YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 547 drug applications between 24 December 2025 and 30 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 139, covering 86 drug names.
2025/12/24 – 2025/12/30
- New acceptances this week
- 547
- Drugs with new generic filings (by drug name, de-duplicated)
- 86
- Accepted this week, now under review
- 143
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
547filings, 139 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 233 |
| Generic | 139 |
| New drug | 124 |
| Import | 20 |
| Import re-registration | 18 |
| Unspecified | 13 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 336 |
| TCM | 112 |
| Therapeutic biologic | 89 |
| Prophylactic biologic | 7 |
| Biologic | 2 |
| In vitro diagnostic reagent | 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
86 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 西诺氨酯片 · No verified English name | 6 | 2 | 24 |
| 2 | Upadacitinib Sustained-release Tablets | 5 | 5 | 43 |
| 3 | Dapagliflozin Tablets | 5 | 3 | 84 |
| 4 | Brexpiprazole Tablets | 5 | 2 | 31 |
| 5 | Acetylcysteine Oral Solution | 4 | 2 | 11 |
| 6 | 瑞维那新吸入溶液 · No verified English name | 3 | 3 | 53 |
| 7 | Glucosamine Sulfate Capsules | 3 | 3 | 51 |
| 8 | Ilaprazole Enteric-coated Tablets | 3 | 3 | 26 |
| 9 | Vonoprazan Fumarate Tablets | 3 | 2 | 60 |
| 10 | Vortioxetine Hydrobromide Tablets | 3 | 2 | 10 |
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
315 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Nei Menggu Da Tang Pharma Co., Ltd. romanized | 21 | 19 | 0 |
| 2 | Amgen Inc. | 15 | 3 | 0 |
| 3 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 12 | 12 | 0 |
| 4 | AstraZeneca AB | 9 | 6 | 0 |
| 5 | medac Gesellschaft für klinische Spezialpr?parate mbH | 8 | 1 | 0 |
| 6 | Hunan Tian Ji Cao Tang Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | Chongqing Zhang Xin Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Hunan Jiudian Pharmaceutical Co., Ltd | 5 | 4 | 1 |
| 9 | Merck Sharp & Dohme LLC | 5 | 3 | 0 |
| 10 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 2 |
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
183 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/12/30Generic · Class 3 | Tolvaptan Orally Disintegrating TabletsCYHS2504488 | Hebei Long Hai Pharma Co., Ltd. romanized |
| 2025/12/30Generic · Class 3 | Phloroglucinol Orally Disintegrating TabletsCYHS2504486 | Yan Tai Lu Yin Pharma Co., Ltd. romanized |
| 2025/12/30Generic · Class 3 | 盐酸丙卡特罗吸入溶液 · No verified English nameCYHS2504475 | Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized; Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized |
| 2025/12/30Generic · Class 3 | 盐酸丙卡特罗吸入溶液 · No verified English nameCYHS2504474 | Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized; Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized |
| 2025/12/30Generic · Class 3 | Entecavir oral solutionCYHS2504473 | Shanghai Hai Hong Industrial (Group) Chao Hu Jin Chen Pharma Co., Ltd. romanized |
| 2025/12/30Generic · Class 3 | Erythromycin Lactobionate for InjectionCYHS2504472 | Suzhou Erye Pharmaceutical Co., Ltd |
| 2025/12/30Generic · Class 3 | Erythromycin Lactobionate for InjectionCYHS2504471 | Suzhou Erye Pharmaceutical Co., Ltd |
| 2025/12/30Generic · Class 3 | 利多卡因丙胺卡因气雾剂 · No verified English nameCYHS2504465 | Jiangsu Ke Fei Ping Pharmaceuticals Co., Ltd. romanized; Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized |
| 2025/12/30Generic · Class 3 | 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2500236 | Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized |
| 2025/12/30Generic · Class 3 | 达普司他片 · No verified English nameCYHL2500235 | Anhui Hong Ye Pharma Co., Ltd. romanized |
| 2025/12/30Generic · Class 3 | 达普司他片 · No verified English nameCYHL2500234 | Anhui Hong Ye Pharma Co., Ltd. romanized |
| 2025/12/30New drug · Class 3.1 | 芍药甘草汤颗粒 · No verified English nameCXZS2500053 | Hua Run Jiang Zhong Pharma Co., Ltd. romanized |
| 2025/12/30New drug · Class 3.1 | 一贯煎颗粒 · No verified English nameCXZS2500052 | Hua Run Jiang Zhong Pharma Co., Ltd. romanized |
| 2025/12/30New drug · Class 1.1 | 麻桂退热贴 · No verified English nameCXZL2500136 | Zhongguo Zhong Yi Ke College Zhong Yao Research Institute romanized |
| 2025/12/30New drug · Class 1 | 注射用QLS5308 · No verified English nameCXSL2501169 | Qilu Pharmaceutical Co., Ltd. |
| 2025/12/30New drug · Class 1 | JL19001注射液 · No verified English nameCXSL2501163 | Jie Ku (Shanghai) Biopharmaceuticals Research Co., Ltd. romanized; Jie Ke (Tianjin) Biopharmaceuticals Co., Ltd. romanized |
| 2025/12/30New drug · Class 1 | IBR854细胞注射液 · No verified English nameCXSL2501162 | Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2025/12/30New drug · Class 1 | IBR854细胞注射液 · No verified English nameCXSL2501161 | Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2025/12/30New drug · Class 1 | Pumitamig注射液 · No verified English nameCXSL2501160 | Bai Shi Mei Shi Gui Bao (Zhongguo) Investment Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2025/12/30New drug · Class 1 | JY47注射液 · No verified English nameCXSL2501159 | Hangzhou Jiu Yuan Ji Yin Biopharmaceuticals Co., Ltd. romanized |
| 2025/12/30New drug · Class 1 | 重组抗EGFR人源化单克隆抗体注射液 · No verified English nameCXSL2501158 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized |
| 2025/12/30New drug · Class 1 | LC-1016注射液 · No verified English nameCXHL2501510 | Chengdu Xin Zheng He Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/30New drug · Class 1 | YD6390片 · No verified English nameCXHL2501509 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2025/12/30New drug · Class 1 | YD6390片 · No verified English nameCXHL2501508 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2025/12/30New drug · Class 1 | YD6390片 · No verified English nameCXHL2501507 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2025/12/30New drug · Class 1 | SYH2059吸入粉雾剂 · No verified English nameCXHL2501506 | Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/30New drug · Class 1 | SYH2059吸入粉雾剂 · No verified English nameCXHL2501505 | Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/30New drug · Class 1 | SYH2059吸入粉雾剂 · No verified English nameCXHL2501504 | Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/30New drug · Class 1 | SYH2059吸入粉雾剂 · No verified English nameCXHL2501503 | Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/30New drug · Class 1 | AOB01-0036胶囊 · No verified English nameCXHL2501502 | Shuang Yi Yuan Chuang (Shanghai) Pharmaceuticals Co., Ltd. romanized |
153 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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