药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/05/16 – 2023/05/22
- New acceptances this week
- 405
- Drugs with new generic filings (by drug name, de-duplicated)
- 44
- 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
405filings, 59 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 237 |
| New drug | 68 |
| Generic | 59 |
| Import | 18 |
| Import re-registration | 14 |
| Unspecified | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 254 |
| TCM | 101 |
| 治疗用生物制品 | 45 |
| Biologic | 3 |
| 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
44 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 恩格列净二甲双胍缓释片 | 4 | 1 | 12 |
| 2 | 盐酸帕罗西汀肠溶缓释片 | 3 | 1 | 0 |
| 3 | 吲哚布芬片 | 2 | 2 | 7 |
| 4 | 玻璃酸钠滴眼液 | 2 | 2 | 29 |
| 5 | 腺苷钴胺胶囊 | 2 | 2 | 8 |
| 6 | 盐酸异丙肾上腺素注射液 | 2 | 1 | 9 |
| 7 | 盐酸纳洛酮注射液 | 2 | 1 | 1 |
| 8 | 盐酸达泊西汀片 | 2 | 1 | 20 |
| 9 | 硫酸特布他林口服溶液 | 2 | 1 | 4 |
| 10 | 罗沙司他胶囊 | 2 | 1 | 17 |
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
184 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 重庆迪康中药制药有限公司 | 76 | 74 | 0 |
| 2 | 中嘉生物科技(湖北省)有限公司 | 24 | 12 | 0 |
| 3 | 湖北朗德药业有限公司 | 20 | 10 | 0 |
| 4 | 平光制药股份有限公司 | 14 | 14 | 0 |
| 5 | AbbVie Inc. | 6 | 2 | 0 |
| 6 | UCB Pharma SA | 6 | 1 | 0 |
| 7 | 百济神州(苏州)生物科技有限公司 | 5 | 2 | 0 |
| 8 | 石家庄四药有限公司 | 4 | 3 | 3 |
| 9 | 上海汇伦江苏药业有限公司 | 4 | 1 | 4 |
| 10 | 上海银诺生物医药工程有限公司 | 4 | 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
112 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/05/22Import · Class 1 | SAR442501JXSL2300097 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2023/05/22Generic · Class 3 | 盐酸林可霉素注射液CYHS2301368 | 华夏生生药业(北京)有限公司 |
| 2023/05/22Generic · Class 3 | 注射用比阿培南CYHS2301365 | 安徽省先锋制药有限公司 |
| 2023/05/22Generic · Class 3 | 甲氨蝶呤片CYHS2301363 | 国药一心制药有限公司 |
| 2023/05/22Generic · Class 3 | 喷他佐辛注射液CYHS2301361 | 山东新华制药股份有限公司 |
| 2023/05/22New drug · Class 1 | 注射用XNW28012CXSL2300365 | 上海信诺维生物医药有限公司 |
| 2023/05/22New drug · Class 1 | SM17单克隆抗体注射液CXSL2300364 | 杏联药业(苏州)有限公司 |
| 2023/05/22New drug · Class 1 | ONC-392注射液CXSL2300363 | 广州昂科免疫生物技术有限公司 |
| 2023/05/22New drug · Class 1 | 靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液CXSL2300362 | 上海先博生物科技有限公司 |
| 2023/05/22New drug · Class 1 | 靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液CXSL2300361 | 上海先博生物科技有限公司 |
| 2023/05/22New drug · Class 1 | 靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液CXSL2300360 | 上海先博生物科技有限公司 |
| 2023/05/22New drug · Class 1 | TQ-B3525片CXHS2300050 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2023/05/22New drug · Class 1 | XYD-A01CXHL2300555 | 昆山新蕴达生物科技有限公司 |
| 2023/05/22New drug · Class 1 | BGB-24714胶囊CXHL2300554 | 百济神州(苏州)生物科技有限公司 |
| 2023/05/22New drug · Class 1 | BGB-24714胶囊CXHL2300553 | 百济神州(苏州)生物科技有限公司 |
| 2023/05/22New drug · Class 1 | BGB-24714胶囊CXHL2300552 | 百济神州(苏州)生物科技有限公司 |
| 2023/05/22New drug · Class 2.1 | SF001CXHL2300551 | 普济生物科技(台州)有限公司 |
| 2023/05/22New drug · Class 2.1 | SF001CXHL2300550 | 普济生物科技(台州)有限公司 |
| 2023/05/22New drug · Class 2.1 | SF001CXHL2300549 | 普济生物科技(台州)有限公司 |
| 2023/05/22New drug · Class 1 | YL-17231片CXHL2300548 | 上海璎黎药业有限公司 |
| 2023/05/22New drug · Class 1 | YL-17231片CXHL2300547 | 上海璎黎药业有限公司 |
| 2023/05/22New drug · Class 1 | YL-17231片CXHL2300546 | 上海璎黎药业有限公司 |
| 2023/05/22New drug · Class 1 | ASP3082注射液CXHL2300545 | 安斯泰来(中国)投资有限公司 |
| 2023/05/22New drug · Class 1 | APG-2449胶囊CXHL2300544 | 苏州亚盛药业有限公司 |
| 2023/05/22New drug · Class 1 | DF-006CXHL2300543 | 浙江药苑生物科技有限公司 |
| 2023/05/19Import · Class 1 | Cenerimod片JXHL2300122 | Idorsia Pharmaceuticals Ltd; Idorsia (Beijing) Pharmaceuticals Co. Ltd |
| 2023/05/19Import · Class 1 | Aficamten片JXHL2300121 | Cytokinetics Incorporated; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd |
| 2023/05/19Import · Class 1 | Aficamten片JXHL2300120 | Cytokinetics Incorporated; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd |
| 2023/05/19Generic · Class 3 | 盐酸纳洛酮注射液CYHS2301360 | 成都瑞尔医药科技有限公司; 成都市海通药业有限公司 |
| 2023/05/19Generic · Class 3 | 盐酸纳洛酮注射液CYHS2301359 | 成都瑞尔医药科技有限公司; 成都市海通药业有限公司 |
82 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.