药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/07/20 – 2021/07/26
- New acceptances this week
- 173
- Drugs with new generic filings (by drug name, de-duplicated)
- 20
- 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
173filings, 27 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 98 |
| New drug | 31 |
| Generic | 27 |
| Import | 10 |
| Unspecified | 4 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 121 |
| 治疗用生物制品 | 33 |
| TCM | 10 |
| 预防用生物制品 | 9 |
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
20 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 甲硫酸新斯的明注射液 | 3 | 1 | 4 |
| 2 | 卡贝缩宫素注射液 | 2 | 2 | 6 |
| 3 | 注射用米卡芬净钠 | 2 | 1 | 0 |
| 4 | 碘克沙醇注射液 | 2 | 1 | 0 |
| 5 | 艾地骨化醇软胶囊 | 2 | 1 | 8 |
| 6 | 达格列净片 | 2 | 1 | 82 |
| 7 | 利马前列素阿法环糊精片 | 1 | 1 | 0 |
| 8 | 对乙酰氨基酚片 | 1 | 1 | 6 |
| 9 | 左氧氟沙星片 | 1 | 1 | 8 |
| 10 | 异丙托溴铵吸入气雾剂 | 1 | 1 | 2 |
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
113 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 西安汤臣制药有限公司 | 7 | 6 | 0 |
| 2 | SANOFI PASTEUR | 4 | 2 | 0 |
| 3 | 广州百特医疗用品有限公司 | 4 | 2 | 0 |
| 4 | 武汉生物制品研究所有限责任公司 | 4 | 1 | 0 |
| 5 | 合肥立方制药股份有限公司 | 3 | 3 | 0 |
| 6 | 江苏恒瑞医药股份有限公司 | 3 | 3 | 0 |
| 7 | 黑龙江林海雪原药业有限公司 | 3 | 3 | 0 |
| 8 | Novo Nordisk A/S | 3 | 2 | 0 |
| 9 | 广州必贝特医药技术有限公司 | 3 | 2 | 0 |
| 10 | 东莞市阳之康医药有限责任公司 | 3 | 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
48 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/07/26Import · Class 1 | RO7030816JXSL2101073 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2021/07/26Import · Class 1 | RO7030816JXSL2101072 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2021/07/26Import · Class 2.2 | 帕博利珠单抗注射液JXSL2101071 | Merck Sharp & Dohme Corp.; MSD R&D（China）Co. Ltd. |
| 2021/07/26Import · Class 1 | PF-06823859注射液JXSL2101070 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2021/07/26Import · Class 2.4 | Lazertinib片JXHL2101140 | Janssen-Cilag International NV; Johnson & Johnson (China) Investment Ltd. |
| 2021/07/26Generic · Class 3 | 利马前列素阿法环糊精片CYHS2101475 | 北京泰德制药股份有限公司 |
| 2021/07/26New drug · Class 1 | QX006N注射液CXSL2101214 | 江苏荃信生物医药有限公司 |
| 2021/07/26New drug · Class 1 | 注射用BC3448CXSL2101213 | 无锡智康弘义生物科技有限公司 |
| 2021/07/26New drug · Class 2.4 | 硝羟喹啉片CXHL2101329 | 江苏亚虹医药科技股份有限公司 |
| 2021/07/26New drug · Class 1 | 注射用TB001CXHL2101328 | 深圳市图微安创科技开发有限公司 |
| 2021/07/26New drug · Class 1 | 注射用TB001CXHL2101327 | 深圳市图微安创科技开发有限公司 |
| 2021/07/24Import · Class 1 | PF-06863135JXSL2101069 | Pfizer Inc; Pfizer Investment CO. Ltd. |
| 2021/07/24Import · Class 2.2 | Amivantamab注射液JXSL2101068 | Janssen-Cilag International NV; Johnson & Johnson (China) Investment Ltd. |
| 2021/07/24Generic · Class 3 | 甲硫酸新斯的明注射液CYHS2101471 | 成都欣捷高新技术开发股份有限公司; 太极集团四川太极制药有限公司 |
| 2021/07/24Generic · Class 3 | 甲硫酸新斯的明注射液CYHS2101470 | 成都欣捷高新技术开发股份有限公司; 太极集团四川太极制药有限公司 |
| 2021/07/24Generic · Class 3 | 甲硫酸新斯的明注射液CYHS2101469 | 成都欣捷高新技术开发股份有限公司; 太极集团四川太极制药有限公司 |
| 2021/07/24Generic · Class 3 | 盐酸右美托咪定注射液CYHS2101468 | 江苏正大丰海制药有限公司 |
| 2021/07/24Generic · Class 3 | 卡贝缩宫素注射液CYHS2101453 | 辉凌制药(中国)有限公司 |
| 2021/07/24New drug · Class 1 | BA1105注射液CXSL2101212 | 山东博安生物技术股份有限公司 |
| 2021/07/24New drug · Class 1 | 注射用SSGJ-705CXSL2101211 | 三生国健药业（上海）股份有限公司 |
| 2021/07/24New drug · Class 1 | AK112注射液CXSL2101210 | 中山康方生物医药有限公司 |
| 2021/07/24New drug · Class 1 | AK120注射液CXSL2101209 | 中山康方生物医药有限公司 |
| 2021/07/24New drug · Class 1 | 依鲁奥克片CXHS2101032 | 齐鲁制药有限公司 |
| 2021/07/24New drug · Class 1 | 依鲁奥克片CXHS2101031 | 齐鲁制药有限公司 |
| 2021/07/24New drug · Class 1 | NB003片CXHL2101323 | 宁波新湾科技发展有限公司 |
| 2021/07/24New drug · Class 1 | NB003片CXHL2101322 | 宁波新湾科技发展有限公司 |
| 2021/07/24New drug · Class 1 | NB003片CXHL2101321 | 宁波新湾科技发展有限公司 |
| 2021/07/24New drug · Class 1 | 苯磺酸克立福替尼片CXHL2101317 | 广东东阳光药业有限公司 |
| 2021/07/24New drug · Class 1 | 苯磺酸克立福替尼片CXHL2101316 | 广东东阳光药业有限公司 |
| 2021/07/24New drug · Class 1 | 苯磺酸克立福替尼片CXHL2101315 | 广东东阳光药业有限公司 |
18 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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