药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/02/18 – 2025/02/24
- New acceptances this week
- 282
- Drugs with new generic filings (by drug name, de-duplicated)
- 53
- Accepted this week, now under review
- 15
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
282filings, 72 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 142 |
| Generic | 72 |
| New drug | 47 |
| Import | 14 |
| Import re-registration | 4 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 194 |
| TCM | 46 |
| 治疗用生物制品 | 38 |
| 预防用生物制品 | 4 |
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
53 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 艾司奥美拉唑镁肠溶干混悬剂 | 4 | 2 | 4 |
| 2 | 盐酸美金刚多奈哌齐缓释胶囊 | 4 | 1 | 2 |
| 3 | 布瑞哌唑片 | 3 | 2 | 31 |
| 4 | 盐酸舍曲林口服浓缩液 | 2 | 2 | 3 |
| 5 | 复方电解质醋酸钠注射液 | 2 | 1 | 4 |
| 6 | 多种油脂肪乳注射液(C?~??) | 2 | 1 | 0 |
| 7 | 氯雷他定口服溶液 | 2 | 1 | 3 |
| 8 | 沙库巴曲缬沙坦钠片 | 2 | 1 | 72 |
| 9 | 注射用甲磺酸萘莫司他 | 2 | 1 | 38 |
| 10 | 环硅酸锆钠散 | 2 | 1 | 12 |
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
178 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 吉林菲诺制药有限公司 | 14 | 14 | 0 |
| 2 | 河南赢丰医药有限公司 | 10 | 6 | 0 |
| 3 | Janssen-Cilag International NV | 9 | 3 | 0 |
| 4 | 苏州盛迪亚生物医药有限公司 | 7 | 7 | 0 |
| 5 | 河北华晨药业集团有限公司 | 4 | 4 | 0 |
| 6 | 华川制药有限公司 | 4 | 3 | 0 |
| 7 | 博志研新泰州药物技术有限公司 | 4 | 1 | 4 |
| 8 | 石家庄四药有限公司 | 3 | 3 | 3 |
| 9 | 内蒙古库伦蒙药有限公司 | 3 | 2 | 0 |
| 10 | 四川好医生攀西药业有限责任公司 | 3 | 2 | 1 |
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 |
|---|---|---|
| 2025/02/22Generic · Class 3 | 盐酸舍曲林口服浓缩液CYHS2500823 | 海南海灵化学制药有限公司; 合肥诚志生物制药有限公司 |
| 2025/02/22Generic · Class 3 | 葡萄糖酸钙氯化钠注射液CYHS2500820 | 石家庄四药有限公司 |
| 2025/02/22Generic · Class 3 | 盐酸异丙肾上腺素注射液CYHS2500819 | 成都瑞尔医药科技有限公司; 成都市海通药业有限公司 |
| 2025/02/22Generic · Class 3 | 盐酸异丙肾上腺素注射液CYHS2500818 | 成都瑞尔医药科技有限公司; 成都市海通药业有限公司 |
| 2025/02/22Generic · Class 3 | 维生素K滴剂CYHS2500817 | 合肥科大生物技术有限公司; 安徽威尔曼制药有限公司 |
| 2025/02/22Generic · Class 3 | 帕拉米韦注射液CYHS2500816 | 安徽丰原药业股份有限公司 |
| 2025/02/22Generic · Class 3 | 腺苷钴胺胶囊CYHS2500814 | 湖南柏齐鹤药物研发有限公司; 浙江康恩贝制药股份有限公司 |
| 2025/02/22Generic · Class 3 | 注射用甲磺酸萘莫司他CYHL2500050 | 浙江同伍生物医药有限公司 |
| 2025/02/22Generic · Class 3 | 注射用甲磺酸萘莫司他CYHL2500049 | 浙江同伍生物医药有限公司 |
| 2025/02/22New drug · Class 2.2 | 伊匹木单抗注射液CXSS2500032 | 信达生物医药科技(杭州)有限公司; 信达生物制药(苏州)有限公司 |
| 2025/02/22New drug · Class 2.2 | 信迪利单抗注射液CXSS2500031 | 信达生物制药(苏州)有限公司 |
| 2025/02/22New drug · Class 1 | 注射用QLS5132CXSL2500173 | 齐鲁制药有限公司 |
| 2025/02/22New drug · Class 2.2;2.4 | 优替德隆胶囊CXHL2500214 | 成都华昊中天药业有限公司; 北京华昊中天生物医药股份有限公司 |
| 2025/02/22New drug · Class 2.2 | X001 干混悬剂CXHL2500213 | 辽宁海一制药有限公司 |
| 2025/02/22New drug · Class 1 | TFX06片CXHL2500212 | 浙江扬厉医药技术有限公司 |
| 2025/02/22New drug · Class 1 | TFX06片CXHL2500211 | 浙江扬厉医药技术有限公司 |
| 2025/02/21Import · Class 3.1 | Tremelimumab注射液JXSS2500016 | AstraZeneca AB; Vetter Pharma-Fertigung GmbH & Co. KG; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/02/21Import · Class 3.1 | Tremelimumab注射液JXSS2500015 | AstraZeneca AB; Vetter Pharma-Fertigung GmbH & Co. KG; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/02/21Import · Class 3.1 | 度伐利尤单抗注射液JXSS2500014 | AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2025/02/21Import · Class 3.1 | 度伐利尤单抗注射液JXSS2500013 | AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2025/02/21Generic · Class 3 | 乙酰半胱氨酸注射液CYHS2500813 | 远大医药(中国)有限公司 |
| 2025/02/21Generic · Class 3 | 草酸艾司西酞普兰口服溶液CYHS2500812 | 成都倍特得诺药业有限公司 |
| 2025/02/21Generic · Class 3 | 草酸艾司西酞普兰口服溶液CYHS2500811 | 成都倍特得诺药业有限公司 |
| 2025/02/21Generic · Class 3 | 盐酸缬更昔洛韦颗粒CYHS2500808 | 湖北唯森制药有限公司 |
| 2025/02/21New drug · Class 1 | TAEST1901注射液CXSL2500172 | 香雪生命科学技术(广东)有限公司 |
| 2025/02/21New drug · Class 2.2 | 吸附无细胞百白破(组分)b型流感嗜血杆菌(结合)联合疫苗CXSL2500171 | 北京智飞绿竹生物制药有限公司 |
| 2025/02/21New drug · Class 1 | Afuresertib片CXHL2500210 | 来凯制药(宁波)有限公司 |
| 2025/02/21New drug · Class 1 | Afuresertib片CXHL2500209 | 来凯制药(宁波)有限公司 |
| 2025/02/21New drug · Class 1 | WXSH0493片CXHL2500208 | 江苏康缘药业股份有限公司 |
| 2025/02/20Import · Class 2.4 | 硫酸氢司美替尼胶囊JXHS2500026 | ASTRAZENECA UK LIMITED; PATHEON PHARMACEUTICALS INCORPORATED; AstraZeneca Investment (China) Co. Ltd |
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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