药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/05/02 – 2023/05/08
- New acceptances this week
- 191
- Drugs with new generic filings (by drug name, de-duplicated)
- 33
- 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
191filings, 39 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 88 |
| New drug | 44 |
| Generic | 39 |
| Import | 11 |
| Import re-registration | 7 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 119 |
| 治疗用生物制品 | 42 |
| TCM | 29 |
| 预防用生物制品 | 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
33 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 精氨酸布洛芬颗粒 | 3 | 1 | 11 |
| 2 | 氟尿嘧啶注射液 | 2 | 1 | 6 |
| 3 | 注射用尼可地尔 | 2 | 1 | 1 |
| 4 | 硝酸甘油葡萄糖注射液 | 2 | 1 | 0 |
| 5 | 硫酸阿米卡星注射液 | 2 | 1 | 4 |
| 6 | 他达拉非片 | 1 | 1 | 23 |
| 7 | 伏立康唑干混悬剂 | 1 | 1 | 1 |
| 8 | 依帕司他片 | 1 | 1 | 1 |
| 9 | 吲哚布芬片 | 1 | 1 | 7 |
| 10 | 吸入用复方异丙托溴铵溶液 | 1 | 1 | 4 |
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
115 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 河北凯威恒诚制药有限公司 | 9 | 8 | 0 |
| 2 | Novo Nordisk A/S | 8 | 2 | 0 |
| 3 | 陕西清华紫光生物科技有限公司 | 6 | 6 | 0 |
| 4 | 四川核力欣健药业有限公司 | 4 | 4 | 0 |
| 5 | McNeil Sweden AB | 4 | 1 | 0 |
| 6 | 哈药集团制药总厂 | 4 | 1 | 0 |
| 7 | 锦州奥鸿药业有限责任公司 | 4 | 1 | 0 |
| 8 | 黑龙江嘉悦泽医疗科技有限公司 | 3 | 3 | 0 |
| 9 | 仁合益康集团有限公司 | 3 | 2 | 3 |
| 10 | 惠升生物制药股份有限公司 | 3 | 2 | 1 |
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
71 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/05/08New drug · Class 2.2 | 注射用维迪西妥单抗CXSL2300319 | 荣昌生物制药（烟台）股份有限公司 |
| 2023/05/08New drug · Class 1 | LP-005 注射液CXSL2300318 | 天辰生物医药（苏州）有限公司 |
| 2023/05/08New drug · Class 1 | BW-00112 注射液CXHL2300474 | 杭州舶临医药科技有限公司 |
| 2023/05/07Import · Class 1 | 依柯胰岛素注射液JXSS2300036 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2023/05/07Import · Class 1 | 依柯胰岛素注射液JXSS2300035 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2023/05/07Import · Class 1 | 依柯胰岛素注射液JXSS2300034 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2023/05/07Import · Class 1 | VAY736注射液JXSL2300091 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2023/05/07Import · Class 2.2 | (decitabine and cedazuridine)片JXHL2300103 | Otsuka Pharmaceutical Co. Ltd; Otsuka Beijing Research Institute |
| 2023/05/07Generic · Class 3 | 盐酸氨溴索口服溶液CYHS2301237 | 安徽海斯美医药有限公司; 江苏欧歌制药有限公司 |
| 2023/05/07Generic · Class 3 | 氟尿嘧啶注射液CYHS2301235 | 湖北民康药业集团有限公司; 天津金耀药业有限公司 |
| 2023/05/07Generic · Class 3 | 氟尿嘧啶注射液CYHS2301234 | 湖北民康药业集团有限公司; 天津金耀药业有限公司 |
| 2023/05/07Generic · Class 3 | 米诺地尔搽剂CYHS2301232 | 北京博喆研医药科技有限公司; 浙江赛默制药有限公司 |
| 2023/05/07Generic · Class 3 | 盐酸艾司氯胺酮注射液CYHL2300070 | 成都倍特药业股份有限公司 |
| 2023/05/07New drug · Class 3.3 | 德谷门冬双胰岛素注射液CXSS2300029 | 惠升生物制药股份有限公司 |
| 2023/05/07New drug · Class 3.3 | 德谷门冬双胰岛素注射液CXSS2300028 | 惠升生物制药股份有限公司 |
| 2023/05/07New drug · Class 3.3 | 注射用BLB101CXSL2300317 | 北京力邦生物医药科技有限公司 |
| 2023/05/07New drug · Class 3.3 | GLR1023注射液CXSL2300316 | 甘李药业股份有限公司 |
| 2023/05/07New drug · Class 1 | FCN-437c胶囊CXHL2300473 | 锦州奥鸿药业有限责任公司 |
| 2023/05/07New drug · Class 1 | FCN-437c胶囊CXHL2300472 | 锦州奥鸿药业有限责任公司 |
| 2023/05/07New drug · Class 1 | FCN-437c胶囊CXHL2300471 | 锦州奥鸿药业有限责任公司 |
| 2023/05/07New drug · Class 1 | FCN-437c胶囊CXHL2300470 | 锦州奥鸿药业有限责任公司 |
| 2023/05/07New drug · Class 2.2 | 盐酸达泊西汀口溶膜CXHL2300469 | 四川科伦药业股份有限公司 |
| 2023/05/06Import · Class 1 | Mim8JXSL2300090 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2023/05/06Import · Class 1 | Mim8JXSL2300089 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2023/05/06Import · Class 1 | Mim8JXSL2300088 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2023/05/06Import · Class 1 | Mim8JXSL2300087 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2023/05/06Import · Class 1 | Mim8JXSL2300086 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2023/05/06Generic · Class 3 | 盐酸丙卡特罗口服溶液CYHS2301228 | 安徽环球药业股份有限公司 |
| 2023/05/06Generic · Class 3 | 硝酸甘油葡萄糖注射液CYHS2301227 | 仁合益康集团有限公司; 河北仁合益康药业有限公司 |
| 2023/05/06Generic · Class 3 | 硝酸甘油葡萄糖注射液CYHS2301226 | 仁合益康集团有限公司; 河北仁合益康药业有限公司 |
41 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.