药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/01/30 – 2024/02/05
- New acceptances this week
- 412
- Drugs with new generic filings (by drug name, de-duplicated)
- 93
- Accepted this week, now under review
- 8
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
412filings, 127 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 185 |
| Generic | 127 |
| New drug | 58 |
| Import | 23 |
| Unspecified | 10 |
| Import re-registration | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 278 |
| 治疗用生物制品 | 68 |
| TCM | 52 |
| 预防用生物制品 | 9 |
| Biologic | 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
93 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 米诺地尔搽剂 | 5 | 1 | 49 |
| 2 | 富马酸伏诺拉生片 | 4 | 2 | 58 |
| 3 | 利丙双卡因乳膏 | 3 | 3 | 25 |
| 4 | 盐酸左米那普仑缓释胶囊 | 3 | 1 | 6 |
| 5 | 二羟丙茶碱注射液 | 2 | 2 | 7 |
| 6 | 他达拉非片 | 2 | 2 | 23 |
| 7 | 加替沙星滴眼液 | 2 | 2 | 3 |
| 8 | 盐酸决奈达隆片 | 2 | 2 | 4 |
| 9 | 盐酸甲氧氯普胺注射液 | 2 | 2 | 6 |
| 10 | 硫酸镁钠钾口服用浓溶液 | 2 | 2 | 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
264 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Pfizer Inc. | 7 | 3 | 0 |
| 2 | 四川医颗草药业有限公司 | 6 | 6 | 0 |
| 3 | 四川科伦药业股份有限公司 | 6 | 4 | 4 |
| 4 | 江苏恩华药业股份有限公司 | 6 | 3 | 4 |
| 5 | Pfizer Europe MA EEIG | 5 | 3 | 0 |
| 6 | 浙江赛默制药有限公司 | 5 | 3 | 5 |
| 7 | 乐福思健康产业股份公司 | 5 | 1 | 5 |
| 8 | 深圳翰宇药业股份有限公司 | 5 | 1 | 0 |
| 9 | Novo Nordisk A/S | 4 | 4 | 0 |
| 10 | BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED | 4 | 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
131 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/02/05Import · Class 1 | Livmoniplimab 注射液JXSL2400035 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/02/05Import · Class 2.2 | 注射用德曲妥珠单抗JXSL2400034 | Daiichi Sankyo Inc.; IQVIA RDS (Shanghai) Co. Ltd. |
| 2024/02/05Generic · Class 3 | 己酮可可碱注射液CYHS2400498 | 辰欣药业股份有限公司 |
| 2024/02/05Generic · Class 3 | 复合磷酸氢钾注射液CYHS2400497 | 广州艾格生物科技有限公司; 广东星昊药业有限公司 |
| 2024/02/05Generic · Class 3 | 复合磷酸氢钾注射液CYHS2400496 | 广州艾格生物科技有限公司; 广东星昊药业有限公司 |
| 2024/02/05Generic · Class 3 | 别嘌醇片CYHS2400495 | 石家庄四药有限公司 |
| 2024/02/05Generic · Class 3 | 地氯雷他定口服溶液CYHS2400494 | 圣嘉(滨海)生物医药科技有限公司; 江苏欧歌制药有限公司 |
| 2024/02/05Generic · Class 3 | 乙酰半胱氨酸注射液CYHS2400493 | 合肥国药诺和药业有限公司; 国药集团国瑞药业有限公司 |
| 2024/02/05Generic · Class 3 | 酮咯酸氨丁三醇注射液CYHS2400490 | 江苏明圣康源药业有限公司; 江苏九旭药业有限公司 |
| 2024/02/05Generic · Class 3 | 己酮可可碱缓释片CYHS2400489 | 石药集团中诺药业(石家庄)有限公司; 石药集团欧意药业有限公司 |
| 2024/02/05Generic · Class 3 | 布洛芬注射液CYHS2400488 | 陕西天宇制药有限公司 |
| 2024/02/05Generic · Class 3 | 氨溴特罗口服溶液CYHS2400486 | 湖北凯纳药业有限公司; 湖北美思创药业有限公司 |
| 2024/02/05Generic · Class 3 | 布洛芬注射液CYHS2400485 | 陕西天宇制药有限公司 |
| 2024/02/05Generic · Class 3 | 小儿复方氨基酸注射液(19AA-Ⅰ)CYHS2400484 | 四川科伦药业股份有限公司 |
| 2024/02/05Generic · Class 3 | 小儿复方氨基酸注射液(19AA-Ⅰ)CYHS2400483 | 四川科伦药业股份有限公司 |
| 2024/02/05Generic · Class 3 | 加替沙星滴眼液CYHS2400482 | 合肥利民制药有限公司 |
| 2024/02/05Generic · Class 3 | 氨氯地平贝那普利胶囊CYHS2400478 | 东阳祥昇医药科技有限公司; 乐普制药科技有限公司 |
| 2024/02/05Generic · Class 3 | 二羟丙茶碱注射液CYHS2400476 | 成都欣捷高新技术开发股份有限公司; 成都市海通药业有限公司 |
| 2024/02/05Generic · Class 3 | 二羟丙茶碱注射液CYHS2400475 | 海南爱科制药有限公司 |
| 2024/02/05Generic · Class 3 | 吸入用雷芬那辛溶液CYHL2400035 | 云南龙海天然植物药业有限公司 |
| 2024/02/05New drug · Class 2.2 | 注射用重组人组织型纤溶酶原激酶衍生物CXSS2400016 | 华润昂德生物药业有限公司 |
| 2024/02/05New drug · Class 1.4 | 26价肺炎球菌结合疫苗CXSL2400099 | 北京智飞绿竹生物制药有限公司 |
| 2024/02/05New drug · Class 1 | KAL-002CXSL2400098 | 四川厌氧生物科技有限责任公司 |
| 2024/02/05New drug · Class 1 | KAL-002CXSL2400097 | 四川厌氧生物科技有限责任公司 |
| 2024/02/05New drug · Class 1 | KAL-002CXSL2400096 | 四川厌氧生物科技有限责任公司 |
| 2024/02/05New drug · Class 1 | KAL-002CXSL2400095 | 四川厌氧生物科技有限责任公司 |
| 2024/02/05New drug · Class 1 | LY01620CXSL2400094 | 南京吉迈生物技术有限公司 |
| 2024/02/05New drug · Class 1 | HLX53CXSL2400093 | 上海复宏汉霖生物技术股份有限公司; 上海复宏汉霖生物制药有限公司 |
| 2024/02/05New drug · Class 1 | SK-08片CXHL2400142 | 广州康臣药业有限公司 |
| 2024/02/05New drug · Class 1 | SK-08片CXHL2400141 | 广州康臣药业有限公司 |
101 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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