ltd. romanized |
| 2026/06/29New drug · Class 1 | OX-1胶囊 · No verified English nameCXSL2600680 | Wuhan Kang Fu De Bio Technology Co., Ltd. romanized; Wuhan Kang Fu De Mi Niao Xi Jie Shi Research Institute Co., Ltd. romanized |
| 2026/06/29New drug · Class 1 | OV329胶囊 · No verified English nameCXHL2600776 | Di Mai Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/06/29New drug · Class 1 | OV329胶囊 · No verified English nameCXHL2600775 | Di Mai Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/06/29New drug · Class 1 | SZJ0107片 · No verified English nameCXHL2600774 | Anhui San Zhi Jian Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/06/29New drug · Class 1 | BB3008片 · No verified English nameCXHL2600773 | Beijing Bo Hui Bio Technology Co., Ltd. romanized |
| 2026/06/29New drug · Class 1 | BB3008片 · No verified English nameCXHL2600772 | Beijing Bo Hui Bio Technology Co., Ltd. romanized |
| 2026/06/29New drug · Class 2.2; 2.4 | CZ028 · No verified English nameCXHL2600771 | Zhejiang Cui Ze Biopharmaceuticals Co., Ltd. romanized |
| 2026/06/29New drug · Class 1 | HCXT-2001片 · No verified English nameCXHL2600770 | Shanghai Han Chen Xing Tai Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/06/29New drug · Class 1 | HCXT-2001片 · No verified English nameCXHL2600769 | Shanghai Han Chen Xing Tai Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/06/26Import · Class 1 | 托雷奇单抗注射液 · No verified English nameJXSS2600055 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/06/26Generic · Class 3 | 聚普瑞锌口崩片 · No verified English nameCYHS2601515 | Jilin Sheng Bo Da Wei Ye Pharmaceutical Co., Ltd. romanized |
| 2026/06/26Generic · Class 3 | 比拉斯汀口崩片 · No verified English nameCYHS2601514 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
| 2026/06/26Generic · Class 3 | Terbutaline Sulfate InjectionCYHS2601511 | Jiangsu Fu Bang Pharma Co., Ltd. romanized |
| 2026/06/26Generic · Class 3 | Terbutaline Sulfate InjectionCYHS2601509 | Jiangsu Fu Bang Pharma Co., Ltd. romanized |
87 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.