药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/01/26 – 2021/02/01
- New acceptances this week
- 154
- Drugs with new generic filings (by drug name, de-duplicated)
- 22
- 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
154filings, 30 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 76 |
| Generic | 30 |
| New drug | 28 |
| Import | 14 |
| Unspecified | 4 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 127 |
| 治疗用生物制品 | 16 |
| TCM | 8 |
| 预防用生物制品 | 3 |
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
22 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 氨甲环酸注射液 | 3 | 1 | 11 |
| 2 | 帕拉米韦注射液 | 2 | 2 | 7 |
| 3 | 丙戊酸钠注射用浓溶液 | 2 | 1 | 0 |
| 4 | 吸入用异丙托溴铵溶液 | 2 | 1 | 2 |
| 5 | 注射用卡非佐米 | 2 | 1 | 0 |
| 6 | 盐酸普拉克索缓释片 | 2 | 1 | 0 |
| 7 | 达格列净片 | 2 | 1 | 82 |
| 8 | 卡格列净片 | 1 | 1 | 8 |
| 9 | 吸入用盐酸氨溴索溶液 | 1 | 1 | 10 |
| 10 | 富马酸丙酚替诺福韦片 | 1 | 1 | 0 |
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
98 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 苏州开拓药业股份有限公司 | 9 | 2 | 0 |
| 2 | 湖北一半天制药有限公司 | 5 | 2 | 0 |
| 3 | 扬子江药业集团有限公司 | 4 | 3 | 4 |
| 4 | Roche Pharma（Schweiz）AG | 4 | 1 | 0 |
| 5 | 江苏新元素医药科技有限公司 | 4 | 1 | 0 |
| 6 | 浙江海康生物制品有限责任公司 | 4 | 1 | 0 |
| 7 | 国药集团威奇达药业有限公司 | 3 | 3 | 0 |
| 8 | Karyopharm Therapeutics Inc. | 3 | 2 | 0 |
| 9 | Genzyme Corporation | 3 | 1 | 0 |
| 10 | 信达生物制药（苏州）有限公司 | 3 | 1 | 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
47 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/01/30Import · Class 1 | Tiragolumab注射液JXSL2100014 | F.Hoffmann-La Roche Ltd |
| 2021/01/30Import · Class 3.3 | 阿柏西普眼内注射溶液JXSL2100013 | Affamed Therapeutics (HK) Limited |
| 2021/01/30Import · Class 1 | AMG 570JXSL2100012 | Amgen Inc. |
| 2021/01/30Import · Class 1 | ATG-019 片JXHL2100031 | Karyopharm Therapeutics Inc. |
| 2021/01/30Import · Class 1 | ATG-019 片JXHL2100030 | Karyopharm Therapeutics Inc. |
| 2021/01/30Generic · Class 3 | 丙戊酸钠注射用浓溶液CYHS2100139 | 成都苑东生物制药股份有限公司 |
| 2021/01/30Generic · Class 3 | 丙戊酸钠注射用浓溶液CYHS2100138 | 成都苑东生物制药股份有限公司 |
| 2021/01/30Generic · Class 3 | 帕拉米韦注射液CYHS2100136 | 扬子江药业集团有限公司 |
| 2021/01/30Generic · Class 3 | 帕拉米韦注射液CYHS2100134 | 扬子江药业集团四川海蓉药业有限公司 |
| 2021/01/30New drug · Class 1 | HH30134片CXHL2100079 | 上海海和药物研究开发股份有限公司 |
| 2021/01/30New drug · Class 1 | HH30134片CXHL2100078 | 上海海和药物研究开发股份有限公司 |
| 2021/01/30New drug · Class 2.4 | 奥布替尼片CXHL2100077 | 北京诺诚健华医药科技有限公司 |
| 2021/01/30New drug · Class 2.4 | 奥布替尼片CXHL2100076 | 北京诺诚健华医药科技有限公司 |
| 2021/01/29Generic · Class 3 | 盐酸氮卓斯汀丙酸氟替卡松鼻喷雾剂CYHS2100131 | 长风药业股份有限公司 |
| 2021/01/29Generic · Class 3 | 盐酸美金刚口服溶液CYHS2100130 | 西洲医药科技（浙江）有限公司; 浙江北生药业汉生制药有限公司 |
| 2021/01/29Generic · Class 3 | 吸入用盐酸氨溴索溶液CYHS2100128 | 银谷制药有限责任公司 |
| 2021/01/29Generic · Class 3 | 马来酸依那普利口服溶液CYHS2100127 | 四川百利药业有限责任公司 |
| 2021/01/29New drug · Class 1.1 | 雪蟾软坚柔肝片CXZL2100001 | 上海天蟾生物科技有限公司 |
| 2021/01/29New drug · Class 1 | 注射用SHR-A1904CXSL2100034 | 上海恒瑞医药有限公司 |
| 2021/01/29New drug · Class 1 | CN401片CXHL2100075 | 同润生物医药（上海）有限公司 |
| 2021/01/29New drug · Class 1 | CN401片CXHL2100074 | 同润生物医药（上海）有限公司 |
| 2021/01/29New drug · Class 1 | IBI362注射液CXHL2100073 | 信达生物制药（苏州）有限公司 |
| 2021/01/29New drug · Class 1 | IBI362注射液CXHL2100072 | 信达生物制药（苏州）有限公司 |
| 2021/01/29New drug · Class 1 | IBI362注射液CXHL2100071 | 信达生物制药（苏州）有限公司 |
| 2021/01/29New drug · Class 1 | GT20029凝胶CXHL2100070 | 苏州开拓药业股份有限公司 |
| 2021/01/29New drug · Class 1 | GT20029凝胶CXHL2100069 | 苏州开拓药业股份有限公司 |
| 2021/01/29New drug · Class 1 | GT20029凝胶CXHL2100068 | 苏州开拓药业股份有限公司 |
| 2021/01/29New drug · Class 1 | GT20029凝胶CXHL2100067 | 苏州开拓药业股份有限公司 |
| 2021/01/29New drug · Class 1 | GT20029凝胶CXHL2100066 | 苏州开拓药业股份有限公司 |
| 2021/01/29New drug · Class 1 | GT20029凝胶CXHL2100065 | 苏州开拓药业股份有限公司 |
17 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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