药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/08/29 – 2023/09/04
- New acceptances this week
- 334
- Drugs with new generic filings (by drug name, de-duplicated)
- 66
- 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
334filings, 90 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 172 |
| Generic | 90 |
| New drug | 52 |
| Import | 13 |
| Import re-registration | 5 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 234 |
| TCM | 58 |
| 治疗用生物制品 | 34 |
| 预防用生物制品 | 6 |
| 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
66 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 注射用尼可地尔 | 3 | 2 | 1 |
| 2 | 依托考昔片 | 3 | 1 | 8 |
| 3 | 富马酸喹硫平片 | 3 | 1 | 0 |
| 4 | 利丙双卡因乳膏 | 2 | 2 | 25 |
| 5 | 己酮可可碱注射液 | 2 | 2 | 3 |
| 6 | 氯化钾注射液 | 2 | 2 | 10 |
| 7 | 注射用氯诺昔康 | 2 | 2 | 2 |
| 8 | 盐酸莫西沙星片 | 2 | 2 | 11 |
| 9 | 腺苷钴胺胶囊 | 2 | 2 | 8 |
| 10 | 间苯三酚注射液 | 2 | 2 | 2 |
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
204 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 修正药业集团天汉药业有限公司 | 18 | 14 | 0 |
| 2 | 贵州瑞和制药有限公司 | 10 | 10 | 0 |
| 3 | 黑龙江宋慈制药有限责任公司 | 8 | 8 | 0 |
| 4 | Celgene Corporation | 6 | 1 | 0 |
| 5 | Pfizer Europe MA EEIG | 5 | 2 | 0 |
| 6 | AstraZeneca AB | 4 | 3 | 0 |
| 7 | Merck Sharp & Dohme LLC | 4 | 2 | 0 |
| 8 | 海南倍特药业有限公司 | 4 | 2 | 1 |
| 9 | 瑞阳制药股份有限公司 | 4 | 2 | 0 |
| 10 | Organon Pharma (UK) Limited | 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
94 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/09/04Generic · Class 3 | 己酮可可碱注射液CYHS2302369 | 山西惠达林曦医药科技有限公司; 山西威奇达光明制药有限公司 |
| 2023/09/02Generic · Class 3 | 氯化钾注射液CYHS2302366 | 海南欧若拉生物技术有限公司; 江苏大红鹰恒顺药业有限公司 |
| 2023/09/02Generic · Class 3 | 吲哚布芬片CYHS2302365 | 深圳市朗博生物医药股份有限公司; 亚宝药业太原制药有限公司 |
| 2023/09/02Generic · Class 3 | 吲哚布芬片CYHS2302364 | 深圳市朗博生物医药股份有限公司; 亚宝药业太原制药有限公司 |
| 2023/09/02Generic · Class 3 | 法莫替丁注射液CYHS2302358 | 云南药科院生物医药股份有限公司; 楚雄和创药业有限责任公司 |
| 2023/09/02Generic · Class 3 | 顺铂注射液CYHS2302357 | 吉斯美(武汉)制药有限公司 |
| 2023/09/02New drug · Class 2.1 | 清喉咽含片CXZS2300018 | 浙江康恩贝制药股份有限公司; 苏州吴淞江制药有限公司 |
| 2023/09/02New drug · Class 1.2 | 洋常春藤叶口服液CXZL2300058 | 浙江康恩贝中药有限公司 |
| 2023/09/02New drug · Class 1.2 | 洋常春藤叶提取物CXZL2300057 | 浙江康恩贝中药有限公司 |
| 2023/09/02New drug · Class 3.4 | 人凝血因子IXCXSL2300595 | 华兰生物工程股份有限公司 |
| 2023/09/02New drug · Class 2.2 | 大流行流感全病毒灭活疫苗(H5N1)CXSL2300594 | 武汉生物制品研究所有限责任公司; 兰州百灵生物技术有限公司 |
| 2023/09/02New drug · Class 3.4 | 人纤维蛋白原CXSL2300593 | 广东丹霞生物制药有限公司 |
| 2023/09/02New drug · Class 3.4 | 人纤维蛋白原CXSL2300592 | 广东丹霞生物制药有限公司 |
| 2023/09/02New drug · Class 1 | 177Lu-LNC1003 注射液CXHL2300945 | 烟台蓝纳成生物技术有限公司 |
| 2023/09/02New drug · Class 2.2 | 氢溴酸伏硫西汀口崩片CXHL2300944 | 深圳市泛谷药业股份有限公司 |
| 2023/09/02New drug · Class 2.2 | 氢溴酸伏硫西汀口崩片CXHL2300943 | 深圳市泛谷药业股份有限公司 |
| 2023/09/02New drug · Class 1 | YR001软膏CXHL2300942 | 杭州壹瑞医药科技有限公司 |
| 2023/09/02New drug · Class 1 | YR001软膏CXHL2300941 | 杭州壹瑞医药科技有限公司 |
| 2023/09/01Import · Class 1 | BI 765049 输注用粉末JXSL2300162 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/01Import · Class 1 | AUP1602-CJXSL2300161 | Aurealis Therapeutics AG; Shenzhen Xbiome Biotech Co. Ltd. |
| 2023/09/01Import · Class 2.2 | Anifrolumab注射液JXSL2300160 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2023/09/01Generic · Class 3 | 布美他尼注射液CYHS2302349 | 成都赛璟生物医药科技有限公司; 成都市海通药业有限公司 |
| 2023/09/01Generic · Class 3 | 氯化钾注射液CYHS2302346 | 广州合和医药有限公司; 广东星昊药业有限公司 |
| 2023/09/01Generic · Class 3 | 硫酸沙丁胺醇注射液CYHS2302342 | 华夏生生药业(北京)有限公司 |
| 2023/09/01Generic · Class 3 | 吸入用雷芬那辛溶液CYHL2300111 | 武汉人福利康药业有限公司 |
| 2023/09/01New drug · Class 1 | 注射用RC108CXSL2300591 | 荣昌生物制药(烟台)股份有限公司 |
| 2023/09/01New drug · Class 1 | HB0025注射液CXSL2300590 | 华博生物医药技术(上海)有限公司 |
| 2023/09/01New drug · Class 1 | HB0025注射液CXSL2300589 | 华博生物医药技术(上海)有限公司 |
| 2023/09/01New drug · Class 2.2 | 布地奈德福莫特罗吸入粉雾剂(胶囊型)CXHL2300939 | 珠海瑞思普利医药科技有限公司 |
| 2023/09/01New drug · Class 2.4 | 羟乙磺酸达尔西利片CXHL2300938 | 江苏恒瑞医药股份有限公司 |
64 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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