药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/04/15 – 2025/04/21
- New acceptances this week
- 296
- Drugs with new generic filings (by drug name, de-duplicated)
- 59
- Accepted this week, now under review
- 44
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
296filings, 80 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 133 |
| Generic | 80 |
| New drug | 47 |
| Import | 19 |
| Import re-registration | 13 |
| Unspecified | 2 |
| 药械组合 | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 200 |
| TCM | 50 |
| 治疗用生物制品 | 45 |
| 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
59 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 注射用头孢噻肟钠 | 4 | 1 | 14 |
| 2 | 达普司他片 | 4 | 1 | 0 |
| 3 | 甲氨蝶呤注射液 | 3 | 2 | 12 |
| 4 | 利奥西呱片 | 3 | 1 | 4 |
| 5 | 硫酸氨基葡萄糖胶囊 | 2 | 2 | 50 |
| 6 | 蒙脱石混悬液 | 2 | 2 | 30 |
| 7 | 他克莫司软膏 | 2 | 1 | 8 |
| 8 | 地拉罗司颗粒 | 2 | 1 | 4 |
| 9 | 复方电解质醋酸钠葡萄糖注射液 | 2 | 1 | 22 |
| 10 | 复方聚乙二醇（3350）电解质散 | 2 | 1 | 5 |
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
194 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AstraZeneca AB | 7 | 5 | 0 |
| 2 | 云南白药集团股份有限公司 | 7 | 3 | 0 |
| 3 | 津药达仁堂集团股份有限公司隆顺榕制药厂 | 5 | 5 | 0 |
| 4 | Kowa Company Ltd. | 5 | 1 | 0 |
| 5 | 沈阳东新药业有限公司 | 4 | 2 | 0 |
| 6 | AstraZeneca UK Limited | 4 | 1 | 0 |
| 7 | 广东粤和泽药物研究有限公司 | 4 | 1 | 4 |
| 8 | 科笛生物医药（无锡）有限公司 | 4 | 1 | 0 |
| 9 | 齐鲁制药（海南）有限公司 | 4 | 1 | 4 |
| 10 | 重庆喜旋生物科技有限公司 | 3 | 3 | 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
99 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/04/19Import · Class 1 | SAR442970注射液JXSL2500059 | Sanofi-Aventis Recherche & Développement; Fortrea Pharmaceutical Research and Development (Beijing) Co. Ltd. |
| 2025/04/19Import · Class 2.2 | 诺西那生钠注射液JXHS2500049 | Biogen Netherlands B.V.; Patheon Italia S.p.A. |
| 2025/04/19Import · Class 2.2 | 诺西那生钠注射液JXHS2500048 | Biogen Netherlands B.V.; Patheon Italia S.p.A. |
| 2025/04/19Generic · Class 3 | 坎地沙坦酯氢氯噻嗪片（Ⅱ）CYHS2501500 | 江苏和晨药业有限公司 |
| 2025/04/19Generic · Class 3 | 地氯雷他定口服溶液CYHS2501488 | 河南华雒康润药业有限公司 |
| 2025/04/19Generic · Class 3 | 盐酸甲哌卡因注射液CYHL2500086 | 瑞阳制药股份有限公司 |
| 2025/04/19New drug · Class 2.2 | 布瑞哌唑口溶膜CXHS2500031 | 国药瑞福莱药业有限公司 |
| 2025/04/19New drug · Class 2.2 | 布瑞哌唑口溶膜CXHS2500030 | 国药瑞福莱药业有限公司 |
| 2025/04/18Generic · Class 3 | 盐酸卡利拉嗪胶囊CYHS2501485 | 浙江京新药业股份有限公司 |
| 2025/04/18Generic · Class 3 | 盐酸卡利拉嗪胶囊CYHS2501484 | 浙江京新药业股份有限公司 |
| 2025/04/18Generic · Class 3 | 对乙酰氨基酚维生素C泡腾片CYHS2501482 | 上海欣峰制药有限公司; 浙江赛默制药有限公司 |
| 2025/04/18Generic · Class 3 | 硝普钠注射液CYHS2501479 | 广州泽盛药业科技有限公司; 海南普利制药股份有限公司 |
| 2025/04/18Generic · Class 3 | 布美他尼片CYHS2501478 | 中山万汉制药有限公司 |
| 2025/04/18Generic · Class 3 | 布美他尼片CYHS2501477 | 中山万汉制药有限公司 |
| 2025/04/18Generic · Class 3 | 镥[177Lu]氧奥曲肽注射液CYHS2501474 | 北京先通国际医药科技股份有限公司; 中国工程物理研究院核物理与化学研究所 |
| 2025/04/18New drug · Class 1 | ZVS101e注射液CXSL2500319 | 北京中因科技有限公司 |
| 2025/04/18New drug · Class 1 | AK2024 注射液CXSL2500318 | 安徽安科生物工程（集团）股份有限公司 |
| 2025/04/18New drug · Class 1 | 注射用HDM2020CXSL2500317 | 杭州中美华东制药有限公司 |
| 2025/04/18New drug · Class 1 | 玛硒洛沙韦片CXHS2500029 | 征祥医药（南京）集团股份有限公司; 江苏宣泰药业有限公司 |
| 2025/04/18New drug · Class 1 | HS387片CXHL2500402 | 浙江海正药业股份有限公司 |
| 2025/04/18New drug · Class 1 | HS387片CXHL2500401 | 浙江海正药业股份有限公司 |
| 2025/04/18New drug · Class 1 | HS387片CXHL2500400 | 浙江海正药业股份有限公司 |
| 2025/04/17Generic · Class 3 | 碳酸钙片CYHS2501473 | 中和医药（湖北）有限公司; 北京百美特生物制药有限公司 |
| 2025/04/17Generic · Class 3 | 布美他尼注射液CYHS2501471 | 山东辉成药业有限公司 |
| 2025/04/17Generic · Class 3 | 盐酸异丙嗪注射液CYHS2501466 | 江西人可医药科技有限公司; 成都天台山制药股份有限公司 |
| 2025/04/17Generic · Class 3 | 盐酸异丙嗪注射液CYHS2501465 | 江西人可医药科技有限公司; 成都天台山制药股份有限公司 |
| 2025/04/17Generic · Class 3 | 吲哚布芬片CYHS2501464 | 湖南千金协力药业有限公司 |
| 2025/04/17Generic · Class 3 | 坎地氢噻片CYHS2501463 | 河北宏鑫堂药业有限公司; 江苏诚康药业有限公司 |
| 2025/04/17Generic · Class 3 | 己酮可可碱缓释片CYHS2501461 | 北京星昊医药股份有限公司 |
| 2025/04/17New drug · Class 1 | 注射用HY05350CXSL2500316 | 四川汇宇海玥医药科技有限公司 |
69 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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