YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 520 drug applications between 23 December 2025 and 29 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 117, covering 78 drug names.
2025/12/23 – 2025/12/29
- New acceptances this week
- 520
- Drugs with new generic filings (by drug name, de-duplicated)
- 78
- Accepted this week, now under review
- 123
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
520filings, 117 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 230 |
| New drug | 123 |
| Generic | 117 |
| Import | 21 |
| Unspecified | 15 |
| Import re-registration | 14 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 312 |
| TCM | 103 |
| Therapeutic biologic | 92 |
| Prophylactic biologic | 9 |
| Biologic | 3 |
| 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
78 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 | Glucosamine Sulfate Capsules | 3 | 3 | 51 |
| 7 | Vortioxetine Hydrobromide Tablets | 3 | 2 | 10 |
| 8 | Oseltamivir Phosphate Capsules | 3 | 1 | 39 |
| 9 | Crisaborole Ointment | 2 | 2 | 26 |
| 10 | Baloxavir Marboxil Tablets | 2 | 2 | 12 |
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
301 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Amgen Inc. | 15 | 3 | 0 |
| 2 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 13 | 13 | 0 |
| 3 | Jilin Sheng De Shang Pharma Co., Ltd. romanized | 8 | 7 | 0 |
| 4 | AstraZeneca AB | 8 | 5 | 0 |
| 5 | medac Gesellschaft für klinische Spezialpr?parate mbH | 8 | 1 | 0 |
| 6 | Merck Sharp & Dohme LLC | 7 | 4 | 0 |
| 7 | Hunan Tian Ji Cao Tang Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 8 | Chongqing Zhang Xin Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Hunan Jiudian Pharmaceutical Co., Ltd | 5 | 4 | 1 |
| 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
177 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/12/29Import · Class 1 | 注射用MK-1022 · No verified English nameJXSL2500250 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2025/12/29Import · Class 2.4 | 匹妥布替尼片 · No verified English nameJXHS2500142 | Eli Lilly Nederland B.V.; Lilly del Caribe lnc.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/12/29Import · Class 2.4 | 匹妥布替尼片 · No verified English nameJXHS2500141 | Eli Lilly Nederland B.V.; Lilly del Caribe lnc.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/12/29Import · Class 1 | AMG 436 · No verified English nameJXHL2500397 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd. |
| 2025/12/29Import · Class 1 | AMG 436 · No verified English nameJXHL2500396 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd. |
| 2025/12/29Generic · Class 3 | Relugolix TabletsCYHS2504454 | Jiangxi Shan Xiang Pharma Co., Ltd. romanized |
| 2025/12/29Generic · Class 3 | Ferrous Succinate TabletsCYHS2504452 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2025/12/29Generic · Class 3 | 达普司他片 · No verified English nameCYHL2500233 | Anhui Hong Ye Pharma Co., Ltd. romanized |
| 2025/12/29New drug · Class 3.3 | 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSS2500145 | Jiangsu Rui Ke Bio Technology Co., Ltd. romanized |
| 2025/12/29New drug · Class 1 | LQ036雾化液 · No verified English nameCXSL2501157 | Shanghai Luo Qi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/29New drug · Class 1 | 重组L-IFN腺病毒注射液 · No verified English nameCXSL2501156 | Shanghai Yuan Song Bio Technology Co., Ltd. romanized |
| 2025/12/29New drug · Class 1 | SV003注射液 · No verified English nameCXSL2501155 | Shanghai Xun Yao Bio Technology Co., Ltd. romanized; Shao Xing Xun Yao Pan Tuo Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/29New drug · Class 3.2 | 20价肺炎球菌多糖结合疫苗 · No verified English nameCXSL2501154 | Shandong Yi Du Bio Technology Co., Ltd. Beijing Branch romanized; Chongqing Yi Du Bio Technology (Group) Co., Ltd. romanized; Shandong Yi Du Bio Technology Co., Ltd. romanized |
| 2025/12/29New drug · Class 1 | 注射用AK150 · No verified English nameCXSL2501152 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2025/12/29New drug · Class 1 | BKB020靶向活化型T细胞注射液 · No verified English nameCXSL2501151 | Ben Kang Biopharmaceutical (Shenzhen) Co., Ltd. romanized |
| 2025/12/29New drug · Class 1 | QY211凝胶 · No verified English nameCXHL2501492 | Qi Yuan Bio (Hangzhou) Co., Ltd. romanized |
| 2025/12/29New drug · Class 1 | QY211凝胶 · No verified English nameCXHL2501491 | Qi Yuan Bio (Hangzhou) Co., Ltd. romanized |
| 2025/12/29New drug · Class 1 | IAMA-001凝胶 · No verified English nameCXHL2501490 | Nanjing Ji Sheng Ao Ma Biopharmaceuticals Co., Ltd. romanized |
| 2025/12/29New drug · Class 1 | HSK55879片 · No verified English nameCXHL2501489 | Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/29New drug · Class 1 | IAMA-001凝胶 · No verified English nameCXHL2501488 | Nanjing Ji Sheng Ao Ma Biopharmaceuticals Co., Ltd. romanized |
| 2025/12/29New drug · Class 1 | HSK55879片 · No verified English nameCXHL2501487 | Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/29New drug · Class 1 | HSK55879片 · No verified English nameCXHL2501486 | Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/29New drug · Class 1 | GD-20片 · No verified English nameCXHL2501485 | Tianjin Gu Dui Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/29New drug · Class 1 | GD-20片 · No verified English nameCXHL2501484 | Tianjin Gu Dui Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/29New drug · Class 1 | 注射用TRD221 · No verified English nameCXHL2501483 | Zhongguo Yi Xue Ke College Drug Research Institute romanized; Beijing Tai De Pharmaceutical Co., Ltd. romanized |
| 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 |
147 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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