药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/07/26 – 2022/08/01
- New acceptances this week
- 298
- Drugs with new generic filings (by drug name, de-duplicated)
- 45
- 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
298filings, 63 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 178 |
| Generic | 63 |
| New drug | 32 |
| Import | 14 |
| Unspecified | 6 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 211 |
| TCM | 56 |
| 治疗用生物制品 | 25 |
| 预防用生物制品 | 4 |
| 体外诊断试剂 | 1 |
| 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
45 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸乌拉地尔注射液 | 4 | 2 | 5 |
| 2 | 氢溴酸加兰他敏口腔崩解片 | 3 | 1 | 0 |
| 3 | 二甲双胍恩格列净片（Ⅰ） | 2 | 2 | 7 |
| 4 | 盐酸奥洛他定滴眼液 | 2 | 2 | 13 |
| 5 | 硝呋太尔制霉菌素阴道软胶囊 | 2 | 2 | 2 |
| 6 | 丙泊酚中/长链脂肪乳注射液 | 2 | 1 | 3 |
| 7 | 对乙酰氨基酚栓 | 2 | 1 | 0 |
| 8 | 布洛芬注射液 | 2 | 1 | 4 |
| 9 | 恩格列净片 | 2 | 1 | 18 |
| 10 | 曲氟尿苷替匹嘧啶片 | 2 | 1 | 0 |
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
153 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 东陵药业科技（辽宁）有限公司 | 37 | 36 | 0 |
| 2 | 广西修正制药有限公司 | 22 | 16 | 0 |
| 3 | 兰州佛慈（瑞诺欣）药业股份有限公司 | 9 | 9 | 0 |
| 4 | 河北武罗药业有限公司 | 9 | 7 | 0 |
| 5 | 吉林特研药业有限公司 | 7 | 7 | 0 |
| 6 | 齐鲁制药有限公司 | 5 | 5 | 3 |
| 7 | AstraZeneca UK Limited | 4 | 1 | 0 |
| 8 | Boehringer Ingelheim International GmbH | 4 | 1 | 0 |
| 9 | 乐泰药业有限公司 | 3 | 3 | 0 |
| 10 | 株洲千金药业股份有限公司 | 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
66 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/08/01Import · Class 1 | BI 1015550 片JXHL2200219 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2022/08/01Import · Class 1 | BI 1015550 片JXHL2200218 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2022/08/01Generic · Class 3 | 二氮嗪口服混悬液CYHS2201199 | 宿州亿帆药业有限公司 |
| 2022/08/01Generic · Class 3 | 对乙酰氨基酚栓CYHS2201185 | 浙江尔婴药品有限公司; 浙江尖峰药业有限公司 |
| 2022/08/01Generic · Class 3 | 对乙酰氨基酚栓CYHS2201184 | 浙江尔婴药品有限公司; 浙江尖峰药业有限公司 |
| 2022/08/01Generic · Class 3 | 盐酸多巴胺注射液CYHS2201181 | 杭州云柏医药科技有限公司; 浙江赛默制药有限公司 |
| 2022/08/01Generic · Class 3 | 盐酸多巴胺注射液CYHS2201180 | 杭州云柏医药科技有限公司; 浙江赛默制药有限公司 |
| 2022/08/01New drug · Class 3.3 | 精蛋白锌赖脯胰岛素混合注射液（50R）CXSS2200071 | 江苏万邦生化医药集团有限责任公司 |
| 2022/08/01New drug · Class 3.3 | 精蛋白锌赖脯胰岛素混合注射液（25R）CXSS2200070 | 复星万邦（江苏）医药集团有限公司 |
| 2022/08/01New drug · Class 1 | 普那利单抗注射液CXSL2200348 | 天境生物科技（杭州）有限公司 |
| 2022/08/01New drug · Class 1 | 重组抗PD-1全人源单克隆抗体注射液CXSL2200347 | 石药集团中奇制药技术（石家庄）有限公司 |
| 2022/08/01New drug · Class 1 | HEC138671片CXHL2200546 | 广东东阳光药业有限公司 |
| 2022/08/01New drug · Class 1 | HEC138671片CXHL2200545 | 广东东阳光药业有限公司 |
| 2022/07/29Import · Class 3.1 | 注射用艾夫糖苷酶αJXSS2200029 | Genzyme Corporation; Genzyme Ireland Limited; Sanofi (China) Investment Co. Ltd. |
| 2022/07/29Import · Class 3.1 | 人轮状病毒减毒活疫苗JXSL2200131 | GlaxoSmithKline Biologicals S.A. |
| 2022/07/29Generic · Class 3 | 奥扎格雷钠注射液CYHS2201170 | 北京六环药业有限公司; 华夏生生药业（北京）有限公司 |
| 2022/07/29Generic · Class 3 | 氨溴特罗口服溶液CYHS2201169 | 福建省闽东力捷迅药业股份有限公司; 葵花药业集团（冀州）有限公司 |
| 2022/07/29Generic · Class 3 | 美沙拉秦肠溶片CYHS2201167 | 上海宣泰医药科技股份有限公司; 江苏宣泰药业有限公司 |
| 2022/07/29Generic · Class 3 | 维生素B12滴眼液CYHS2201153 | 江苏万高药业股份有限公司 |
| 2022/07/29New drug · Class 1 | TUL01101软膏CXHL2200544 | 珠海联邦制药股份有限公司 |
| 2022/07/29New drug · Class 1 | TUL01101软膏CXHL2200543 | 珠海联邦制药股份有限公司 |
| 2022/07/29New drug · Class 1 | TUL01101软膏CXHL2200542 | 珠海联邦制药股份有限公司 |
| 2022/07/28Import · Class 3.1 | ACYW群脑膜炎球菌多糖结合疫苗JXSL2200130 | Sanofi Pasteur Inc.; Shenzhen Sanofi Pasteur Biological Products Co. Ltd. |
| 2022/07/28Generic · Class 3 | 注射用盐酸罗沙替丁醋酸酯CYHS2201160 | 四川汇宇制药股份有限公司 |
| 2022/07/28Generic · Class 3 | 吸入用色甘酸钠溶液CYHS2201159 | 扬州中宝药业股份有限公司 |
| 2022/07/28New drug · Class 1 | 重组结核杆菌融合蛋白（EEC）CXSL2200345 | 成都可恩生物科技有限公司 |
| 2022/07/28New drug · Class 1 | 重组结核杆菌融合蛋白（EEC）CXSL2200344 | 成都可恩生物科技有限公司 |
| 2022/07/28New drug · Class 1 | 重组结核杆菌融合蛋白（EEC）CXSL2200343 | 成都可恩生物科技有限公司 |
| 2022/07/28New drug · Class 2.2 | 冻干人用狂犬病疫苗（无血清Vero细胞）CXSL2200342 | 宁波荣安生物药业有限公司 |
| 2022/07/28New drug · Class 1 | 人脐带间充质干细胞注射液CXSL2200341 | 上海泉生生物科技有限公司 |
36 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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