YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 303 drug applications between 31 May 2024 and 6 June 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 78, covering 61 drug names.
2024/05/31 – 2024/06/06
- New acceptances this week
- 303
- Drugs with new generic filings (by drug name, de-duplicated)
- 61
- Accepted this week, now under review
- 4
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
303filings, 78 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 144 |
| Generic | 78 |
| New drug | 52 |
| Import | 19 |
| Import re-registration | 8 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 208 |
| TCM | 45 |
| Therapeutic biologic | 41 |
| Prophylactic biologic | 8 |
| Biologic | 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
61 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 二甲硅油乳剂 · No verified English name | 3 | 1 | 14 |
| 2 | 阿普米司特片 · No verified English name | 3 | 1 | 3 |
| 3 | Baricitinib Tablets | 2 | 2 | 32 |
| 4 | Potassium Chloride Oral Solution | 2 | 2 | 11 |
| 5 | Nicardipine Hydrochloride Injection | 2 | 2 | 13 |
| 6 | 维生素B6注射液 · No verified English name | 2 | 2 | 10 |
| 7 | Bumetanide Injection | 2 | 1 | 13 |
| 8 | Vortioxetine Hydrobromide Tablets | 2 | 1 | 10 |
| 9 | Sacubitril Valsartan Sodium Tablets | 2 | 1 | 70 |
| 10 | Methotrexate Injection | 2 | 1 | 11 |
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
194 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guizhou Rui He Pharmaceutical Co., Ltd. romanized | 12 | 12 | 1 |
| 2 | Qin Huang Dao Ai Hui Pharma Co., Ltd. romanized | 9 | 8 | 0 |
| 3 | Shanghai Yi Feng Bio Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 4 | Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 5 | Sui Cheng Pharma Co., Ltd. romanized | 4 | 3 | 4 |
| 6 | Merck Sharp & Dohme LLC | 4 | 2 | 0 |
| 7 | SANOFI WINTHROP INDUSTRIE | 4 | 2 | 0 |
| 8 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 4 | 2 | 4 |
| 9 | Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized | 3 | 3 | 3 |
| 10 | AbbVie Inc. | 3 | 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
97 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/06/06Import · Class 1 | Bexotegrast片 · No verified English nameJXHL2400126 | Pliant Therapeutics Inc.; IQVIA RDS (Shanghai) Co. Ltd. |
| 2024/06/06Generic · Class 3 | Sodium Valproate Concentrated Solution for InjectionCYHS2401704 | Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized |
| 2024/06/06Generic · Class 3 | Polymyxin B sulfate for InjectionCYHS2401700 | Health Yuan Pharma Group Co., Ltd. romanized; Health Yuan Hai Bin Pharma Co., Ltd. romanized |
| 2024/06/06Generic · Class 3 | 烟酸缓释片 · No verified English nameCYHS2401697 | Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized |
| 2024/06/06Generic · Class 3 | Isoprenaline Hydrochloride InjectionCYHS2401694 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2024/06/06Generic · Class 3 | Chlorphenamine Maleate InjectionCYHS2401692 | Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized |
| 2024/06/06New drug · Class 1 | 司普奇拜单抗注射液 · No verified English nameCXSS2400055 | Chengdu Kang Nuo Xing Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/06/06New drug · Class 2.2 | 外用红色诺卡氏菌细胞壁骨架 · No verified English nameCXSL2400369 | Liaoning Tian An Biopharmaceutical Co., Ltd. romanized |
| 2024/06/06New drug · Class 1.1 | 四价重组诺如病毒疫苗(汉逊酵母) · No verified English nameCXSL2400368 | Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized |
| 2024/06/06New drug · Class 1.1 | 四价重组诺如病毒疫苗(汉逊酵母) · No verified English nameCXSL2400367 | Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized |
| 2024/06/06New drug · Class 1 | 复迈替尼片 · No verified English nameCXHS2400049 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized |
| 2024/06/06New drug · Class 1 | 复迈替尼片 · No verified English nameCXHS2400048 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized |
| 2024/06/06New drug · Class 1 | K-13片 · No verified English nameCXHL2400579 | Shanghai Yi Feng Bio Technology Co., Ltd. romanized |
| 2024/06/06New drug · Class 1 | K-13片 · No verified English nameCXHL2400578 | Shanghai Yi Feng Bio Technology Co., Ltd. romanized |
| 2024/06/06New drug · Class 1 | K-13片 · No verified English nameCXHL2400577 | Shanghai Yi Feng Bio Technology Co., Ltd. romanized |
| 2024/06/06New drug · Class 2.2; 2.4 | PG-F01凝胶 · No verified English nameCXHL2400576 | Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/06/06New drug · Class 2.2; 2.4 | PG-F01凝胶 · No verified English nameCXHL2400575 | Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/06/06New drug · Class 2.2; 2.4 | PG-F01凝胶 · No verified English nameCXHL2400574 | Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/06/06New drug · Class 1 | FP-208片 · No verified English nameCXHL2400573 | Beijing Fu Long Kang Tai Bio Technology Co., Ltd. romanized |
| 2024/06/06New drug · Class 1 | FP-208片 · No verified English nameCXHL2400572 | Beijing Fu Long Kang Tai Bio Technology Co., Ltd. romanized |
| 2024/06/06New drug · Class 1 | K-13片 · No verified English nameCXHL2400571 | Shanghai Yi Feng Bio Technology Co., Ltd. romanized |
| 2024/06/06New drug · Class 1 | K-13片 · No verified English nameCXHL2400570 | Shanghai Yi Feng Bio Technology Co., Ltd. romanized |
| 2024/06/06New drug · Class 1 | K-13片 · No verified English nameCXHL2400569 | Shanghai Yi Feng Bio Technology Co., Ltd. romanized |
| 2024/06/05Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2401689 | Zhejiang AngLiKang Pharmaceutical CO.,LTD. |
| 2024/06/05Generic · Class 3 | Labetalol Hydrochloride InjectionCYHS2401686 | Sui Cheng Pharma Co., Ltd. romanized |
| 2024/06/05Generic · Class 3 | Labetalol Hydrochloride InjectionCYHS2401684 | Sui Cheng Pharma Co., Ltd. romanized |
| 2024/06/05Generic · Class 3 | Acetylcysteine InjectionCYHS2401681 | Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized |
| 2024/06/05Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2401674 | Bao Li Hua (Nanjing) Pharmaceutical Co., Ltd. romanized |
| 2024/06/05Generic · Class 3 | Levofloxacin InjectionCYHS2401672 | CISEN PHARMACEUTICAL CO., LTD. |
| 2024/06/05Generic · Class 3 | Sulfamethoxazole and Trimethoprim InjectionCYHS2401671 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
67 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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