药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/02/01 – 2022/02/07
- New acceptances this week
- 15
- Drugs with new generic filings (by drug name, de-duplicated)
- 2
- 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
15filings, 2 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 6 |
| New drug | 5 |
| Generic | 2 |
| Import | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 10 |
| 治疗用生物制品 | 5 |
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
2 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 利奈唑胺氯化钠注射液 | 1 | 1 | 0 |
| 2 | 阿哌沙班片 | 1 | 1 | 3 |
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
9 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 石药集团欧意药业有限公司 | 3 | 1 | 0 |
| 2 | 正大天晴药业集团南京顺欣制药有限公司 | 2 | 2 | 0 |
| 3 | 神州细胞工程有限公司 | 2 | 2 | 0 |
| 4 | Biogen Idec Research Limited | 2 | 1 | 0 |
| 5 | 辉瑞制药科技有限公司 | 2 | 1 | 0 |
| 6 | 北京盛迪医药有限公司 | 1 | 1 | 0 |
| 7 | 山东新华制药股份有限公司 | 1 | 1 | 1 |
| 8 | 江苏吴中医药集团有限公司苏州制药厂 | 1 | 1 | 1 |
| 9 | 陕西九州制药有限责任公司 | 1 | 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
8 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/02/07Import · Class 2.2 | 诺西那生钠注射液JXHL2200035 | Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd |
| 2022/02/07Import · Class 2.2 | 诺西那生钠注射液JXHL2200034 | Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd |
| 2022/02/07Generic · Class 3 | 利奈唑胺氯化钠注射液CYHS2200067 | 江苏吴中医药集团有限公司苏州制药厂; 江苏大红鹰恒顺药业有限公司 |
| 2022/02/07New drug · Class 3.4 | 注射用重组人凝血因子ⅧCXSS2200013 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2022/02/07New drug · Class 1 | SHR-2004注射液CXSL2200072 | 北京盛迪医药有限公司 |
| 2022/02/07New drug · Class 1 | TQH2722注射液CXSL2200071 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2022/02/07New drug · Class 1 | 重组人源化抗PD-1单克隆抗体注射液CXSL2200069 | 神州细胞工程有限公司 |
| 2022/02/07New drug · Class 1 | 重组全人源抗人表皮生长因子受体单克隆抗体注射液CXSL2200068 | 神州细胞工程有限公司 |
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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