药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/10/14 – 2025/10/20
- New acceptances this week
- 635
- Drugs with new generic filings (by drug name, de-duplicated)
- 79
- Accepted this week, now under review
- 136
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
635filings, 107 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 346 |
| New drug | 117 |
| Generic | 107 |
| Unspecified | 34 |
| Import | 26 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 394 |
| TCM | 122 |
| 治疗用生物制品 | 84 |
| Biologic | 24 |
| 预防用生物制品 | 8 |
| Unspecified | 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
79 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 硫酸氨基葡萄糖胶囊 | 5 | 5 | 50 |
| 2 | 富马酸伏诺拉生片 | 4 | 2 | 58 |
| 3 | 沙库巴曲缬沙坦钠片 | 3 | 2 | 72 |
| 4 | 甘油灌肠剂 | 3 | 1 | 2 |
| 5 | 甲苯磺酸卢美哌隆胶囊 | 3 | 1 | 2 |
| 6 | 盐酸左米那普仑缓释胶囊 | 3 | 1 | 6 |
| 7 | 达普司他片 | 3 | 1 | 0 |
| 8 | 磷酸奥司他韦颗粒 | 2 | 2 | 11 |
| 9 | 呋喃妥因胶囊 | 2 | 1 | 4 |
| 10 | 地高辛注射液 | 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
319 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 吉林省祈克药业有限公司 | 74 | 54 | 0 |
| 2 | 福建盛迪医药有限公司 | 10 | 2 | 0 |
| 3 | AstraZeneca AB | 9 | 5 | 0 |
| 4 | 齐鲁制药有限公司 | 8 | 4 | 3 |
| 5 | Actelion Pharmaceuticals Ltd | 8 | 1 | 0 |
| 6 | Terumo Corporation Kofu Factory | 8 | 1 | 0 |
| 7 | 湖南诺纳医药科技有限公司 | 7 | 7 | 0 |
| 8 | 中山万汉制药有限公司 | 7 | 3 | 2 |
| 9 | Boehringer Ingelheim International GmbH | 7 | 1 | 0 |
| 10 | Wyeth Pharmaceutical Division of Wyeth Holdings LLC | 6 | 6 | 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
187 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/10/20New drug · Class 1 | EPI-003注射液CXSL2500909 | 益杰立科（上海）生物科技有限公司 |
| 2025/10/18Import · Class 3.1 | 古塞奇尤单抗注射液JXSL2500206 | Janssen-Cilag International NV; Johnson & Johnson (China) Investment Ltd. |
| 2025/10/18Import · Class 1 | Duvakitug注射液JXSL2500205 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2025/10/18Import · Class 1 | Duvakitug注射液JXSL2500204 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2025/10/18Import · Class 1 | Duvakitug注射液JXSL2500203 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2025/10/18Generic · Class 3 | 盐酸昂丹司琼口服溶液CYHS2503739 | 安徽新世纪药业有限公司 |
| 2025/10/18Generic · Class 3 | 盐酸昂丹司琼口服溶液CYHS2503738 | 安徽新世纪药业有限公司 |
| 2025/10/18Generic · Class 3 | 呋喃妥因胶囊CYHS2503732 | 西藏珠峰寿高生物药业有限公司; 山东药石药业有限公司 |
| 2025/10/18Generic · Class 3 | 呋喃妥因胶囊CYHS2503731 | 西藏珠峰寿高生物药业有限公司; 山东药石药业有限公司 |
| 2025/10/18Generic · Class 3 | 米诺地尔搽剂CYHS2503730 | 翔宇药业股份有限公司 |
| 2025/10/18Generic · Class 3 | 米诺地尔搽剂CYHS2503729 | 翔宇药业股份有限公司 |
| 2025/10/18Generic · Class 3 | 中性低钙腹膜透析液（碳酸氢盐-G2.5%）CYHS2503727 | 石家庄四药有限公司 |
| 2025/10/18New drug · Class 3.1 | 桃红四物颗粒CXZS2500045 | 上海凯宝药业股份有限公司 |
| 2025/10/18New drug · Class 2.3 | 舒肝解郁胶囊CXZS2500044 | 四川济生堂药业有限公司 |
| 2025/10/18New drug · Class 1 | AVL-101 注射液CXSL2500905 | 北京安韦拓生物医药有限公司; 安韦拓（固安）生物医药有限公司; 安韦拓（烟台）生物医药科技有限公司 |
| 2025/10/18New drug · Class 2.4 | 苹果酸奈诺沙星胶囊CXHS2500124 | 浙江医药股份有限公司新昌制药厂 |
| 2025/10/18New drug · Class 1 | MY008211A片CXHS2500123 | 武汉启瑞药业有限公司 |
| 2025/10/18New drug · Class 1 | ICP-488片CXHL2501138 | 北京诺诚健华医药科技有限公司 |
| 2025/10/17Import · Class 1 | Duvakitug注射液JXSL2500202 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2025/10/17Generic · Class 3 | 地高辛注射液CYHS2503725 | 河南普瑞药业有限公司 |
| 2025/10/17Generic · Class 3 | 地高辛注射液CYHS2503724 | 河南普瑞药业有限公司 |
| 2025/10/17Generic · Class 3 | 多种微量元素注射液（Ι）CYHS2503721 | 维生原（厦门）生物科技有限公司; 广东星昊药业有限公司 |
| 2025/10/17Generic · Class 3 | 醋酸锌颗粒CYHS2503719 | 四川科伦药业股份有限公司 |
| 2025/10/17Generic · Class 3 | 醋酸锌颗粒CYHS2503718 | 四川科伦药业股份有限公司 |
| 2025/10/17New drug · Class 2.1 | TFA003片CXZL2500101 | 杭州康恩贝制药有限公司 |
| 2025/10/17New drug · Class 1 | 注射用BG-C9074CXSL2500904 | 广州百济神州生物制药有限公司 |
| 2025/10/17New drug · Class 1 | IM19嵌合抗原受体T细胞注射液（IM19 CAR-T细胞注射液）CXSL2500903 | 山东金赛生物科技有限公司 |
| 2025/10/17New drug · Class 1 | INS19嵌合抗原受体T细胞注射液（INS19 CAR-T细胞注射液）CXSL2500902 | 山东金赛生物科技有限公司 |
| 2025/10/17New drug · Class 1 | INS19嵌合抗原受体T细胞注射液（INS19 CAR-T细胞注射液）CXSL2500901 | 山东金赛生物科技有限公司 |
| 2025/10/17New drug · Class 1 | MIL116注射液CXSL2500900 | 北京天广实生物技术股份有限公司 |
157 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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