YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 473 drug applications between 2 June 2026 and 8 June 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 99, covering 69 drug names.
2026/06/02 – 2026/06/08
- New acceptances this week
- 473
- Drugs with new generic filings (by drug name, de-duplicated)
- 69
- Accepted this week, now under review
- 137
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
473filings, 99 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 243 |
| Generic | 99 |
| New drug | 83 |
| Import | 37 |
| Import re-registration | 6 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 234 |
| TCM | 157 |
| Therapeutic biologic | 77 |
| Prophylactic biologic | 3 |
| Biologic | 2 |
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
69 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dotinurad Tablets | 5 | 3 | 55 |
| 2 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 3 | Ilaprazole Enteric-coated Tablets | 3 | 3 | 26 |
| 4 | Pregabalin Orally Disintegrating Tablets | 3 | 1 | 3 |
| 5 | Metformin Hydrochloride Extended-release Tablets | 3 | 1 | 10 |
| 6 | Rotigotine Patches | 3 | 1 | 7 |
| 7 | Nafamostat Mesilate for Injection | 2 | 2 | 38 |
| 8 | Landiolol Hydrochloride for Injection | 2 | 2 | 19 |
| 9 | Sivelestat Sodium for Injection | 2 | 2 | 5 |
| 10 | Loxoprofen Sodium Oral Solution | 2 | 2 | 6 |
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
280 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 19 | 14 | 0 |
| 2 | Eli Lilly and Company | 13 | 2 | 0 |
| 3 | Novo Nordisk A/S | 12 | 1 | 0 |
| 4 | Eli Lilly Nederland B.V. | 8 | 1 | 0 |
| 5 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized | 6 | 2 | 0 |
| 6 | Celgene Corporation a Bristol-Myers Squibb Company | 6 | 1 | 0 |
| 7 | Chengdu Hua Sen Ao Rui Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 8 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 6 | 1 | 0 |
| 9 | Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Qilu Pharmaceutical Co., Ltd. | 5 | 3 | 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
153 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/06/08Import · Class 2.2 | 注射用罗特西普 · No verified English nameJXSS2600051 | Celgene Corporation a Bristol-Myers Squibb Company; Patheon Italia S.p.A.; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2026/06/08Import · Class 2.2 | 注射用罗特西普 · No verified English nameJXSS2600050 | Celgene Corporation a Bristol-Myers Squibb Company; Patheon Italia S.p.A.; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2026/06/08Import · Class 1 | GIA632注射液 · No verified English nameJXSL2600140 | Novartis Pharma AG |
| 2026/06/08Generic · Class 3 | Doxepin Hydrochloride TabletsCYHS2601336 | Shenyang Hua Tai Drug Research Co., Ltd. romanized |
| 2026/06/08Generic · Class 3 | Simethicone Chewable TabletsCYHS2601335 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2026/06/08Generic · Class 3 | Pregabalin Orally Disintegrating TabletsCYHS2601334 | Shandong Innovation Drug Research and Development Co., Ltd. romanized; Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2026/06/08Generic · Class 3 | Pregabalin Orally Disintegrating TabletsCYHS2601333 | Shandong Innovation Drug Research and Development Co., Ltd. romanized; Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2026/06/08Generic · Class 3 | Pregabalin Orally Disintegrating TabletsCYHS2601332 | Shandong Innovation Drug Research and Development Co., Ltd. romanized; Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2026/06/08Generic · Class 3 | 美洛昔康注射液(III) · No verified English nameCYHS2601331 | Health Yuan Pharma Group Co., Ltd. romanized; Health Yuan Hai Bin Pharma Co., Ltd. romanized |
| 2026/06/08Generic · Class 3 | Pregabalin Extended release TabletsCYHS2601329 | Beijing Tai De Pharmaceutical Co., Ltd. romanized |
| 2026/06/08Generic · Class 3 | Pregabalin Extended release TabletsCYHS2601328 | Beijing Tai De Pharmaceutical Co., Ltd. romanized |
| 2026/06/08Generic · Class 3 | Nafamostat Mesilate for InjectionCYHS2601327 | Hunan Ai Wei Ge Lin Pharmaceuticals Technology Co., Ltd. romanized; Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized |
| 2026/06/08Generic · Class 3 | Loxoprofen Sodium Oral SolutionCYHS2601325 | Jiangxi Zhong Ze Yuan Pharmaceuticals Technology Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized |
| 2026/06/08Generic · Class 3 | Timolol Maleate Eye DropsCYHS2601324 | Guangdong Nan Guo Pharma Co., Ltd. romanized |
| 2026/06/08New drug · Class 1.1 | 芪地通便颗粒 · No verified English nameCXZL2600054 | Shandong Han Fang Pharmaceutical Co., Ltd. romanized |
| 2026/06/08New drug · Class 1 | Pumitamig注射液 · No verified English nameCXSL2600617 | Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized; Bai Shi Mei Shi Gui Bao (Zhongguo) Investment Co., Ltd. romanized |
| 2026/06/08New drug · Class 1 | 注射用RT023 · No verified English nameCXSL2600616 | Shanghai Ruo Tuo Bio Technology Co., Ltd. romanized |
| 2026/06/08New drug · Class 2.2 | 西妥昔单抗β注射液 · No verified English nameCXSL2600615 | Tai Zhou Mai Bo Tai Ke Pharma Co., Ltd. romanized |
| 2026/06/08New drug · Class 1 | ZMPB-NK006注射液 · No verified English nameCXSL2600614 | Beijing Mei Ou Sai Ao Jin Bio Technology Co., Ltd. romanized |
| 2026/06/08New drug · Class 1 | IBR822细胞注射液 · No verified English nameCXSL2600613 | Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2026/06/08New drug · Class 1 | IBR822细胞注射液 · No verified English nameCXSL2600612 | Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2026/06/08New drug · Class 1 | RG002注射液 · No verified English nameCXSL2600611 | Ren Jing (Suzhou) Bio Technology Co., Ltd. romanized |
| 2026/06/08New drug · Class 1 | CA-301注射液 · No verified English nameCXHL2600682 | Yuan Yan Gang Nao Ke Xue Technology (Shanghai) Co., Ltd. romanized; Yuan Yan Yao Gang Sheng Ming Ke Xue Technology (Beijing) Group Co., Ltd. romanized |
| 2026/06/08New drug · Class 2.4 | 莫米司特片 · No verified English nameCXHL2600681 | Gan Zhou He Mei Pharma Co., Ltd. romanized |
| 2026/06/08New drug · Class 1 | HSK47388片(I) · No verified English nameCXHL2600680 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2026/06/08New drug · Class 1 | HSK47388片(I) · No verified English nameCXHL2600679 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2026/06/08New drug · Class 1 | YL-13027片 · No verified English nameCXHL2600678 | Shanghai Ying Li Pharma Co., Ltd. romanized |
| 2026/06/08New drug · Class 1 | YL-13027片 · No verified English nameCXHL2600677 | Shanghai Ying Li Pharma Co., Ltd. romanized |
| 2026/06/05Import · Class 1 | NNC0487-0111注射液 · No verified English nameJXSL2600139 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/06/05Import · Class 1 | NNC0487-0111注射液 · No verified English nameJXSL2600138 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
123 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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