药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/09/02 – 2025/09/08
- New acceptances this week
- 413
- Drugs with new generic filings (by drug name, de-duplicated)
- 79
- Accepted this week, now under review
- 131
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
413filings, 119 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 175 |
| Generic | 119 |
| New drug | 79 |
| Import | 29 |
| Unspecified | 6 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 271 |
| TCM | 74 |
| 治疗用生物制品 | 63 |
| Biologic | 4 |
| 预防用生物制品 | 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
79 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 沙库巴曲缬沙坦钠片 | 8 | 3 | 72 |
| 2 | 聚多卡醇注射液 | 4 | 2 | 21 |
| 3 | 苯磺酸左氨氯地平片 | 3 | 2 | 47 |
| 4 | 奥扎格雷钠注射液 | 3 | 1 | 5 |
| 5 | 左羟丙哌嗪口服溶液 | 3 | 1 | 8 |
| 6 | 布瑞哌唑片 | 3 | 1 | 31 |
| 7 | 佩玛贝特片 | 2 | 2 | 25 |
| 8 | 注射用头孢他啶阿维巴坦钠 | 2 | 2 | 12 |
| 9 | 利伐沙班片 | 2 | 1 | 3 |
| 10 | 双氯芬酸二乙胺乳胶剂 | 2 | 1 | 21 |
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
241 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 福建盛迪医药有限公司 | 11 | 2 | 0 |
| 2 | 齐鲁制药有限公司 | 10 | 5 | 2 |
| 3 | 福州海王金象中药制药有限公司 | 9 | 7 | 0 |
| 4 | 天方药业有限公司 | 8 | 8 | 0 |
| 5 | Eli Lilly and Company | 8 | 2 | 0 |
| 6 | Janssen Research & Development LLC | 6 | 2 | 0 |
| 7 | 山东健滨医药科技有限公司 | 5 | 5 | 0 |
| 8 | 湖北科伦药业有限公司 | 5 | 1 | 0 |
| 9 | 四川依科制药有限公司 | 4 | 2 | 4 |
| 10 | 上海奥科达医药科技股份有限公司 | 4 | 1 | 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
153 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/09/08Generic · Class 3 | 重酒石酸去甲肾上腺素注射液CYHS2503325 | 辰欣药业股份有限公司 |
| 2025/09/08Generic · Class 3 | 硫酸奈替米星注射液CYHS2503318 | 江苏润恒制药有限公司 |
| 2025/09/08Generic · Class 3 | 中性低钙腹膜透析液（乳酸盐-G1.5%）CYHS2503317 | 石家庄四药有限公司 |
| 2025/09/08Generic · Class 3 | 盐酸克林霉素棕榈酸酯颗粒CYHS2503314 | 广州大光制药有限公司; 湖北唯森制药有限公司 |
| 2025/09/08Generic · Class 3 | 盐酸达克罗宁局部溶液CYHL2500163 | 中山万汉制药有限公司 |
| 2025/09/08New drug · Class 1 | CM383(SC)注射液CXSL2500775 | 康诺亚生物医药科技（成都）有限公司 |
| 2025/09/06Import · Class 2.2 | 帕博利珠单抗注射液JXSS2500122 | MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2025/09/06Import · Class 1 | FUB523注射液JXSL2500169 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/09/06Generic · Class 3 | 复方醋酸钠葡萄糖注射液CYHS2503313 | 山东齐都药业有限公司 |
| 2025/09/06Generic · Class 3 | 复方醋酸钠葡萄糖注射液CYHS2503312 | 山东齐都药业有限公司 |
| 2025/09/06Generic · Class 3 | 硫普罗宁片CYHS2503304 | 北京远方通达医药技术有限公司; 华益药业科技（安徽）有限公司 |
| 2025/09/06Generic · Class 3 | 瑞卢戈利片CYHL2500162 | 杭州康恩贝制药有限公司 |
| 2025/09/06New drug · Class 1.1 | 小儿六味湿疹凝胶CXZL2500075 | 山东汉方制药股份有限公司 |
| 2025/09/06New drug · Class 2.2 | 信迪利单抗注射液CXSL2500774 | 信达生物制药（苏州）有限公司 |
| 2025/09/06New drug · Class 1 | TQB2922注射液（皮下注射）CXSL2500773 | 上海正大天晴医药科技开发有限公司 |
| 2025/09/06New drug · Class 1 | ESG206注射液CXSL2500772 | 上海诗健生物科技有限公司 |
| 2025/09/06New drug · Class 1 | 注射用间充质干细胞（脐带）CXSL2500771 | 天津昂赛细胞基因工程有限公司 |
| 2025/09/06New drug · Class 1 | HWS117注射液CXSL2500770 | 湖北生物医药产业技术研究院有限公司 |
| 2025/09/06New drug · Class 1 | 注射用ZG006CXSL2500769 | 苏州泽璟生物制药股份有限公司; 上海泽璟医药技术有限公司 |
| 2025/09/06New drug · Class 1 | IBI3033CXSL2500768 | 信达生物制药（苏州）有限公司 |
| 2025/09/06New drug · Class 1 | IBI3033CXSL2500767 | 信达生物制药（苏州）有限公司 |
| 2025/09/06New drug · Class 1 | GW5282片CXHL2500970 | 迪哲（江苏）医药股份有限公司 |
| 2025/09/06New drug · Class 1 | GW5282片CXHL2500969 | 迪哲（江苏）医药股份有限公司 |
| 2025/09/06New drug · Class 1 | GS3-007a干混悬剂CXHL2500968 | 长春金赛药业有限责任公司 |
| 2025/09/06New drug · Class 1 | QLS1304片CXHL2500967 | 齐鲁制药有限公司 |
| 2025/09/06New drug · Class 1 | QLS1304片CXHL2500966 | 齐鲁制药有限公司 |
| 2025/09/06New drug · Class 1 | QLS1304片CXHL2500965 | 齐鲁制药有限公司 |
| 2025/09/06New drug · Class 1 | QLC1401片CXHL2500964 | 齐鲁制药有限公司 |
| 2025/09/06New drug · Class 2.4 | 阿贝西利片CXHL2500963 | 齐鲁制药有限公司 |
| 2025/09/06New drug · Class 2.4 | 阿贝西利片CXHL2500962 | 齐鲁制药有限公司 |
123 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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