药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/06/16 – 2026/06/22
- New acceptances this week
- 383
- Drugs with new generic filings (by drug name, de-duplicated)
- 37
- Accepted this week, now under review
- 109
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
383filings, 49 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 236 |
| New drug | 58 |
| Generic | 49 |
| Import | 20 |
| Unspecified | 10 |
| Import re-registration | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 168 |
| TCM | 144 |
| 治疗用生物制品 | 62 |
| 预防用生物制品 | 6 |
| Biologic | 3 |
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
37 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 注射用甲磺酸萘莫司他 | 4 | 2 | 38 |
| 2 | 注射用盐酸兰地洛尔 | 3 | 3 | 19 |
| 3 | 盐酸普萘洛尔口服溶液 | 2 | 2 | 4 |
| 4 | 富马酸依美斯汀缓释胶囊 | 2 | 1 | 11 |
| 5 | 环硅酸锆钠散 | 2 | 1 | 12 |
| 6 | 碘佛醇注射液 | 2 | 1 | 9 |
| 7 | 苯磺酸左氨氯地平片 | 2 | 1 | 47 |
| 8 | 苯磺酸美洛加巴林片 | 2 | 1 | 58 |
| 9 | 达格列净片 | 2 | 1 | 82 |
| 10 | 乙酰半胱氨酸片 | 1 | 1 | 8 |
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
227 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 中美华医(河北)制药有限公司 | 9 | 9 | 0 |
| 2 | 陕西东泰制药有限公司 | 8 | 8 | 0 |
| 3 | Novo Nordisk A/S | 8 | 2 | 0 |
| 4 | 黑龙江珍宝岛药业股份有限公司 | 6 | 6 | 0 |
| 5 | 北京同仁堂科技发展股份有限公司制药厂 | 5 | 4 | 0 |
| 6 | 浙江我武生物科技股份有限公司 | 5 | 1 | 0 |
| 7 | 山西华康药业股份有限公司 | 4 | 4 | 0 |
| 8 | 山西晋新双鹤药业有限责任公司 | 4 | 4 | 0 |
| 9 | 四川省通园制药集团有限公司 | 4 | 2 | 0 |
| 10 | Bristol-Myers Squibb Pharma EEIG | 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 no longer on the under-review list whose last snapshot sighting falls in this week, meaning approved or terminated, to be verified. Companies are counted by first applicant.
Class 3 and new-drug acceptances
104 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/06/22Import · Class 2.4 | 甲苯磺酸他拉唑帕利胶囊JXHS2600071 | Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd. |
| 2026/06/22Import · Class 2.4 | 甲苯磺酸他拉唑帕利胶囊JXHS2600070 | Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd. |
| 2026/06/22Import · Class 2.4 | 甲苯磺酸他拉唑帕利胶囊JXHS2600069 | Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd. |
| 2026/06/22Import · Class 2.4 | 甲苯磺酸他拉唑帕利胶囊JXHS2600068 | Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd. |
| 2026/06/22Generic · Class 3 | 乙酰半胱氨酸片CYHS2601460 | 浙江金华康恩贝生物制药有限公司 |
| 2026/06/22Generic · Class 3 | 盐酸多西环素片CYHS2601459 | 福建海西新药创制股份有限公司 |
| 2026/06/22New drug · Class 3.1 | 清金化痰汤颗粒CXZS2600032 | 湖南九典制药股份有限公司 |
| 2026/06/22New drug · Class 1 | 注射用LYNC-101CXSL2600660 | 翎泰天润生物技术(上海)有限公司 |
| 2026/06/22New drug · Class 1 | TVAX-008注射液CXSL2600659 | 远大赛威信生命科学(杭州)有限公司 |
| 2026/06/22New drug · Class 1.2 | 新型流感病毒mRNA疫苗CXSL2600658 | 华兰生物疫苗股份有限公司 |
| 2026/06/22New drug · Class 1 | MT2004胶囊CXHL2600745 | 西安奥立泰医药科技有限公司 |
| 2026/06/22New drug · Class 1 | MT2004胶囊CXHL2600744 | 西安奥立泰医药科技有限公司 |
| 2026/06/22New drug · Class 1 | AHB-137注射液CXHL2600743 | 杭州浩博医药有限公司 |
| 2026/06/18Import · Class 1 | BI 764532 输注用浓缩粉末JXSL2600146 | Boehringer lngelheim International GmbH; Boehringer lngelheim (China) Investment Co. Ltd. |
| 2026/06/18Generic · Class 3 | 注射用甲磺酸萘莫司他CYHS2601456 | 山东百诺医药股份有限公司; 吉林津升制药有限公司 |
| 2026/06/18Generic · Class 3 | 注射用甲磺酸萘莫司他CYHS2601455 | 山东百诺医药股份有限公司; 吉林津升制药有限公司 |
| 2026/06/18Generic · Class 3 | 富马酸依美斯汀缓释胶囊CYHS2601452 | 桂林华信制药有限公司 |
| 2026/06/18Generic · Class 3 | 富马酸依美斯汀缓释胶囊CYHS2601451 | 桂林华信制药有限公司 |
| 2026/06/18Generic · Class 3 | 对乙酰氨基酚甘露醇注射液CYHS2601450 | 广州南新制药有限公司; 东莞市普济药业有限公司 |
| 2026/06/18Generic · Class 3 | 盐酸普萘洛尔口服溶液CYHS2601449 | 江苏天士力帝益药业有限公司 |
| 2026/06/18Generic · Class 3 | 盐酸氨溴索滴剂CYHS2601448 | 江苏天士力帝益药业有限公司 |
| 2026/06/18New drug · Class 1 | Pumitamig注射液CXSL2600657 | 百欧恩泰(上海)医药有限公司 |
| 2026/06/18New drug · Class 1 | HEC-921注射液CXSL2600656 | 东莞市东阳光生物药研发有限公司; 广东东阳光药业股份有限公司 |
| 2026/06/18New drug · Class 1 | YKYY033注射液CXHL2600742 | 北京悦康科创医药科技股份有限公司; 杭州天龙药业有限公司 |
| 2026/06/18New drug · Class 1 | YKYY033注射液CXHL2600741 | 北京悦康科创医药科技股份有限公司; 杭州天龙药业有限公司 |
| 2026/06/18New drug · Class 2.3 | TSL2402片CXHL2600740 | 天津天士力圣特制药有限公司; 中国药科大学 |
| 2026/06/17Import · Class 1 | Lunsekimig注射液JXSL2600145 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2026/06/17Import · Class 1 | HDP-101JXSL2600144 | Heidelberg Pharma AG; Hangzhou Zhongmei HuaDong Pharmaceutical Co. Ltd. |
| 2026/06/17Import · Class 1 | ASP2138注射液JXSL2600143 | Astellas Pharma Global Development Inc.; Astellas (Beijing) Pharmaceutical R&D Co. Ltd. |
| 2026/06/17Generic · Class 3 | 氯化琥珀胆碱注射液CYHS2601444 | 北京远方通达医药技术有限公司; 山西威奇达光明制药有限公司 |
74 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.