药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/06/23 – 2026/06/29
- New acceptances this week
- 526
- Drugs with new generic filings (by drug name, de-duplicated)
- 52
- Accepted this week, now under review
- 165
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
526filings, 73 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 356 |
| Generic | 73 |
| New drug | 66 |
| Import | 18 |
| Unspecified | 10 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| TCM | 232 |
| Chemical drug | 215 |
| 治疗用生物制品 | 74 |
| Biologic | 4 |
| 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
52 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 | 11 | 6 | 38 |
| 2 | 米诺地尔搽剂 | 3 | 2 | 49 |
| 3 | 注射用磷霉素钠 | 3 | 1 | 13 |
| 4 | 艾托格列净片 | 2 | 2 | 11 |
| 5 | 注射用甲泼尼龙琥珀酸钠 | 2 | 1 | 12 |
| 6 | 环索奈德吸入气雾剂 | 2 | 1 | 0 |
| 7 | 盐酸丁卡因凝胶 | 2 | 1 | 5 |
| 8 | 盐酸溴己新口服溶液 | 2 | 1 | 23 |
| 9 | 硫酸特布他林注射液 | 2 | 1 | 2 |
| 10 | 马来酸左氨氯地平片 | 2 | 1 | 3 |
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
311 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 牡丹江灵泰药业股份有限公司 | 17 | 16 | 0 |
| 2 | 成都地奥集团天府药业股份有限公司 | 12 | 5 | 0 |
| 3 | 东阿阿胶股份有限公司 | 10 | 10 | 0 |
| 4 | 贵州益佰女子大药厂有限责任公司 | 7 | 7 | 0 |
| 5 | AstraZeneca AB | 7 | 6 | 0 |
| 6 | 哈尔滨珍宝制药有限公司 | 5 | 5 | 0 |
| 7 | 沈阳东新药业有限公司 | 5 | 5 | 0 |
| 8 | Janssen-Cilag International NV | 5 | 3 | 0 |
| 9 | 上海上药新亚药业有限公司 | 5 | 2 | 0 |
| 10 | 士泽生物药业(上海)有限公司 | 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 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
117 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/06/29Import · Class 2.4 | Revumenib片JXHL2600230 | Syndax Pharmaceuticals Inc.; PAREXEL China Co. Ltd. |
| 2026/06/29Import · Class 2.4 | Revumenib片JXHL2600229 | Syndax Pharmaceuticals Inc.; PAREXEL China Co. Ltd. |
| 2026/06/29Import · Class 2.4 | Revumenib片JXHL2600228 | Syndax Pharmaceuticals Inc.; PAREXEL China Co. Ltd. |
| 2026/06/29Generic · Class 3 | 米诺地尔搽剂CYHS2601529 | 安徽得宏生制药有限公司; 浙江鼎泰药业股份有限公司 |
| 2026/06/29Generic · Class 3 | 盐酸丁卡因凝胶CYHS2601527 | 湖南九典制药股份有限公司 |
| 2026/06/29Generic · Class 3 | 盐酸丁卡因凝胶CYHS2601526 | 湖南九典制药股份有限公司 |
| 2026/06/29Generic · Class 3 | 瑞加诺生注射液CYHS2601525 | 康普药业股份有限公司 |
| 2026/06/29Generic · Class 3 | 乙酰半胱氨酸片CYHS2601524 | 华益药业科技(安徽)有限公司 |
| 2026/06/29Generic · Class 3 | 醋酸钙片CYHS2601522 | 黑龙江龙德药业有限公司 |
| 2026/06/29Generic · Class 3 | 吡拉西坦注射液CYHS2601521 | 成都华宇制药有限公司 |
| 2026/06/29Generic · Class 3 | 注射用甲磺酸萘莫司他CYHS2601519 | 成都青山利康药业股份有限公司; 湖南科伦制药有限公司 |
| 2026/06/29Generic · Class 3 | 注射用甲磺酸萘莫司他CYHS2601518 | 成都青山利康药业股份有限公司; 湖南科伦制药有限公司 |
| 2026/06/29New drug · Class 2.2 | 注射用瑞康曲妥珠单抗CXSS2600103 | 苏州盛迪亚生物医药有限公司; 苏州盛迪亚生物医药有限公司(小分子SHR169106:江苏恒瑞医药股份有限公司) |
| 2026/06/29New drug · Class 1 | SHR-4610注射液CXSL2600683 | 上海盛迪医药有限公司 |
| 2026/06/29New drug · Class 1 | 注射用HS-20093CXSL2600682 | 上海翰森生物医药科技有限公司; 常州恒邦药业有限公司 |
| 2026/06/29New drug · Class 1 | 注射用HC029CXSL2600681 | 上海宏成药业有限公司 |
| 2026/06/29New drug · Class 1 | OX-1胶囊CXSL2600680 | 武汉康复得生物科技股份有限公司; 武汉康复得泌尿系结石研究院有限公司 |
| 2026/06/29New drug · Class 1 | OV329胶囊CXHL2600776 | 缔脉生物医药科技(上海)有限公司 |
| 2026/06/29New drug · Class 1 | OV329胶囊CXHL2600775 | 缔脉生物医药科技(上海)有限公司 |
| 2026/06/29New drug · Class 1 | SZJ0107片CXHL2600774 | 安徽三之健医药科技有限公司 |
| 2026/06/29New drug · Class 1 | BB3008片CXHL2600773 | 北京伯汇生物技术有限公司 |
| 2026/06/29New drug · Class 1 | BB3008片CXHL2600772 | 北京伯汇生物技术有限公司 |
| 2026/06/29New drug · Class 2.2;2.4 | CZ028CXHL2600771 | 浙江萃泽生物医药有限公司 |
| 2026/06/29New drug · Class 1 | HCXT-2001片CXHL2600770 | 上海瀚辰星泰医药科技有限公司 |
| 2026/06/29New drug · Class 1 | HCXT-2001片CXHL2600769 | 上海瀚辰星泰医药科技有限公司 |
| 2026/06/26Import · Class 1 | 托雷奇单抗注射液JXSS2600055 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/06/26Generic · Class 3 | 聚普瑞锌口崩片CYHS2601515 | 吉林省博大伟业制药有限公司 |
| 2026/06/26Generic · Class 3 | 比拉斯汀口崩片CYHS2601514 | 山东朗诺制药有限公司 |
| 2026/06/26Generic · Class 3 | 硫酸特布他林注射液CYHS2601511 | 江苏福邦药业有限公司 |
| 2026/06/26Generic · Class 3 | 硫酸特布他林注射液CYHS2601509 | 江苏福邦药业有限公司 |
87 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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