药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/08/15 – 2023/08/21
- New acceptances this week
- 417
- Drugs with new generic filings (by drug name, de-duplicated)
- 75
- Accepted this week, now under review
- 1
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
417filings, 106 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 213 |
| Generic | 106 |
| New drug | 57 |
| Import | 32 |
| Import re-registration | 5 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 301 |
| TCM | 63 |
| 治疗用生物制品 | 46 |
| 预防用生物制品 | 6 |
| 体外诊断试剂 | 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
75 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 钆特醇注射液 | 4 | 1 | 3 |
| 2 | 乳果糖口服溶液 | 3 | 2 | 36 |
| 3 | 恩格列净片 | 3 | 2 | 18 |
| 4 | 盐酸乌拉地尔注射液 | 3 | 2 | 5 |
| 5 | 碘普罗胺注射液 | 3 | 2 | 27 |
| 6 | 恩那度司他片 | 3 | 1 | 0 |
| 7 | 复方匹可硫酸钠口服溶液 | 2 | 2 | 2 |
| 8 | 盐酸拉贝洛尔注射液 | 2 | 2 | 4 |
| 9 | 莫匹罗星软膏 | 2 | 2 | 31 |
| 10 | 马来酸阿伐曲泊帕片 | 2 | 2 | 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
248 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 山东威智百科药业有限公司 | 24 | 19 | 1 |
| 2 | 修正药业集团天汉药业有限公司 | 9 | 9 | 0 |
| 3 | 长沙爱贝高药业有限公司 | 5 | 5 | 0 |
| 4 | 广西修正制药有限公司 | 5 | 4 | 0 |
| 5 | 广东大冢制药有限公司 | 5 | 3 | 0 |
| 6 | 石家庄四药有限公司 | 5 | 3 | 1 |
| 7 | Myokardia Inc. | 5 | 1 | 0 |
| 8 | Janssen Research & Development LLC | 4 | 2 | 0 |
| 9 | 浙江昂利康制药股份有限公司 | 4 | 2 | 2 |
| 10 | Eli Lilly and Company | 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
124 this week
94 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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