药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/02/07 – 2023/02/13
- New acceptances this week
- 446
- Drugs with new generic filings (by drug name, de-duplicated)
- 90
- Accepted this week, now under review
- 1
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
446filings, 129 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 185 |
| Generic | 129 |
| New drug | 83 |
| Import | 23 |
| Unspecified | 15 |
| Import re-registration | 11 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 334 |
| 治疗用生物制品 | 55 |
| TCM | 52 |
| 预防用生物制品 | 5 |
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
90 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 氯化钾颗粒 | 5 | 4 | 4 |
| 2 | 钆特酸葡胺注射液 | 5 | 1 | 1 |
| 3 | 盐酸乌拉地尔注射液 | 4 | 2 | 5 |
| 4 | 羟考酮纳洛酮缓释片 | 4 | 1 | 3 |
| 5 | 氨溴特罗口服溶液 | 3 | 2 | 23 |
| 6 | 沙美特罗替卡松吸入粉雾剂 | 3 | 1 | 12 |
| 7 | 注射用哌拉西林钠他唑巴坦钠 | 3 | 1 | 5 |
| 8 | 磷酸西格列汀片 | 3 | 1 | 2 |
| 9 | 他达拉非片 | 2 | 2 | 23 |
| 10 | 地夸磷索钠滴眼液 | 2 | 2 | 5 |
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
267 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 云南神威施普瑞药业有限公司 | 15 | 15 | 0 |
| 2 | 海南普利制药股份有限公司 | 7 | 2 | 5 |
| 3 | 润缘制药有限公司 | 6 | 6 | 0 |
| 4 | 鲁南厚普制药有限公司 | 6 | 5 | 0 |
| 5 | 广西裕源药业有限公司 | 5 | 4 | 0 |
| 6 | 正大天晴药业集团股份有限公司 | 5 | 4 | 0 |
| 7 | 宜昌人福药业有限责任公司 | 5 | 3 | 2 |
| 8 | 山东新时代药业有限公司 | 5 | 3 | 5 |
| 9 | Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A | 5 | 1 | 0 |
| 10 | 芜湖道润药业有限责任公司 | 4 | 4 | 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
130 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/02/13New drug · Class 1 | CM326注射液CXSL2300122 | 康诺亚生物医药科技（成都）有限公司 |
| 2023/02/13New drug · Class 1 | CM326注射液CXSL2300121 | 康诺亚生物医药科技（成都）有限公司 |
| 2023/02/13New drug · Class 2.2 | 塞来昔布胶囊（Ⅰ）CXHL2300211 | 上海上药创新医药技术有限公司 |
| 2023/02/13New drug · Class 1 | Y-1注射液CXHL2300210 | 南京宁丹新药技术有限公司 |
| 2023/02/13New drug · Class 1 | EOC237胶囊CXHL2300209 | 上海亿腾景昂生物医药科技有限公司 |
| 2023/02/13New drug · Class 1 | EOC237胶囊CXHL2300208 | 上海亿腾景昂生物医药科技有限公司 |
| 2023/02/11Import · Class 2.2;2.4 | LYR-210系统JXHL2300022 | LianBio Development (HK) Limited; Shanghai LianBio Development Co. Ltd. |
| 2023/02/11Generic · Class 3 | 盐酸溴己新口服溶液CYHS2300482 | 浙江寰领医药科技有限公司; 浙江康恩贝制药股份有限公司 |
| 2023/02/11Generic · Class 3 | 复方电解质醋酸钠注射液CYHS2300481 | 仁合益康集团有限公司; 河北仁合益康药业有限公司 |
| 2023/02/11Generic · Class 3 | 注射用氨磷汀CYHS2300477 | 四川汇宇海玥医药科技有限公司; 四川汇宇制药股份有限公司 |
| 2023/02/11Generic · Class 3 | 福多司坦口服溶液CYHS2300476 | 北京民康百草医药科技有限公司; 天大药业（珠海）有限公司 |
| 2023/02/11Generic · Class 3 | 氯化钾颗粒CYHS2300473 | 北京柏雅联合药物研究所有限公司; 湖南九典制药股份有限公司 |
| 2023/02/11Generic · Class 3 | 氨溴特罗口服溶液CYHS2300461 | 遂成药业股份有限公司 |
| 2023/02/11Generic · Class 3 | 依帕司他片CYHS2300456 | 北京双鹭药业股份有限公司 |
| 2023/02/11Generic · Class 3 | 利多卡因凝胶贴膏CYHS2300452 | 海南回元堂药业有限公司 |
| 2023/02/11Generic · Class 3 | 米诺地尔外用溶液CYHS2300446 | 杭州康恩贝制药有限公司; 云南康恩贝希陶药业有限公司 |
| 2023/02/11Generic · Class 3 | 米诺地尔外用溶液CYHS2300445 | 杭州康恩贝制药有限公司; 云南康恩贝希陶药业有限公司 |
| 2023/02/11Generic · Class 3 | 丙酸氟替卡松乳膏CYHS2300444 | 福元药业有限公司 |
| 2023/02/11Generic · Class 3 | 复方醋酸钠林格注射液CYHS2300437 | 西藏多瑞医药股份有限公司; 湖北多瑞药业有限公司 |
| 2023/02/11Generic · Class 3 | 复方醋酸钠林格注射液CYHS2300436 | 西藏多瑞医药股份有限公司; 湖北多瑞药业有限公司 |
| 2023/02/11Generic · Class 3 | 地氯雷他定口服溶液CYHS2300435 | 深圳市贝美药业有限公司; 华益药业科技（安徽）有限公司 |
| 2023/02/11Generic · Class 3 | 西洛他唑片CYHS2300434 | 杭州沐源生物医药科技有限公司; 华益药业科技（安徽）有限公司 |
| 2023/02/11Generic · Class 3 | 二羟丙茶碱注射液CYHS2300433 | 杭州沐源生物医药科技有限公司; 新乡市常乐制药有限责任公司 |
| 2023/02/11Generic · Class 3 | 氟[18F]妥西吡注射液CYHL2300018 | 北京欣翮医药科技有限公司 |
| 2023/02/11New drug · Class 3.1 | 苓桂术甘汤颗粒CXZS2300006 | 浙江康恩贝制药股份有限公司 |
| 2023/02/11New drug · Class 1.1 | 消风宣窍颗粒CXZL2300010 | 苏中药业集团股份有限公司 |
| 2023/02/11New drug · Class 2.2 | 信迪利单抗注射液CXSL2300120 | 信达生物制药（苏州）有限公司 |
| 2023/02/11New drug · Class 1 | 注射用BL-M11D1CXSL2300119 | 成都百利多特生物药业有限责任公司; 四川百利药业有限责任公司 |
| 2023/02/11New drug · Class 1 | 注射用ZGGS15CXSL2300118 | 苏州泽璟生物制药股份有限公司 |
| 2023/02/11New drug · Class 1 | NM1F注射液CXSL2300117 | 合肥天港免疫药物有限公司 |
100 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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