药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/08/27 – 2024/09/02
- New acceptances this week
- 348
- Drugs with new generic filings (by drug name, de-duplicated)
- 81
- Accepted this week, now under review
- 1
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
348filings, 107 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 156 |
| Generic | 107 |
| New drug | 63 |
| Import | 11 |
| Unspecified | 9 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 237 |
| TCM | 67 |
| 治疗用生物制品 | 36 |
| 预防用生物制品 | 7 |
| Biologic | 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
81 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 布美他尼注射液 | 6 | 3 | 16 |
| 2 | 利伐沙班片 | 4 | 1 | 3 |
| 3 | 维生素B6注射液 | 3 | 3 | 13 |
| 4 | 他达拉非片 | 3 | 1 | 23 |
| 5 | 钆布醇注射液 | 3 | 1 | 8 |
| 6 | 硫酸沙丁胺醇注射液 | 2 | 2 | 1 |
| 7 | 乳酸钠林格注射液 | 2 | 1 | 6 |
| 8 | 恩格列净片 | 2 | 1 | 20 |
| 9 | 枸橼酸西地那非片 | 2 | 1 | 12 |
| 10 | 注射用甲磺酸萘莫司他 | 2 | 1 | 38 |
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
228 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 吉林真元制药有限公司 | 7 | 6 | 0 |
| 2 | 北京质肽生物医药科技有限公司 | 6 | 1 | 0 |
| 3 | 吉林新万联医药有限公司 | 5 | 3 | 0 |
| 4 | 江苏康缘药业股份有限公司 | 5 | 2 | 0 |
| 5 | 上海长征富民金山制药有限公司 | 4 | 4 | 4 |
| 6 | 贵州良济药业有限公司 | 4 | 4 | 0 |
| 7 | 青岛东海药业有限公司 | 4 | 4 | 0 |
| 8 | 海南慧通生物医药科技有限公司 | 4 | 2 | 4 |
| 9 | 拜耳医药保健有限公司 | 4 | 1 | 4 |
| 10 | 哈尔滨美君制药有限公司 | 3 | 3 | 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
109 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/09/02New drug · Class 3.1 | 二冬颗粒CXZS2400029 | 神威药业集团有限公司 |
| 2024/09/02New drug · Class 1 | ALMB-0168注射液CXSL2400582 | 上海恩乐迈生物科技有限公司 |
| 2024/09/02New drug · Class 1 | 人生长激素-Fc融合蛋白注射液CXSL2400581 | 长春生物制品研究所有限责任公司 |
| 2024/09/02New drug · Class 2.2 | 尼莫地平注射用浓溶液CXHL2400895 | 北京德立福瑞医药科技有限公司 |
| 2024/09/02New drug · Class 1 | RAY1225注射液CXHL2400894 | 广东众生睿创生物科技有限公司 |
| 2024/09/01Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G1.5%)CYHS2402869 | 上海长征富民金山制药有限公司 |
| 2024/09/01Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G2.5%)CYHS2402868 | 上海长征富民金山制药有限公司 |
| 2024/09/01Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G2.5%)CYHS2402867 | 上海长征富民金山制药有限公司 |
| 2024/09/01Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G1.5%)CYHS2402866 | 上海长征富民金山制药有限公司 |
| 2024/08/31Import · Class 2.4 | 注射用六氟化硫微泡JXHS2400060 | Bracco International B.V.; Bracco Suisse SA; Bracco Imaging Medical Technologies (Shanghai) Co. Ltd |
| 2024/08/31Generic · Class 3 | 氯化钙注射液CYHS2402865 | 石家庄杏泽医药科技有限公司; 山东华鲁制药有限公司 |
| 2024/08/31Generic · Class 3 | 维生素B6注射液CYHS2402860 | 江苏润恒制药有限公司 |
| 2024/08/31Generic · Class 3 | 富马酸依美斯汀缓释胶囊CYHS2402858 | 湖南普道医药技术有限公司; 湖南九典制药股份有限公司 |
| 2024/08/31Generic · Class 3 | 吸入用雷芬那辛溶液CYHL2400182 | 长风药业股份有限公司 |
| 2024/08/31New drug · Class 1.1 | 玉蚕颗粒CXZL2400049 | 武汉人福创新药物研发中心有限公司; 上海复活石医药科技有限公司 |
| 2024/08/31New drug · Class 1.1 | 膝痛颗粒CXZL2400048 | 仲颐(广州)科技创新研究有限公司; 中国中医科学院中药研究所 |
| 2024/08/31New drug · Class 3.3 | 冻干人用狂犬病疫苗(人二倍体细胞)CXSS2400092 | 成大生物(本溪)有限公司 |
| 2024/08/31New drug · Class 2.2 | 氨酚羟考酮缓释片CXHS2400088 | 成都苑东生物制药股份有限公司 |
| 2024/08/31New drug · Class 1 | CPI-818片CXHL2400893 | 嘉兴和剂药业有限公司 |
| 2024/08/31New drug · Class 1 | CPI-818片CXHL2400892 | 嘉兴和剂药业有限公司 |
| 2024/08/30Generic · Class 3 | 阿瑞匹坦注射液CYHS2402842 | 江苏康禾生物制药有限公司 |
| 2024/08/30Generic · Class 3 | 盐酸拉贝洛尔注射液CYHS2402839 | 海南慧通生物医药科技有限公司; 山东北大高科华泰制药有限公司 |
| 2024/08/30Generic · Class 3 | 盐酸拉贝洛尔注射液CYHS2402838 | 海南慧通生物医药科技有限公司; 山东北大高科华泰制药有限公司 |
| 2024/08/30Generic · Class 3 | 硝普钠注射液CYHS2402836 | 华夏生生药业(北京)有限公司 |
| 2024/08/30Generic · Class 3 | 维生素B6注射液CYHS2402833 | 国仁健康制药(北京)有限公司; 西安汉丰药业有限责任公司 |
| 2024/08/30Generic · Class 3 | 己酮可可碱缓释片CYHS2402832 | 本溪匠成医药科技有限公司; 吉林四环制药有限公司 |
| 2024/08/30Generic · Class 3 | 盐酸曲唑酮片CYHS2402827 | 浙江江北药业有限公司 |
| 2024/08/30Generic · Class 3 | 脂溶性维生素注射液(Ⅰ)CYHS2402823 | 石家庄四药有限公司 |
| 2024/08/30Generic · Class 3 | 吡格列酮二甲双胍片CYHS2402822 | 杭州呋欧医药科技有限公司; 浙江赛默制药有限公司 |
| 2024/08/30Generic · Class 3 | 注射用甲磺酸萘莫司他CYHL2400181 | 杭州沐源生物医药科技有限公司 |
79 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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