药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/09/28 – 2021/10/04
- New acceptances this week
- 175
- Drugs with new generic filings (by drug name, de-duplicated)
- 23
- Accepted this week, now under review
- 0
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
175filings, 33 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 78 |
| New drug | 34 |
| Generic | 33 |
| Import | 14 |
| Import re-registration | 9 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 141 |
| TCM | 18 |
| 治疗用生物制品 | 15 |
| 预防用生物制品 | 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
23 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 拉考沙胺糖浆 | 2 | 2 | 0 |
| 2 | 注射用伏立康唑 | 2 | 2 | 4 |
| 3 | 利奈唑胺葡萄糖注射液 | 2 | 1 | 3 |
| 4 | 托吡司特片 | 2 | 1 | 0 |
| 5 | 托拉塞米注射液 | 2 | 1 | 1 |
| 6 | 拉考沙胺片 | 2 | 1 | 0 |
| 7 | 氯沙坦钾片 | 2 | 1 | 5 |
| 8 | 注射用尼可地尔 | 2 | 1 | 1 |
| 9 | 盐酸多巴胺注射液 | 2 | 1 | 3 |
| 10 | 酒石酸布托啡诺注射液 | 2 | 1 | 0 |
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
106 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 南京艾美斐生物医药科技有限公司 | 6 | 2 | 0 |
| 2 | 深圳科兴药业有限公司 | 6 | 1 | 0 |
| 3 | 江苏豪森药业集团有限公司 | 5 | 3 | 0 |
| 4 | Bayer AG | 5 | 1 | 0 |
| 5 | 湖北长联杜勒制药有限公司 | 4 | 3 | 0 |
| 6 | 湖北民康制药有限公司 | 4 | 2 | 0 |
| 7 | 科笛生物医药（无锡）有限公司 | 4 | 1 | 0 |
| 8 | 江西地康药业有限公司 | 3 | 3 | 0 |
| 9 | 河北武罗药业有限公司 | 3 | 3 | 0 |
| 10 | 上海强生制药有限公司 | 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
60 this week
30 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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