药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/01/19 – 2021/01/25
- New acceptances this week
- 307
- Drugs with new generic filings (by drug name, de-duplicated)
- 35
- 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
307filings, 44 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 163 |
| Generic | 44 |
| New drug | 41 |
| Import | 31 |
| Unspecified | 17 |
| Import re-registration | 11 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 241 |
| 治疗用生物制品 | 47 |
| TCM | 11 |
| 预防用生物制品 | 5 |
| 体外诊断试剂 | 2 |
| 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
35 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 注射用德拉沙星 | 2 | 2 | 0 |
| 2 | 磷酸奥司他韦胶囊 | 2 | 2 | 42 |
| 3 | ω-3鱼油中长链脂肪乳/氨基酸（16）/葡萄糖（36%）注射液 | 2 | 1 | 0 |
| 4 | 丙戊酸钠注射用浓溶液 | 2 | 1 | 0 |
| 5 | 卡格列净片 | 2 | 1 | 8 |
| 6 | 左卡尼汀注射液 | 2 | 1 | 5 |
| 7 | 替莫唑胺胶囊 | 2 | 1 | 0 |
| 8 | 苯磺顺阿曲库铵注射液 | 2 | 1 | 4 |
| 9 | 非布司他片 | 2 | 1 | 15 |
| 10 | 依托咪酯乳状注射液 | 1 | 1 | 1 |
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
172 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 海口市制药厂有限公司 | 7 | 3 | 0 |
| 2 | AstraZeneca AB | 7 | 2 | 0 |
| 3 | Pfizer Europe MA EEIG | 6 | 3 | 0 |
| 4 | 江苏恒瑞医药股份有限公司 | 6 | 3 | 0 |
| 5 | 齐鲁制药有限公司 | 5 | 4 | 1 |
| 6 | 四川科伦药业股份有限公司 | 5 | 3 | 3 |
| 7 | 长春金赛药业有限责任公司 | 5 | 2 | 0 |
| 8 | Guilin Pharmaceutical Co. Ltd China | 5 | 1 | 0 |
| 9 | 常州恒邦药业有限公司 | 4 | 3 | 0 |
| 10 | Boehringer Ingelheim International GmbH | 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
75 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/01/25Import · Class 2.2 | DS-8201aJXSL2100011 | Daiichi Sankyo Inc. |
| 2021/01/25Import · Class 1 | Faricimab注射液JXSL2100010 | F. Hoffmann-La Roche Ltd |
| 2021/01/25Import · Class 2.2 | JKB-122胶囊JXHL2100028 | Unspecified |
| 2021/01/25Import · Class 2.2;2.4 | JKB-122胶囊JXHL2100027 | Unspecified |
| 2021/01/25Generic · Class 3 | 吸入用氯化乙酰甲胆碱粉末CYHS2100110 | 北京泰德制药股份有限公司; 山西普德药业有限公司 |
| 2021/01/25Generic · Class 3 | 注射用德拉沙星CYHL2100006 | 江苏奥赛康药业有限公司 |
| 2021/01/25Generic · Class 3 | 立他司特滴眼液CYHL2100005 | 成都康弘药业集团股份有限公司 |
| 2021/01/25New drug · Class 2.2 | 康柏西普眼用注射液CXSS2100012 | 成都康弘生物科技有限公司 |
| 2021/01/25New drug · Class 1 | AK120注射液CXSL2100014 | 中山康方生物医药有限公司 |
| 2021/01/23Import · Class 2.4 | 达格列净片JXHS2100010 | AstraZeneca AB; AstraZeneca Pharmaceuticals LP |
| 2021/01/23Import · Class 2.4 | 达格列净片JXHS2100009 | AstraZeneca AB; AstraZeneca Pharmaceuticals LP |
| 2021/01/23Import · Class 2.2;2.4 | 硫酸阿托品滴眼液JXHL2100026 | Santen Pharmaceutical Co. Ltd. |
| 2021/01/23Import · Class 2.2 | 硫酸阿托品滴眼液JXHL2100025 | Santen Pharmaceutical Co. Ltd. |
| 2021/01/23Import · Class 2.2;2.4 | 硫酸阿托品滴眼液JXHL2100024 | Santen Pharmaceutical Co. Ltd. |
| 2021/01/23Generic · Class 3 | 丙戊酸钠注射用浓溶液CYHS2100101 | 成都利尔药业有限公司 |
| 2021/01/23Generic · Class 3 | 丙戊酸钠注射用浓溶液CYHS2100100 | 成都利尔药业有限公司 |
| 2021/01/23Generic · Class 3 | 注射用德拉沙星CYHL2100004 | 扬子江药业集团有限公司 |
| 2021/01/23New drug · Class 1 | IBI318CXSL2100029 | 信达生物制药（苏州）有限公司 |
| 2021/01/23New drug · Class 1 | 盐酸依地西汀片CXHL2100055 | 苏州西克罗制药有限公司 |
| 2021/01/23New drug · Class 1 | 盐酸依地西汀片CXHL2100054 | 苏州西克罗制药有限公司 |
| 2021/01/23New drug · Class 1 | 盐酸依地西汀片CXHL2100053 | 苏州西克罗制药有限公司 |
| 2021/01/23New drug · Class 1 | 盐酸依地西汀片CXHL2100052 | 苏州西克罗制药有限公司 |
| 2021/01/23New drug · Class 1 | HSK29116散CXHL2100051 | 四川海思科制药有限公司 |
| 2021/01/23New drug · Class 1 | HSK29116散CXHL2100050 | 四川海思科制药有限公司 |
| 2021/01/23New drug · Class 1 | HSK29116散CXHL2100049 | 四川海思科制药有限公司 |
| 2021/01/22Generic · Class 3 | ω-3鱼油中长链脂肪乳/氨基酸（16）/葡萄糖（36%）注射液CYHS2100094 | 四川科伦药业股份有限公司 |
| 2021/01/22Generic · Class 3 | ω-3鱼油中长链脂肪乳/氨基酸（16）/葡萄糖（36%）注射液CYHS2100093 | 四川科伦药业股份有限公司 |
| 2021/01/22New drug · Class 2.2 | 特瑞普利单抗注射液CXSL2100028 | 上海君实生物医药科技股份有限公司 |
| 2021/01/22New drug · Class 2.2 | 特瑞普利单抗注射液CXSL2100027 | 上海君实生物医药科技股份有限公司 |
| 2021/01/22New drug · Class 2.2 | 特瑞普利单抗注射液CXSL2100026 | 上海君实生物医药科技股份有限公司 |
45 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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