YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 555 drug applications between 22 December 2025 and 28 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 128, covering 83 drug names.
2025/12/22 – 2025/12/28
- New acceptances this week
- 555
- Drugs with new generic filings (by drug name, de-duplicated)
- 83
- Accepted this week, now under review
- 134
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
555filings, 128 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 246 |
| Generic | 128 |
| New drug | 128 |
| Import | 20 |
| Import re-registration | 17 |
| Unspecified | 16 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 330 |
| TCM | 110 |
| Therapeutic biologic | 100 |
| Biologic | 7 |
| Prophylactic biologic | 7 |
| 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
83 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 | Dapagliflozin Tablets | 5 | 3 | 84 |
| 3 | Brexpiprazole Tablets | 5 | 2 | 31 |
| 4 | Upadacitinib Sustained-release Tablets | 4 | 4 | 43 |
| 5 | Acetylcysteine Oral Solution | 4 | 2 | 11 |
| 6 | 苯磺酸左氨氯地平片 · No verified English name | 4 | 2 | 45 |
| 7 | 草酸艾司西酞普兰口服溶液 · No verified English name | 4 | 2 | 11 |
| 8 | Vortioxetine Hydrobromide Tablets | 3 | 2 | 10 |
| 9 | Oseltamivir Phosphate Capsules | 3 | 1 | 39 |
| 10 | Crisaborole Ointment | 2 | 2 | 26 |
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
311 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Sheng De Shang Pharma Co., Ltd. romanized | 23 | 17 | 0 |
| 2 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 16 | 16 | 0 |
| 3 | Amgen Inc. | 13 | 2 | 0 |
| 4 | AstraZeneca AB | 11 | 7 | 0 |
| 5 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized | 9 | 1 | 0 |
| 6 | medac Gesellschaft für klinische Spezialpr?parate mbH | 8 | 1 | 0 |
| 7 | Merck Sharp & Dohme LLC | 7 | 4 | 0 |
| 8 | Hunan Jiudian Pharmaceutical Co., Ltd | 6 | 5 | 1 |
| 9 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 2 |
| 10 | Name not romanized | 5 | 2 | 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
187 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/12/27Import · Class 1 | Iberdomide胶囊 · No verified English nameJXHS2500139 | Bristol-Myers Squibb Pharma EEIG; Celgene International Sarl; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/12/27Import · Class 1 | Iberdomide胶囊 · No verified English nameJXHS2500138 | Bristol-Myers Squibb Pharma EEIG; Celgene International Sarl; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/12/27Generic · Class 3 | 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2504440 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized |
| 2025/12/27Generic · Class 3 | Topiroxostat TabletsCYHL2500232 | Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized |
| 2025/12/27Generic · Class 3 | Topiroxostat TabletsCYHL2500231 | Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized |
| 2025/12/27New drug · Class 1 | IBI3028 · No verified English nameCXSL2501150 | Xin Da Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized |
| 2025/12/27New drug · Class 1 | 注射用ACT100 · No verified English nameCXSL2501149 | Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized |
| 2025/12/27New drug · Class 1 | 注射用ACT100 · No verified English nameCXSL2501148 | Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized |
| 2025/12/27New drug · Class 1 | JMB2202注射液 · No verified English nameCXSL2501147 | Jiangsu Ji Ye Biopharmaceutical Co., Ltd. romanized |
| 2025/12/27New drug · Class 1 | RC148注射液 · No verified English nameCXSL2501146 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2025/12/27New drug · Class 1 | GV20-0251注射液 · No verified English nameCXSL2501145 | Shanghai Xun Bai Hui Bio Technology Co., Ltd. romanized |
| 2025/12/27New drug · Class 1 | YHL-2101注射液 · No verified English nameCXSL2501144 | Shanghai Hai Lu Bio Technology Co., Ltd. romanized; Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Hai Bo Biopharmaceutical Co., Ltd. romanized |
| 2025/12/27New drug · Class 1 | HSK50042片 · No verified English nameCXHL2501482 | Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/27New drug · Class 1 | HSK50042片 · No verified English nameCXHL2501481 | Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/27New drug · Class 1 | EGFNASA软膏 · No verified English nameCXHL2501480 | Ningbo Ai Ke Suo Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/27New drug · Class 1 | EGFNASA软膏 · No verified English nameCXHL2501479 | Ningbo Ai Ke Suo Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/26Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2504437 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/12/26Generic · Class 3 | Acetylcysteine Oral SolutionCYHS2504423 | Sichuan Hai Meng Zhi Sen Biopharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2025/12/26Generic · Class 3 | Acetylcysteine Oral SolutionCYHS2504422 | Sichuan Hai Meng Zhi Sen Biopharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2025/12/26Generic · Class 3 | Acetylcysteine Oral SolutionCYHS2504421 | Sichuan Hai Meng Zhi Sen Biopharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2025/12/26Generic · Class 3 | Acetylcysteine Oral SolutionCYHS2504420 | Chengdu Bai Teng Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized |
| 2025/12/26Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2504418 | Hua Zhong Pharma Co., Ltd. romanized |
| 2025/12/26Generic · Class 3 | Netilmicin Sulfate InjectionCYHS2504415 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2025/12/26Generic · Class 3 | 氯雷他定口服溶液 · No verified English nameCYHS2504410 | Jiangxi Ren Qi Pharmaceutical Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2025/12/26Generic · Class 3 | Pioglitazone and Metformin Hydrochloride TabletsCYHS2504409 | Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized |
| 2025/12/26Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2504407 | Guangdong Ke Hong Pharma Co., Ltd. romanized |
| 2025/12/26New drug · Class 1.1 | 九味合欢颗粒 · No verified English nameCXZL2500135 | Ningbo Jiu Rui Pharma Co., Ltd. romanized |
| 2025/12/26New drug · Class 1 | 注射用经应激诱导的间充质干细胞衍生物 · No verified English nameCXSL2501153 | Da Er Wen Qi Dian (Hubei) Biopharmaceutical Co., Ltd. romanized |
| 2025/12/26New drug · Class 1 | 舒西利单抗注射液 · No verified English nameCXSL2501143 | Zhong Kang Biopharmaceutical (Haikou) Co., Ltd. romanized |
| 2025/12/26New drug · Class 1 | CG-BM1异体人骨髓间充质干细胞注射液 · No verified English nameCXSL2501142 | Guangzhou Sai Juan Bio Technology Co., Ltd. romanized |
157 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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