药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/10/07 – 2025/10/13
- New acceptances this week
- 199
- Drugs with new generic filings (by drug name, de-duplicated)
- 42
- Accepted this week, now under review
- 56
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
199filings, 48 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 96 |
| Generic | 48 |
| New drug | 37 |
| Import | 13 |
| Import re-registration | 4 |
| Unspecified | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 113 |
| TCM | 49 |
| 治疗用生物制品 | 35 |
| 体外诊断试剂 | 1 |
| Biologic | 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
42 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 呋塞米注射液 | 2 | 2 | 6 |
| 2 | 多替诺雷片 | 2 | 1 | 49 |
| 3 | 对乙酰氨基酚片 | 2 | 1 | 6 |
| 4 | 枸橼酸西地那非口溶膜 | 2 | 1 | 8 |
| 5 | 盐酸乐卡地平片 | 2 | 1 | 6 |
| 6 | 盐酸尼卡地平注射液 | 2 | 1 | 12 |
| 7 | 丙酸氟替卡松乳膏 | 1 | 1 | 12 |
| 8 | 亚叶酸钙注射液 | 1 | 1 | 4 |
| 9 | 佩玛贝特片 | 1 | 1 | 25 |
| 10 | 克立硼罗软膏 | 1 | 1 | 28 |
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
137 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 上海海思盛诺医药科技有限公司 | 6 | 3 | 0 |
| 2 | 吉林菲诺制药有限公司 | 5 | 5 | 0 |
| 3 | 江苏恒瑞医药股份有限公司 | 4 | 4 | 0 |
| 4 | 达嘉维康生物制药有限公司 | 4 | 4 | 0 |
| 5 | 陕西孙思邈高新制药有限公司 | 4 | 4 | 0 |
| 6 | AbbVie Deutschland GmbH & Co. KG | 4 | 1 | 0 |
| 7 | Bristol-Myers Squibb Company | 4 | 1 | 0 |
| 8 | 长春海外制药集团有限公司 | 4 | 1 | 0 |
| 9 | 四川泰华堂制药有限公司 | 3 | 3 | 0 |
| 10 | 杭州和泽坤元药业有限公司 | 3 | 3 | 3 |
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
62 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/10/13Import · Class 1 | 注射用E型肉毒毒素JXSS2500131 | AbbVie Limited; Allergan Pharmaceuticals Ireland Unlimited Company; Allergan Information Consulting (Shanghai) Co. Ltd |
| 2025/10/13New drug · Class 1 | 注射用BG-C0902CXSL2500877 | 广州百济神州生物制药有限公司 |
| 2025/10/13New drug · Class 2.2 | GLX002CXHL2501089 | 北京亚宝生物药业有限公司 |
| 2025/10/12New drug · Class 1.1 | 复方南藤胶囊CXZL2500094 | 南京中医药大学; 江苏金氏丹科技有限公司 |
| 2025/10/12New drug · Class 3.4 | 抗五步蛇毒血清CXSL2500869 | 江西生物制品研究所股份有限公司 |
| 2025/10/12New drug · Class 2.2 | 注射用硼[10B]法仑CXHL2501079 | 深圳市中核海得威生物科技有限公司 |
| 2025/10/12New drug · Class 1 | 注射用HSK55718CXHL2501078 | 上海海思盛诺医药科技有限公司 |
| 2025/10/12New drug · Class 1 | 注射用HSK55718CXHL2501077 | 上海海思盛诺医药科技有限公司 |
| 2025/10/12New drug · Class 1 | RTX-117片CXHL2501076 | 溪砾科技（深圳）有限公司 |
| 2025/10/12New drug · Class 1 | RTX-117片CXHL2501075 | 溪砾科技（深圳）有限公司 |
| 2025/10/12New drug · Class 1 | ICP-332CXHL2501074 | 广州诺诚健华医药科技有限公司 |
| 2025/10/11Import · Class 3.4 | 注射用A型肉毒毒素JXSS2500130 | Daewoong Pharmaceutical Co. Ltd.; Beijing Daewoong Pharmaceutical R&D Center Co. Ltd. |
| 2025/10/11Import · Class 2.4 | Entrectinib胶囊JXHL2500309 | F. Hoffmann-La Roche Ltd |
| 2025/10/11Generic · Class 3 | 多索茶碱片CYHS2503631 | 合肥合源药业有限公司 |
| 2025/10/11Generic · Class 3 | 枸橼酸西地那非口溶膜CYHS2503629 | 合肥华方医药科技有限公司; 合肥思普瑞药业有限公司 |
| 2025/10/11Generic · Class 3 | 枸橼酸西地那非口溶膜CYHS2503628 | 合肥华方医药科技有限公司; 合肥思普瑞药业有限公司 |
| 2025/10/11Generic · Class 3 | 硫代硫酸钠注射液CYHS2503624 | 成都诺和晟鸿生物制药有限公司; 成都天台山制药股份有限公司 |
| 2025/10/11Generic · Class 3 | 呋塞米注射液CYHS2503622 | 亚邦医药股份有限公司 |
| 2025/10/11Generic · Class 3 | 酮洛芬贴剂CYHL2500179 | 海南合瑞制药股份有限公司 |
| 2025/10/11New drug · Class 2.2 | TQA凝胶贴膏CXZL2500093 | 赛灵药业科技集团股份有限公司 |
| 2025/10/11New drug · Class 1 | 注射用ISH0688CXSL2500868 | 盛禾（中国）生物制药有限公司 |
| 2025/10/11New drug · Class 1 | YF-3注射液CXSL2500865 | 苏州永心生物科技有限公司 |
| 2025/10/11New drug · Class 1 | 人前/中脑神经前体细胞注射液CXSL2500864 | 浙江泉生生物科技有限公司 |
| 2025/10/11New drug · Class 1 | 注射用SHR-4394CXSL2500863 | 江苏恒瑞医药股份有限公司; 上海恒瑞医药有限公司 |
| 2025/10/11New drug · Class 1 | 重组人源化抗HER2双特异性抗体注射液CXSL2500862 | 上海津曼特生物科技有限公司 |
| 2025/10/11New drug · Class 1 | HSK45019片CXHL2501073 | 上海海思盛诺医药科技有限公司 |
| 2025/10/11New drug · Class 1 | HSK45019片CXHL2501072 | 上海海思盛诺医药科技有限公司 |
| 2025/10/11New drug · Class 1 | HRL1101散CXHL2501071 | 北京华睿鼎信科技有限公司; 湖南明瑞制药股份有限公司 |
| 2025/10/11New drug · Class 2.2 | 1861BCXHL2501070 | 普照国康（湖北）药业有限公司 |
| 2025/10/11New drug · Class 2.4 | 泽美妥司他片CXHL2501069 | 江苏恒瑞医药股份有限公司 |
32 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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