药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/09/12 – 2023/09/18
- New acceptances this week
- 371
- Drugs with new generic filings (by drug name, de-duplicated)
- 45
- 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
371filings, 62 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 196 |
| New drug | 65 |
| Generic | 62 |
| Import | 25 |
| Unspecified | 14 |
| Import re-registration | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 258 |
| TCM | 62 |
| 治疗用生物制品 | 44 |
| 预防用生物制品 | 7 |
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
45 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 法莫替丁注射液 | 4 | 2 | 8 |
| 2 | 氨溴特罗口服溶液 | 3 | 3 | 23 |
| 3 | 氢溴酸伏硫西汀片 | 3 | 2 | 8 |
| 4 | 利伐沙班颗粒 | 2 | 1 | 2 |
| 5 | 奥美拉唑碳酸氢钠胶囊 | 2 | 1 | 0 |
| 6 | 普瑞巴林口服溶液 | 2 | 1 | 5 |
| 7 | 沙库巴曲缬沙坦钠片 | 2 | 1 | 68 |
| 8 | 注射用苯唑西林钠 | 2 | 1 | 13 |
| 9 | 洛索洛芬钠贴剂 | 2 | 1 | 30 |
| 10 | 溴芬酸钠滴眼液 | 2 | 1 | 7 |
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
192 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Boehringer Ingelheim International GmbH | 17 | 1 | 0 |
| 2 | 江西人可医药科技有限公司 | 14 | 10 | 2 |
| 3 | 河南越人药业有限公司 | 12 | 12 | 0 |
| 4 | 河南双鹤华利药业有限公司 | 12 | 3 | 0 |
| 5 | Bard Pharmaceuticals Limited | 9 | 9 | 0 |
| 6 | 西安京西双鹤药业有限公司 | 9 | 2 | 0 |
| 7 | 上海百特医疗用品有限公司 | 6 | 1 | 0 |
| 8 | 广东心宝药业科技有限公司 | 5 | 5 | 0 |
| 9 | 河北万邦复临药业有限公司 | 5 | 5 | 0 |
| 10 | 北京智飞绿竹生物制药有限公司 | 5 | 3 | 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
117 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/09/18Import · Class 1 | BI 456906 注射液JXHL2300231 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/18Import · Class 1 | BI 456906 注射液JXHL2300230 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/18Import · Class 1 | BI 456906 注射液JXHL2300229 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/18Import · Class 1 | LOXO-435片JXHL2300228 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/09/18Import · Class 1 | LOXO-435片JXHL2300227 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/09/17New drug · Class 1 | 艾帕洛利单抗注射液CXSS2300077 | 齐鲁制药有限公司 |
| 2023/09/16Import · Class 2.4 | 米罗那非片JXHL2300226 | AriBio Co. Ltd.; Panacro (Hefei) Pharmaceutical Technology Co. Ltd. |
| 2023/09/16Import · Class 2.4 | 米罗那非片JXHL2300225 | AriBio Co. Ltd.; Panacro (Hefei) Pharmaceutical Technology Co. Ltd. |
| 2023/09/16Generic · Class 3 | 法莫替丁注射液CYHS2302501 | 四川益生智同医药生物科技发展有限公司; 太极集团四川太极制药有限公司 |
| 2023/09/16Generic · Class 3 | 法莫替丁注射液CYHS2302500 | 四川益生智同医药生物科技发展有限公司; 太极集团四川太极制药有限公司 |
| 2023/09/16Generic · Class 3 | 奥美拉唑碳酸氢钠胶囊CYHS2302498 | 海南广升誉制药有限公司; 浙江赛默制药有限公司 |
| 2023/09/16Generic · Class 3 | 奥美拉唑碳酸氢钠胶囊CYHS2302497 | 海南广升誉制药有限公司; 浙江赛默制药有限公司 |
| 2023/09/16New drug · Class 1 | 人源多巴胺能前体细胞注射液CXSL2300628 | 睿健医药科技(苏州)有限公司; 武汉睿健医药科技有限公司 |
| 2023/09/16New drug · Class 1 | SKG0201注射液CXSL2300627 | 揽月生物医药科技(杭州)有限公司 |
| 2023/09/16New drug · Class 1 | SHR2554片CXHL2301008 | 江苏恒瑞医药股份有限公司 |
| 2023/09/16New drug · Class 1 | SYH2053注射液CXHL2301007 | 石药集团中诺药业(石家庄)有限公司; 石药集团中奇制药技术(石家庄)有限公司 |
| 2023/09/15Import · Class 1 | SAR442168JXHL2300224 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2023/09/15Generic · Class 3 | 氨溴特罗口服溶液CYHS2302491 | 海门普适医药有限公司 |
| 2023/09/15Generic · Class 3 | 右酮洛芬氨丁三醇注射液CYHL2300118 | 中润药业有限公司 |
| 2023/09/15Generic · Class 3 | 酒石酸阿福特罗雾化吸入用溶液CYHL2300117 | 江苏和晨药业有限公司 |
| 2023/09/15New drug · Class 2.3 | 菖麻熄风片CXZL2300061 | 黑龙江省济仁药业有限公司 |
| 2023/09/15New drug · Class 2.2 | 特瑞普利单抗注射液CXSL2300626 | 上海君实生物医药科技股份有限公司 |
| 2023/09/15New drug · Class 2.2 | 特瑞普利单抗注射液CXSL2300625 | 上海君实生物医药科技股份有限公司 |
| 2023/09/15New drug · Class 1 | C-13-60细胞制剂CXSL2300624 | 重庆精准生物技术有限公司 |
| 2023/09/15New drug · Class 1 | 注射用重组WNV-HCD86CXSL2300623 | 四川安可康生物医药有限公司 |
| 2023/09/15New drug · Class 1 | 注射用重组WNV-HCD86CXSL2300622 | 四川安可康生物医药有限公司 |
| 2023/09/15New drug · Class 1 | 注射用重组WNV-HCD86CXSL2300621 | 四川安可康生物医药有限公司 |
| 2023/09/15New drug · Class 1 | MC-1-50细胞制剂CXSL2300620 | 重庆精准生物技术有限公司 |
| 2023/09/15New drug · Class 1 | BGT-004胶囊CXHL2301006 | 博骥源(上海)生物医药有限公司 |
| 2023/09/15New drug · Class 1 | BGT-004胶囊CXHL2301005 | 博骥源(上海)生物医药有限公司 |
87 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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