药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/07/01 – 2025/07/07
- New acceptances this week
- 299
- Drugs with new generic filings (by drug name, de-duplicated)
- 49
- Accepted this week, now under review
- 57
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
299filings, 69 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 152 |
| Generic | 69 |
| New drug | 56 |
| Import | 15 |
| Import re-registration | 5 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 191 |
| TCM | 55 |
| 治疗用生物制品 | 51 |
| 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
49 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 磷酸奥司他韦胶囊 | 5 | 2 | 42 |
| 2 | 乙酰半胱氨酸注射液 | 3 | 3 | 53 |
| 3 | 瑞维那新吸入溶液 | 3 | 3 | 53 |
| 4 | 注射用头孢唑林钠 | 3 | 1 | 11 |
| 5 | 阿昔洛韦片 | 3 | 1 | 6 |
| 6 | 蔗糖羟基氧化铁咀嚼片 | 2 | 2 | 0 |
| 7 | 帕拉米韦氯化钠注射液 | 2 | 1 | 17 |
| 8 | 氨溴特罗口服溶液 | 2 | 1 | 23 |
| 9 | 氨甲环酸片 | 2 | 1 | 11 |
| 10 | 沙库巴曲缬沙坦钠片 | 2 | 1 | 72 |
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
188 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 广西来宾葫芦娃药业有限公司 | 6 | 6 | 0 |
| 2 | 津药达仁堂集团股份有限公司达仁堂制药厂 | 6 | 5 | 0 |
| 3 | 齐鲁制药有限公司 | 5 | 3 | 0 |
| 4 | Celgene Corporation | 5 | 1 | 0 |
| 5 | Karuna Therapeutics Inc. | 5 | 1 | 0 |
| 6 | 广东和香生物医药有限公司 | 4 | 4 | 0 |
| 7 | 贵州益佰女子大药厂有限责任公司 | 4 | 4 | 0 |
| 8 | 湖南科伦制药有限公司 | 4 | 3 | 0 |
| 9 | Eli Lilly Nederland B.V. | 4 | 2 | 0 |
| 10 | 宜昌人福药业有限责任公司 | 4 | 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
96 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/07/07New drug · Class 3.3 | QL2106注射液CXSL2500545 | 齐鲁制药有限公司 |
| 2025/07/05Import · Class 1 | 乙磺酸LY4066434片JXHL2500161 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/07/05Import · Class 1 | 乙磺酸LY4066434片JXHL2500160 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/07/05Import · Class 1 | 乙磺酸LY4066434片JXHL2500159 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/07/05Generic · Class 3 | 阿昔洛韦片CYHS2502385 | 浙江车头制药股份有限公司; 浙江京新药业股份有限公司 |
| 2025/07/05Generic · Class 3 | 阿昔洛韦片CYHS2502384 | 浙江车头制药股份有限公司; 浙江京新药业股份有限公司 |
| 2025/07/05Generic · Class 3 | 阿昔洛韦片CYHS2502383 | 浙江车头制药股份有限公司; 浙江京新药业股份有限公司 |
| 2025/07/05Generic · Class 3 | 普瑞巴林口服溶液CYHS2502378 | 石家庄市华新药业有限责任公司 |
| 2025/07/05New drug · Class 1.1 | 参榆消银软膏CXZL2500044 | 北京斯利安药业有限公司 |
| 2025/07/05New drug · Class 3.3 | 司美格鲁肽注射液CXSL2500551 | 太极集团重庆涪陵制药厂有限公司 |
| 2025/07/05New drug · Class 3.3 | 司美格鲁肽注射液CXSL2500550 | 太极集团重庆涪陵制药厂有限公司 |
| 2025/07/05New drug · Class 1 | HEC-151注射液CXSL2500549 | 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 |
| 2025/07/05New drug · Class 1 | 人脐带CD146间充质干细胞注射液CXSL2500548 | 北京三有利康细胞科技有限公司 |
| 2025/07/05New drug · Class 1 | 宫血间充质干细胞注射液CXSL2500547 | 浙江生创精准医疗科技有限公司 |
| 2025/07/05New drug · Class 1 | QH104A细胞注射液CXSL2500546 | 北京清辉联诺生物科技有限责任公司 |
| 2025/07/05New drug · Class 1 | IPG0521注射液CXSL2500544 | 南京艾美斐生物医药科技有限公司 |
| 2025/07/05New drug · Class 1 | GZR101-80注射液CXSL2500543 | 甘李药业山东有限公司 |
| 2025/07/05New drug · Class 1 | 注射用MCLA-129CXSL2500542 | 贝达药业股份有限公司 |
| 2025/07/05New drug · Class 1 | 人源化抗CD19 CAR-T细胞注射液CXSL2500541 | 沈阳竞生生物科技有限公司 |
| 2025/07/05New drug · Class 1 | ZHB110舌下片CXSL2500540 | 江苏众红生物工程创药研究院有限公司 |
| 2025/07/05New drug · Class 1 | ZHB110舌下片CXSL2500539 | 江苏众红生物工程创药研究院有限公司 |
| 2025/07/05New drug · Class 2.2 | 布瑞哌唑口溶膜CXHS2500072 | 深圳市宇健生物医药有限公司; 深圳市新阳唯康科技有限公司 |
| 2025/07/05New drug · Class 2.2 | 布瑞哌唑口溶膜CXHS2500071 | 深圳市宇健生物医药有限公司; 深圳市新阳唯康科技有限公司 |
| 2025/07/05New drug · Class 1 | 硫酸酯化聚古罗糖醛酸钠颗粒CXHL2500650 | 中国科学院上海药物研究所; 绿谷(上海)医药科技有限公司 |
| 2025/07/05New drug · Class 1 | SYH2066片CXHL2500649 | 石药集团欧意药业有限公司 |
| 2025/07/05New drug · Class 1 | SYH2066片CXHL2500648 | 石药集团欧意药业有限公司 |
| 2025/07/05New drug · Class 2.4 | 盐酸恩沙替尼胶囊CXHL2500647 | 贝达药业股份有限公司 |
| 2025/07/05New drug · Class 2.4 | 盐酸恩沙替尼胶囊CXHL2500646 | 贝达药业股份有限公司 |
| 2025/07/04Import · Class 2.3 | 迈之灵片JXZL2500002 | Aescuven Pharma Deutschland GmbH & Co.KG; Shenzhen Xingyin Pharmaceutical Co. Ltd. |
| 2025/07/04Import · Class 2.3 | 迈之灵片JXZL2500001 | Aescuven Pharma Deutschland GmbH & Co. KG; Shenzhen Xingyin Pharmaceutical Co. Ltd. |
66 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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