药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/01/18 – 2022/01/24
- New acceptances this week
- 265
- Drugs with new generic filings (by drug name, de-duplicated)
- 50
- 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
265filings, 69 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 134 |
| Generic | 69 |
| New drug | 34 |
| Import | 14 |
| Import re-registration | 9 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 193 |
| TCM | 36 |
| 治疗用生物制品 | 29 |
| 预防用生物制品 | 7 |
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
50 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸美金刚缓释胶囊 | 4 | 1 | 2 |
| 2 | 利伐沙班片 | 3 | 1 | 3 |
| 3 | 他达拉非片 | 2 | 1 | 23 |
| 4 | 依诺肝素钠注射液 | 2 | 1 | 16 |
| 5 | 双氯芬酸钠缓释片 | 2 | 1 | 10 |
| 6 | 恩格列净片 | 2 | 1 | 18 |
| 7 | 沙库巴曲缬沙坦钠片 | 2 | 1 | 68 |
| 8 | 注射用帕瑞昔布钠 | 2 | 1 | 2 |
| 9 | 盐酸多巴胺注射液 | 2 | 1 | 3 |
| 10 | 盐酸鲁拉西酮片 | 2 | 1 | 2 |
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
150 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 湖北太子药业有限公司 | 8 | 8 | 0 |
| 2 | 湖北睿泽药业有限公司 | 7 | 6 | 0 |
| 3 | 锦州福寿堂医药科技有限公司 | 7 | 6 | 0 |
| 4 | 钓鱼台医药集团吉林天强制药股份有限公司 | 6 | 6 | 0 |
| 5 | 湘北威尔曼制药股份有限公司 | 6 | 4 | 0 |
| 6 | PFIZER EUROPE MA EEIG | 6 | 2 | 0 |
| 7 | 正大天晴药业集团股份有限公司 | 5 | 4 | 0 |
| 8 | 海南通用三洋药业有限公司 | 5 | 1 | 0 |
| 9 | 西安乐析医疗科技有限公司 | 4 | 4 | 4 |
| 10 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc | 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
69 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/01/24Import · Class 1 | MK-6024注射液JXSL2200014 | Merck Sharp & Dohme Corp.; MSD R&D(China)Co. Ltd. |
| 2022/01/24Import · Class 1 | MK-6024注射液JXSL2200013 | Merck Sharp & Dohme Corp.; MSD R&D(China)Co. Ltd. |
| 2022/01/24Import · Class 1 | 注射用3D-189JXHL2200026 | 3D Medicines Inc.; 3D Medicines(Qingdao)Co. Limited |
| 2022/01/24Generic · Class 3 | 福多司坦口服溶液CYHS2200169 | 浙江国镜药业有限公司 |
| 2022/01/24Generic · Class 3 | 福多司坦口服溶液CYHS2200168 | 浙江国镜药业有限公司 |
| 2022/01/24Generic · Class 3 | 西格列汀二甲双胍缓释片CYHS2200155 | 上海安必生制药技术有限公司; 江苏安必生制药有限公司 |
| 2022/01/24Generic · Class 3 | 阿立哌唑口服溶液CYHS2200104 | 成都苑东生物制药股份有限公司; 华北制药股份有限公司 |
| 2022/01/24Generic · Class 3 | 阿立哌唑口服溶液CYHS2200103 | 成都苑东生物制药股份有限公司; 华北制药股份有限公司 |
| 2022/01/24Generic · Class 3 | 羟考酮纳洛酮缓释片CYHS2200102 | 山东绿叶制药有限公司 |
| 2022/01/24Generic · Class 3 | 利多卡因凝胶贴膏CYHL2200009 | 南京海纳医药科技股份有限公司 |
| 2022/01/24New drug · Class 1 | CM313注射液CXSL2200042 | 康诺亚生物医药科技(成都)有限公司 |
| 2022/01/24New drug · Class 1 | 注射用YK012CXSL2200041 | 益科思特(北京)医药科技发展有限公司 |
| 2022/01/24New drug · Class 1 | 斯鲁利单抗注射液CXSL2200040 | 上海复宏汉霖生物技术股份有限公司 |
| 2022/01/24New drug · Class 1 | TQB2450注射液CXSL2200039 | 正大天晴药业集团股份有限公司 |
| 2022/01/24New drug · Class 1 | BC008抗体注射液CXSL2200037 | 宝船生物医药科技(上海)有限公司 |
| 2022/01/24New drug · Class 1 | IBI323CXSL2200036 | 信达生物制药(苏州)有限公司 |
| 2022/01/24New drug · Class 1 | TQB2618注射液CXSL2200035 | 正大天晴药业集团股份有限公司 |
| 2022/01/24New drug · Class 2.3 | 依折麦布匹伐他汀钙片CXHL2200044 | 乐普制药科技有限公司 |
| 2022/01/24New drug · Class 1 | DC05F01CXHL2200043 | 北京双鹤润创科技有限公司 |
| 2022/01/24New drug · Class 1 | ABSK043胶囊CXHL2200042 | 上海和誉生物医药科技有限公司 |
| 2022/01/24New drug · Class 1 | ABSK043胶囊CXHL2200041 | 上海和誉生物医药科技有限公司 |
| 2022/01/21Generic · Class 3 | 羧甲司坦口服溶液CYHS2200153 | 广东华南药业集团有限公司; 广东众生药业股份有限公司 |
| 2022/01/21Generic · Class 3 | 羧甲司坦口服溶液CYHS2200152 | 广东华南药业集团有限公司; 广东众生药业股份有限公司 |
| 2022/01/21Generic · Class 3 | 依非韦伦拉米夫定替诺福韦片CYHS2200146 | 上海迪赛诺医药集团股份有限公司 |
| 2022/01/21Generic · Class 3 | 醋酸去氨加压素口服溶液CYHS2200141 | 杭州和泽坤元药业有限公司; 浙江康恩贝制药股份有限公司 |
| 2022/01/21New drug · Class 1 | 注射用重组人源化抗HER2单抗-AS269偶联物(ARX788)CXSL2200033 | 浙江新码生物医药有限公司 |
| 2022/01/21New drug · Class 1 | IBI319CXSL2200030 | 信达生物制药(苏州)有限公司 |
| 2022/01/21New drug · Class 2.4 | 环泊酚注射液CXHS2200006 | 辽宁海思科制药有限公司 |
| 2022/01/21New drug · Class 2.4 | 硫酸阿托品滴眼液CXHL2200035 | 博瑞制药(苏州)有限公司 |
| 2022/01/21New drug · Class 2.4 | 硫酸阿托品滴眼液CXHL2200034 | 博瑞制药(苏州)有限公司 |
39 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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