药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/12/31 – 2025/01/06
- New acceptances this week
- 396
- Drugs with new generic filings (by drug name, de-duplicated)
- 92
- Accepted this week, now under review
- 13
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
396filings, 130 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 174 |
| Generic | 130 |
| New drug | 67 |
| Import | 16 |
| Unspecified | 6 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 282 |
| TCM | 57 |
| 治疗用生物制品 | 50 |
| 预防用生物制品 | 7 |
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
92 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 富马酸伏诺拉生片 | 5 | 3 | 58 |
| 2 | 他克莫司软膏 | 4 | 2 | 8 |
| 3 | 利丙双卡因乳膏 | 3 | 2 | 25 |
| 4 | 米库氯铵注射液 | 3 | 2 | 3 |
| 5 | 他达拉非片 | 3 | 1 | 23 |
| 6 | 托吡司特片 | 3 | 1 | 0 |
| 7 | 棕榈酸帕利哌酮注射液 | 3 | 1 | 8 |
| 8 | 乳果糖口服溶液 | 2 | 2 | 40 |
| 9 | 夫西地酸乳膏 | 2 | 2 | 16 |
| 10 | 富马酸福莫特罗吸入溶液 | 2 | 2 | 7 |
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
254 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Pfizer Europe MA EEIG | 7 | 3 | 0 |
| 2 | 陕西步长制药有限公司 | 7 | 3 | 0 |
| 3 | 吉林菲诺制药有限公司 | 6 | 5 | 0 |
| 4 | 浙江华海药业股份有限公司 | 5 | 4 | 5 |
| 5 | 新乡市常乐制药有限责任公司 | 5 | 2 | 0 |
| 6 | 内蒙古大唐药业股份有限公司 | 4 | 4 | 0 |
| 7 | 金鸿药业股份有限公司 | 4 | 2 | 1 |
| 8 | GlaxoSmithKline Trading Services Limited | 4 | 1 | 0 |
| 9 | 广东香山堂制药有限公司 | 3 | 3 | 0 |
| 10 | 恒昌（广州）新药研究有限公司 | 3 | 3 | 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
120 this week
90 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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