药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/12/14 – 2021/12/20
- New acceptances this week
- 426
- Drugs with new generic filings (by drug name, de-duplicated)
- 36
- 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
426filings, 51 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 251 |
| New drug | 89 |
| Generic | 51 |
| Import | 13 |
| Import re-registration | 12 |
| Unspecified | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 311 |
| TCM | 60 |
| 治疗用生物制品 | 50 |
| 预防用生物制品 | 5 |
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
36 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸胍法辛缓释片 | 4 | 1 | 4 |
| 2 | 玻璃酸钠滴眼液 | 3 | 2 | 29 |
| 3 | 盐酸左沙丁胺醇雾化吸入溶液 | 3 | 1 | 2 |
| 4 | 吸入用盐酸氨溴索溶液 | 2 | 2 | 10 |
| 5 | 地氯雷他定口服溶液 | 2 | 2 | 26 |
| 6 | 维格列汀片 | 2 | 2 | 0 |
| 7 | 乙磺酸尼达尼布软胶囊 | 2 | 1 | 6 |
| 8 | 依普利酮片 | 2 | 1 | 4 |
| 9 | 吸入用异丙托溴铵溶液 | 2 | 1 | 2 |
| 10 | 枸橼酸西地那非片 | 2 | 1 | 12 |
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
187 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 华润双鹤药业股份有限公司 | 66 | 56 | 0 |
| 2 | 吉林省神鹿制药有限公司 | 32 | 25 | 0 |
| 3 | 郑州豫港之星制药有限公司 | 10 | 9 | 0 |
| 4 | 哈尔滨田美药业股份有限公司 | 10 | 6 | 0 |
| 5 | 贵州良济药业有限公司 | 6 | 6 | 0 |
| 6 | 黑龙江葵花药业股份有限公司 | 6 | 5 | 0 |
| 7 | 江苏恒瑞医药股份有限公司 | 6 | 3 | 0 |
| 8 | 宜昌人福药业有限责任公司 | 6 | 2 | 4 |
| 9 | Janssen-Cilag International NV | 6 | 1 | 0 |
| 10 | Eli Lilly and Company | 5 | 2 | 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
120 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/12/20Import · Class 1 | Ritlecitinib胶囊JXHL2101275 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2021/12/20Import · Class 1 | Ritlecitinib胶囊JXHL2101274 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2021/12/20Generic · Class 3 | 注射用头孢美唑钠/氯化钠注射液CYHS2102231 | 湖南科伦制药有限公司 |
| 2021/12/20Generic · Class 3 | 地氯雷他定口服溶液CYHS2102216 | 安徽新世纪药业有限公司 |
| 2021/12/20Generic · Class 3 | 乙酰唑胺缓释胶囊CYHL2101056 | 河南中帅医药科技股份有限公司 |
| 2021/12/20New drug · Class 1 | 注射用重组变构人肿瘤坏死因子相关凋亡诱导配体CXSS2101065 | 武汉海特生物制药股份有限公司 |
| 2021/12/20New drug · Class 1 | PM8002注射液CXSL2101495 | 普米斯生物技术（珠海）有限公司 |
| 2021/12/20New drug · Class 1 | SHR-1316注射液CXSL2101493 | 上海盛迪医药有限公司 |
| 2021/12/20New drug · Class 1 | 注射用SHR-A1811CXSL2101492 | 苏州盛迪亚生物医药有限公司 |
| 2021/12/20New drug · Class 1 | HBW-3220胶囊CXHL2101795 | 成都海博为药业有限公司 |
| 2021/12/20New drug · Class 1 | HMPL-689胶囊CXHL2101794 | 和记黄埔医药（上海）有限公司 |
| 2021/12/20New drug · Class 1 | HMPL-689胶囊CXHL2101793 | 和记黄埔医药（上海）有限公司 |
| 2021/12/20New drug · Class 2.4 | 马来酸吡咯替尼片CXHL2101792 | 江苏恒瑞医药股份有限公司 |
| 2021/12/20New drug · Class 2.4 | 马来酸吡咯替尼片CXHL2101791 | 江苏恒瑞医药股份有限公司 |
| 2021/12/20New drug · Class 1 | SHR0302片CXHL2101790 | 江苏恒瑞医药股份有限公司 |
| 2021/12/20New drug · Class 1 | SHR0302片CXHL2101789 | 江苏恒瑞医药股份有限公司 |
| 2021/12/20New drug · Class 1 | SHR0302片CXHL2101788 | 江苏恒瑞医药股份有限公司 |
| 2021/12/20New drug · Class 1 | IMP9064片CXHL2101780 | 上海瑛派药业有限公司 |
| 2021/12/20New drug · Class 1 | IMP9064片CXHL2101779 | 上海瑛派药业有限公司 |
| 2021/12/17Import · Class 1 | 注射用TNP-2092JXHL2101269 | TenNor Therapeutics Limited; TenNor (Suzhou) Therapeutics Limited |
| 2021/12/17Generic · Class 3 | 注射用甲氨蝶呤CYHS2102209 | 上海上药睿尔药品有限公司; 上海医药集团（本溪）北方药业有限公司 |
| 2021/12/17Generic · Class 3 | 依普利酮片CYHS2102151 | 南京卡文迪许生物工程技术有限公司; 江苏云阳集团药业有限公司 |
| 2021/12/17Generic · Class 3 | 依普利酮片CYHS2102150 | 南京卡文迪许生物工程技术有限公司; 江苏云阳集团药业有限公司 |
| 2021/12/17New drug · Class 1 | 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液CXSL2101491 | 江苏康宁杰瑞生物制药有限公司 |
| 2021/12/17New drug · Class 1 | 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液CXSL2101490 | 江苏康宁杰瑞生物制药有限公司 |
| 2021/12/17New drug · Class 1 | 人iPSC来源心肌细胞注射液CXSL2101489 | 南京艾尔普再生医学科技有限公司 |
| 2021/12/17New drug · Class 1 | 重组抗HER2结构域Ⅱ和结构域Ⅳ双特异性抗体注射液CXSL2101488 | 轩竹生物科技股份有限公司; 北京轩竹康明生物科技有限公司 |
| 2021/12/17New drug · Class 1 | YH001注射液CXSL2101481 | 祐和医药科技（北京）有限公司 |
| 2021/12/17New drug · Class 2.4 | 甲磺酸伏美替尼片CXHS2101055 | 上海艾力斯医药科技股份有限公司; 江苏艾力斯生物医药有限公司 |
| 2021/12/17New drug · Class 1 | ABSK061胶囊CXHL2101785 | 上海和誉生物医药科技有限公司 |
90 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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