药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/10/21 – 2025/10/27
- New acceptances this week
- 302
- Drugs with new generic filings (by drug name, de-duplicated)
- 45
- Accepted this week, now under review
- 85
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.
Drug and company names link to detail pages; sign in to view them.
New acceptances this week
By application type and drug type
302filings, 58 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 168 |
| Generic | 58 |
| New drug | 50 |
| Import | 14 |
| Import re-registration | 8 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 207 |
| TCM | 59 |
| 治疗用生物制品 | 32 |
| 预防用生物制品 | 2 |
| Unspecified | 1 |
| 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
45 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 达格列净片 | 3 | 2 | 82 |
| 2 | 硫酸氨基葡萄糖胶囊 | 2 | 2 | 50 |
| 3 | 克林霉素磷酸酯注射液 | 2 | 1 | 4 |
| 4 | 头孢托仑匹酯颗粒 | 2 | 1 | 18 |
| 5 | 左甲状腺素钠片 | 2 | 1 | 9 |
| 6 | 注射用亚胺培南西司他丁钠 | 2 | 1 | 6 |
| 7 | 注射用托伐普坦磷酸钠 | 2 | 1 | 15 |
| 8 | 注射用磷霉素钠 | 2 | 1 | 13 |
| 9 | 甲磺酸沙非胺片 | 2 | 1 | 20 |
| 10 | 盐酸异丙嗪注射液 | 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
173 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 吉林省祈克药业有限公司 | 12 | 12 | 0 |
| 2 | 新疆华世丹药业股份有限公司 | 12 | 1 | 0 |
| 3 | 江苏思家蔚康医药科技有限公司 | 9 | 1 | 0 |
| 4 | 齐鲁制药（海南）有限公司 | 8 | 3 | 0 |
| 5 | 黑龙江宋慈制药有限责任公司 | 7 | 6 | 0 |
| 6 | 黑龙江君安药业集团鸿祥制药有限公司 | 6 | 6 | 0 |
| 7 | Boehringer Ingelheim International GmbH | 5 | 2 | 0 |
| 8 | 四川依科制药有限公司 | 4 | 4 | 0 |
| 9 | 通化斯威药业股份有限公司 | 4 | 4 | 0 |
| 10 | Pfizer Europe MA EEIG | 4 | 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
86 this week
56 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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