药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/08/08 – 2023/08/14
- New acceptances this week
- 114
- Drugs with new generic filings (by drug name, de-duplicated)
- 18
- 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
114filings, 26 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 50 |
| Generic | 26 |
| Import re-registration | 18 |
| New drug | 15 |
| Unspecified | 4 |
| Import | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 69 |
| TCM | 26 |
| 治疗用生物制品 | 16 |
| 预防用生物制品 | 2 |
| Biologic | 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
18 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 他克莫司缓释胶囊 | 2 | 1 | 6 |
| 2 | 吡拉西坦注射液 | 2 | 1 | 9 |
| 3 | 昂丹司琼口溶膜 | 2 | 1 | 2 |
| 4 | 氨茶碱注射液 | 2 | 1 | 3 |
| 5 | 注射用培门冬酶 | 2 | 1 | 0 |
| 6 | 注射用尼可地尔 | 2 | 1 | 1 |
| 7 | 注射用艾司奥美拉唑钠 | 2 | 1 | 1 |
| 8 | 米库氯铵注射液 | 2 | 1 | 3 |
| 9 | 二甲双胍恩格列净片(Ⅴ) | 1 | 1 | 0 |
| 10 | 富马酸福莫特罗吸入溶液 | 1 | 1 | 7 |
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
62 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | GE Healthcare AS | 14 | 1 | 0 |
| 2 | 沈阳清宫药业集团有限公司 | 9 | 9 | 0 |
| 3 | 长沙爱贝高药业有限公司 | 6 | 6 | 0 |
| 4 | 无锡福祈制药有限公司 | 4 | 1 | 0 |
| 5 | 江苏星盛新辉医药有限公司 | 3 | 1 | 0 |
| 6 | 浙江亚太药业股份有限公司 | 3 | 1 | 0 |
| 7 | 广州百济神州生物制药有限公司 | 2 | 2 | 0 |
| 8 | 恒拓集团广西圣康制药有限公司 | 2 | 2 | 0 |
| 9 | 黑龙江乌苏里江制药有限公司 | 2 | 2 | 0 |
| 10 | Amgen Inc. | 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
28 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/08/14Generic · Class 3 | 氨茶碱注射液CYHS2302103 | 江西人可医药科技有限公司; 成都天台山制药股份有限公司 |
| 2023/08/14Generic · Class 3 | 氨茶碱注射液CYHS2302102 | 江西人可医药科技有限公司; 成都天台山制药股份有限公司 |
| 2023/08/14New drug · Class 1 | WXFL10203614片CXHL2300862 | 无锡福祈制药有限公司 |
| 2023/08/14New drug · Class 1 | WXFL10203614片CXHL2300861 | 无锡福祈制药有限公司 |
| 2023/08/12Generic · Class 3 | 吡拉西坦注射液CYHS2302098 | 合肥国药诺和药业有限公司; 国药集团国瑞药业有限公司 |
| 2023/08/12Generic · Class 3 | 吡拉西坦注射液CYHS2302097 | 合肥国药诺和药业有限公司; 国药集团国瑞药业有限公司 |
| 2023/08/12Generic · Class 3 | 瑞加诺生注射液CYHS2302096 | 博瑞制药（苏州）有限公司 |
| 2023/08/12Generic · Class 3 | 注射用尼可地尔CYHS2302095 | 海南皇隆制药股份有限公司 |
| 2023/08/12Generic · Class 3 | 注射用尼可地尔CYHS2302094 | 海南皇隆制药股份有限公司 |
| 2023/08/12Generic · Class 3 | 昂丹司琼口溶膜CYHS2302092 | 江苏和晨药业有限公司 |
| 2023/08/12Generic · Class 3 | 昂丹司琼口溶膜CYHS2302091 | 江苏和晨药业有限公司 |
| 2023/08/12Generic · Class 3 | 注射用培门冬酶CYHS2302085 | 北京双鹭药业股份有限公司 |
| 2023/08/12Generic · Class 3 | 注射用培门冬酶CYHS2302083 | 北京双鹭药业股份有限公司 |
| 2023/08/12New drug · Class 1 | 艾帕洛利单抗托沃瑞利单抗注射液CXSS2300066 | 齐鲁制药有限公司 |
| 2023/08/12New drug · Class 3.3 | 乌司奴单抗注射液CXSS2300065 | 杭州中美华东制药有限公司; 江苏赛孚士生物技术有限公司 |
| 2023/08/12New drug · Class 1 | QX005N注射液CXSL2300540 | 江苏荃信生物医药股份有限公司 |
| 2023/08/12New drug · Class 1 | RRG001眼内注射液CXSL2300539 | 上海鼎新基因科技有限公司 |
| 2023/08/12New drug · Class 1 | 注射用NBL-028CXSL2300538 | 上海新石生物医药有限公司 |
| 2023/08/12New drug · Class 1 | WXFL10203614片CXHL2300860 | 无锡福祈制药有限公司 |
| 2023/08/12New drug · Class 1 | WXFL10203614片CXHL2300859 | 无锡福祈制药有限公司 |
| 2023/08/12New drug · Class 1 | XS-03片CXHL2300858 | 江苏星盛新辉医药有限公司 |
| 2023/08/12New drug · Class 1 | XS-03片CXHL2300857 | 江苏星盛新辉医药有限公司 |
| 2023/08/12New drug · Class 1 | XS-03片CXHL2300856 | 江苏星盛新辉医药有限公司 |
| 2023/08/12New drug · Class 2.4 | 枸橼酸坦度螺酮胶囊CXHL2300855 | 四川科瑞德制药股份有限公司 |
| 2023/08/12New drug · Class 2.4 | 枸橼酸坦度螺酮胶囊CXHL2300854 | 四川科瑞德制药股份有限公司 |
| 2023/08/11Generic · Class 3 | 帕拉米韦注射液CYHS2302082 | 陕西博森生物制药股份集团有限公司 |
| 2023/08/10Generic · Class 3 | 硫酸沙丁胺醇注射液CYHS2302079 | 四川国瑞药业有限责任公司 |
| 2023/08/10New drug · Class 1 | M108单抗注射液CXSL2300537 | 明济生物制药（北京）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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