YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 422 drug applications between 6 August 2025 and 12 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 122, covering 83 drug names.
2025/08/06 – 2025/08/12
- New acceptances this week
- 422
- Drugs with new generic filings (by drug name, de-duplicated)
- 83
- Accepted this week, now under review
- 115
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
422filings, 122 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 190 |
| Generic | 122 |
| New drug | 67 |
| Import re-registration | 18 |
| Import | 15 |
| Unspecified | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 267 |
| TCM | 84 |
| Therapeutic biologic | 63 |
| Biologic | 5 |
| 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
83 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sacubitril Valsartan Sodium Tablets | 4 | 2 | 70 |
| 2 | 苯磺酸左氨氯地平片 · No verified English name | 4 | 2 | 45 |
| 3 | 替尔泊肽注射液 · No verified English name | 4 | 1 | 22 |
| 4 | Acetylcysteine Injection | 3 | 3 | 53 |
| 5 | Finerenone Tablets | 3 | 2 | 69 |
| 6 | 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English name | 3 | 1 | 7 |
| 7 | 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English name | 3 | 1 | 7 |
| 8 | 呫诺美林曲司氯铵胶囊 · No verified English name | 3 | 1 | 0 |
| 9 | Ampicillin Sodium and Sulbactam Sodium for Injection | 3 | 1 | 13 |
| 10 | Adapalene Gel | 2 | 2 | 30 |
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
234 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shen Yao He Ze Pharma (Shandong) Co., Ltd. romanized | 15 | 6 | 0 |
| 2 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized | 12 | 4 | 6 |
| 3 | Shanxi Hua Kang Pharma Co., Ltd. romanized | 11 | 10 | 0 |
| 4 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 10 | 8 | 0 |
| 5 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 9 | 6 | 6 |
| 6 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 7 | 4 | 0 |
| 7 | Henan Ling Rui Pharmaceutical Co., Ltd. romanized | 6 | 4 | 0 |
| 8 | Bayer Inc. | 6 | 1 | 0 |
| 9 | Guizhou Yi Bai Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Hua Run Zi Zhu Pharma Co., Ltd. romanized | 5 | 4 | 2 |
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
120 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/08/12Import · Class 2.1 | 艾沙妥昔单抗注射液(皮下注射) · No verified English nameJXSS2500108 | Sanofi Winthrop Industrie; Sanofi-Aventis Deutschland GmbH |
| 2025/08/12Import · Class 1 | 注射用SAR446523 · No verified English nameJXSL2500144 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2025/08/12Generic · Class 3 | Sodium Cromoglicate Eye DropsCYHS2502936 | Suzhou Le Zhu Pharmaceutical Co., Ltd. romanized |
| 2025/08/12Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2502930 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized |
| 2025/08/12Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2502929 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized |
| 2025/08/12Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2502928 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized |
| 2025/08/12Generic · Class 3 | 磷/碳酸氢钠血滤置换液(4mmol/L钾、1.25mmol/L钙) · No verified English nameCYHS2502922 | Ningbo Tian Yi Pharma Technology Co., Ltd. romanized |
| 2025/08/12Generic · Class 3 | Peramivir InjectionCYHS2502916 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2025/08/12Generic · Class 3 | 甲磺酸酚妥拉明滴眼液 · No verified English nameCYHL2500143 | Zhejiang Shi Fang Ji Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/08/12Generic · Class 3 | 呫诺美林曲司氯铵胶囊 · No verified English nameCYHL2500142 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2025/08/12Generic · Class 3 | 呫诺美林曲司氯铵胶囊 · No verified English nameCYHL2500141 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2025/08/12Generic · Class 3 | 呫诺美林曲司氯铵胶囊 · No verified English nameCYHL2500140 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2025/08/12New drug · Class 1.1 | 小儿胆青双解颗粒 · No verified English nameCXZL2500065 | Hainan Huluwa Pharmaceutical Group Co., Ltd. |
| 2025/08/12New drug · Class 1.2 | 重组呼吸道合胞病毒疫苗(CHO细胞) · No verified English nameCXSL2500691 | Beijing Hua Nuo Tai Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu Hua Nuo Tai Biopharmaceuticals Technology Co., Ltd. romanized; Hua Nuo Tai Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2025/08/12New drug · Class 1 | 注射用QLC5513 · No verified English nameCXSL2500690 | Qilu Pharmaceutical Co., Ltd. |
| 2025/08/12New drug · Class 2.4 | 吡非尼酮胶囊 · No verified English nameCXHL2500836 | Beijing Kang Di Ni Pharma Co., Ltd. romanized |
| 2025/08/12New drug · Class 1 | ARTS-023片 · No verified English nameCXHL2500835 | An Rui Biopharmaceuticals Technology (Guangzhou) Co., Ltd. romanized |
| 2025/08/12New drug · Class 1 | ARTS-023片 · No verified English nameCXHL2500834 | An Rui Biopharmaceuticals Technology (Guangzhou) Co., Ltd. romanized |
| 2025/08/12New drug · Class 2.4 | 结合雌激素乳膏 · No verified English nameCXHL2500833 | Xinjiang Xin Zi Yuan Biopharmaceutical Co., Ltd. romanized |
| 2025/08/11Import · Class 1 | Icotrokinra片 · No verified English nameJXHL2500213 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2025/08/11Import · Class 2.4; 2.2 | 马立巴韦干混悬剂 · No verified English nameJXHL2500212 | Takeda Pharmaceuticals U.S.A. Inc; Takeda(China) International Company Ltd. |
| 2025/08/11Import · Class 2.4; 2.2 | 马立巴韦干混悬剂 · No verified English nameJXHL2500211 | Takeda Pharmaceuticals U.S.A. Inc.; Takeda(China) International Company Ltd. |
| 2025/08/11New drug · Class 2.4 | 海曲泊帕乙醇胺片 · No verified English nameCXHS2500094 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/08/11New drug · Class 2.4 | 海曲泊帕乙醇胺片 · No verified English nameCXHS2500093 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/08/11New drug · Class 2.4 | 海曲泊帕乙醇胺片 · No verified English nameCXHS2500092 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/08/09Generic · Class 3 | Glycopyrrolate InjectionCYHS2502894 | Henan Pu Rui Pharma Co., Ltd. romanized |
| 2025/08/09Generic · Class 3 | Glycopyrrolate InjectionCYHS2502893 | Henan Pu Rui Pharma Co., Ltd. romanized |
| 2025/08/09Generic · Class 3 | Elagolix Sodium TabletsCYHS2502892 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2025/08/09Generic · Class 3 | Elagolix Sodium TabletsCYHS2502891 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2025/08/09Generic · Class 3 | Naloxone Hydrochloride InjectionCYHS2502890 | Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized |
90 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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