药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/04/25 – 2023/05/01
- New acceptances this week
- 367
- Drugs with new generic filings (by drug name, de-duplicated)
- 41
- 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
367filings, 61 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 203 |
| Generic | 61 |
| New drug | 55 |
| Import | 29 |
| Import re-registration | 12 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 242 |
| TCM | 66 |
| 治疗用生物制品 | 53 |
| 预防用生物制品 | 4 |
| Biologic | 2 |
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
41 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 碘克沙醇注射液 | 8 | 1 | 0 |
| 2 | 盐酸度洛西汀肠溶胶囊 | 3 | 1 | 5 |
| 3 | 硫酸特布他林雾化吸入用溶液 | 2 | 2 | 1 |
| 4 | 吸入用异丙托溴铵溶液 | 2 | 1 | 2 |
| 5 | 异氟烷 | 2 | 1 | 0 |
| 6 | 托吡司特片 | 2 | 1 | 0 |
| 7 | 曲氟尿苷替匹嘧啶片 | 2 | 1 | 0 |
| 8 | 氢化可的松缓释片 | 2 | 1 | 0 |
| 9 | 盐酸丙卡特罗口服溶液 | 2 | 1 | 12 |
| 10 | 苯磺酸左氨氯地平片 | 2 | 1 | 47 |
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
189 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 中嘉生物科技(湖北省)有限公司 | 30 | 17 | 0 |
| 2 | 安徽贤桂医药科技有限公司 | 14 | 14 | 0 |
| 3 | 四川核力欣健药业有限公司 | 14 | 10 | 0 |
| 4 | 重庆迪康中药制药有限公司 | 10 | 9 | 0 |
| 5 | 通用电气药业(上海)有限公司 | 8 | 1 | 8 |
| 6 | 国信(黑龙江)制药有限公司 | 7 | 7 | 0 |
| 7 | 长沙爱贝高药业有限公司 | 7 | 7 | 0 |
| 8 | Roche Pharma (Schweiz) AG | 6 | 2 | 0 |
| 9 | Merck Sharp & Dohme LLC | 5 | 2 | 0 |
| 10 | 正大天晴药业集团股份有限公司 | 5 | 2 | 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
96 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/04/29Import · Class 1 | MK-6024注射液JXSL2300085 | Merck Sharp & Dohme LLC; MSD R&D(China)Co. Ltd. |
| 2023/04/29Import · Class 1 | MK-6024注射液JXSL2300084 | Merck Sharp & Dohme LLC; MSD R&D(China)Co. Ltd. |
| 2023/04/29Import · Class 1 | MK-6024注射液JXSL2300083 | Merck Sharp & Dohme LLC; MSD R&D(China)Co. Ltd. |
| 2023/04/29Import · Class 1 | MK-6024注射液JXSL2300082 | Merck Sharp & Dohme LLC; MSD R&D(China)Co. Ltd. |
| 2023/04/29Import · Class 1 | BBP-398胶囊JXHL2300102 | LianBio Development (HK) Limited; Shanghai LianBio Development Co. Ltd. |
| 2023/04/29Import · Class 1 | BBP-398胶囊JXHL2300101 | LianBio Development (HK) Limited; Shanghai LianBio Development Co. Ltd. |
| 2023/04/29Import · Class 1 | AMG 890JXHL2300100 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd. |
| 2023/04/29Generic · Class 3 | 氨溴特罗口服溶液CYHS2301203 | 海南全星制药有限公司 |
| 2023/04/29Generic · Class 3 | 头孢丙烯干混悬剂CYHS2301198 | 广东恒健制药有限公司 |
| 2023/04/29Generic · Class 3 | 己酮可可碱注射液CYHS2301197 | 华夏生生药业(北京)有限公司 |
| 2023/04/29Generic · Class 3 | 盐酸甲哌卡因注射液CYHS2301195 | 济南辰欣医药科技有限公司; 辰欣药业股份有限公司 |
| 2023/04/29New drug · Class 3.3 | 水痘减毒活疫苗CXSL2300299 | 中逸安科生物技术股份有限公司; 辽宁茂康源生物科技有限公司 |
| 2023/04/29New drug · Class 1 | 重组抗PEAR1人源化单克隆抗体雾化吸入溶液CXSL2300298 | 上海循曜生物科技有限公司 |
| 2023/04/29New drug · Class 2.4 | 注射用左亚叶酸CXHL2300453 | 上海汇伦医药股份有限公司 |
| 2023/04/29New drug · Class 2.4 | 注射用左亚叶酸CXHL2300452 | 上海汇伦医药股份有限公司 |
| 2023/04/29New drug · Class 1 | PG-011凝胶CXHL2300451 | 北京普祺医药科技股份有限公司 |
| 2023/04/29New drug · Class 1 | PG-011凝胶CXHL2300450 | 北京普祺医药科技股份有限公司 |
| 2023/04/29New drug · Class 1 | BPYT-01胶囊CXHL2300449 | 百极优棠(广东)医药科技有限公司 |
| 2023/04/29New drug · Class 1 | TQB3454片CXHL2300448 | 正大天晴药业集团股份有限公司 |
| 2023/04/29New drug · Class 1 | BPYT-01胶囊CXHL2300447 | 百极优棠(广东)医药科技有限公司 |
| 2023/04/29New drug · Class 1 | TQB3454片CXHL2300446 | 正大天晴药业集团股份有限公司 |
| 2023/04/28Import · Class 2.2 | TV-44749JXHL2300099 | Teva Branded Pharmaceutical Products R&D Inc. |
| 2023/04/28Generic · Class 3 | 氢化可的松缓释片CYHL2300068 | 津药药业股份有限公司 |
| 2023/04/28Generic · Class 3 | 氢化可的松缓释片CYHL2300067 | 津药药业股份有限公司 |
| 2023/04/28New drug · Class 3.1 | 芍药甘草颗粒CXZS2300010 | 神威药业集团有限公司 |
| 2023/04/28New drug · Class 1 | SNP201注射液CXSL2300297 | 赛神(上海)医药科技有限公司 |
| 2023/04/28New drug · Class 2.2 | 注射用重组改构人肿瘤坏死因子CXSL2300296 | 上海唯科生物制药有限公司 |
| 2023/04/28New drug · Class 1 | JY016注射液CXSL2300295 | 北京东方百泰生物科技股份有限公司; 北京精益泰翔技术发展有限公司 |
| 2023/04/28New drug · Class 1 | VGM-R02bCXSL2300294 | 上海天泽云泰生物医药有限公司 |
| 2023/04/28New drug · Class 1 | QB0208-1胶囊CXHL2300445 | 北京清博汇能医药科技有限公司 |
66 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.