药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/07/02 – 2024/07/08
- New acceptances this week
- 387
- Drugs with new generic filings (by drug name, de-duplicated)
- 78
- Accepted this week, now under review
- 5
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
387filings, 109 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 189 |
| Generic | 109 |
| New drug | 41 |
| Import | 25 |
| Import re-registration | 15 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 284 |
| 治疗用生物制品 | 48 |
| TCM | 47 |
| 预防用生物制品 | 8 |
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
78 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸达泊西汀片 | 5 | 3 | 20 |
| 2 | 依帕司他片 | 3 | 3 | 2 |
| 3 | 地夸磷索钠滴眼液 | 3 | 2 | 5 |
| 4 | 米诺地尔搽剂 | 3 | 2 | 49 |
| 5 | 地氯雷他定口服溶液 | 3 | 1 | 26 |
| 6 | 复合磷酸氢钾注射液 | 2 | 2 | 2 |
| 7 | 氢溴酸伏硫西汀片 | 2 | 2 | 8 |
| 8 | 盐酸尼卡地平注射液 | 2 | 2 | 12 |
| 9 | 维生素B12滴眼液 | 2 | 2 | 2 |
| 10 | 乙酰半胱氨酸颗粒 | 2 | 1 | 4 |
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
234 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 洛阳昊隆药业有限公司 | 17 | 8 | 0 |
| 2 | Janssen Research & Development LLC | 9 | 3 | 0 |
| 3 | 津药达仁堂集团股份有限公司达仁堂制药厂 | 6 | 4 | 0 |
| 4 | AstraZeneca AB | 6 | 3 | 0 |
| 5 | 湘北威尔曼制药股份有限公司 | 5 | 1 | 0 |
| 6 | 广西维威制药有限公司 | 4 | 3 | 3 |
| 7 | 浙江赛默制药有限公司 | 4 | 3 | 4 |
| 8 | Sanofi Winthrop Industrie | 4 | 2 | 0 |
| 9 | 北京四环科宝制药股份有限公司 | 4 | 2 | 4 |
| 10 | 成都第一制药有限公司 | 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
106 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/07/08Import · Class 1 | PF-06821497片JXHL2400166 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2024/07/08Import · Class 1 | PF-06821497片JXHL2400165 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2024/07/08Generic · Class 3 | 复合磷酸氢钾注射液CYHS2402065 | 石家庄迪斯凯威医药科技有限公司; 知和(山东)大药厂有限公司 |
| 2024/07/08Generic · Class 3 | 米诺地尔搽剂CYHS2402064 | 武汉华尔生物科技有限公司; 江西德成制药有限公司 |
| 2024/07/08Generic · Class 3 | 米诺地尔搽剂CYHS2402063 | 河北义海医药科技有限公司; 丽彩甘肃西峰制药有限公司 |
| 2024/07/08Generic · Class 3 | 米诺地尔搽剂CYHS2402062 | 河北义海医药科技有限公司; 丽彩甘肃西峰制药有限公司 |
| 2024/07/08Generic · Class 3 | 维生素B6注射液CYHS2402061 | 济川药业集团有限公司 |
| 2024/07/08Generic · Class 3 | 阿仑膦酸钠口服溶液CYHS2402058 | 湖南普道医药技术有限公司; 湖南九典制药股份有限公司 |
| 2024/07/08New drug · Class 1 | SCTB35注射液CXSL2400435 | 神州细胞工程有限公司 |
| 2024/07/08New drug · Class 3.2 | 皮下注射人免疫球蛋白CXSL2400434 | 四川远大蜀阳药业有限责任公司 |
| 2024/07/08New drug · Class 1 | TDI01混悬液CXHL2400663 | 北京泰德制药股份有限公司 |
| 2024/07/08New drug · Class 1 | HBW-004285片CXHL2400662 | 成都海博为药业有限公司 |
| 2024/07/08New drug · Class 1 | 注射用NC527-XCXHL2400661 | 浙江海擘生物科技有限公司 |
| 2024/07/06Import · Class 1 | Bleximenib片JXHL2400164 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/07/06Import · Class 1 | Bleximenib片JXHL2400163 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/07/06Import · Class 1 | Bleximenib片JXHL2400162 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/07/06Generic · Class 3 | 普瑞巴林口服溶液CYHS2402049 | 浙江赛默制药有限公司 |
| 2024/07/06Generic · Class 3 | 替比培南匹伏酯细粒剂CYHL2400135 | 石药集团中诺药业(石家庄)有限公司 |
| 2024/07/06Generic · Class 3 | 布洛芬盐酸去氧肾上腺素片CYHL2400134 | 北京阳光诺和药物研究股份有限公司 |
| 2024/07/06New drug · Class 1 | ZL-1218注射液CXSL2400433 | 再鼎医药(上海)有限公司 |
| 2024/07/06New drug · Class 3.3 | 注射用人生长激素CXSL2400432 | 长春生物制品研究所有限责任公司 |
| 2024/07/06New drug · Class 3.3 | 冻干人用狂犬病疫苗(人二倍体细胞)CXSL2400431 | 复星雅立峰(大连)生物制药有限公司 |
| 2024/07/06New drug · Class 2.2 | 三价流感病毒裂解疫苗(MDCK细胞)CXSL2400430 | 成都欧林生物科技股份有限公司; 兰州百灵生物技术有限公司; 成都新诺明生物科技有限公司 |
| 2024/07/06New drug · Class 1 | SDTM001注射液CXSL2400429 | 赛德特生物制药有限公司 |
| 2024/07/06New drug · Class 1 | DX1002片CXHL2400660 | 广州安好医药科技有限公司 |
| 2024/07/06New drug · Class 1 | DX1002片CXHL2400659 | 广州安好医药科技有限公司 |
| 2024/07/05Import · Class 2.4 | DS-3201b片JXHL2400161 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2024/07/05Import · Class 2.4 | DS-3201b片JXHL2400160 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2024/07/05Generic · Class 3 | 阿莫西林克拉维酸钾片(8:1)CYHS2402042 | 昆明源瑞制药有限公司 |
| 2024/07/05Generic · Class 3 | 琥珀酸亚铁片CYHS2402039 | 浙江华海药业股份有限公司 |
76 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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