药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/01/25 – 2022/01/31
- New acceptances this week
- 374
- Drugs with new generic filings (by drug name, de-duplicated)
- 60
- Accepted this week, now under review
- 1
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
374filings, 95 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 175 |
| Generic | 95 |
| New drug | 66 |
| Import | 24 |
| Unspecified | 7 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 268 |
| 治疗用生物制品 | 64 |
| TCM | 36 |
| 预防用生物制品 | 5 |
| 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
60 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 他达拉非片 | 5 | 3 | 23 |
| 2 | 氧（液态） | 4 | 4 | 14 |
| 3 | 氧 | 3 | 3 | 15 |
| 4 | 氨溴特罗口服溶液 | 3 | 2 | 23 |
| 5 | 磷酸奥司他韦干混悬剂 | 3 | 2 | 2 |
| 6 | 奥赛利定富马酸盐注射液 | 3 | 1 | 0 |
| 7 | 沙美特罗替卡松吸入粉雾剂 | 3 | 1 | 12 |
| 8 | 盐酸鲁拉西酮片 | 3 | 1 | 2 |
| 9 | 叶酸片 | 2 | 2 | 12 |
| 10 | 阿加曲班注射液 | 2 | 2 | 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
214 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 广西迪泰制药股份有限公司 | 15 | 13 | 0 |
| 2 | 海南广升誉制药有限公司 | 13 | 6 | 0 |
| 3 | 湖北睿泽药业有限公司 | 9 | 9 | 0 |
| 4 | N.V. Organon | 8 | 1 | 0 |
| 5 | 齐鲁制药有限公司 | 7 | 5 | 0 |
| 6 | Octapharma AB | 7 | 1 | 0 |
| 7 | 成都倍特药业股份有限公司 | 6 | 3 | 1 |
| 8 | 齐鲁制药（海南）有限公司 | 6 | 3 | 6 |
| 9 | 郑州卓峰制药有限公司 | 5 | 4 | 0 |
| 10 | Janssen Research & Development LLC | 5 | 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
113 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/01/30Import · Class 1 | JNJ-75348780 注射液JXSL2200017 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/01/30Import · Class 1 | JNJ-75348780 注射液JXSL2200016 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/01/30Generic · Class 3 | 二氟泼尼酯滴眼液CYHS2200260 | 天津金耀药业有限公司 |
| 2022/01/30Generic · Class 3 | 氨溴特罗口服溶液CYHS2200253 | 北京民康百草医药科技有限公司; 北京华润高科天然药物有限公司 |
| 2022/01/30New drug · Class 1 | 注射用TQB2930CXSL2200067 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2022/01/30New drug · Class 1.3 | 冻干人用CpG佐剂狂犬病疫苗（Vero细胞）CXSL2200066 | 长春卓谊生物股份有限公司 |
| 2022/01/30New drug · Class 1 | 注射用DB-1303CXSL2200065 | 映恩生物制药（苏州）有限公司 |
| 2022/01/30New drug · Class 1 | IMS001注射液CXSL2200064 | 珠海横琴爱姆斯坦生物科技有限公司 |
| 2022/01/30New drug · Class 1 | TST001注射液CXSL2200063 | 苏州创胜医药集团有限公司 |
| 2022/01/30New drug · Class 1 | GT101注射液CXSL2200061 | 苏州沙砾生物科技有限公司 |
| 2022/01/30New drug · Class 1 | 注射用重组人源化抗CD70单抗-AS269偶联物（ARX305）CXSL2101498 | 浙江新码生物医药有限公司 |
| 2022/01/30New drug · Class 1 | LNK01004软膏CXHL2200070 | 凌科药业（杭州）有限公司 |
| 2022/01/30New drug · Class 1 | LNK01004软膏CXHL2200069 | 凌科药业（杭州）有限公司 |
| 2022/01/30New drug · Class 1 | LNK01004软膏CXHL2200068 | 凌科药业（杭州）有限公司 |
| 2022/01/30New drug · Class 1 | LNK01004软膏CXHL2200067 | 凌科药业（杭州）有限公司 |
| 2022/01/29Import · Class 1 | Nipocalimab注射液JXSL2200015 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/01/29Import · Class 2.4 | OQL011JXHL2200033 | OnQuality Pharmaceuticals（USA）LLC; Suzhou Puhe Biopharma Co. Ltd |
| 2022/01/29Import · Class 2.4 | OQL011JXHL2200032 | OnQuality Pharmaceuticals（USA）LLC; Suzhou Puhe Biopharma Co. Ltd |
| 2022/01/29Import · Class 2.4 | OQL011JXHL2200031 | OnQuality Pharmaceuticals（USA）LLC; Suzhou Puhe Biopharma Co. Ltd |
| 2022/01/29Generic · Class 3 | 注射用头孢噻肟钠CYHS2200249 | 湖南恒生制药股份有限公司 |
| 2022/01/29Generic · Class 3 | 注射用头孢噻肟钠CYHS2200248 | 湖南恒生制药股份有限公司 |
| 2022/01/29Generic · Class 3 | 盐酸阿比多尔片CYHS2200238 | 武汉人福利康药业有限公司 |
| 2022/01/29Generic · Class 3 | 磷酸奥司他韦干混悬剂CYHS2200237 | 广东万方药业科技有限公司; 哈尔滨三联药业股份有限公司 |
| 2022/01/29Generic · Class 3 | 磷酸奥司他韦干混悬剂CYHS2200236 | 广东万方药业科技有限公司; 哈尔滨三联药业股份有限公司 |
| 2022/01/29Generic · Class 3 | 磷酸奥司他韦干混悬剂CYHS2200234 | 哈尔滨华瑞生化药业有限责任公司 |
| 2022/01/29New drug · Class 1.1 | 柴金解郁安神片CXZL2200005 | 湖南中医药大学 |
| 2022/01/29New drug · Class 1 | 注射用MHB008CCXSL2200062 | 明慧医药（杭州）有限公司 |
| 2022/01/29New drug · Class 2.2 | 替雷利珠单抗注射液CXSL2200060 | 百济神州（上海）生物科技有限公司 |
| 2022/01/29New drug · Class 1 | 欧司珀利单抗注射液CXSL2200059 | 广州百济神州生物制药有限公司 |
| 2022/01/29New drug · Class 1 | TAEST1901注射液CXSL2200058 | 香雪生命科学技术（广东）有限公司 |
83 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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