药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/05/20 – 2025/05/26
- New acceptances this week
- 302
- Drugs with new generic filings (by drug name, de-duplicated)
- 48
- Accepted this week, now under review
- 49
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
302filings, 66 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 152 |
| Generic | 66 |
| New drug | 57 |
| Import | 15 |
| Unspecified | 10 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 188 |
| TCM | 57 |
| 治疗用生物制品 | 53 |
| 预防用生物制品 | 3 |
| 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
48 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 阿达帕林过氧苯甲酰凝胶 | 4 | 2 | 30 |
| 2 | 布瑞哌唑口崩片 | 3 | 1 | 10 |
| 3 | 氯化钾口服溶液 | 3 | 1 | 12 |
| 4 | 维立西呱片 | 3 | 1 | 8 |
| 5 | 硫酸氨基葡萄糖胶囊 | 2 | 2 | 50 |
| 6 | 艾拉莫德片 | 2 | 2 | 24 |
| 7 | 丙戊酸钠缓释微片 | 2 | 1 | 0 |
| 8 | 地氯雷他定口服溶液 | 2 | 1 | 26 |
| 9 | 注射用甲泼尼龙琥珀酸钠 | 2 | 1 | 12 |
| 10 | 注射用盐酸地尔硫？ | 2 | 1 | 7 |
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
185 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 福州海王金象中药制药有限公司 | 18 | 17 | 0 |
| 2 | AstraZeneca AB | 9 | 4 | 0 |
| 3 | 广东星昊药业有限公司 | 6 | 3 | 0 |
| 4 | 福建盛迪医药有限公司 | 6 | 1 | 0 |
| 5 | 常州制药厂有限公司 | 5 | 2 | 5 |
| 6 | 中美上海施贵宝制药有限公司 | 4 | 4 | 0 |
| 7 | 国药集团德众（佛山）药业有限公司 | 4 | 4 | 0 |
| 8 | 苏州盛迪亚生物医药有限公司 | 4 | 4 | 0 |
| 9 | 广西万通制药有限公司 | 4 | 2 | 0 |
| 10 | 百济神州（苏州）生物科技有限公司 | 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
95 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/05/24Import · Class 1 | 注射用FelzartamabJXSL2500082 | Biogen Idec Research Limited |
| 2025/05/24New drug · Class 2.2 | 瑞基奥仑赛注射液CXSS2500053 | 上海药明巨诺生物科技有限公司; 苏州药明巨诺生物科技有限公司 |
| 2025/05/24New drug · Class 1 | IBI363CXSL2500421 | 信达生物制药（苏州）有限公司 |
| 2025/05/24New drug · Class 1 | IBI363CXSL2500420 | 信达生物制药（苏州）有限公司 |
| 2025/05/24New drug · Class 1 | SSGJ-706注射液CXSL2500419 | 沈阳三生制药有限责任公司 |
| 2025/05/24New drug · Class 1 | SSGJ-706注射液CXSL2500418 | 沈阳三生制药有限责任公司 |
| 2025/05/24New drug · Class 1 | VB19055片CXHL2500509 | 浙江扬厉医药技术有限公司 |
| 2025/05/24New drug · Class 1 | VB19055片CXHL2500508 | 浙江扬厉医药技术有限公司 |
| 2025/05/24New drug · Class 1 | VB19055片CXHL2500507 | 浙江扬厉医药技术有限公司 |
| 2025/05/24New drug · Class 1 | VB19055片CXHL2500506 | 浙江扬厉医药技术有限公司 |
| 2025/05/24New drug · Class 2.2 | HKG-456CXHL2500505 | 海南元盈医药科技有限公司 |
| 2025/05/23Import · Class 1 | GHZ339注射液JXSL2500081 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/05/23Generic · Class 3 | 布瑞哌唑口崩片CYHS2501864 | 杭州和康药业有限公司 |
| 2025/05/23Generic · Class 3 | 布瑞哌唑口崩片CYHS2501863 | 杭州和康药业有限公司 |
| 2025/05/23Generic · Class 3 | 布瑞哌唑口崩片CYHS2501862 | 杭州和康药业有限公司 |
| 2025/05/23Generic · Class 3 | 铝碳酸镁混悬液CYHS2501860 | 浙江领创优品药业有限公司; 浙江赛默制药有限公司 |
| 2025/05/23Generic · Class 3 | 盐酸普罗帕酮注射液CYHS2501853 | 湖北天圣药业有限公司 |
| 2025/05/23Generic · Class 3 | 复合磷酸氢钾注射液CYHS2501851 | 济南康桥医药科技有限公司; 山东希尔康泰药业有限公司 |
| 2025/05/23New drug · Class 1.1 | 通利肠溶胶囊CXZS2500022 | 荣昌制药（淄博）有限公司 |
| 2025/05/23New drug · Class 3.1 | 完带颗粒CXZS2500021 | 四川光大制药有限公司 |
| 2025/05/23New drug · Class 1.1 | 固本清肺颗粒CXZL2500031 | 深圳市中医院 |
| 2025/05/23New drug · Class 1.1 | 紫英颗粒CXZL2500030 | 广东方盛融科药业有限公司 |
| 2025/05/23New drug · Class 3.3 | 注射用SIM0692CXSL2500417 | 山东先声生物制药有限公司 |
| 2025/05/23New drug · Class 1 | SHR-7782注射液CXSL2500416 | 苏州盛迪亚生物医药有限公司 |
| 2025/05/23New drug · Class 1 | SNUG01CXSL2500415 | 神济昌华（北京）生物科技有限公司 |
| 2025/05/23New drug · Class 1 | 斯乐韦米单抗注射液CXSL2500414 | 重庆智翔金泰生物制药股份有限公司 |
| 2025/05/23New drug · Class 2.2 | 盐酸奥洛他定口服溶液CXHL2500504 | 海南万玮制药有限公司 |
| 2025/05/23New drug · Class 1 | BGB-45035片CXHL2500503 | 百济神州（苏州）生物科技有限公司 |
| 2025/05/22Import · Class 1 | Depemokimab注射液JXSL2500080 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd. |
| 2025/05/22Generic · Class 3 | 地氯雷他定口服溶液CYHS2501850 | 江苏天士力帝益药业有限公司 |
65 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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