药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/08/01 – 2023/08/07
- New acceptances this week
- 225
- Drugs with new generic filings (by drug name, de-duplicated)
- 29
- 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
225filings, 41 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 124 |
| Generic | 41 |
| New drug | 35 |
| Import | 15 |
| Unspecified | 5 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 131 |
| TCM | 67 |
| 治疗用生物制品 | 27 |
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
29 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 沙库巴曲缬沙坦钠片 | 3 | 1 | 68 |
| 2 | 磷酸西格列汀片 | 3 | 1 | 2 |
| 3 | 哌柏西利片 | 2 | 1 | 2 |
| 4 | 复方电解质注射液（Ⅱ） | 2 | 1 | 1 |
| 5 | 注射用头孢唑肟钠 | 2 | 1 | 4 |
| 6 | 注射用盐酸苯达莫司汀 | 2 | 1 | 2 |
| 7 | 甲硫酸新斯的明注射液 | 2 | 1 | 4 |
| 8 | 盐酸他喷他多缓释片 | 2 | 1 | 0 |
| 9 | 米诺地尔搽剂 | 2 | 1 | 49 |
| 10 | 非那雄胺片 | 2 | 1 | 3 |
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
110 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 沈阳清宫药业集团有限公司 | 29 | 29 | 0 |
| 2 | 湖北潜江制药股份有限公司 | 11 | 10 | 0 |
| 3 | 湖北人福成田药业有限公司 | 9 | 1 | 0 |
| 4 | 修正药业集团天汉药业有限公司 | 8 | 7 | 0 |
| 5 | 西安京西双鹤药业有限公司 | 7 | 1 | 0 |
| 6 | 华润三九医药股份有限公司 | 6 | 3 | 0 |
| 7 | 上海信谊万象药业股份有限公司 | 4 | 4 | 0 |
| 8 | 四川合纵泽辉医药科技有限公司 | 4 | 4 | 0 |
| 9 | Zydus Lifesciences Limited | 4 | 2 | 0 |
| 10 | 绿叶嘉奥制药石家庄有限公司 | 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
58 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/08/02Import · Class 3.1 | Brolucizumab注射液JXSS2300068 | Novartis Europharm Ltd.; Alcon-Couvreur N.V.; Beijing Novartis Pharma Co. Ltd. |
| 2023/08/02Import · Class 3.1 | Brolucizumab注射液JXSS2300067 | Novartis Europharm Ltd.; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd. |
| 2023/08/02Import · Class 2.2 | DS-8201aJXSL2300149 | Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited |
| 2023/08/02Import · Class 2.4 | Ritlecitinib胶囊JXHL2300182 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2023/08/02Import · Class 2.4 | Ritlecitinib胶囊JXHL2300181 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2023/08/02Generic · Class 3 | 吸入用盐酸丙卡特罗溶液CYHS2302067 | 深圳大佛药业股份有限公司; 浙江赛默制药有限公司 |
| 2023/08/02Generic · Class 3 | 依巴斯汀口服溶液CYHS2302066 | 海南元盈医药科技有限公司; 成都硕德药业有限公司 |
| 2023/08/02Generic · Class 3 | 米诺地尔搽剂CYHS2302063 | 广东泉新泉益药业有限公司; 浙江赛默制药有限公司 |
| 2023/08/02Generic · Class 3 | 米诺地尔搽剂CYHS2302062 | 广东泉新泉益药业有限公司; 浙江赛默制药有限公司 |
| 2023/08/02Generic · Class 3 | 盐酸他喷他多缓释片CYHL2300096 | 江苏恩华药业股份有限公司 |
| 2023/08/02Generic · Class 3 | 盐酸他喷他多缓释片CYHL2300095 | 江苏恩华药业股份有限公司 |
| 2023/08/02New drug · Class 1 | 悬铃木花粉点刺液CXSS2300064 | 浙江我武生物科技股份有限公司 |
| 2023/08/02New drug · Class 1 | 猫毛皮屑点刺液CXSS2300063 | 浙江我武生物科技股份有限公司 |
| 2023/08/02New drug · Class 1 | 德国小蠊点刺液CXSS2300062 | 浙江我武生物科技股份有限公司 |
| 2023/08/02New drug · Class 1 | 全人源抗破伤风毒素单克隆抗体A82/B86注射液组合制剂CXSL2300536 | 长春百克生物科技股份公司 |
| 2023/08/02New drug · Class 1 | 靶向CD19和CD22的嵌合抗原受体自体T细胞注射液CXSL2300535 | 上海医药集团生物治疗技术有限公司 |
| 2023/08/02New drug · Class 2.1 | 替雷利珠单抗注射液（皮下注射）CXSL2300534 | 广州百济神州生物制药有限公司 |
| 2023/08/02New drug · Class 1 | HB0017注射液CXSL2300533 | 华博生物医药技术（上海）有限公司 |
| 2023/08/02New drug · Class 2.4 | 罗沙司他胶囊CXHS2300068 | 珐博进（中国）医药技术开发有限公司 |
| 2023/08/02New drug · Class 2.4 | 罗沙司他胶囊CXHS2300067 | 珐博进（中国）医药技术开发有限公司 |
| 2023/08/02New drug · Class 1 | 磷酸安泰他韦胶囊CXHS2300066 | 广东东阳光药业股份有限公司; 宜昌东阳光长江药业股份有限公司 |
| 2023/08/02New drug · Class 2.2 | 注射用罗替高汀缓释微球CXHS2300065 | 绿叶嘉奥制药石家庄有限公司; 山东绿叶制药有限公司 |
| 2023/08/02New drug · Class 2.2 | 注射用罗替高汀缓释微球CXHS2300064 | 绿叶嘉奥制药石家庄有限公司; 山东绿叶制药有限公司 |
| 2023/08/02New drug · Class 2.2 | 注射用罗替高汀缓释微球CXHS2300063 | 绿叶嘉奥制药石家庄有限公司; 山东绿叶制药有限公司 |
| 2023/08/02New drug · Class 2.2 | 注射用罗替高汀缓释微球CXHS2300062 | 绿叶嘉奥制药石家庄有限公司; 山东绿叶制药有限公司 |
| 2023/08/02New drug · Class 1 | LT-002-158片CXHL2300853 | 上海领泰生物医药科技有限公司 |
| 2023/08/02New drug · Class 1 | LT-002-158片CXHL2300852 | 上海领泰生物医药科技有限公司 |
| 2023/08/02New drug · Class 1 | 盐酸钩吻素子片CXHL2300851 | 福建医科大学 |
| 2023/08/02New drug · Class 1 | 盐酸钩吻素子片CXHL2300850 | 福建医科大学 |
| 2023/08/01Import · Class 1 | 注射用佐妥昔单抗JXSS2300066 | Astellas Pharma Europe B.V.; Baxter Oncology GmbH; Astellas (China) Investment Co. Ltd. |
28 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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