药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/03/26 – 2024/04/01
- New acceptances this week
- 285
- Drugs with new generic filings (by drug name, de-duplicated)
- 63
- Accepted this week, now under review
- 0
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
285filings, 84 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 128 |
| Generic | 84 |
| New drug | 36 |
| Import | 20 |
| Import re-registration | 10 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 207 |
| TCM | 37 |
| 治疗用生物制品 | 37 |
| Biologic | 3 |
| 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
63 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 米诺地尔搽剂 | 5 | 3 | 49 |
| 2 | 布美他尼注射液 | 3 | 2 | 16 |
| 3 | 二羟丙茶碱注射液 | 2 | 2 | 7 |
| 4 | 吸入用乙酰半胱氨酸溶液 | 2 | 2 | 4 |
| 5 | 盐酸溴己新注射液 | 2 | 2 | 8 |
| 6 | 他克莫司胶囊 | 2 | 1 | 2 |
| 7 | 司来帕格片 | 2 | 1 | 24 |
| 8 | 复方电解质醋酸钠注射液 | 2 | 1 | 4 |
| 9 | 左甲状腺素钠片 | 2 | 1 | 9 |
| 10 | 布洛芬注射液 | 2 | 1 | 4 |
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 | 和记黄埔医药(上海)有限公司 | 6 | 2 | 0 |
| 2 | Pfizer Inc. | 5 | 2 | 0 |
| 3 | 湖南科伦制药有限公司 | 5 | 2 | 0 |
| 4 | 百济神州(苏州)生物科技有限公司 | 5 | 2 | 0 |
| 5 | Myokardia Inc. | 5 | 1 | 0 |
| 6 | 哈尔滨瀚邦医疗科技有限公司 | 5 | 1 | 0 |
| 7 | 通化正源药业有限责任公司 | 4 | 4 | 0 |
| 8 | LG Chem Ltd. | 4 | 1 | 0 |
| 9 | Merck Sharp & Dohme LLC | 3 | 3 | 0 |
| 10 | 石家庄四药有限公司 | 3 | 3 | 3 |
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
97 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/04/01Generic · Class 3 | 盐酸曲唑酮片CYHS2400983 | 江西科睿药业有限公司 |
| 2024/04/01Generic · Class 3 | 盐酸克林霉素棕榈酸酯颗粒CYHS2400981 | 海南海神同洲制药有限公司 |
| 2024/04/01Generic · Class 3 | 己酮可可碱缓释片CYHS2400980 | 广东君康药业有限公司; 天津药物研究院药业有限责任公司 |
| 2024/04/01New drug · Class 2.2 | CB371口溶膜CXHL2400325 | 杭州成邦医药科技有限公司 |
| 2024/03/30Import · Class 1 | 盐酸BAY 3283142片JXHL2400076 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2024/03/30Import · Class 1 | 盐酸BAY 3283142片JXHL2400075 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2024/03/30Generic · Class 3 | 米诺地尔搽剂CYHS2400977 | 山东华铂凯盛生物科技有限公司; 烟台鲁银药业有限公司 |
| 2024/03/30Generic · Class 3 | 米诺地尔搽剂CYHS2400976 | 山东华铂凯盛生物科技有限公司; 烟台鲁银药业有限公司 |
| 2024/03/30Generic · Class 3 | 己酮可可碱注射液CYHS2400975 | 江西远超医药科技有限公司; 浙江赛默制药有限公司 |
| 2024/03/30Generic · Class 3 | 注射用尼可地尔CYHS2400972 | 福建泽瑞药业有限公司; 四川制药制剂有限公司 |
| 2024/03/30Generic · Class 3 | 注射用尼可地尔CYHS2400971 | 福建泽瑞药业有限公司; 四川制药制剂有限公司 |
| 2024/03/30New drug · Class 2.2 | BCM875口溶膜CXHL2400324 | 上海云晟研新生物科技有限公司 |
| 2024/03/30New drug · Class 2.2 | BCM857口溶膜CXHL2400323 | 上海云晟研新生物科技有限公司 |
| 2024/03/30New drug · Class 2.2 | BCM857口溶膜CXHL2400322 | 上海云晟研新生物科技有限公司 |
| 2024/03/30New drug · Class 2.2 | ASKC200搽剂CXHL2400321 | 江苏奥赛康药业有限公司 |
| 2024/03/30New drug · Class 2.2 | ASKC200搽剂CXHL2400320 | 江苏奥赛康药业有限公司 |
| 2024/03/29Import · Class 1 | SasanlimabJXSL2400064 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2024/03/29Import · Class 1 | PF-07820435片JXHL2400074 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2024/03/29Import · Class 1 | PF-07820435片JXHL2400073 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2024/03/29Import · Class 1 | PF-07820435片JXHL2400072 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2024/03/29Import · Class 1 | PF-07820435片JXHL2400071 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2024/03/29Generic · Class 3 | 地拉罗司颗粒CYHS2400968 | 上海复星医药产业发展有限公司; 苏州二叶制药有限公司 |
| 2024/03/29Generic · Class 3 | 托拉塞米注射液CYHS2400967 | 北京百美特生物制药有限公司; 杭州民生药业股份有限公司 |
| 2024/03/29Generic · Class 3 | 托拉塞米注射液CYHS2400965 | 北京百美特生物制药有限公司; 杭州民生药业股份有限公司 |
| 2024/03/29Generic · Class 3 | 盐酸溴己新注射液CYHS2400963 | 云南药科院生物医药股份有限公司; 楚雄和创药业有限责任公司 |
| 2024/03/29Generic · Class 3 | 复方电解质醋酸钠注射液CYHS2400960 | 南京恩泰医药科技有限公司; 江苏大红鹰恒顺药业有限公司 |
| 2024/03/29Generic · Class 3 | 复方电解质醋酸钠注射液CYHS2400959 | 南京恩泰医药科技有限公司; 江苏大红鹰恒顺药业有限公司 |
| 2024/03/29Generic · Class 3 | 二羟丙茶碱注射液CYHS2400958 | 福建品腾药业有限公司; 山东方明药业集团股份有限公司 |
| 2024/03/29Generic · Class 3 | 硝苯地平缓释片(II)CYHS2400954 | 河北山姆士药业有限公司 |
| 2024/03/29Generic · Class 3 | 米诺地尔搽剂CYHS2400953 | 嘉实(湖南)医药科技有限公司; 岳阳新华达制药有限公司 |
67 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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