药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/05/04 – 2021/05/10
- New acceptances this week
- 133
- Drugs with new generic filings (by drug name, de-duplicated)
- 9
- 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
133filings, 10 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 82 |
| New drug | 19 |
| Generic | 10 |
| Import | 10 |
| Unspecified | 6 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 79 |
| TCM | 34 |
| 治疗用生物制品 | 17 |
| 预防用生物制品 | 3 |
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
9 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 富马酸喹硫平缓释片 | 2 | 1 | 0 |
| 2 | 奥氮平片 | 1 | 1 | 4 |
| 3 | 屈螺酮炔雌醇片（Ⅱ） | 1 | 1 | 1 |
| 4 | 替普瑞酮胶囊 | 1 | 1 | 5 |
| 5 | 甘油果糖氯化钠注射液 | 1 | 1 | 3 |
| 6 | 盐酸氨溴索注射液 | 1 | 1 | 9 |
| 7 | 硫酸特布他林雾化吸入用溶液 | 1 | 1 | 1 |
| 8 | 缬沙坦片 | 1 | 1 | 0 |
| 9 | 胞磷胆碱钠注射液 | 1 | 1 | 3 |
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
79 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 内蒙古天奇中蒙制药股份有限公司 | 29 | 29 | 0 |
| 2 | 哈尔滨三联药业股份有限公司 | 3 | 1 | 0 |
| 3 | 正大天晴药业集团股份有限公司 | 3 | 1 | 0 |
| 4 | 西南药业股份有限公司 | 3 | 1 | 0 |
| 5 | AstraZeneca AB | 2 | 2 | 0 |
| 6 | Bright Future Pharmaceuticals Factory | 2 | 2 | 0 |
| 7 | Arctic Vision (Hong Kong) Limited | 2 | 1 | 0 |
| 8 | Eli Lilly Nederland B.V. | 2 | 1 | 0 |
| 9 | Merck Sharp & Dohme Corp. | 2 | 1 | 0 |
| 10 | Sanofi-aventis groupe | 2 | 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
29 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/05/10Import · Class 3.1 | 度普利尤单抗注射液JXSS2101006 | Sanofi-aventis groupe; Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd. |
| 2021/05/10Import · Class 3.1 | 度普利尤单抗注射液JXSS2101005 | Sanofi-aventis groupe; Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd. |
| 2021/05/10Import · Class 2.2 | 硫酸阿托品微量眼用溶液JXHL2101025 | Arctic Vision (Hong Kong) Limited; Arctic Vision (Shanghai) Biotechnology Co Ltd |
| 2021/05/10Import · Class 2.2 | 硫酸阿托品微量眼用溶液JXHL2101024 | Arctic Vision (Hong Kong) Limited; Arctic Vision (Shanghai) Biotechnology Co Ltd |
| 2021/05/10Generic · Class 3 | 甘油果糖氯化钠注射液CYHS2101134 | 辰欣药业股份有限公司 |
| 2021/05/10New drug · Class 1 | 泽贝妥单抗注射液CXSL2101057 | 浙江博锐生物制药有限公司 |
| 2021/05/10New drug · Class 1 | NTQ1062片CXHL2101108 | 南京正大天晴制药有限公司 |
| 2021/05/10New drug · Class 1 | NTQ1062片CXHL2101107 | 南京正大天晴制药有限公司 |
| 2021/05/10New drug · Class 2.4 | 注射用甲苯磺酸瑞马唑仑CXHL2101106 | 福建盛迪医药有限公司 |
| 2021/05/08Import · Class 2.2 | Benralizumab注射液JXSL2101022 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2021/05/08Import · Class 1 | U3-1402JXSL2101021 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2021/05/08Import · Class 2.2 | 硫酸阿托品滴眼液JXHL2101023 | Ocumension (Hong Kong)Limited; Ocumension Therapeutics（Shanghai）Co. Ltd |
| 2021/05/08Generic · Class 3 | 胞磷胆碱钠注射液CYHS2101123 | 广东赛烽医药科技有限公司; 山西普德药业有限公司 |
| 2021/05/08New drug · Class 1 | 派安普利单抗注射液CXSL2101056 | 正大天晴康方（上海）生物医药科技有限公司 |
| 2021/05/08New drug · Class 1 | UB-621注射液CXSL2101055 | 联药（上海）生物科技有限公司 |
| 2021/05/08New drug · Class 1 | 3D-229注射液CXSL2101049 | 徐州思路迪药业有限公司 |
| 2021/05/07New drug · Class 1 | REV001注射液CXSL2101053 | 上海行深生物科技有限公司 |
| 2021/05/07New drug · Class 2.4 | 盐酸安罗替尼胶囊CXHS2101012 | 正大天晴药业集团股份有限公司 |
| 2021/05/07New drug · Class 2.4 | 盐酸安罗替尼胶囊CXHS2101011 | 正大天晴药业集团股份有限公司 |
| 2021/05/07New drug · Class 2.4 | 盐酸安罗替尼胶囊CXHS2101010 | 正大天晴药业集团股份有限公司 |
| 2021/05/07New drug · Class 1 | 甲磺酸瑞泽替尼胶囊CXHS2101009 | 上海倍而达药业有限公司; 上海合全医药有限公司 |
| 2021/05/07New drug · Class 2.2 | 卡左双多巴控释片CXHL2101104 | 上海汉都医药科技有限公司 |
| 2021/05/07New drug · Class 2.2 | 卡左双多巴控释片CXHL2101103 | 上海汉都医药科技有限公司 |
| 2021/05/06Import · Class 1 | Efgartigimod注射液JXSL2101018 | argenx BV; Zai Lab (Shanghai) Co. Ltd. |
| 2021/05/06New drug · Class 1 | BAT6005注射液CXSL2101052 | 百奥泰生物制药股份有限公司 |
| 2021/05/06New drug · Class 1 | AZD4205胶囊CXHL2101102 | 迪哲（江苏）医药股份有限公司 |
| 2021/05/06New drug · Class 1 | AZD4205胶囊CXHL2101101 | 迪哲（江苏）医药股份有限公司 |
| 2021/05/06New drug · Class 2.2 | 雷美替胺双释片CXHL2101100 | 越洋医药开发（广州）有限公司 |
| 2021/05/06New drug · Class 1 | 注射用硝酮嗪CXHL2101099 | 广州喜鹊医药有限公司 |
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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