YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 359 drug applications between 16 July 2025 and 22 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 112, covering 85 drug names.
2025/07/16 – 2025/07/22
- New acceptances this week
- 359
- Drugs with new generic filings (by drug name, de-duplicated)
- 85
- Accepted this week, now under review
- 82
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
359filings, 112 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 155 |
| Generic | 112 |
| New drug | 55 |
| Import | 17 |
| Unspecified | 10 |
| Import re-registration | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 254 |
| TCM | 58 |
| Therapeutic biologic | 30 |
| Prophylactic biologic | 12 |
| Biologic | 5 |
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
85 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Metformin Hydrochloride And Empagliflozin Extended Release Tablets | 3 | 1 | 12 |
| 2 | Ruxolitinib Phosphate Tablets | 3 | 1 | 27 |
| 3 | Upadacitinib Sustained-release Tablets | 2 | 2 | 43 |
| 4 | Acetylcysteine Injection | 2 | 2 | 53 |
| 5 | Crisaborole Ointment | 2 | 2 | 26 |
| 6 | Morinidazole and Sodium Chloride Injection | 2 | 2 | 9 |
| 7 | Bumetanide Injection | 2 | 2 | 13 |
| 8 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
| 9 | 甘油磷酸钠注射液 · No verified English name | 2 | 2 | 7 |
| 10 | 维生素B6注射液 · No verified English name | 2 | 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
227 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jiangxi Qing Feng Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 2 | Beijing Min Hai Bio Technology Co., Ltd. romanized | 6 | 5 | 0 |
| 3 | Bracco Imaging S.P.A. | 6 | 1 | 0 |
| 4 | Ningbo Tian Yi Pharma Technology Co., Ltd. romanized | 5 | 5 | 5 |
| 5 | Changchun Hai Wai Pharmaceutical Group Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Hainan Sai Li Ke Pharma Co., Ltd. romanized | 5 | 3 | 5 |
| 7 | Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 8 | Revance Therapeutics Inc. | 4 | 4 | 0 |
| 9 | Zhu Zhou Qian Jin Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Bristol-Myers Squibb Company | 4 | 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
108 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/07/22Import · Class 1 | BMS-986340注射液 · No verified English nameJXSL2500124 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/07/22Import · Class 2.2 | 特泽利尤单抗注射液 · No verified English nameJXSL2500123 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2025/07/22Generic · Class 3 | Ibuprofen TabletsCYHS2502645 | Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized |
| 2025/07/22Generic · Class 3 | Dienogest TabletsCYHS2502632 | Shanghai Hui Lun Pharmaceuticals Co., Ltd. romanized; Nanjing Bai Jing Yu Pharmaceutical Co., Ltd. romanized |
| 2025/07/22Generic · Class 3 | Doxofylline TabletsCYHS2502629 | Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/07/22Generic · Class 3 | Doxofylline TabletsCYHS2502627 | Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/07/22Generic · Class 3 | Bumetanide InjectionCYHS2502623 | Jiangsu Ming Yuan Pharma Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2025/07/22Generic · Class 3 | 辅酶Q10片 · No verified English nameCYHS2502621 | Ta He Shi Hui Chuang Pharmaceuticals Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized |
| 2025/07/22Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2502619 | Hangzhou Minsheng Pharmaceutical Co., Ltd |
| 2025/07/22Generic · Class 3 | Nebivolol TabletsCYHL2500131 | Zhejiang Hua Yuan Pharma Co., Ltd. romanized |
| 2025/07/22New drug · Class 1 | RC148注射液 · No verified English nameCXSL2500610 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2025/07/22New drug · Class 1 | 注射用RC118 · No verified English nameCXSL2500609 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2025/07/21New drug · Class 1.1 | 重组金黄色葡萄球菌四组分疫苗(大肠杆菌) · No verified English nameCXSL2500611 | Jiangsu Kun Li Biopharmaceutical Co., Ltd. romanized |
| 2025/07/21New drug · Class 3.2 | 三价流感病毒裂解疫苗(BK-01佐剂) · No verified English nameCXSL2500608 | Changchun Bai Ke Bio Technology Shareholding Company romanized |
| 2025/07/21New drug · Class 1 | CMS-D002胶囊 · No verified English nameCXHL2500728 | Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized |
| 2025/07/21New drug · Class 1 | CMS-D002胶囊 · No verified English nameCXHL2500727 | Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized |
| 2025/07/19Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2502610 | Shandong Hua Mao Pharma Co., Ltd. romanized |
| 2025/07/19Generic · Class 3 | 吲哚美辛凝胶贴膏 · No verified English nameCYHL2500130 | Hainan Hui Yuan Tang Pharma Co., Ltd. romanized |
| 2025/07/19New drug · Class 2.2 | AKZ001直服颗粒 · No verified English nameCXHL2500726 | Hainan Ai Ke Pharmaceutical Co., Ltd. romanized |
| 2025/07/19New drug · Class 1 | CKBA乳膏 · No verified English nameCXHL2500725 | Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/07/19New drug · Class 1 | CKBA乳膏 · No verified English nameCXHL2500724 | Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/07/19New drug · Class 1 | CKBA乳膏 · No verified English nameCXHL2500723 | Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/07/19New drug · Class 1 | CKBA乳膏 · No verified English nameCXHL2500722 | Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/07/19New drug · Class 1 | CKBA乳膏 · No verified English nameCXHL2500721 | Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/07/19New drug · Class 1 | YUQ-A1007片 · No verified English nameCXHL2500720 | Yuan Qi (Suzhou) Biopharmaceutical Co., Ltd. romanized |
| 2025/07/19New drug · Class 1 | YUQ-A1007片 · No verified English nameCXHL2500719 | Yuan Qi (Suzhou) Biopharmaceutical Co., Ltd. romanized |
| 2025/07/18Import · Class 1 | BMS-986504片 · No verified English nameJXHL2500189 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2025/07/18Import · Class 1 | BMS-986504片 · No verified English nameJXHL2500188 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2025/07/18Import · Class 1 | BMS-986504片 · No verified English nameJXHL2500187 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2025/07/18Generic · Class 3 | 碳酸氢钠血滤置换液(无钾、无钙、0.6 mmol/L镁) · No verified English nameCYHS2502596 | Ningbo Tian Yi Pharma Technology Co., Ltd. romanized |
78 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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