YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 497 drug applications between 8 January 2025 and 14 January 2025 (data as of 14 November 2026 06:00). Of these, generic applications numbered 199, covering 139 drug names.
2025/01/08 – 2025/01/14
- New acceptances this week
- 497
- Drugs with new generic filings (by drug name, de-duplicated)
- 139
- Accepted this week, now under review
- 12
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
497filings, 199 of them generic
By application type
| Application type | Filings |
|---|---|
| Generic | 199 |
| Supplement | 189 |
| New drug | 83 |
| Import | 14 |
| Unspecified | 7 |
| Import re-registration | 3 |
| Drug-device combination | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 372 |
| TCM | 65 |
| Therapeutic biologic | 52 |
| Biologic | 6 |
| Prophylactic 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
139 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Brexpiprazole Tablets | 6 | 3 | 31 |
| 2 | Azilsartan Medoxomil Potassium Tablets | 6 | 3 | 35 |
| 3 | Vonoprazan Fumarate Tablets | 5 | 3 | 58 |
| 4 | Dapagliflozin Tablets | 4 | 2 | 84 |
| 5 | Crisaborole Ointment | 3 | 3 | 26 |
| 6 | Rosuvastatin Calcium and Ezetimibe Tablets (I) | 3 | 3 | 9 |
| 7 | Apalutamide Tablets | 3 | 3 | 18 |
| 8 | Levocarnitine Oral Solution | 3 | 2 | 9 |
| 9 | Etoricoxib Tablets | 3 | 1 | 8 |
| 10 | 阿贝西利片 · No verified English name | 3 | 1 | 2 |
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 | Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized | 13 | 12 | 0 |
| 2 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 9 | 7 | 9 |
| 3 | Shandong Qidu Pharmaceutical Co., Ltd. | 7 | 7 | 6 |
| 4 | Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 7 | 4 | 5 |
| 5 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 7 | 3 | 0 |
| 6 | Lang Li Biopharmaceuticals (Wuhan) Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | Beijing Foyou Pharma CO.,LTD | 6 | 4 | 6 |
| 8 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 6 | 4 | 0 |
| 9 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 6 | 4 | 6 |
| 10 | Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized | 5 | 5 | 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
161 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/01/14Import · Class 2.2 | Ropeginterferon alfa-2b (P1101) 注射液 · No verified English nameJXSL2500008 | PharmaEssentia Corporation; PharmaEssentia Biotechnology(Beijing)Company limited |
| 2025/01/14Generic · Class 3 | 硫糖铝片 · No verified English nameCYHS2500284 | Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized |
| 2025/01/14Generic · Class 3 | Allopurinol TabletsCYHS2500282 | Anhui Sheng Ying Pharma Co., Ltd. romanized |
| 2025/01/14Generic · Class 3 | 酒石酸阿福特罗吸入溶液 · No verified English nameCYHS2500279 | Jiangsu Zhang Tai Pharma Co., Ltd. romanized |
| 2025/01/14Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2500276 | Hua Zhong Pharma Co., Ltd. romanized |
| 2025/01/14Generic · Class 3 | Methocarbamol TabletsCYHS2500273 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/01/14Generic · Class 3 | 吗替麦考酚酯干混悬剂 · No verified English nameCYHS2500271 | Kunming Bei Ke Nuo Dun Pharmaceutical Co., Ltd. romanized |
| 2025/01/14New drug · Class 1 | 斯乐韦米单抗注射液 · No verified English nameCXSS2500004 | Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized |
| 2025/01/14New drug · Class 2.4 | 注射用重组A型肉毒毒素 · No verified English nameCXSL2500043 | Beijing Bo Te Wei Ke Bio Technology Co., Ltd. romanized |
| 2025/01/14New drug · Class 2.2 | 贝伐珠单抗注射液 · No verified English nameCXSL2500042 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/01/14New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2500041 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/01/14New drug · Class 1.2 | 带状疱疹mRNA疫苗 · No verified English nameCXSL2500040 | Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized; Rong Can Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2025/01/14New drug · Class 1 | 注射用SHR-1826 · No verified English nameCXSL2500039 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/01/14New drug · Class 1 | BGB-43395片 · No verified English nameCXHL2500069 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/01/14New drug · Class 1 | BGB-43395片 · No verified English nameCXHL2500068 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/01/14New drug · Class 2.2 | 注射用全反式维甲酸脂质体 · No verified English nameCXHL2500067 | Hangzhou Gao Tian Biopharmaceuticals Co., Ltd. romanized |
| 2025/01/14New drug · Class 1 | BGB-43395片 · No verified English nameCXHL2500066 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/01/14New drug · Class 1 | 注射用HRS-9190 · No verified English nameCXHL2500065 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/01/14New drug · Class 1 | BG-68501片 · No verified English nameCXHL2500064 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/01/14New drug · Class 1 | BG-68501片 · No verified English nameCXHL2500063 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/01/14New drug · Class 1 | BG-68501片 · No verified English nameCXHL2500062 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/01/14New drug · Class 1 | HRS-7058片 · No verified English nameCXHL2500061 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/01/14New drug · Class 1 | HRS-7058片 · No verified English nameCXHL2500060 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/01/14New drug · Class 1 | HRS-7058胶囊 · No verified English nameCXHL2500059 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/01/14New drug · Class 1 | HRS-7058胶囊 · No verified English nameCXHL2500058 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/01/13Generic · Class 3 | 维生素B12注射液 · No verified English nameCYHS2500265 | Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2025/01/13New drug · Class 1 | TQC2938注射液 · No verified English nameCXSL2500038 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2025/01/11Import · Class 1 | AZD2936 · No verified English nameJXSL2500007 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/01/11Import · Class 1 | TAK-360片 · No verified English nameJXHL2500008 | Takeda Development Center Americas Inc. |
| 2025/01/11Import · Class 1 | TAK-360片 · No verified English nameJXHL2500007 | Takeda Development Center Americas Inc. |
131 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.