YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 442 drug applications between 21 August 2026 and 27 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 73, covering 52 drug names.
2026/08/21 – 2026/08/27
- New acceptances this week
- 442
- Drugs with new generic filings (by drug name, de-duplicated)
- 52
- Accepted this week, now under review
- 256
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
442filings, 73 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 248 |
| Generic | 73 |
| New drug | 62 |
| Import | 38 |
| Unspecified | 13 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 224 |
| TCM | 124 |
| Therapeutic biologic | 79 |
| Prophylactic biologic | 14 |
| 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 | Dotinurad Tablets | 4 | 2 | 55 |
| 2 | Brivaracetam Tablets | 3 | 1 | 19 |
| 3 | Pregabalin Extended release Tablets | 3 | 1 | 13 |
| 4 | 生理氯化钠溶液 · No verified English name | 2 | 2 | 17 |
| 5 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 6 | Orlistat Capsules | 2 | 1 | 8 |
| 7 | Ibuprofen Injection | 2 | 1 | 8 |
| 8 | 琥珀酸地文拉法辛缓释片 · No verified English name | 2 | 1 | 3 |
| 9 | 甘油灌肠剂 · No verified English name | 2 | 1 | 2 |
| 10 | Metformin Hydrochloride Tablets | 2 | 1 | 4 |
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
241 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Gao Miao Pharma Co., Ltd. romanized | 39 | 35 | 0 |
| 2 | Luo Yang Yi Long Pharma Co., Ltd. romanized | 10 | 10 | 0 |
| 3 | Ming Hui Pharmaceuticals (Shanghai) Co., Ltd. romanized | 7 | 4 | 0 |
| 4 | Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized | 6 | 4 | 0 |
| 5 | Chengdu Brilliant Pharmaceutical Co., Ltd. | 6 | 3 | 1 |
| 6 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized | 6 | 3 | 0 |
| 7 | Eli Lilly Italia S.p.A. | 6 | 1 | 0 |
| 8 | Eli Lilly and Company | 6 | 1 | 0 |
| 9 | Pfizer Inc. | 5 | 3 | 0 |
| 10 | Haerbin Zhong Yao Si Factory 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
128 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/08/27Import · Class 3.1 | 司美格鲁肽片 · No verified English nameJXSS2600082 | Novo Nordisk A/S; Novo Nordisk Pharmaceutical Industries LP; Novo Nordisk(China) Pharmaceuticals Co. Ltd |
| 2026/08/27Import · Class 3.1 | 司美格鲁肽片 · No verified English nameJXSS2600081 | Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd |
| 2026/08/27Import · Class 3.1 | 司美格鲁肽片 · No verified English nameJXSS2600080 | Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd |
| 2026/08/27Import · Class 3.1 | 司美格鲁肽片 · No verified English nameJXSS2600079 | Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd |
| 2026/08/27Import · Class 1 | 注射用VIR-5500 · No verified English nameJXSL2600231 | Astellas Pharma Global Development Inc.; Astellas (Beijing) Pharmaceutical R&D Co. Ltd. |
| 2026/08/27Import · Class 2.4 | 瑞米布替尼片 · No verified English nameJXHL2600367 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/08/27Import · Class 1 | Petrelintide注射液 · No verified English nameJXHL2600366 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/27Import · Class 1 | Petrelintide注射液 · No verified English nameJXHL2600365 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/27Import · Class 1 | Petrelintide注射液 · No verified English nameJXHL2600364 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/27Import · Class 1 | Petrelintide注射液 · No verified English nameJXHL2600363 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/08/27Generic · Class 3 | Pregabalin Extended release TabletsCYHS2602149 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2026/08/27Generic · Class 3 | Pregabalin Extended release TabletsCYHS2602148 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2026/08/27Generic · Class 3 | Pregabalin Extended release TabletsCYHS2602147 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2026/08/27Generic · Class 3 | Levothyroxine Sodium Oral SolutionCYHS2602146 | Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/08/27Generic · Class 3 | 甘油灌肠剂 · No verified English nameCYHS2602139 | Heilongjiang Lai Kang Pharmaceutical Co., Ltd. romanized; Yi Chun Kang Er Xin Pharma Co., Ltd. romanized |
| 2026/08/27Generic · Class 3 | 甘油灌肠剂 · No verified English nameCYHS2602138 | Heilongjiang Lai Kang Pharmaceutical Co., Ltd. romanized; Yi Chun Kang Er Xin Pharma Co., Ltd. romanized |
| 2026/08/27Generic · Class 3 | Bromhexine Hydrochloride InjectionCYHS2602137 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2026/08/27New drug · Class 1.1 | 麻痛颗粒 · No verified English nameCXZL2600081 | Tai Zhou Le Ye Zhi Neng Technology Partnership (Limited Partnership) romanized |
| 2026/08/27New drug · Class 1 | CUG279 · No verified English nameCXSL2600925 | Shanghai Zheng Yin Da Biopharmaceuticals Co., Ltd. romanized |
| 2026/08/27New drug · Class 1 | 注射用MRG009 · No verified English nameCXSL2600924 | Le Pu Bio Technology Co., Ltd. romanized |
| 2026/08/27New drug · Class 1 | BBT002皮下注射液 · No verified English nameCXSL2600923 | Shan Zhu Yao (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/08/27New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2600922 | Wuhan Han Mi Dun Bio Technology Co., Ltd. romanized |
| 2026/08/27New drug · Class 1 | UX-GIP001注射液 · No verified English nameCXSL2600921 | Shanghai Yue Sai Bio Technology Co., Ltd. romanized |
| 2026/08/27New drug · Class 1 | 注射用BNT3210 · No verified English nameCXSL2600920 | Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2026/08/27New drug · Class 1 | KQB198胶囊 · No verified English nameCXHL2601051 | Jin Ju Bio Technology (Shanghai) Co., Ltd. romanized |
| 2026/08/27New drug · Class 1 | KQB198胶囊 · No verified English nameCXHL2601050 | Jin Ju Bio Technology (Shanghai) Co., Ltd. romanized |
| 2026/08/27New drug · Class 1 | AHB-137注射液 · No verified English nameCXHL2601049 | Hangzhou Hao Bo Pharmaceuticals Co., Ltd. romanized |
| 2026/08/27New drug · Class 1 | PRT-064040鼻喷雾剂 · No verified English nameCXHL2601048 | Sichuan Pu Rui Te Pharma Co., Ltd. romanized |
| 2026/08/27New drug · Class 1 | HW281171片 · No verified English nameCXHL2601047 | Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized |
| 2026/08/27New drug · Class 1 | HW281171片 · No verified English nameCXHL2601046 | Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized |
98 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.