药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/01/09 – 2024/01/15
- New acceptances this week
- 382
- Drugs with new generic filings (by drug name, de-duplicated)
- 102
- 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
382filings, 136 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 141 |
| Generic | 136 |
| New drug | 69 |
| Import | 23 |
| Import re-registration | 10 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 286 |
| TCM | 45 |
| 治疗用生物制品 | 45 |
| 预防用生物制品 | 4 |
| Biologic | 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
102 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 注射用头孢唑肟钠 | 4 | 2 | 6 |
| 2 | 氯化钾口服溶液 | 3 | 3 | 12 |
| 3 | 左氧氟沙星注射液 | 3 | 2 | 1 |
| 4 | 左氧氟沙星氯化钠注射液 | 3 | 1 | 14 |
| 5 | 普瑞巴林缓释片 | 3 | 1 | 13 |
| 6 | 乙酰半胱氨酸注射液 | 2 | 2 | 53 |
| 7 | 二羟丙茶碱注射液 | 2 | 2 | 7 |
| 8 | 吸入用丙酸倍氯米松混悬液 | 2 | 2 | 3 |
| 9 | 多巴丝肼片 | 2 | 2 | 2 |
| 10 | 琥珀酸亚铁片 | 2 | 2 | 21 |
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
235 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novartis Pharma AG | 8 | 3 | 0 |
| 2 | 郑州瑞龙制药股份有限公司 | 6 | 5 | 0 |
| 3 | AstraZeneca AB | 6 | 4 | 0 |
| 4 | 浙江京新药业股份有限公司 | 6 | 3 | 2 |
| 5 | Sanofi-Aventis Recherche & Developpement | 6 | 1 | 0 |
| 6 | 厦门特宝生物工程股份有限公司 | 5 | 1 | 0 |
| 7 | 浙江华海药业股份有限公司 | 4 | 3 | 3 |
| 8 | Novo Nordisk A/S | 4 | 2 | 0 |
| 9 | Boehringer Ingelheim International GmbH | 4 | 1 | 0 |
| 10 | 江苏恩华药业股份有限公司 | 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
145 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/01/15Generic · Class 3 | 盐酸羟考酮片CYHS2400213 | 宜昌人福药业有限责任公司 |
| 2024/01/15Generic · Class 3 | 盐酸羟考酮片CYHS2400212 | 宜昌人福药业有限责任公司 |
| 2024/01/15Generic · Class 3 | 注射用苯唑西林钠CYHS2400211 | 山东如至生物医药科技有限公司; 山东二叶制药有限公司 |
| 2024/01/15Generic · Class 3 | 注射用苯唑西林钠CYHS2400210 | 山东如至生物医药科技有限公司; 山东二叶制药有限公司 |
| 2024/01/15Generic · Class 3 | 硝苯地平缓释片(II)CYHS2400208 | 浙江京新药业股份有限公司 |
| 2024/01/15New drug · Class 2.4 | 醋酸阿比特龙片(Ⅱ)CXHL2400071 | 成都盛迪医药有限公司 |
| 2024/01/13Generic · Class 3 | 腺苷钴胺胶囊CYHS2400206 | 海南紫程众投生物科技有限公司; 天津市中央药业有限公司 |
| 2024/01/13Generic · Class 3 | 苯磺酸氨氯地平口崩片CYHS2400205 | 广东万泰科创药业有限公司; 深圳信立泰药业股份有限公司 |
| 2024/01/13Generic · Class 3 | 苯磺酸氨氯地平口崩片CYHS2400204 | 广东万泰科创药业有限公司; 深圳信立泰药业股份有限公司 |
| 2024/01/13Generic · Class 3 | 琥珀酸亚铁片CYHS2400200 | 华益药业科技(安徽)有限公司 |
| 2024/01/13Generic · Class 3 | 阿奇霉素颗粒CYHS2400199 | 重庆莱美药业股份有限公司 |
| 2024/01/13Generic · Class 3 | 氯化钾口服溶液CYHS2400197 | 苏州朗科生物技术股份有限公司; 南京海纳制药有限公司 |
| 2024/01/13Generic · Class 3 | 联苯苄唑溶液CYHS2400194 | 福元药业有限公司 |
| 2024/01/13Generic · Class 3 | 普瑞巴林缓释片CYHL2400019 | 石药集团欧意药业有限公司 |
| 2024/01/13Generic · Class 3 | 普瑞巴林缓释片CYHL2400018 | 石药集团欧意药业有限公司 |
| 2024/01/13Generic · Class 3 | 普瑞巴林缓释片CYHL2400017 | 石药集团欧意药业有限公司 |
| 2024/01/13New drug · Class 1.1 | 香术平胃散CXZL2400003 | 江苏中雍红瑞制药有限公司 |
| 2024/01/13New drug · Class 1 | HB0046注射液CXSL2400029 | 上海华奥泰生物药业股份有限公司; 华博生物医药技术(上海)有限公司 |
| 2024/01/13New drug · Class 1 | JX2105胶囊CXHL2400070 | 浙江京新药业股份有限公司 |
| 2024/01/13New drug · Class 1 | JX2105胶囊CXHL2400069 | 浙江京新药业股份有限公司 |
| 2024/01/13New drug · Class 1 | JX2105胶囊CXHL2400068 | 浙江京新药业股份有限公司 |
| 2024/01/13New drug · Class 1 | JX2105胶囊CXHL2400067 | 浙江京新药业股份有限公司 |
| 2024/01/13New drug · Class 2.2 | SL-0013片CXHL2400066 | 上海则正生物医药股份有限公司; 山东大学 |
| 2024/01/12Import · Class 1 | Amlitelimab注射液JXSL2400018 | Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD |
| 2024/01/12Import · Class 1 | Amlitelimab注射液JXSL2400017 | Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD |
| 2024/01/12Import · Class 1 | Amlitelimab注射液JXSL2400016 | Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD |
| 2024/01/12Import · Class 1 | Amlitelimab注射液JXSL2400015 | Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD |
| 2024/01/12Import · Class 1 | Amlitelimab注射液JXSL2400014 | Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD |
| 2024/01/12Import · Class 1 | Amlitelimab注射液JXSL2400013 | Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD |
| 2024/01/12Generic · Class 3 | 氯化钾颗粒CYHS2400193 | 福州基石医药科技有限公司 |
115 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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