药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/06/24 – 2025/06/30
- New acceptances this week
- 310
- Drugs with new generic filings (by drug name, de-duplicated)
- 54
- Accepted this week, now under review
- 55
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
310filings, 72 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 168 |
| Generic | 72 |
| New drug | 43 |
| Import re-registration | 14 |
| Import | 10 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 181 |
| TCM | 84 |
| 治疗用生物制品 | 42 |
| 预防用生物制品 | 2 |
| 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
54 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 乙酰半胱氨酸注射液 | 7 | 7 | 53 |
| 2 | 非布司他片 | 3 | 2 | 15 |
| 3 | 普瑞巴林缓释片 | 3 | 1 | 13 |
| 4 | 佩玛贝特片 | 2 | 2 | 25 |
| 5 | 依巴斯汀口服溶液 | 2 | 2 | 9 |
| 6 | 对乙酰氨基酚布洛芬片 | 2 | 2 | 7 |
| 7 | 氧 | 2 | 2 | 15 |
| 8 | 沙库巴曲缬沙坦钠片 | 2 | 2 | 72 |
| 9 | 瑞维那新吸入溶液 | 2 | 2 | 53 |
| 10 | 盐酸丙卡特罗颗粒 | 2 | 1 | 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
206 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 黑龙江君安药业集团鸿祥制药有限公司 | 13 | 13 | 0 |
| 2 | 大同市利群药业有限责任公司 | 5 | 5 | 0 |
| 3 | 山西华康药业股份有限公司 | 5 | 5 | 0 |
| 4 | 兰州太宝制药有限公司 | 4 | 3 | 0 |
| 5 | 天方药业有限公司 | 4 | 3 | 1 |
| 6 | 山东新华制药股份有限公司 | 4 | 3 | 2 |
| 7 | 广东和香生物医药有限公司 | 4 | 3 | 0 |
| 8 | 神威药业集团有限公司 | 4 | 3 | 0 |
| 9 | Pfizer Australia Pty Ltd | 4 | 2 | 0 |
| 10 | Roche Pharma (Schweiz) AG | 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
75 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/06/30Generic · Class 3 | 氨溴特罗口服溶液CYHS2502325 | 通化万通药业股份有限公司 |
| 2025/06/30New drug · Class 1 | 注射用DXC014CXSL2500523 | 杭州多禧生物科技有限公司 |
| 2025/06/28Import · Class 1 | PF-07868489JXSL2500114 | Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd. |
| 2025/06/28Import · Class 1 | VAY736注射液JXSL2500113 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/06/28Generic · Class 3 | 普瑞巴林缓释片CYHS2502317 | 石药集团欧意药业有限公司 |
| 2025/06/28Generic · Class 3 | 普瑞巴林缓释片CYHS2502316 | 石药集团欧意药业有限公司 |
| 2025/06/28Generic · Class 3 | 普瑞巴林缓释片CYHS2502315 | 石药集团欧意药业有限公司 |
| 2025/06/28Generic · Class 3 | 坎地沙坦酯氢氯噻嗪片(Ⅱ)CYHS2502312 | 江西施美药业股份有限公司 |
| 2025/06/28Generic · Class 3 | 坎地沙坦酯氢氯噻嗪片(Ⅰ)CYHS2502311 | 江西施美药业股份有限公司 |
| 2025/06/28Generic · Class 3 | 利多卡因丁卡因乳膏CYHS2502305 | 浙江孚诺医药股份有限公司 |
| 2025/06/28Generic · Class 3 | 瑞卢戈利片CYHL2500122 | 成都倍特药业股份有限公司 |
| 2025/06/28New drug · Class 1.1 | 补肾痹通丸CXZL2500042 | 新疆维吾尔自治区中医医院 |
| 2025/06/28New drug · Class 1 | 重组乙型肝炎治疗性疫苗CXSL2500522 | 远大赛威信生命科学(南京)有限公司; 远大赛威信生命科学(杭州)有限公司 |
| 2025/06/28New drug · Class 1 | 重组乙型肝炎治疗性疫苗CXSL2500521 | 远大赛威信生命科学(南京)有限公司; 远大赛威信生命科学(杭州)有限公司 |
| 2025/06/28New drug · Class 1 | 注射用MHB048CCXSL2500520 | 明慧医药(杭州)有限公司 |
| 2025/06/28New drug · Class 1 | ALK2401片CXHL2500628 | 艾立康(合肥)医药科技有限公司 |
| 2025/06/28New drug · Class 1 | ALK2401片CXHL2500627 | 艾立康(合肥)医药科技有限公司 |
| 2025/06/28New drug · Class 1 | 64Cu-TR2205注射液CXHL2500626 | 通瑞生物制药(成都)有限公司 |
| 2025/06/27Generic · Class 3 | 注射用氢化可的松琥珀酸钠CYHS2502300 | 湖南醇健制药科技有限公司; 国药集团容生制药有限公司 |
| 2025/06/27Generic · Class 3 | 氨磺必利口服溶液CYHS2502294 | 江苏贝佳制药有限公司 |
| 2025/06/27Generic · Class 3 | 依巴斯汀口服溶液CYHS2502291 | 海南斯达制药有限公司 |
| 2025/06/27New drug · Class 3.3 | 重组人促卵泡激素注射液CXSS2500071 | 成都景泽生物制药有限公司 |
| 2025/06/27New drug · Class 3.3 | 重组人促卵泡激素注射液CXSS2500070 | 成都景泽生物制药有限公司 |
| 2025/06/27New drug · Class 1 | 注射用QLC5508CXSL2500519 | 齐鲁制药有限公司 |
| 2025/06/27New drug · Class 2.2 | 培集成干扰素α-2注射液CXSL2500518 | 北京凯因科技股份有限公司 |
| 2025/06/27New drug · Class 1 | QLH12016胶囊CXHL2500625 | 齐鲁制药有限公司 |
| 2025/06/27New drug · Class 1 | QLH12016胶囊CXHL2500624 | 齐鲁制药有限公司 |
| 2025/06/27New drug · Class 1 | ICP-332片CXHL2500621 | 广州诺诚健华医药科技有限公司 |
| 2025/06/26Import · Class 3.1 | 注射用A型肉毒毒素JXSS2500098 | AbbVie Limited; Allergan Pharmaceuticals Ireland; Allergan Information Consulting (Shanghai) Co. Ltd. |
| 2025/06/26Import · Class 3.1 | 注射用A型肉毒毒素JXSS2500097 | AbbVie Limited; Allergan Pharmaceuticals Ireland; Allergan Information Consulting (Shanghai) Co. Ltd. |
45 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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