药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/01/28 – 2025/02/03
- New acceptances this week
- 29
- Drugs with new generic filings (by drug name, de-duplicated)
- 9
- 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
29filings, 10 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 12 |
| Generic | 10 |
| New drug | 6 |
| Unspecified | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 21 |
| 治疗用生物制品 | 4 |
| TCM | 2 |
| Biologic | 1 |
| 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
9 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 注射用阿莫西林钠克拉维酸钾 | 2 | 1 | 4 |
| 2 | 泊沙康唑注射液 | 1 | 1 | 1 |
| 3 | 盐酸胺碘酮注射液 | 1 | 1 | 0 |
| 4 | 碳酸氢钠/葡萄糖2mmol/L钾电解质血滤置换液 | 1 | 1 | 0 |
| 5 | 磷/碳酸氢钠血滤置换液 | 1 | 1 | 4 |
| 6 | 磷酸奥司他韦胶囊 | 1 | 1 | 42 |
| 7 | 缩宫素注射液 | 1 | 1 | 8 |
| 8 | 醋酸钙口服溶液 | 1 | 1 | 1 |
| 9 | 阿仑膦酸钠口服溶液 | 1 | 1 | 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
22 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 海口市制药厂有限公司 | 3 | 1 | 0 |
| 2 | 成都青山利康药业股份有限公司 | 2 | 2 | 2 |
| 3 | 百欧恩泰（上海）医药有限公司 | 2 | 2 | 0 |
| 4 | Biohaven Therapeutics Ltd | 2 | 1 | 0 |
| 5 | 山东安信制药有限公司 | 2 | 1 | 2 |
| 6 | 西安利君制药有限责任公司 | 2 | 1 | 0 |
| 7 | Terumo Corporation Kofu Factory | 1 | 1 | 0 |
| 8 | 上海先祥医药科技有限公司 | 1 | 1 | 0 |
| 9 | 华益药业科技（安徽）有限公司 | 1 | 1 | 1 |
| 10 | 天津市中央药业有限公司 | 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
10 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/01/28Generic · Class 3 | 醋酸钙口服溶液CYHS2500553 | 华益药业科技（安徽）有限公司 |
| 2025/01/28Generic · Class 3 | 缩宫素注射液CYHS2500550 | 苏州天马医药集团天吉生物制药有限公司 |
| 2025/01/28Generic · Class 3 | 碳酸氢钠/葡萄糖2mmol/L钾电解质血滤置换液CYHS2500549 | 成都青山利康药业股份有限公司 |
| 2025/01/28Generic · Class 3 | 阿仑膦酸钠口服溶液CYHS2500547 | 河北仁合益康药业有限公司 |
| 2025/01/28New drug · Class 3.3 | 吸附破伤风疫苗CXSS2500022 | 康希诺生物股份公司 |
| 2025/01/28New drug · Class 1 | 重组抗人EGFR抗体/IL-10双特异Fc融合蛋白注射液CXSL2500098 | 施慧达药业集团（吉林）有限公司 |
| 2025/01/28New drug · Class 1 | 注射用SIM0686CXSL2500097 | 上海先祥医药科技有限公司 |
| 2025/01/28New drug · Class 1 | BNT327CXSL2500096 | 百欧恩泰（上海）医药有限公司; 普米斯生物技术（珠海）有限公司 |
| 2025/01/28New drug · Class 1 | BNT326CXSL2500095 | 百欧恩泰（上海）医药有限公司; 苏州宜联生物医药有限公司 |
| 2025/01/28New drug · Class 1 | HRS-9813胶囊CXHL2500147 | 广东恒瑞医药有限公司 |
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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