药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/07/23 – 2024/07/29
- New acceptances this week
- 348
- Drugs with new generic filings (by drug name, de-duplicated)
- 64
- Accepted this week, now under review
- 4
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, 93 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 161 |
| Generic | 93 |
| New drug | 56 |
| Unspecified | 22 |
| Import | 10 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 241 |
| TCM | 55 |
| 治疗用生物制品 | 38 |
| Biologic | 10 |
| 预防用生物制品 | 4 |
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
64 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 布瑞哌唑片 | 8 | 3 | 31 |
| 2 | 氟马西尼注射液 | 3 | 1 | 2 |
| 3 | 地氯雷他定口服溶液 | 2 | 2 | 26 |
| 4 | 普拉洛芬滴眼液 | 2 | 2 | 7 |
| 5 | 注射用硫酸艾沙康唑 | 2 | 2 | 15 |
| 6 | 盐酸鲁拉西酮片 | 2 | 2 | 2 |
| 7 | 维生素B6注射液 | 2 | 2 | 13 |
| 8 | 达格列净片 | 2 | 2 | 82 |
| 9 | 吸入用盐酸溴己新溶液 | 2 | 1 | 1 |
| 10 | 复方电解质醋酸钠葡萄糖注射液 | 2 | 1 | 22 |
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
216 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 11 | 7 | 0 |
| 2 | 杭州高光制药有限公司 | 9 | 1 | 0 |
| 3 | 福州海王金象中药制药有限公司 | 6 | 6 | 0 |
| 4 | 山东绿叶制药有限公司 | 6 | 1 | 0 |
| 5 | Pfizer Inc. | 5 | 2 | 0 |
| 6 | 山东如至生物医药科技有限公司 | 4 | 4 | 4 |
| 7 | 青海鲁抗大地药业有限公司 | 4 | 4 | 0 |
| 8 | AstraZeneca AB | 4 | 3 | 0 |
| 9 | Baxter Deutschland GmbH | 4 | 3 | 0 |
| 10 | 北京泰德制药股份有限公司 | 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
95 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/07/29New drug · Class 1.4 | 流感病毒亚单位疫苗(佐剂)CXSL2400493 | 江苏中慧元通生物科技股份有限公司; 易慧生物技术(上海)有限公司 |
| 2024/07/29New drug · Class 1 | NK510细胞注射液CXSL2400492 | 上海贝斯昂科生物科技有限公司; 珠海贝斯昂科科技有限责任公司 |
| 2024/07/27Import · Class 2.2 | 阿替利珠单抗注射液(皮下注射)JXSS2400064 | Roche Registration GmbH; Roche Diagnostics GmbH; Roche (China) Holding Ltd. |
| 2024/07/27Import · Class 3.1 | 阿替利珠单抗注射液(皮下注射)JXSS2400063 | Roche Registration GmbH; Roche Diagnostics GmbH; Roche (China) Holding Ltd. |
| 2024/07/27Generic · Class 3 | 盐酸曲唑酮片CYHS2402382 | 浙江诺得药业有限公司 |
| 2024/07/27Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液CYHS2402380 | 江苏正大丰海制药有限公司 |
| 2024/07/27Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液CYHS2402378 | 江苏正大丰海制药有限公司 |
| 2024/07/27Generic · Class 3 | 依帕司他片CYHS2402372 | 宁夏康亚药业股份有限公司 |
| 2024/07/27New drug · Class 1.2 | ZY13提取物CXZL2400043 | 浙江康恩贝制药股份有限公司 |
| 2024/07/27New drug · Class 1.2 | ZY13片CXZL2400042 | 浙江康恩贝制药股份有限公司 |
| 2024/07/27New drug · Class 1.1 | 通塞颗粒CXZL2400041 | 河南中医药大学 |
| 2024/07/27New drug · Class 2.2 | 依沃西单抗注射液CXSS2400080 | 康方赛诺医药有限公司; 康方药业有限公司 |
| 2024/07/27New drug · Class 1 | 注射用SHR-9839CXSL2400491 | 上海恒瑞医药有限公司 |
| 2024/07/27New drug · Class 1 | 注射用SHR-1826CXSL2400490 | 苏州盛迪亚生物医药有限公司 |
| 2024/07/27New drug · Class 2.2 | SHR-8068注射液CXSL2400489 | 苏州盛迪亚生物医药有限公司 |
| 2024/07/27New drug · Class 2.2 | 贝伐珠单抗注射液CXSL2400488 | 苏州盛迪亚生物医药有限公司 |
| 2024/07/27New drug · Class 2.2 | 阿得贝利单抗注射液CXSL2400487 | 上海盛迪医药有限公司 |
| 2024/07/27New drug · Class 1 | SHR-6934注射液CXSL2400486 | 北京盛迪医药有限公司; 北京拓界生物医药科技有限公司; 上海迈晋生物医药科技有限公司 |
| 2024/07/27New drug · Class 1.3 | 四价流感病毒裂解疫苗(ZFA02佐剂)CXSL2400485 | 安徽智飞龙科马生物制药有限公司 |
| 2024/07/27New drug · Class 1 | 注射用重组人源化抗BCMA/CD3双特异性抗体CXSL2400484 | 山东新时代药业有限公司 |
| 2024/07/27New drug · Class 1 | 注射用AK138D1CXSL2400483 | 中山康方生物医药有限公司 |
| 2024/07/27New drug · Class 1 | POV-601-1A1溶瘤病毒注射液CXSL2400482 | 苏州般若生物科技有限公司 |
| 2024/07/27New drug · Class 2.2 | 棕榈酸帕利哌酮注射液(II)CXHS2400066 | 山东绿叶制药有限公司 |
| 2024/07/27New drug · Class 2.2 | 棕榈酸帕利哌酮注射液(II)CXHS2400065 | 山东绿叶制药有限公司 |
| 2024/07/27New drug · Class 2.2 | 棕榈酸帕利哌酮注射液(II)CXHS2400064 | 山东绿叶制药有限公司 |
| 2024/07/27New drug · Class 2.2 | 棕榈酸帕利哌酮注射液(II)CXHS2400063 | 山东绿叶制药有限公司 |
| 2024/07/27New drug · Class 2.2 | 棕榈酸帕利哌酮注射液(II)CXHS2400062 | 山东绿叶制药有限公司 |
| 2024/07/27New drug · Class 2.2 | 棕榈酸帕利哌酮注射液(II)CXHS2400061 | 山东绿叶制药有限公司 |
| 2024/07/27New drug · Class 1 | GTA182片CXHL2400763 | 上海湃隆生物科技有限公司 |
| 2024/07/27New drug · Class 1 | GTA182片CXHL2400762 | 上海湃隆生物科技有限公司 |
65 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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