YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 403 drug applications between 9 August 2025 and 15 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 124, covering 80 drug names.
2025/08/09 – 2025/08/15
- New acceptances this week
- 403
- Drugs with new generic filings (by drug name, de-duplicated)
- 80
- Accepted this week, now under review
- 103
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
403filings, 124 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 167 |
| Generic | 124 |
| New drug | 66 |
| Import | 24 |
| Unspecified | 19 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 269 |
| Therapeutic biologic | 67 |
| TCM | 56 |
| Biologic | 7 |
| Prophylactic biologic | 4 |
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
80 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sacubitril Valsartan Sodium Tablets | 6 | 3 | 70 |
| 2 | Lactulose Oral Solution | 5 | 2 | 34 |
| 3 | 苯磺酸左氨氯地平片 · No verified English name | 4 | 2 | 45 |
| 4 | Baricitinib Tablets | 3 | 2 | 32 |
| 5 | Finerenone Tablets | 3 | 2 | 69 |
| 6 | 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English name | 3 | 1 | 7 |
| 7 | 中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English name | 3 | 1 | 7 |
| 8 | 中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English name | 3 | 1 | 7 |
| 9 | 呫诺美林曲司氯铵胶囊 · No verified English name | 3 | 1 | 0 |
| 10 | Ampicillin Sodium and Sulbactam Sodium for Injection | 3 | 1 | 13 |
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
230 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized | 15 | 5 | 9 |
| 2 | Qilu Pharmaceutical Co., Ltd. | 10 | 6 | 3 |
| 3 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 10 | 4 | 0 |
| 4 | AstraZeneca AB | 9 | 4 | 0 |
| 5 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 7 | 6 | 0 |
| 6 | Henan Ling Rui Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 6 | 3 | 0 |
| 8 | Shanxi Zheng Lai Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 9 | Terumo Corporation Kofu Factory | 5 | 1 | 0 |
| 10 | Shandong Er Ye Pharmaceutical Co., Ltd. romanized | 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
129 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/08/15Generic · Class 3 | 枸橼酸西地那非口溶膜 · No verified English nameCYHS2502996 | Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Jiangsu He Chen Pharma Co., Ltd. romanized |
| 2025/08/15Generic · Class 3 | JP-1366片 · No verified English nameCYHS2502991 | Li Zhu Pharmaceuticals Group Co., Ltd. romanized; Li Zhu Group Li Zhu Pharmaceutical Factory romanized |
| 2025/08/15Generic · Class 3 | 聚乙二醇4000散 · No verified English nameCYHS2502988 | Xian An Jian Pharma Co., Ltd. romanized |
| 2025/08/15Generic · Class 3 | Pregabalin Oral SolutionCYHS2502986 | Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized |
| 2025/08/15Generic · Class 3 | Pregabalin Oral SolutionCYHS2502983 | Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized |
| 2025/08/15Generic · Class 3 | Relugolix TabletsCYHL2500147 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
| 2025/08/15New drug · Class 1 | GenSci098注射液 · No verified English nameCXSL2500703 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2025/08/15New drug · Class 1 | Cizutamig注射液 · No verified English nameCXSL2500702 | Shanghai Tan Di Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/08/15New drug · Class 1 | 注射用YP004 · No verified English nameCXSL2500701 | Yuan Pu Bio Technology (Wuhan) Co., Ltd. romanized |
| 2025/08/15New drug · Class 1 | VBC101 · No verified English nameCXSL2500700 | Shanghai Cheng Fan Pharmaceuticals Co., Ltd. romanized |
| 2025/08/15New drug · Class 1 | ZX2021注射液 · No verified English nameCXSL2500699 | Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized |
| 2025/08/15New drug · Class 1 | ZX2021注射液 · No verified English nameCXSL2500698 | Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized |
| 2025/08/15New drug · Class 1 | ZX2021注射液 · No verified English nameCXSL2500697 | Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized |
| 2025/08/15New drug · Class 1 | ZX2021注射液 · No verified English nameCXSL2500696 | Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized |
| 2025/08/15New drug · Class 1 | ZX2021注射液 · No verified English nameCXSL2500695 | Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized |
| 2025/08/15New drug · Class 1 | HSK39297片 · No verified English nameCXHL2500855 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2025/08/15New drug · Class 1 | HSK39297片 · No verified English nameCXHL2500854 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2025/08/15New drug · Class 1 | HSK39297片 · No verified English nameCXHL2500853 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2025/08/15New drug · Class 1 | HSK39297片 · No verified English nameCXHL2500852 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2025/08/15New drug · Class 2.4 | 注射用戈舍瑞林微球 · No verified English nameCXHL2500851 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2025/08/15New drug · Class 1 | TGRX-678片 · No verified English nameCXHL2500850 | Shenzhen Shi Ta Ji Rui Biopharmaceuticals Co., Ltd. romanized |
| 2025/08/15New drug · Class 1 | D-2570片 · No verified English nameCXHL2500849 | Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized |
| 2025/08/14Import · Class 2.2 | 注射用替奈普酶 · No verified English nameJXSL2500155 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2025/08/14Import · Class 1 | AZD0486 · No verified English nameJXSL2500154 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/08/14Import · Class 1 | AZD0486 · No verified English nameJXSL2500153 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/08/14Import · Class 1 | AZD0486 · No verified English nameJXSL2500152 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/08/14Import · Class 1 | AZD0486 · No verified English nameJXSL2500151 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/08/14Import · Class 1 | AZD0486 · No verified English nameJXSL2500150 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/08/14Import · Class 1 | BCD-261注射液 · No verified English nameJXSL2500149 | SPH-BIOCAD (HK) LIMITED; SPH-BIOCAD Biopharmaceuticals (SH) Co. Ltd. |
| 2025/08/14Import · Class 1 | MEDI5752 · No verified English nameJXSL2500148 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
99 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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