YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 239 drug applications between 11 February 2025 and 17 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 81, covering 59 drug names.
2025/02/11 – 2025/02/17
- New acceptances this week
- 239
- Drugs with new generic filings (by drug name, de-duplicated)
- 59
- Accepted this week, now under review
- 15
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
239filings, 81 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 87 |
| Generic | 81 |
| New drug | 42 |
| Import | 19 |
| Unspecified | 6 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 161 |
| Therapeutic biologic | 48 |
| TCM | 26 |
| Biologic | 2 |
| 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
59 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ruxolitinib Phosphate Tablets | 5 | 3 | 27 |
| 2 | Nitroglycerin Injection | 4 | 2 | 7 |
| 3 | Polymyxin B sulfate for Injection | 2 | 2 | 6 |
| 4 | Diclofenac Sodium Sustained Release Tablets | 2 | 1 | 10 |
| 5 | Cefditoren Pivoxil Granules | 2 | 1 | 18 |
| 6 | Oxcarbazepine Tablets | 2 | 1 | 4 |
| 7 | Ornidazole Injection | 2 | 1 | 0 |
| 8 | Brexpiprazole Tablets | 2 | 1 | 31 |
| 9 | Bumetanide Injection | 2 | 1 | 13 |
| 10 | Topiroxostat Tablets | 2 | 1 | 0 |
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
162 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | CSPC OUYI PHARMACEUTICAL CO., LTD. | 5 | 4 | 0 |
| 2 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized | 5 | 3 | 5 |
| 3 | Novo Nordisk A/S | 5 | 1 | 0 |
| 4 | Jiangsu Vanguard Pharmaceutical Co., Ltd. | 4 | 2 | 4 |
| 5 | Xian Li Bang Pharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 6 | Jiangxi Pu Zheng Pharmaceutical Co., Ltd. romanized | 3 | 2 | 0 |
| 7 | Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | 3 | 2 | 3 |
| 8 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized | 3 | 2 | 0 |
| 9 | Janssen-Cilag International NV | 3 | 1 | 0 |
| 10 | Novartis Pharma AG | 3 | 1 | 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
102 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/02/17Import · Class 1 | RO7446603注射液 · No verified English nameJXSL2500027 | Genentech Inc.; Roche (China) Holding Ltd. |
| 2025/02/17Generic · Class 3 | 小儿复方氨基酸注射液(19AA-Ⅰ) · No verified English nameCYHS2500752 | Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized |
| 2025/02/17New drug · Class 3.1 | 泻白颗粒 · No verified English nameCXZS2500008 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2025/02/17New drug · Class 1 | 注射用IBB0979 · No verified English nameCXSL2500150 | Sheng He (Zhongguo) Biopharmaceutical Co., Ltd. romanized |
| 2025/02/17New drug · Class 3.4 | 冻干马抗眼镜蛇毒F(ab′)2抗体 · No verified English nameCXSL2500149 | Zhejiang Jian Bo Bio Technology Co., Ltd. romanized |
| 2025/02/15Import · Class 3.1 | 呼吸道合胞病毒疫苗 · No verified English nameJXSL2500026 | Pfizer Inc.; Pfizer Investment CO Ltd. |
| 2025/02/15Generic · Class 3 | Metoprolol Tartrate InjectionCYHS2500749 | Bai Yun Shandong Tai Shang Qiu Pharma Co., Ltd. romanized; Shanghai Xian Dai Ha Sen (Shang Qiu) Pharma Co., Ltd. romanized |
| 2025/02/15Generic · Class 3 | Trelagliptin Succinate TabletsCYHS2500748 | Nanjing Wan Rong Jian Cheng Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Wan He Pharmaceutical Co., Ltd. romanized |
| 2025/02/15Generic · Class 3 | Trelagliptin Succinate TabletsCYHS2500747 | Nanjing Wan Rong Jian Cheng Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Wan He Pharmaceutical Co., Ltd. romanized |
| 2025/02/15New drug · Class 1 | 注射用MK-3120 · No verified English nameCXSL2500148 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2025/02/15New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2500147 | Wuhan Han Mi Dun Bio Technology Co., Ltd. romanized |
| 2025/02/15New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2500146 | Wuhan Han Mi Dun Bio Technology Co., Ltd. romanized |
| 2025/02/15New drug · Class 1 | 艾玛昔替尼软膏 · No verified English nameCXHS2500018 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/02/14Generic · Class 3 | 盐酸半胱氨酸注射液 · No verified English nameCYHS2500743 | Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2025/02/14Generic · Class 3 | Trazodone Hydrochloride TabletsCYHS2500738 | Jiangsu Vanguard Pharmaceutical Co., Ltd. |
| 2025/02/14Generic · Class 3 | Trazodone Hydrochloride TabletsCYHS2500737 | Jiangsu Vanguard Pharmaceutical Co., Ltd. |
| 2025/02/14Generic · Class 3 | 米诺地尔泡沫剂(男用) · No verified English nameCYHL2500041 | Jewim Pharmaceutical (Shandong) Co., Ltd. |
| 2025/02/14New drug · Class 1 | 注射用AS1501 · No verified English nameCXSL2500145 | Shenzhen Shi Zhong Ke Ai Shen Pharmaceuticals Co., Ltd. romanized |
| 2025/02/14New drug · Class 2.2; 2.4 | 枸地氯雷他定口服溶液 · No verified English nameCXHS2500017 | Hefei En Rui Te Pharma Co., Ltd. romanized |
| 2025/02/13Import · Class 3.1 | 西妥昔单抗注射液 · No verified English nameJXSS2500012 | Merck Europe B.V.; Merck Healthcare KGaA; Merck Serono Co. Ltd. |
| 2025/02/13Import · Class 2.2 | 艾加莫德α注射液(皮下注射) · No verified English nameJXSL2500025 | argenx BV; Zai Lab (Shanghai) Co. Ltd. |
| 2025/02/13Generic · Class 3 | Erythromycin Lactobionate for InjectionCYHS2500734 | Hai Tao Xin Yao Research and Development (Jiangsu) Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2025/02/13Generic · Class 3 | Ferrous Succinate TabletsCYHS2500733 | Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/02/13Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2500732 | Chengdu Heng Rui Pharmaceutical Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2025/02/13Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2500731 | Chengdu Heng Rui Pharmaceutical Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2025/02/13Generic · Class 3 | Diprophylline InjectionCYHS2500730 | Chengdu Hua Yu Pharmaceutical Co., Ltd. romanized |
| 2025/02/13Generic · Class 3 | Olprinone Hydrochloride InjectionCYHS2500729 | Shandong Jian Bin Pharmaceuticals Technology Co., Ltd. romanized; Xian Han Feng Pharma Co., Ltd. romanized |
| 2025/02/13Generic · Class 3 | Potassium Phosphates InjectionCYHS2500728 | Chengdu Nuo He Cheng Hong Biopharmaceutical Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2025/02/13Generic · Class 3 | 复方聚乙二醇电解质散(儿童型) · No verified English nameCYHS2500725 | Shandong Yi Kang Pharma Co., Ltd. romanized |
| 2025/02/13Generic · Class 3 | Polymyxin B sulfate for InjectionCYHS2500724 | Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized |
72 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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