YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 481 drug applications between 7 August 2026 and 13 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 85, covering 59 drug names.
2026/08/07 – 2026/08/13
- New acceptances this week
- 481
- Drugs with new generic filings (by drug name, de-duplicated)
- 59
- Accepted this week, now under review
- 246
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
481filings, 85 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 286 |
| Generic | 85 |
| New drug | 63 |
| Import | 32 |
| Import re-registration | 8 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 230 |
| TCM | 172 |
| Therapeutic biologic | 71 |
| Prophylactic biologic | 6 |
| 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
59 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dapagliflozin Tablets | 4 | 2 | 84 |
| 2 | 注射用磷酸左奥硝唑酯二钠 · No verified English name | 3 | 2 | 22 |
| 3 | 苯磺酸左氨氯地平片 · No verified English name | 3 | 2 | 45 |
| 4 | Brexpiprazole Orally Disintegrating Tablets | 3 | 1 | 10 |
| 5 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 6 | 鱼油(3%)橄榄油中/长链脂肪乳/氨基酸(16)/葡萄糖(13%)注射液 · No verified English name | 3 | 1 | 6 |
| 7 | Lactulose Oral Solution | 2 | 2 | 34 |
| 8 | Ferrous Succinate Tablets | 2 | 2 | 20 |
| 9 | 盐酸阿莫罗芬搽剂 · No verified English name | 2 | 2 | 15 |
| 10 | Mupirocin Ointment | 2 | 2 | 30 |
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
292 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Gao Miao Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 2 | AstraZeneca AB | 8 | 5 | 0 |
| 3 | Xin Da Bio Technology Co., Ltd. romanized | 8 | 1 | 0 |
| 4 | Liaoning Shang Yao Hao Hu Shi Pharma (Group) Co., Ltd. romanized | 7 | 5 | 0 |
| 5 | Novo Nordisk A/S | 7 | 1 | 0 |
| 6 | F. Hoffmann-La Roche Ltd | 6 | 1 | 0 |
| 7 | Sichuan Tai Le Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Heng Yi Biopharmaceuticals (Jiangsu) Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized | 4 | 4 | 0 |
| 10 | Qinghai Di Ma Er Zang Yao Pharma Co., Ltd. romanized | 4 | 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
121 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/08/13Import · Class 3.1 | 阿柏西普眼内注射溶液 · No verified English nameJXSS2600073 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2026/08/13Import · Class 2.4 | Finerenone TabletsJXHS2600089 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2026/08/13Import · Class 2.4 | Finerenone TabletsJXHS2600088 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2026/08/13Generic · Class 3 | Idebenone TabletsCYHS2602008 | Qilu Pharmaceutical Co., Ltd. |
| 2026/08/13Generic · Class 3 | Ferrous Succinate TabletsCYHS2601997 | Zhejiang Qian Jin Pharma Co., Ltd. romanized |
| 2026/08/13Generic · Class 3 | Levofloxacin Oral SolutionCYHS2601992 | Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized |
| 2026/08/13Generic · Class 3 | Glycerol Fructose And Sodium Chloride InjectionCYHS2601988 | Chi Feng Yuan Sheng Pharma Co., Ltd. romanized |
| 2026/08/13New drug · Class 1 | HB0056注射液 · No verified English nameCXSL2600863 | Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/08/13New drug · Class 1 | ZHB 103注射液 · No verified English nameCXSL2600862 | Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized |
| 2026/08/13New drug · Class 2.4 | RY001 注射用重组A型肉毒毒素(大肠杆菌) · No verified English nameCXSL2600861 | Chengdu Rui Yi Bio Technology Co., Ltd. romanized |
| 2026/08/13New drug · Class 1 | FG-M108注射液 · No verified English nameCXSL2600860 | Ming Ji Biopharmaceutical (Beijing) Co., Ltd. romanized |
| 2026/08/13New drug · Class 1 | ACE723 · No verified English nameCXSL2600859 | Ai Si Bo Di Ya (Shanghai) Bio Technology Co., Ltd. romanized |
| 2026/08/13New drug · Class 1 | 注射用SAL012 · No verified English nameCXSL2600858 | Xin Li Tai (Chengdu) Bio Technology Co., Ltd. romanized; Xin Li Tai (Suzhou) Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2026/08/13New drug · Class 1 | 注射用SHR-8925 · No verified English nameCXSL2600857 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/08/13New drug · Class 1 | BC923注射液 · No verified English nameCXHL2601000 | Beijing Bo Yuan Run Bu Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2026/08/13New drug · Class 1 | HTMC0658片 · No verified English nameCXHL2600999 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2026/08/13New drug · Class 1 | HTMC0658片 · No verified English nameCXHL2600998 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2026/08/13New drug · Class 1 | HTMC0658片 · No verified English nameCXHL2600997 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2026/08/13New drug · Class 1 | VC005凝胶 · No verified English nameCXHL2600996 | Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/08/13New drug · Class 1 | VC005凝胶 · No verified English nameCXHL2600995 | Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/08/13New drug · Class 2.2 | YR-2316吸入粉雾剂 · No verified English nameCXHL2600994 | Yangtze River Pharmaceutical Group Co., Ltd; Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized |
| 2026/08/13New drug · Class 2.2 | YR-2316吸入粉雾剂 · No verified English nameCXHL2600993 | Yangtze River Pharmaceutical Group Co., Ltd; Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized |
| 2026/08/12Import · Class 1 | RO7589655注射液 · No verified English nameJXSL2600206 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/12Import · Class 1 | RO7589655注射液 · No verified English nameJXSL2600205 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/12Import · Class 1 | RO7589655注射液 · No verified English nameJXSL2600204 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/12Import · Class 1 | RO7589655注射液 · No verified English nameJXSL2600203 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/12Import · Class 1 | RO7589655注射液 · No verified English nameJXSL2600202 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/12Import · Class 1 | RO7589655注射液 · No verified English nameJXSL2600201 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/12Import · Class 1 | zenagamtide注射液 · No verified English nameJXSL2600200 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/08/12Import · Class 1 | zenagamtide注射液 · No verified English nameJXSL2600199 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
91 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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