YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 451 drug applications between 5 June 2026 and 11 June 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 90, covering 57 drug names.
2026/06/05 – 2026/06/11
- New acceptances this week
- 451
- Drugs with new generic filings (by drug name, de-duplicated)
- 57
- Accepted this week, now under review
- 136
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
451filings, 90 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 246 |
| Generic | 90 |
| New drug | 77 |
| Import | 27 |
| Unspecified | 6 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 229 |
| TCM | 143 |
| Therapeutic biologic | 78 |
| 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
57 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dotinurad Tablets | 4 | 2 | 55 |
| 2 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 3 | Mirogabalin Besilate Tablets | 4 | 2 | 61 |
| 4 | Nafamostat Mesilate for Injection | 3 | 2 | 38 |
| 5 | Pregabalin Orally Disintegrating Tablets | 3 | 1 | 3 |
| 6 | Rotigotine Patches | 3 | 1 | 7 |
| 7 | 西诺氨酯片 · No verified English name | 3 | 1 | 24 |
| 8 | Landiolol Hydrochloride for Injection | 2 | 2 | 19 |
| 9 | Loxoprofen Sodium Oral Solution | 2 | 2 | 6 |
| 10 | Brexpiprazole Tablets | 2 | 1 | 31 |
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
264 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 15 | 2 | 0 |
| 2 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 8 | 7 | 0 |
| 3 | Eli Lilly and Company | 8 | 3 | 0 |
| 4 | Jiangsu En Hua Pharma Co., Ltd. romanized | 8 | 3 | 3 |
| 5 | Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 6 | 2 | 3 |
| 7 | Amgen Inc. | 6 | 1 | 0 |
| 8 | Hua Run Shuang He Xiang Zhong Pharma (Hunan) Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized | 5 | 4 | 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
137 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/06/11Import · Class 2.4 | Elafibranor片 · No verified English nameJXHL2600215 | Ipsen Bioscience Inc.; Ipsen (Shanghai) Innovation Pharmaceutical Co. Ltd |
| 2026/06/11Generic · Class 3 | Chloroprocaine Hydrochloride InjectionCYHS2601393 | Jiangsu Vanguard Pharmaceutical Co., Ltd. |
| 2026/06/11Generic · Class 3 | Chloroprocaine Hydrochloride InjectionCYHS2601392 | Jiangsu Vanguard Pharmaceutical Co., Ltd. |
| 2026/06/11Generic · Class 3 | Ambroxol Hydrochloride DropsCYHS2601389 | Anhui Kang Rong Pharma Co., Ltd. romanized |
| 2026/06/11Generic · Class 3 | Bumetanide InjectionCYHS2601384 | Dan Dong Yi Chuang Pharma Co., Ltd. romanized |
| 2026/06/11Generic · Class 3 | Bumetanide InjectionCYHS2601382 | Dan Dong Yi Chuang Pharma Co., Ltd. romanized |
| 2026/06/11Generic · Class 3 | 磷酸奥司他韦颗粒 · No verified English nameCYHS2601380 | Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2026/06/11Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2601379 | Jiangsu Shen Hua Pharma Co., Ltd. romanized |
| 2026/06/11New drug · Class 3.1 | 苓桂术甘汤颗粒 · No verified English nameCXZS2600031 | Changsha Xin Lin Pharmaceutical Co., Ltd. romanized |
| 2026/06/11New drug · Class 3.3 | 德谷门冬双胰岛素注射液 · No verified English nameCXSS2600092 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2026/06/11New drug · Class 3.3 | 德谷门冬双胰岛素注射液 · No verified English nameCXSS2600091 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2026/06/11New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSS2600090 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized |
| 2026/06/11New drug · Class 1 | HS-IT101注射液 · No verified English nameCXSL2600631 | Qingdao Zhong Sai Bo Man Bio Technology Co., Ltd. romanized |
| 2026/06/11New drug · Class 1 | SCTB10注射液 · No verified English nameCXSL2600630 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2026/06/11New drug · Class 1 | 注射用AK157D1 · No verified English nameCXSL2600629 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2026/06/11New drug · Class 1 | HY001N细胞注射液 · No verified English nameCXSL2600628 | He Yuan Bio Technology Co., Ltd. romanized; Guangdong He Yuan Biopharmaceuticals Co., Ltd. romanized |
| 2026/06/11New drug · Class 1 | BGM0504注射液 · No verified English nameCXHS2600089 | Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/06/11New drug · Class 1 | BGM0504注射液 · No verified English nameCXHS2600088 | Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/06/11New drug · Class 1 | BGM0504注射液 · No verified English nameCXHS2600087 | Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/06/11New drug · Class 1 | BGM0504注射液 · No verified English nameCXHS2600086 | Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/06/11New drug · Class 1 | YKYY033注射液 · No verified English nameCXHL2600704 | Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Tian Long Pharma Co., Ltd. romanized |
| 2026/06/11New drug · Class 1 | YKYY033注射液 · No verified English nameCXHL2600703 | Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Tian Long Pharma Co., Ltd. romanized |
| 2026/06/11New drug · Class 1 | YKYY033注射液 · No verified English nameCXHL2600702 | Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Tian Long Pharma Co., Ltd. romanized |
| 2026/06/11New drug · Class 2.2; 2.4 | WTITD003片 · No verified English nameCXHL2600701 | Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized |
| 2026/06/11New drug · Class 2.2; 2.4 | WTITD003片 · No verified English nameCXHL2600700 | Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized |
| 2026/06/11New drug · Class 2.2; 2.4 | 甲硝唑滴眼液 · No verified English nameCXHL2600699 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2026/06/11New drug · Class 2.2; 2.4 | 甲硝唑滴眼液 · No verified English nameCXHL2600698 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2026/06/11New drug · Class 1 | TB-B002D注射液 · No verified English nameCXHL2600697 | Shenzhen Shi Tu Wei An Chuang Technology Kai Fa Co., Ltd. romanized |
| 2026/06/11New drug · Class 1 | TB-B002D注射液 · No verified English nameCXHL2600696 | Shenzhen Shi Tu Wei An Chuang Technology Kai Fa Co., Ltd. romanized |
| 2026/06/11New drug · Class 2.4 | Pantoprazole Sodium For InjectionCXHL2600695 | Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized |
107 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.