药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/08/19 – 2025/08/25
- New acceptances this week
- 394
- Drugs with new generic filings (by drug name, de-duplicated)
- 69
- 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.
Drug and company names link to detail pages; sign in to view them.
New acceptances this week
By application type and drug type
394filings, 98 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 188 |
| Generic | 98 |
| New drug | 66 |
| Import | 28 |
| Unspecified | 9 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 265 |
| TCM | 68 |
| 治疗用生物制品 | 51 |
| Biologic | 6 |
| 预防用生物制品 | 3 |
| Unspecified | 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
69 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 卡格列净二甲双胍缓释片 | 4 | 1 | 5 |
| 2 | 盐酸非索非那定片 | 4 | 1 | 10 |
| 3 | 富马酸伏诺拉生片 | 3 | 2 | 58 |
| 4 | 硫酸镁注射液 | 3 | 2 | 7 |
| 5 | 苯磺酸美洛加巴林片 | 3 | 2 | 58 |
| 6 | 达格列净二甲双胍缓释片（Ⅰ） | 3 | 2 | 17 |
| 7 | 盐酸美金刚口崩片 | 3 | 1 | 2 |
| 8 | 来特莫韦片 | 2 | 2 | 6 |
| 9 | 氯化钾注射液 | 2 | 2 | 9 |
| 10 | 瑞维那新吸入溶液 | 2 | 2 | 53 |
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
247 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Eli Lilly and Company | 19 | 2 | 0 |
| 2 | NAPP PHARMACEUTICALS LIMITED | 9 | 1 | 0 |
| 3 | 石药集团欧意药业有限公司 | 6 | 5 | 5 |
| 4 | 山东盛迪医药有限公司 | 6 | 2 | 0 |
| 5 | 苏州盛迪亚生物医药有限公司 | 5 | 5 | 0 |
| 6 | 长春金赛药业有限责任公司 | 5 | 4 | 1 |
| 7 | BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED | 5 | 3 | 0 |
| 8 | Janssen-Cilag International NV | 5 | 2 | 0 |
| 9 | AstraZeneca AB | 4 | 3 | 0 |
| 10 | Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc. | 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
127 this week
97 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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