药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/04/04 – 2023/04/10
- New acceptances this week
- 291
- Drugs with new generic filings (by drug name, de-duplicated)
- 53
- 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
291filings, 76 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 171 |
| Generic | 76 |
| New drug | 31 |
| Import | 6 |
| Unspecified | 5 |
| 药械组合产品 | 1 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 219 |
| 治疗用生物制品 | 37 |
| TCM | 33 |
| 预防用生物制品 | 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
53 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 奥美沙坦酯氨氯地平氢氯噻嗪片 | 5 | 1 | 5 |
| 2 | 氧（液态） | 3 | 3 | 14 |
| 3 | 己酮可可碱注射液 | 2 | 2 | 3 |
| 4 | 磷酸奥司他韦干混悬剂 | 2 | 2 | 2 |
| 5 | 聚乙烯醇滴眼液 | 2 | 2 | 22 |
| 6 | 他达拉非片 | 2 | 1 | 23 |
| 7 | 依维莫司片 | 2 | 1 | 2 |
| 8 | 奥扎格雷钠注射液 | 2 | 1 | 3 |
| 9 | 左卡尼汀口服溶液 | 2 | 1 | 9 |
| 10 | 布洛芬注射液 | 2 | 1 | 4 |
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
172 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 武汉香草堂药业有限公司 | 9 | 9 | 0 |
| 2 | Luye Pharma Limited | 7 | 1 | 0 |
| 3 | 齐鲁制药有限公司 | 6 | 3 | 0 |
| 4 | 海南恒诚三叶制药有限公司 | 5 | 5 | 0 |
| 5 | 黑龙江华玺生物医药科技有限公司 | 5 | 5 | 0 |
| 6 | Organon Pharma (UK) Limited | 5 | 1 | 0 |
| 7 | 上海腾瑞制药股份有限公司 | 5 | 1 | 5 |
| 8 | 北京韩美药品有限公司 | 4 | 4 | 3 |
| 9 | 楚雄和创药业有限责任公司 | 4 | 3 | 0 |
| 10 | Actelion Pharmaceuticals Ltd | 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
75 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/04/10Generic · Class 3 | 布洛芬注射液CYHS2301016 | 山西德元堂药业有限公司 |
| 2023/04/10Generic · Class 3 | 布洛芬注射液CYHS2301015 | 山西德元堂药业有限公司 |
| 2023/04/10Generic · Class 3 | 依折麦布瑞舒伐他汀钙片（Ⅲ）CYHS2301014 | 北京韩美药品有限公司 |
| 2023/04/10Generic · Class 3 | 依折麦布瑞舒伐他汀钙片（Ⅱ）CYHS2301013 | 北京韩美药品有限公司 |
| 2023/04/10Generic · Class 3 | 依折麦布瑞舒伐他汀钙片（Ⅰ）CYHS2301012 | 北京韩美药品有限公司 |
| 2023/04/10Generic · Class 3 | 托拉塞米注射液CYHS2301009 | 海南斯达制药有限公司 |
| 2023/04/10Generic · Class 3 | 托拉塞米注射液CYHS2301008 | 海南斯达制药有限公司 |
| 2023/04/10Generic · Class 3 | 琥珀酸亚铁片CYHS2301006 | 北京福元医药股份有限公司 |
| 2023/04/10Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液CYHS2301005 | 合肥国药诺和药业有限公司; 江苏大红鹰恒顺药业有限公司 |
| 2023/04/10Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液CYHS2301004 | 合肥国药诺和药业有限公司; 江苏大红鹰恒顺药业有限公司 |
| 2023/04/10Generic · Class 3 | 黄体酮注射液CYHS2301003 | 华夏生生药业（北京）有限公司 |
| 2023/04/10Generic · Class 3 | 己酮可可碱注射液CYHS2301000 | 武汉海特生物制药股份有限公司 |
| 2023/04/10Generic · Class 3 | 地塞米松磷酸钠注射液CYHS2300998 | 汇禹远和（海南）药业有限公司; 津药和平(天津)制药有限公司 |
| 2023/04/10Generic · Class 3 | 奥美沙坦酯氨氯地平氢氯噻嗪片CYHL2300052 | 上海腾瑞制药股份有限公司 |
| 2023/04/10Generic · Class 3 | 奥美沙坦酯氨氯地平氢氯噻嗪片CYHL2300051 | 上海腾瑞制药股份有限公司 |
| 2023/04/10Generic · Class 3 | 奥美沙坦酯氨氯地平氢氯噻嗪片CYHL2300050 | 上海腾瑞制药股份有限公司 |
| 2023/04/10Generic · Class 3 | 奥美沙坦酯氨氯地平氢氯噻嗪片CYHL2300049 | 上海腾瑞制药股份有限公司 |
| 2023/04/10Generic · Class 3 | 奥美沙坦酯氨氯地平氢氯噻嗪片CYHL2300048 | 上海腾瑞制药股份有限公司 |
| 2023/04/10Generic · Class 3 | 前列地尔注射液CYHL2300047 | 石家庄四药有限公司 |
| 2023/04/10Generic · Class 3 | 盐酸考来维仑片CYHL2300046 | 浙江京新药业股份有限公司 |
| 2023/04/10Generic · Class 3 | 艾氟洛芬贴剂CYHL2300045 | 江苏恒瑞医药股份有限公司 |
| 2023/04/10New drug · Class 1 | XKH002注射液CXSL2300245 | 苏州鑫康合生物医药科技有限公司 |
| 2023/04/10New drug · Class 2.2 | 吸附无细胞百（五组分）白破联合疫苗（6岁及以上人群用）CXSL2300244 | 康希诺生物股份公司 |
| 2023/04/10New drug · Class 1 | ZS802注射液CXSL2300243 | 四川至善唯新生物科技有限公司 |
| 2023/04/10New drug · Class 1 | 抗CD30嵌合抗原受体自体T细胞注射液CXSL2300242 | 明慧（南京）基因生物技术有限公司 |
| 2023/04/10New drug · Class 1 | LP-005 注射液CXSL2300241 | 天辰生物医药（苏州）有限公司 |
| 2023/04/10New drug · Class 3.3 | 人生长激素注射液CXSL2300240 | 科兴生物制药股份有限公司 |
| 2023/04/10New drug · Class 1 | 注射用JS107CXSL2300239 | 上海君实生物医药科技股份有限公司 |
| 2023/04/10New drug · Class 1 | 注射用QLS32015CXSL2300238 | 齐鲁制药有限公司 |
| 2023/04/10New drug · Class 1 | LBL-007注射液CXSL2300235 | 广州百济神州生物制药有限公司 |
45 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.