药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/09/05 – 2023/09/11
- New acceptances this week
- 361
- Drugs with new generic filings (by drug name, de-duplicated)
- 64
- 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
361filings, 78 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 185 |
| Generic | 78 |
| New drug | 47 |
| Import | 24 |
| Import re-registration | 21 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 268 |
| TCM | 62 |
| 治疗用生物制品 | 25 |
| 预防用生物制品 | 5 |
| 体外诊断试剂 | 1 |
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
64 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 注射用阿莫西林钠 | 5 | 2 | 0 |
| 2 | 利丙双卡因乳膏 | 2 | 2 | 25 |
| 3 | 复方聚乙二醇电解质散(儿童型) | 2 | 2 | 2 |
| 4 | 富马酸福莫特罗吸入溶液 | 2 | 2 | 7 |
| 5 | 己酮可可碱注射液 | 2 | 2 | 3 |
| 6 | 艾曲泊帕乙醇胺片 | 2 | 2 | 1 |
| 7 | 重酒石酸间羟胺注射液 | 2 | 2 | 2 |
| 8 | 间苯三酚注射液 | 2 | 2 | 2 |
| 9 | 注射用尼可地尔 | 2 | 1 | 1 |
| 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
220 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | NAPP PHARMACEUTICALS LIMITED | 15 | 1 | 0 |
| 2 | 哈尔滨同一堂药业有限公司 | 11 | 11 | 0 |
| 3 | 山西振东五和堂制药有限公司 | 6 | 6 | 0 |
| 4 | 神威药业集团有限公司 | 6 | 6 | 0 |
| 5 | Eli Lilly and Company | 6 | 1 | 0 |
| 6 | 上海皇象铁力蓝天制药有限公司 | 5 | 5 | 0 |
| 7 | 修正药业集团天汉药业有限公司 | 5 | 5 | 0 |
| 8 | 山东威智百科药业有限公司 | 5 | 3 | 0 |
| 9 | 深圳市天道医药有限公司 | 5 | 1 | 0 |
| 10 | 广西壮族自治区药物研究所有限公司 | 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
97 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/09/11Import · Class 2.2 | Talquetamab注射液JXSL2300168 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/09/11Import · Class 2.2 | Talquetamab注射液JXSL2300167 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/09/11Import · Class 2.2 | Teclistamab 注射液JXSL2300166 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/09/11Import · Class 2.2 | Teclistamab 注射液JXSL2300165 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/09/11Generic · Class 3 | 立他司特滴眼液CYHS2302444 | 成都康弘药业集团股份有限公司; 成都普什制药有限公司 |
| 2023/09/11Generic · Class 3 | 己酮可可碱注射液CYHS2302437 | 华中药业股份有限公司 |
| 2023/09/11Generic · Class 3 | 吡非尼酮片CYHS2302435 | 四川依科制药有限公司 |
| 2023/09/11New drug · Class 1 | 注射用IAE0972CXSL2300602 | 盛禾(中国)生物制药有限公司 |
| 2023/09/11New drug · Class 1 | GS1-144片CXHL2300977 | 长春金赛药业有限责任公司 |
| 2023/09/11New drug · Class 1 | GS1-144片CXHL2300976 | 长春金赛药业有限责任公司 |
| 2023/09/11New drug · Class 1 | GS1-144片CXHL2300975 | 长春金赛药业有限责任公司 |
| 2023/09/11New drug · Class 1 | BL0020注射液CXHL2300974 | 上海弼领生物技术有限公司 |
| 2023/09/11New drug · Class 1 | GK201胶囊CXHL2300973 | 苏州国匡医药科技有限公司 |
| 2023/09/11New drug · Class 1 | GK201胶囊CXHL2300972 | 苏州国匡医药科技有限公司 |
| 2023/09/09Import · Class 1 | GDC-9545JXHL2300209 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2023/09/09Generic · Class 3 | 己酮可可碱注射液CYHS2302430 | 海南普利制药股份有限公司 |
| 2023/09/09Generic · Class 3 | 复方匹可硫酸钠颗粒CYHS2302428 | 江西科睿药业有限公司 |
| 2023/09/09Generic · Class 3 | 依帕司他片CYHS2302427 | 河北瑞森药业有限公司 |
| 2023/09/09Generic · Class 3 | 吲哚布芬片CYHS2302426 | 北京伟林恒昌医药科技有限公司; 北京四环科宝制药股份有限公司 |
| 2023/09/09New drug · Class 3.3 | 西妥昔单抗注射液CXSS2300075 | 四川科伦博泰生物医药股份有限公司 |
| 2023/09/09New drug · Class 1 | HSK36357胶囊CXHL2300971 | 西藏海思科制药有限公司 |
| 2023/09/09New drug · Class 1 | HSK36357胶囊CXHL2300970 | 西藏海思科制药有限公司 |
| 2023/09/09New drug · Class 2.2 | 盐酸达泊西汀口溶膜CXHL2300969 | 上海欣峰制药有限公司 |
| 2023/09/09New drug · Class 1 | 注射用XCCS605BCXHL2300968 | 上海华禹生物科技有限公司 |
| 2023/09/08Import · Class 2.2 | 度伐利尤单抗注射液JXSS2300078 | AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd. |
| 2023/09/08Import · Class 2.2 | 度伐利尤单抗注射液JXSS2300077 | AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd. |
| 2023/09/08Import · Class 1 | LY3502970胶囊JXHL2300208 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/09/08Import · Class 1 | LY3502970胶囊JXHL2300207 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/09/08Import · Class 1 | LY3502970胶囊JXHL2300206 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/09/08Import · Class 1 | LY3502970胶囊JXHL2300205 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
67 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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