药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/01/07 – 2025/01/13
- New acceptances this week
- 519
- Drugs with new generic filings (by drug name, de-duplicated)
- 150
- Accepted this week, now under review
- 20
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
519filings, 212 of them generic
By application type
| Application type | Filings |
|---|---|
| Generic | 212 |
| Supplement | 200 |
| New drug | 84 |
| Import | 13 |
| Unspecified | 4 |
| Import re-registration | 4 |
| 药械组合 | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 387 |
| TCM | 70 |
| 治疗用生物制品 | 57 |
| Biologic | 3 |
| 预防用生物制品 | 2 |
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
150 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 美阿沙坦钾片 | 6 | 3 | 33 |
| 2 | 恩格列净二甲双胍缓释片 | 5 | 2 | 12 |
| 3 | 瑞舒伐他汀依折麦布片(I) | 4 | 4 | 9 |
| 4 | 布瑞哌唑片 | 4 | 2 | 31 |
| 5 | 达格列净片 | 4 | 2 | 82 |
| 6 | 克立硼罗软膏 | 3 | 3 | 28 |
| 7 | 阿帕他胺片 | 3 | 3 | 17 |
| 8 | 富马酸伏诺拉生片 | 3 | 2 | 58 |
| 9 | 左卡尼汀口服溶液 | 3 | 2 | 9 |
| 10 | 依托考昔片 | 3 | 1 | 8 |
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
301 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 吉林菲诺制药有限公司 | 17 | 16 | 0 |
| 2 | 成都地奥集团天府药业股份有限公司 | 13 | 12 | 0 |
| 3 | 湖南千金湘江药业股份有限公司 | 7 | 4 | 5 |
| 4 | 信达生物制药(苏州)有限公司 | 7 | 1 | 0 |
| 5 | 山东齐都药业有限公司 | 6 | 6 | 5 |
| 6 | 石家庄四药有限公司 | 6 | 5 | 6 |
| 7 | 北京福元医药股份有限公司 | 6 | 4 | 6 |
| 8 | 浙江华海药业股份有限公司 | 5 | 4 | 5 |
| 9 | 齐鲁制药有限公司 | 5 | 4 | 0 |
| 10 | Takeda Development Center Americas Inc. | 5 | 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
171 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/01/13Generic · Class 3 | 维生素B12注射液CYHS2500265 | 南京赛瑞谱顿制药有限公司; 山东新时代药业有限公司 |
| 2025/01/13New drug · Class 1 | TQC2938注射液CXSL2500038 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2025/01/11Import · Class 1 | AZD2936JXSL2500007 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/01/11Import · Class 1 | TAK-360片JXHL2500008 | Takeda Development Center Americas Inc. |
| 2025/01/11Import · Class 1 | TAK-360片JXHL2500007 | Takeda Development Center Americas Inc. |
| 2025/01/11Import · Class 1 | TAK-360片JXHL2500006 | Takeda Development Center Americas Inc. |
| 2025/01/11Generic · Class 3 | 盐酸普萘洛尔片CYHS2500261 | 合肥国药诺和药业有限公司; 华益药业科技(安徽)有限公司 |
| 2025/01/11Generic · Class 3 | 复方匹可硫酸钠口服溶液CYHS2500260 | 江苏润恒制药有限公司 |
| 2025/01/11Generic · Class 3 | 维生素B6注射液CYHS2500259 | 江苏迪赛诺制药有限公司 |
| 2025/01/11Generic · Class 3 | 氯化钾口服溶液CYHS2500249 | 山东齐都药业有限公司; 山东益康药业股份有限公司 |
| 2025/01/11Generic · Class 3 | 氯雷他定口服溶液CYHS2500246 | 海南万玮制药有限公司 |
| 2025/01/11Generic · Class 3 | 氯雷他定口服溶液CYHS2500245 | 海南万玮制药有限公司 |
| 2025/01/11Generic · Class 3 | 注射用吲哚菁绿CYHS2500244 | 河北锐健医药科技有限公司; 成都通德药业有限公司 |
| 2025/01/11Generic · Class 3 | 布立西坦注射液CYHS2500242 | 江西科睿药业有限公司; 江西青峰药业有限公司 |
| 2025/01/11Generic · Class 3 | 阿瑞匹坦注射液CYHL2500016 | 山东齐都药业有限公司 |
| 2025/01/11Generic · Class 3 | 尿素[13C]呼气试验药盒CYHL2500015 | 辐瑞森生物科技(昆山)有限公司 |
| 2025/01/11Generic · Class 3 | 尿素[13C]呼气试验药盒CYHL2500014 | 辐瑞森生物科技(昆山)有限公司 |
| 2025/01/11Generic · Class 3 | 利多卡因软膏CYHL2500013 | 北京中泰邦医药科技有限公司 |
| 2025/01/11Generic · Class 3 | 利多卡因软膏CYHL2500012 | 北京中泰邦医药科技有限公司 |
| 2025/01/11New drug · Class 3.1 | 清金化痰颗粒CXZS2500001 | 山东齐都药业有限公司 |
| 2025/01/11New drug · Class 1 | ZHB117舌下片CXSL2500037 | 江苏众红生物工程创药研究院有限公司 |
| 2025/01/11New drug · Class 1 | ZHB117舌下片CXSL2500036 | 江苏众红生物工程创药研究院有限公司 |
| 2025/01/11New drug · Class 2.2 | 布瑞哌唑口服混悬液CXHS2500007 | 山东朗诺制药有限公司 |
| 2025/01/11New drug · Class 1 | KHN702片CXHL2500057 | 成都康弘药业集团股份有限公司 |
| 2025/01/11New drug · Class 1 | KHN702片CXHL2500056 | 成都康弘药业集团股份有限公司 |
| 2025/01/11New drug · Class 1 | KHN702片CXHL2500055 | 成都康弘药业集团股份有限公司 |
| 2025/01/11New drug · Class 2.2 | XZ157CXHL2500054 | 山东新时代药业有限公司 |
| 2025/01/10Generic · Class 3 | 米诺地尔搽剂CYHS2500239 | 湖南千金湘江药业股份有限公司; 浙江赛默制药有限公司 |
| 2025/01/10Generic · Class 3 | 米诺地尔搽剂CYHS2500238 | 湖南千金湘江药业股份有限公司; 浙江赛默制药有限公司 |
| 2025/01/10Generic · Class 3 | 布美他尼注射液CYHS2500229 | 江苏开元药业有限公司; 江苏苏中药业集团生物制药有限公司 |
141 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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