药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/11/08 – 2022/11/14
- New acceptances this week
- 302
- Drugs with new generic filings (by drug name, de-duplicated)
- 54
- 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
302filings, 81 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 156 |
| Generic | 81 |
| New drug | 36 |
| Import | 13 |
| Unspecified | 12 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 207 |
| TCM | 68 |
| 治疗用生物制品 | 25 |
| Biologic | 1 |
| 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
54 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 布洛芬注射液 | 5 | 3 | 4 |
| 2 | 普瑞巴林胶囊 | 3 | 1 | 12 |
| 3 | 氨甲环酸注射液 | 3 | 1 | 11 |
| 4 | 盐酸利多卡因注射液 | 3 | 1 | 6 |
| 5 | 盐酸莫西沙星滴眼液 | 2 | 2 | 5 |
| 6 | 磷酸奥司他韦干混悬剂 | 2 | 2 | 2 |
| 7 | 伏立康唑片 | 2 | 1 | 1 |
| 8 | 富马酸非索罗定缓释片 | 2 | 1 | 0 |
| 9 | 布洛氢可酮片 | 2 | 1 | 0 |
| 10 | 枸橼酸坦度螺酮片 | 2 | 1 | 2 |
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
166 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 甘肃新岷海制药有限公司 | 18 | 18 | 0 |
| 2 | 内蒙古孟和制药股份有限公司 | 13 | 13 | 0 |
| 3 | 亳州亚英医药科技有限公司 | 10 | 9 | 0 |
| 4 | 广西联禾生生药业有限责任公司 | 6 | 6 | 0 |
| 5 | 哈尔滨瀚邦医疗科技有限公司 | 5 | 1 | 0 |
| 6 | 江苏普莱医药生物技术有限公司 | 5 | 1 | 0 |
| 7 | 成都倍特药业股份有限公司 | 4 | 2 | 1 |
| 8 | 湖北一半天制药有限公司 | 4 | 2 | 0 |
| 9 | Excella GmbH & Co. KG | 4 | 1 | 0 |
| 10 | IBSA Institut Biochimique SA | 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
71 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/11/14Generic · Class 3 | 盐酸利多卡因注射液CYHS2201979 | 北京世桥生物制药有限公司 |
| 2022/11/14Generic · Class 3 | 盐酸利多卡因注射液CYHS2201978 | 北京世桥生物制药有限公司 |
| 2022/11/14Generic · Class 3 | 盐酸利多卡因注射液CYHS2201977 | 北京世桥生物制药有限公司 |
| 2022/11/14Generic · Class 3 | 羟苯磺酸钙片CYHS2201974 | 浙江视方极医药科技有限公司; 宁夏康亚药业股份有限公司 |
| 2022/11/14New drug · Class 1 | SIM0270胶囊CXHL2200894 | 先声药业有限公司 |
| 2022/11/13Import · Class 2.2;2.4 | INOpulseJXHL2200334 | Bellerophon Pulse Technologies LLC; Baylor Biosciences Inc |
| 2022/11/12Import · Class 1 | Remternetug注射液(静脉注射)JXSL2200200 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/11/12Import · Class 1 | Remternetug注射液JXSL2200199 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/11/12Import · Class 1 | 注射用OregovomabJXSL2200198 | OncoQuest Pharmaceuticals Inc.; IQVIA RDS (Shanghai) Co. Ltd. |
| 2022/11/12Generic · Class 3 | 氨溴特罗口服溶液CYHS2201970 | 上海葆隆生物科技有限公司; 上海美优制药有限公司 |
| 2022/11/12Generic · Class 3 | 布洛芬注射液CYHS2201969 | 山东罗欣药业集团股份有限公司 |
| 2022/11/12Generic · Class 3 | 镥[177Lu]氧奥曲肽注射液CYHL2200102 | 天津恒瑞医药有限公司 |
| 2022/11/12New drug · Class 1 | SM3321注射液CXSL2200572 | 北京烁星生物医药科技有限公司 |
| 2022/11/12New drug · Class 1 | NMM肿瘤治疗性DNA疫苗裸质粒注射液CXSL2200571 | 固安鼎泰海规生物科技有限公司 |
| 2022/11/12New drug · Class 1 | 注射用IMM01CXSL2200570 | 宜明昂科生物医药技术(上海)股份有限公司 |
| 2022/11/12New drug · Class 1 | 莫非赛定利托那韦片CXHL2200893 | 广东东阳光药业有限公司 |
| 2022/11/12New drug · Class 1 | 注射用贺普拉肽CXHL2200892 | 上海贺普药业股份有限公司 |
| 2022/11/12New drug · Class 2.2 | HECB1701001缓释片CXHL2200891 | 广东东阳光药业有限公司 |
| 2022/11/12New drug · Class 2.2 | HECB1701001缓释片CXHL2200890 | 广东东阳光药业有限公司 |
| 2022/11/11Generic · Class 3 | 磷酸奥司他韦干混悬剂CYHS2201959 | 海南斯达制药有限公司; 天津汉瑞药业有限公司 |
| 2022/11/11Generic · Class 3 | 钠钾镁钙葡萄糖注射液CYHS2201956 | 宜昌人福药业有限责任公司; 宜昌三峡制药有限公司 |
| 2022/11/11Generic · Class 3 | 布洛氢可酮片CYHS2201954 | 宜昌人福药业有限责任公司 |
| 2022/11/11Generic · Class 3 | 布洛氢可酮片CYHS2201953 | 宜昌人福药业有限责任公司 |
| 2022/11/11Generic · Class 3 | 酮咯酸氨丁三醇注射液CYHS2201947 | 吉林振澳制药有限公司 |
| 2022/11/11Generic · Class 3 | 盐酸非索非那定干混悬剂CYHS2201943 | 济川药业集团有限公司 |
| 2022/11/11Generic · Class 3 | 盐酸非索非那定干混悬剂CYHS2201942 | 济川药业集团有限公司 |
| 2022/11/11New drug · Class 1.1 | 风叶咳喘平口服液CXZS2200014 | 卓和药业集团股份有限公司; 亚宝药业四川制药有限公司 |
| 2022/11/11New drug · Class 1.1 | 止得咳颗粒CXZL2200049 | 广西中医药大学附属瑞康医院; 广西中医药大学 |
| 2022/11/11New drug · Class 1 | GC001溶瘤痘苗病毒注射液CXSL2200569 | 杭州功楚生物科技有限公司 |
| 2022/11/10Generic · Class 3 | 注射用尼可地尔CYHS2201940 | 科贝园(北京)医药科技有限公司; 山西普德药业有限公司 |
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.
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