YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 376 drug applications between 11 March 2025 and 17 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 95, covering 64 drug names.
2025/03/11 – 2025/03/17
- New acceptances this week
- 376
- Drugs with new generic filings (by drug name, de-duplicated)
- 64
- Accepted this week, now under review
- 21
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
376filings, 95 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 169 |
| Generic | 95 |
| New drug | 49 |
| Import re-registration | 23 |
| Import | 21 |
| Unspecified | 19 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 286 |
| TCM | 45 |
| Therapeutic biologic | 41 |
| 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
64 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 地氯雷他定口服溶液 · No verified English name | 4 | 2 | 26 |
| 2 | Sacubitril Valsartan Sodium Tablets | 4 | 2 | 70 |
| 3 | Mivacurium Chloride Injection | 4 | 2 | 3 |
| 4 | Lactulose Oral Solution | 3 | 2 | 34 |
| 5 | 甲氧氯普胺片 · No verified English name | 3 | 2 | 3 |
| 6 | Riociguat Tablets | 3 | 1 | 4 |
| 7 | Levofloxacin and Sodium Chloride Injection | 3 | 1 | 14 |
| 8 | 腺苷钴胺胶囊 · No verified English name | 2 | 2 | 8 |
| 9 | Multiple Vitamins Injection | 2 | 1 | 4 |
| 10 | Brexpiprazole Tablets | 2 | 1 | 31 |
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
211 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Nan Yang Pu Kang Heng Wang Pharma Co., Ltd. romanized | 17 | 16 | 0 |
| 2 | Bracco Imaging S.P.A. | 13 | 1 | 0 |
| 3 | Fresenius Kabi Deutschland GmbH | 12 | 2 | 0 |
| 4 | Beijing Xing Hao Ying Sheng Pharma Co., Ltd. romanized | 6 | 3 | 0 |
| 5 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 3 | 0 |
| 6 | AstraZeneca AB | 5 | 3 | 0 |
| 7 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 5 | 2 | 2 |
| 8 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Zhongguo Ke College Shanghai Drug Research Institute romanized | 4 | 3 | 0 |
| 10 | Qilu Pharmaceutical Co., Ltd. | 4 | 3 | 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
100 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/03/17Import · Class 1 | [225Ac]Ac-PSMA-617注射液 · No verified English nameJXHL2500047 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/03/15Import · Class 2.2 | 度普利尤单抗注射液 · No verified English nameJXSS2500026 | Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd. |
| 2025/03/15Import · Class 2.2 | 度普利尤单抗注射液 · No verified English nameJXSS2500025 | Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd. |
| 2025/03/15Import · Class 1 | ADI-001 · No verified English nameJXSL2500038 | Adicet Therapeutics Inc.; Shanghai Adicet Biotechnology Co. Ltd. |
| 2025/03/15Import · Class 1 | VSA001注射液 · No verified English nameJXHL2500045 | Arrowhead Pharmaceuticals Inc.; Sanofi (China) Investment Co. Ltd. |
| 2025/03/15Generic · Class 3 | Lanthanum Carbonate Hydrate GranulesCYHS2501085 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2025/03/15Generic · Class 3 | Lanthanum Carbonate Hydrate GranulesCYHS2501084 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2025/03/15Generic · Class 3 | 聚乙二醇3350散 · No verified English nameCYHS2501080 | Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized; Hunan Tian Ji Cao Tang Pharmaceutical Co., Ltd. romanized |
| 2025/03/15Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2501078 | Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/03/15Generic · Class 3 | Nimodipine Oral SolutionCYHS2501074 | Shijiazhuang No.4 Pharmaceutical Co., Ltd.; Zhejiang Guo Jing Pharma Co., Ltd. romanized |
| 2025/03/15New drug · Class 1.2 | SOC201胶囊 · No verified English nameCXZL2500017 | Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhi Jiang Run Tian Tian Cha Bio Technology Co., Ltd. romanized |
| 2025/03/15New drug · Class 1.2 | SOC201提取物 · No verified English nameCXZL2500016 | Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhi Jiang Run Tian Tian Cha Bio Technology Co., Ltd. romanized |
| 2025/03/15New drug · Class 1.1 | 小儿热立清颗粒 · No verified English nameCXZL2500015 | Qi Zheng (Zhuhai Shi Heng Qin) International Pharmaceuticals Co., Ltd. romanized; Gansu Qi Zheng Zang Yao Co., Ltd. romanized |
| 2025/03/15New drug · Class 1 | 注射用AK146D1 · No verified English nameCXSL2500227 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2025/03/15New drug · Class 1 | JWK002注射液 · No verified English nameCXSL2500225 | Wuhan Jin Wei Ke Bio Technology Co., Ltd. romanized; Chengdu Jin Wei Ke Bio Technology Co., Ltd. romanized |
| 2025/03/15New drug · Class 1 | GLS-W1100胶囊 · No verified English nameCXSL2500224 | Hangzhou Yuan Da Biopharmaceutical Co., Ltd. romanized |
| 2025/03/15New drug · Class 1 | 玛氘诺沙韦片 · No verified English nameCXHS2500022 | Jia Xing An Di Kang Bio Technology Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized |
| 2025/03/15New drug · Class 1 | 塞拉维诺片 · No verified English nameCXHL2500291 | Zhongguo Ke College Shanghai Drug Research Institute romanized; Shou Du Yi Ke University Fu Shu Beijing Tian Tan Hospital romanized |
| 2025/03/15New drug · Class 1 | 塞拉维诺片 · No verified English nameCXHL2500290 | Zhongguo Ke College Shanghai Drug Research Institute romanized; Shou Du Yi Ke University Fu Shu Beijing Tian Tan Hospital romanized |
| 2025/03/15New drug · Class 2.2 | PDX-04 · No verified English nameCXHL2500289 | Hunan Jiudian Pharmaceutical Co., Ltd |
| 2025/03/15New drug · Class 2.2 | PDX-04 · No verified English nameCXHL2500288 | Hunan Jiudian Pharmaceutical Co., Ltd |
| 2025/03/15New drug · Class 1 | 伊匹乌肽散剂 · No verified English nameCXHL2500287 | Yi Cheng Kang Tai (Xiamen) Bio Technology Co., Ltd. romanized |
| 2025/03/15New drug · Class 1 | ZYS-1肠溶片 · No verified English nameCXHL2500286 | Beijing Ke You Ai Technology Co., Ltd. romanized |
| 2025/03/15New drug · Class 2.2 | KEM2414直服颗粒 · No verified English nameCXHL2500285 | Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized |
| 2025/03/15New drug · Class 1 | PLB1004胶囊 · No verified English nameCXHL2500284 | An Shi Pharma (Ningbo) Co., Ltd. romanized |
| 2025/03/15New drug · Class 1 | PLB1004胶囊 · No verified English nameCXHL2500283 | An Shi Pharma (Ningbo) Co., Ltd. romanized |
| 2025/03/14Import · Class 1 | TQJ230注射液 · No verified English nameJXHL2500044 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/03/14Import · Class 1 | ELVN-001胶囊 · No verified English nameJXHL2500043 | Enliven Therapeutics Inc.; R&G PharmaStudies Co. Ltd. |
| 2025/03/14Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2501064 | Shandong Yi Kang Pharma Co., Ltd. romanized |
| 2025/03/14Generic · Class 3 | Famotidine InjectionCYHS2501060 | Anhui Mei Lai Pharma Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized |
70 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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