药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/07/08 – 2025/07/14
- New acceptances this week
- 469
- Drugs with new generic filings (by drug name, de-duplicated)
- 84
- 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
469filings, 128 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 192 |
| Generic | 128 |
| New drug | 107 |
| Import | 30 |
| Import re-registration | 10 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 318 |
| TCM | 79 |
| 治疗用生物制品 | 68 |
| Biologic | 2 |
| 预防用生物制品 | 2 |
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
84 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 恩格列净片 | 6 | 3 | 20 |
| 2 | 瑞维那新吸入溶液 | 5 | 5 | 53 |
| 3 | 复方电解质醋酸钠葡萄糖注射液 | 4 | 2 | 22 |
| 4 | 米诺地尔搽剂 | 4 | 2 | 49 |
| 5 | 富马酸喹硫平缓释片 | 4 | 1 | 0 |
| 6 | 盐酸胍法辛缓释片 | 4 | 1 | 4 |
| 7 | 比拉斯汀口服溶液 | 2 | 2 | 7 |
| 8 | 艾拉莫德片 | 2 | 2 | 24 |
| 9 | 艾普拉唑肠溶片 | 2 | 2 | 26 |
| 10 | 醋酸钠林格葡萄糖注射液(Ⅰ) | 2 | 2 | 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
275 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 黑龙江深行生物医药科技有限公司 | 17 | 14 | 0 |
| 2 | 山东盛迪医药有限公司 | 9 | 4 | 0 |
| 3 | 昆明中药厂有限公司 | 8 | 6 | 0 |
| 4 | 百济神州(苏州)生物科技有限公司 | 8 | 2 | 0 |
| 5 | 南京正大天晴制药有限公司 | 7 | 5 | 5 |
| 6 | 四川青山利康药业有限公司 | 7 | 4 | 7 |
| 7 | Eli Lilly and Company | 7 | 2 | 0 |
| 8 | AstraZeneca AB | 6 | 3 | 0 |
| 9 | Celgene Corporation | 6 | 1 | 0 |
| 10 | 苏州盛迪亚生物医药有限公司 | 5 | 5 | 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
183 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/07/14Import · Class 1 | IcoSema 注射液JXSL2500122 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2025/07/14Generic · Class 3 | 盐酸普萘洛尔注射液CYHS2502518 | 德全药品(江苏)股份有限公司 |
| 2025/07/14New drug · Class 2.2 | 恩朗苏拜单抗注射液CXSL2500588 | 石药集团巨石生物制药有限公司 |
| 2025/07/14New drug · Class 2.2 | QL2107注射液CXSL2500587 | 齐鲁制药有限公司 |
| 2025/07/14New drug · Class 1 | KDTV001注射液CXSL2500586 | 武汉凯德基诺生物技术有限公司 |
| 2025/07/14New drug · Class 1 | 注射用QLC5508CXSL2500585 | 齐鲁制药有限公司 |
| 2025/07/14New drug · Class 1 | EVM14注射液CXSL2500584 | 云顶新耀(北京)医药科技有限公司 |
| 2025/07/14New drug · Class 2.3 | BTP4507CXHL2500698 | 江苏诺和必拓新药研发有限公司; 北京阳光诺和药物研究股份有限公司; 北京百奥药业有限责任公司 |
| 2025/07/12Import · Class 1 | AZD5335JXSL2500121 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/07/12Import · Class 2.4 | 注射用六氟化硫微泡JXHL2500183 | Bracco International B.V.; Bracco Imaging Medical Technologies (Shanghai) Co. Ltd |
| 2025/07/12Import · Class 1 | AZD9574JXHL2500182 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/07/12Import · Class 1 | AZD9574JXHL2500181 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/07/12Import · Class 1 | AZD9574JXHL2500180 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/07/12Import · Class 1 | AZD9574JXHL2500179 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/07/12Generic · Class 3 | 盐酸西替利嗪干糖浆CYHS2502516 | 海南元盈医药科技有限公司; 海南海神同洲制药有限公司 |
| 2025/07/12Generic · Class 3 | 西咪替丁注射液CYHS2502505 | 森淼(山东)药业有限公司; 湖北津药药业股份有限公司 |
| 2025/07/12Generic · Class 3 | 复方聚乙二醇电解质散(Ⅱ)CYHS2502504 | 上海朝晖药业有限公司 |
| 2025/07/12Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液CYHS2502503 | 山东化药医药科技有限公司; 山东华鲁制药有限公司 |
| 2025/07/12Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液CYHS2502502 | 山东化药医药科技有限公司; 山东华鲁制药有限公司 |
| 2025/07/12Generic · Class 3 | 米诺地尔搽剂CYHS2502500 | 科笛生物医药(无锡)有限公司 |
| 2025/07/12Generic · Class 3 | 米诺地尔搽剂CYHS2502499 | 科笛生物医药(无锡)有限公司 |
| 2025/07/12Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液CYHS2502498 | 南京正大天晴制药有限公司 |
| 2025/07/12Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液CYHS2502497 | 南京正大天晴制药有限公司 |
| 2025/07/12Generic · Class 3 | 碳酸氢钠林格注射液(Ⅰ)CYHS2502496 | 南京正科医药股份有限公司; 山东华鲁制药有限公司 |
| 2025/07/12Generic · Class 3 | 米诺地尔搽剂CYHS2502494 | 湖北午时药业股份有限公司 |
| 2025/07/12Generic · Class 3 | 米诺地尔搽剂CYHS2502493 | 湖北午时药业股份有限公司 |
| 2025/07/12Generic · Class 3 | 注射用乳糖酸红霉素CYHS2502490 | 苏州朗科生物技术股份有限公司; 江苏海岸药业有限公司 |
| 2025/07/12Generic · Class 3 | 注射用乳糖酸红霉素CYHS2502489 | 苏州朗科生物技术股份有限公司; 江苏海岸药业有限公司 |
| 2025/07/12Generic · Class 3 | 吸入用盐酸氨溴索溶液CYHS2502485 | 北京韩美药品有限公司 |
| 2025/07/12Generic · Class 3 | 吸入用盐酸氨溴索溶液CYHS2502484 | 北京韩美药品有限公司 |
153 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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