YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 520 drug applications between 4 January 2025 and 10 January 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 210, covering 154 drug names.
2025/01/04 – 2025/01/10
- New acceptances this week
- 520
- Drugs with new generic filings (by drug name, de-duplicated)
- 154
- Accepted this week, now under review
- 18
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, 210 of them generic
By application type
| Application type | Filings |
|---|---|
| Generic | 210 |
| Supplement | 200 |
| New drug | 86 |
| Import | 12 |
| Unspecified | 5 |
| Import re-registration | 5 |
| Drug-device combination | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 379 |
| Therapeutic biologic | 68 |
| TCM | 67 |
| Biologic | 3 |
| Prophylactic biologic | 3 |
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
154 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Rosuvastatin Calcium and Ezetimibe Tablets (I) | 5 | 5 | 9 |
| 2 | Metformin Hydrochloride And Empagliflozin Extended Release Tablets | 5 | 2 | 12 |
| 3 | Brexpiprazole Tablets | 4 | 2 | 31 |
| 4 | Azilsartan Medoxomil Potassium Tablets | 4 | 2 | 35 |
| 5 | Crisaborole Ointment | 3 | 3 | 26 |
| 6 | Vonoprazan Fumarate Tablets | 3 | 2 | 60 |
| 7 | Bromfenac Sodium Eye Drops | 3 | 2 | 7 |
| 8 | Mivacurium Chloride Injection | 3 | 2 | 3 |
| 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
305 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized | 20 | 18 | 0 |
| 2 | Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized | 10 | 9 | 0 |
| 3 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 7 | 6 | 6 |
| 4 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 7 | 5 | 7 |
| 5 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 7 | 1 | 0 |
| 6 | Qilu Pharmaceutical Co., Ltd. | 5 | 4 | 0 |
| 7 | Beijing Foyou Pharma CO.,LTD | 5 | 3 | 5 |
| 8 | Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 5 | 3 | 5 |
| 9 | Nan Tong Lian Ya Pharma Co., Ltd. romanized | 5 | 2 | 5 |
| 10 | Novo Nordisk A/S | 5 | 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
168 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/01/10Generic · Class 3 | Minoxidil LinimentCYHS2500239 | Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/01/10Generic · Class 3 | Minoxidil LinimentCYHS2500238 | Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/01/10Generic · Class 3 | Bumetanide InjectionCYHS2500229 | Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Jiangsu Su Zhong Pharma Group Biopharmaceutical Co., Ltd. romanized |
| 2025/01/10Generic · Class 3 | Magnesium Sulfate InjectionCYHS2500228 | Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2025/01/10Generic · Class 3 | Indocyaninegreen for InjectionCYHS2500221 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/01/10Generic · Class 3 | Bumetanide InjectionCYHS2500216 | Shandong Nuo Ming Kang Drug Research Institute Co., Ltd. romanized; Ji Ning Shen Zhou Pharmaceuticals Co., Ltd. romanized |
| 2025/01/10Generic · Class 3 | 复方电解质注射液(V) · No verified English nameCYHS2500207 | Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2025/01/10Generic · Class 3 | 磷酸奥司他韦颗粒 · No verified English nameCYHS2500204 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2025/01/10Generic · Class 3 | Trazodone Hydrochloride TabletsCYHS2500203 | Anhui Wan Bang Pharmaceuticals Technology Co., Ltd. romanized; Jilin Tian Heng Ying Rui Pharmaceutical Co., Ltd. romanized |
| 2025/01/10Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2500199 | Ao Mei Pharmaceutical (Hainan) Co., Ltd. romanized |
| 2025/01/10Generic · Class 3 | Dexketoprofen Trometamol InjectionCYHL2500011 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2025/01/10New drug · Class 1 | XS411细胞注射液 · No verified English nameCXSL2500035 | Shi Ze Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2025/01/10New drug · Class 1 | CM518D1 · No verified English nameCXSL2500034 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2025/01/10New drug · Class 1 | JSKN016注射液 · No verified English nameCXSL2500033 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2025/01/10New drug · Class 1 | P134细胞注射液 · No verified English nameCXSL2500032 | Tian Shi Li Pharmaceuticals Group Co., Ltd. romanized |
| 2025/01/10New drug · Class 3.2 | 皮下注射人免疫球蛋白 · No verified English nameCXSL2500031 | Hua Run Bo Ya Biopharmaceutical Group Co., Ltd. romanized |
| 2025/01/10New drug · Class 2.2 | 纳基奥仑赛注射液 · No verified English nameCXSL2500030 | Guangdong He Yuan Biopharmaceuticals Co., Ltd. romanized; He Yuan Bio Technology (Tianjin) Co., Ltd. romanized |
| 2025/01/10New drug · Class 1 | 注射用IMBZ18g · No verified English nameCXHL2500053 | Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized; Zhongguo Yi Xue Ke College Pharmaceuticals Bio Technology Research Institute romanized |
| 2025/01/10New drug · Class 1 | HRS-9813胶囊 · No verified English nameCXHL2500052 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/01/10New drug · Class 2.2 | HKGM-333 · No verified English nameCXHL2500051 | Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/01/10New drug · Class 2.2 | BCM896缓释片 · No verified English nameCXHL2500050 | Shanghai Qi Hang Pharmaceuticals Technology Development Co., Ltd. romanized |
| 2025/01/10New drug · Class 2.2 | BCM896缓释片 · No verified English nameCXHL2500049 | Shanghai Qi Hang Pharmaceuticals Technology Development Co., Ltd. romanized |
| 2025/01/09Import · Class 1 | AZD2936 · No verified English nameJXSL2500006 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/01/09Import · Class 2.2 | Tremelimumab · No verified English nameJXSL2500005 | MedImmune LLC; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/01/09Import · Class 2.2 | Tremelimumab · No verified English nameJXSL2500004 | MedImmune LLC; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/01/09Generic · Class 3 | Aztreonam For InjectionCYHS2500196 | Shaanxi Hai Hui Pharmaceuticals Technology Co., Ltd. romanized; Haikou Shi Pharmaceutical Factory Co., Ltd. romanized |
| 2025/01/09Generic · Class 3 | Aztreonam For InjectionCYHS2500195 | Shaanxi Hai Hui Pharmaceuticals Technology Co., Ltd. romanized; Haikou Shi Pharmaceutical Factory Co., Ltd. romanized |
| 2025/01/09Generic · Class 3 | 硫酸特布他林口服溶液 · No verified English nameCYHS2500186 | Bao Li Hua (Nanjing) Pharmaceutical Co., Ltd. romanized; Shanghai Mei You Pharmaceutical Co., Ltd. romanized |
| 2025/01/09Generic · Class 3 | Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate and Aspirin Tablets(Ⅱ)CYHS2500185 | Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized; Le Pu Pharmaceutical Technology Co., Ltd. romanized |
| 2025/01/09Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2500184 | Ta He Shi Hui Chuang Pharmaceuticals Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
138 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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