药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/04/09 – 2024/04/15
- New acceptances this week
- 316
- Drugs with new generic filings (by drug name, de-duplicated)
- 69
- 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
316filings, 89 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 136 |
| Generic | 89 |
| New drug | 56 |
| Import | 17 |
| Import re-registration | 11 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 227 |
| TCM | 44 |
| 治疗用生物制品 | 34 |
| 预防用生物制品 | 6 |
| Biologic | 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
69 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 硫酸镁钠钾口服用浓溶液 | 4 | 4 | 8 |
| 2 | 利丙双卡因乳膏 | 2 | 2 | 25 |
| 3 | 左氧氟沙星片 | 2 | 2 | 8 |
| 4 | 氟比洛芬凝胶贴膏 | 2 | 2 | 16 |
| 5 | 注射用硫酸艾沙康唑 | 2 | 2 | 15 |
| 6 | 米拉贝隆缓释片 | 2 | 2 | 1 |
| 7 | 利培酮口崩片 | 2 | 1 | 0 |
| 8 | 复方电解质注射液（Ⅱ） | 2 | 1 | 1 |
| 9 | 复方聚乙二醇（3350）电解质散 | 2 | 1 | 5 |
| 10 | 头孢托仑匹酯颗粒 | 2 | 1 | 18 |
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
199 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 江苏豪森药业集团有限公司 | 8 | 1 | 0 |
| 2 | Boehringer Ingelheim International GmbH | 5 | 2 | 0 |
| 3 | 成都倍特得诺药业有限公司 | 4 | 4 | 0 |
| 4 | 昆明中药厂有限公司 | 4 | 3 | 0 |
| 5 | 漳州片仔癀药业股份有限公司 | 4 | 3 | 0 |
| 6 | 北京星昊医药股份有限公司 | 4 | 2 | 2 |
| 7 | 广西裕源药业有限公司 | 4 | 2 | 0 |
| 8 | 舒泰神（北京）生物制药股份有限公司 | 4 | 2 | 0 |
| 9 | Seagen Inc. | 4 | 1 | 0 |
| 10 | 浙江文达医药科技有限公司 | 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
94 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/04/13Generic · Class 3 | 硝普钠注射液CYHS2401109 | 湖南恒生制药股份有限公司 |
| 2024/04/13Generic · Class 3 | 西咪替丁注射液CYHS2401106 | 石家庄迪斯凯威医药科技有限公司; 山东威智百科药业有限公司 |
| 2024/04/13Generic · Class 3 | 氟轻松氢醌维A酸乳膏CYHL2400075 | 杭州中美华东制药有限公司 |
| 2024/04/13Generic · Class 3 | 甘露醇山梨醇注射液CYHL2400074 | 南京恩泰医药科技有限公司 |
| 2024/04/13New drug · Class 1 | T3011疱疹病毒注射液CXSL2400230 | 苏州亦诺微医药科技有限公司 |
| 2024/04/13New drug · Class 1 | T3011疱疹病毒注射液CXSL2400229 | 苏州亦诺微医药科技有限公司 |
| 2024/04/13New drug · Class 1 | SGB-9768注射液CXHL2400373 | 苏州圣因生物医药有限公司 |
| 2024/04/13New drug · Class 1 | PZH2113 胶囊CXHL2400372 | 漳州片仔癀药业股份有限公司 |
| 2024/04/13New drug · Class 1 | PZH2113 胶囊CXHL2400371 | 漳州片仔癀药业股份有限公司 |
| 2024/04/13New drug · Class 1 | JNJ-88998377口服片CXHL2400370 | 强生（中国）投资有限公司 |
| 2024/04/13New drug · Class 1 | JNJ-88998377口服片CXHL2400369 | 强生（中国）投资有限公司 |
| 2024/04/13New drug · Class 1 | JNJ-88998377口服片CXHL2400368 | 强生（中国）投资有限公司 |
| 2024/04/13New drug · Class 2.2 | LN2227CXHL2400367 | 山东新时代药业有限公司 |
| 2024/04/13New drug · Class 1 | NS-136片CXHL2400366 | 纽欧申医药（上海）有限公司 |
| 2024/04/13New drug · Class 1 | NS-136片CXHL2400365 | 纽欧申医药（上海）有限公司 |
| 2024/04/12Import · Class 3.1 | 注射用罗特西普JXSS2400036 | Celgene Corporation a Bristol-Myers Squibb Company; Patheon Italia S.p.A.; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2024/04/12Import · Class 3.1 | 注射用罗特西普JXSS2400035 | Celgene Corporation a Bristol-Myers Squibb Company; Patheon Italia S.p.A.; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2024/04/12Generic · Class 3 | 水合氯醛灌肠剂CYHS2401094 | 宏越科技（湖州）有限公司; 浙江康恩贝制药股份有限公司 |
| 2024/04/12Generic · Class 3 | 依巴斯汀口服溶液CYHS2401093 | 合肥国药诺和药业有限公司; 华益药业科技(安徽)有限公司 |
| 2024/04/12Generic · Class 3 | 左氧氟沙星注射液CYHS2401087 | 陕西博森生物制药股份集团有限公司 |
| 2024/04/12New drug · Class 3.3 | Sabin株脊髓灰质炎灭活疫苗（Vero细胞）CXSS2400041 | 北京民海生物科技有限公司 |
| 2024/04/12New drug · Class 1.3 | 重组呼吸道合胞病毒疫苗（CHO细胞）CXSL2400228 | 成都华任康生物科技有限公司; 上海迈科康生物科技有限公司 |
| 2024/04/12New drug · Class 1 | STSP-0902注射液CXSL2400227 | 舒泰神（北京）生物制药股份有限公司 |
| 2024/04/12New drug · Class 1 | STSP-0902滴眼液CXSL2400226 | 舒泰神（北京）生物制药股份有限公司 |
| 2024/04/12New drug · Class 1 | STSP-0902滴眼液CXSL2400225 | 舒泰神（北京）生物制药股份有限公司 |
| 2024/04/12New drug · Class 1 | STSP-0902滴眼液CXSL2400224 | 舒泰神（北京）生物制药股份有限公司 |
| 2024/04/12New drug · Class 1 | GH21胶囊CXHL2400364 | 勤浩医药（苏州）有限公司 |
| 2024/04/12New drug · Class 1 | GH21胶囊CXHL2400363 | 勤浩医药（苏州）有限公司 |
| 2024/04/12New drug · Class 1 | D-1553片CXHL2400362 | 上海正大天晴医药科技开发有限公司 |
| 2024/04/12New drug · Class 1 | WD-890片CXHL2400361 | 浙江文达医药科技有限公司 |
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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.