药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/11/14 – 2023/11/20
- New acceptances this week
- 351
- Drugs with new generic filings (by drug name, de-duplicated)
- 53
- Accepted this week, now under review
- 4
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
351filings, 68 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 204 |
| Generic | 68 |
| New drug | 44 |
| Import | 23 |
| Import re-registration | 7 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 239 |
| TCM | 69 |
| 治疗用生物制品 | 39 |
| Biologic | 2 |
| 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 | 氯化钾颗粒 | 4 | 2 | 4 |
| 2 | 达比加群酯胶囊 | 3 | 1 | 2 |
| 3 | 加巴喷丁胶囊 | 2 | 1 | 0 |
| 4 | 培哚普利氨氯地平片(Ⅰ) | 2 | 1 | 3 |
| 5 | 富马酸伏诺拉生片 | 2 | 1 | 58 |
| 6 | 法莫替丁注射液 | 2 | 1 | 8 |
| 7 | 注射用头孢哌酮钠舒巴坦钠(2:1) | 2 | 1 | 2 |
| 8 | 甲硫酸新斯的明注射液 | 2 | 1 | 4 |
| 9 | 米诺地尔搽剂 | 2 | 1 | 49 |
| 10 | 艾地骨化醇软胶囊 | 2 | 1 | 8 |
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
204 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 山西双雁药业有限公司 | 27 | 26 | 0 |
| 2 | AstraZeneca AB | 10 | 5 | 0 |
| 3 | 九华华源药业股份有限公司 | 8 | 8 | 0 |
| 4 | 正大天晴药业集团股份有限公司 | 8 | 1 | 0 |
| 5 | 宝光药业(成都)有限责任公司 | 5 | 5 | 0 |
| 6 | 山东二叶制药有限公司 | 5 | 2 | 0 |
| 7 | Novo Nordisk A/S | 5 | 1 | 0 |
| 8 | Pfizer Europe MA EEIG | 4 | 2 | 0 |
| 9 | 广州银诺医药集团股份有限公司 | 4 | 1 | 0 |
| 10 | 修正药业集团天汉药业有限公司 | 3 | 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
91 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/11/20Import · Class 1 | AZD3470薄膜衣片JXHL2300292 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/11/20Import · Class 1 | AZD3470薄膜衣片JXHL2300291 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/11/20Generic · Class 3 | 醋酸葡萄糖维持液CYHS2303177 | 仁合益康集团有限公司; 河北仁合益康药业有限公司 |
| 2023/11/20Generic · Class 3 | 醋酸葡萄糖维持液CYHS2303176 | 仁合益康集团有限公司; 河北仁合益康药业有限公司 |
| 2023/11/20Generic · Class 3 | 普瑞巴林口服溶液CYHS2303172 | 北京索普兴大医药研究有限公司; 青岛国信制药有限公司 |
| 2023/11/20Generic · Class 3 | 盐酸非索非那定口服混悬液CYHS2303171 | 浙江普利药业有限公司 |
| 2023/11/20New drug · Class 3.1 | 桃红四物汤颗粒CXZS2300023 | 海南康茂信医药科技有限公司; 国药集团德众(佛山)药业有限公司 |
| 2023/11/20New drug · Class 1.1 | 四仙颗粒CXZL2300071 | 四川省中医药科学院 |
| 2023/11/20New drug · Class 2.2 | 阿得贝利单抗注射液CXSL2300794 | 上海盛迪医药有限公司 |
| 2023/11/20New drug · Class 1 | TQB2223 注射液CXSL2300793 | 正大天晴(广州)医药有限公司 |
| 2023/11/20New drug · Class 1 | IMC001注射液CXSL2300792 | 成都易慕峰生物科技有限公司; 苏州易慕峰生物科技有限公司 |
| 2023/11/20New drug · Class 2.4 | 镥[177Lu]氧奥曲肽注射液CXHL2301284 | 北京先通国际医药科技股份有限公司 |
| 2023/11/18Generic · Class 3 | 盐酸阿比多尔片CYHS2303169 | 武汉人福利康药业有限公司 |
| 2023/11/18Generic · Class 3 | 西咪替丁注射液CYHS2303168 | 广州市联瑞制药有限公司 |
| 2023/11/18New drug · Class 2.3 | 小儿热速清口服液CXZL2300070 | 吉林一正药业集团有限公司 |
| 2023/11/18New drug · Class 1 | BW-20507注射液CXHL2301283 | 杭州舶临医药科技有限公司 |
| 2023/11/18New drug · Class 2.1;2.2;2.4 | 盐酸(R)-氯胺酮鼻喷雾剂CXHL2301282 | 四川普锐特药业有限公司 |
| 2023/11/18New drug · Class 2.1;2.2;2.4 | 盐酸(R)-氯胺酮鼻喷雾剂CXHL2301281 | 四川普锐特药业有限公司 |
| 2023/11/17Import · Class 2.3 | 注射用氨曲南阿维巴坦钠JXHS2300103 | Pfizer Europe MA EEIG; Hospira Australia Pty Ltd; Pfizer Investment Co. Ltd. |
| 2023/11/17Generic · Class 3 | 盐酸甲氧氯普胺注射液CYHS2303156 | 朗天医药科技(武汉)有限公司; 朗天药业(湖北)有限公司 |
| 2023/11/17Generic · Class 3 | 聚乙烯醇滴眼液CYHS2303155 | 浙江视方极医药科技有限公司; 浙江赛默制药有限公司 |
| 2023/11/17Generic · Class 3 | 重酒石酸去甲肾上腺素注射液CYHS2303150 | 河北科源药业有限公司; 河北仁合益康药业有限公司 |
| 2023/11/17Generic · Class 3 | 美洛昔康纳米晶注射液CYHL2300139 | 江苏慧聚药业股份有限公司 |
| 2023/11/17New drug · Class 2.3 | 八宝丹胶囊CXZL2300069 | 厦门中药厂有限公司 |
| 2023/11/17New drug · Class 1 | ZVS203e 注射液CXSL2300790 | 北京中因制药有限公司 |
| 2023/11/17New drug · Class 1 | 注射用重组酰化胰高血糖素样肽2类似物CXSL2300789 | 重庆派金生物科技有限公司 |
| 2023/11/17New drug · Class 1 | 靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液CXSL2300788 | 上海先博生物科技有限公司 |
| 2023/11/17New drug · Class 1 | 靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液CXSL2300787 | 上海先博生物科技有限公司 |
| 2023/11/17New drug · Class 1 | 靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液CXSL2300786 | 上海先博生物科技有限公司 |
| 2023/11/17New drug · Class 1 | ZHB103注射液CXSL2300785 | 江苏众红生物工程创药研究院有限公司 |
61 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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