药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/02/02 – 2021/02/08
- New acceptances this week
- 244
- Drugs with new generic filings (by drug name, de-duplicated)
- 33
- Accepted this week, now under review
- 5
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
244filings, 42 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 86 |
| Generic | 42 |
| New drug | 41 |
| Import | 40 |
| Unspecified | 23 |
| Import re-registration | 12 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 190 |
| 治疗用生物制品 | 30 |
| TCM | 15 |
| Biologic | 6 |
| 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
33 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸度洛西汀肠溶胶囊 | 3 | 1 | 5 |
| 2 | 重酒石酸间羟胺注射液 | 2 | 2 | 2 |
| 3 | 厄贝沙坦片 | 2 | 1 | 4 |
| 4 | 氢溴酸伏硫西汀片 | 2 | 1 | 8 |
| 5 | 氨甲环酸注射液 | 2 | 1 | 11 |
| 6 | 盐酸替罗非班氯化钠注射液 | 2 | 1 | 2 |
| 7 | 艾地骨化醇软胶囊 | 2 | 1 | 8 |
| 8 | 莫米松福莫特罗吸入气雾剂 | 2 | 1 | 0 |
| 9 | 他达拉非片 | 1 | 1 | 23 |
| 10 | 依达拉奉氯化钠注射液 | 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
156 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AstraZeneca AB | 5 | 3 | 0 |
| 2 | 苏州沪云新药研发股份有限公司 | 5 | 1 | 0 |
| 3 | AbbVie Inc. | 4 | 2 | 0 |
| 4 | Actelion Pharmaceuticals Ltd | 4 | 2 | 0 |
| 5 | Pfizer Europe MA EEIG | 4 | 2 | 0 |
| 6 | 浙江华海药业股份有限公司 | 4 | 2 | 4 |
| 7 | Dr. Reddy's Laboratories Limited | 4 | 1 | 0 |
| 8 | Amgen Inc. | 3 | 1 | 0 |
| 9 | Aspen Pharma Trading Limited | 3 | 1 | 0 |
| 10 | Ferring Pharmaceuticals A/S | 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
84 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/02/08Import · Class 3.1 | 重组人促卵泡激素δ注射液JXSS2100014 | Ferring Pharmaceuticals A/S; Vetter Pharma-Fertigung GmbH & Co.KG |
| 2021/02/08Import · Class 3.1 | 重组人促卵泡激素δ注射液JXSS2100013 | Ferring Pharmaceuticals A/S; Vetter Pharma-Fertigung GmbH & Co.KG |
| 2021/02/08Import · Class 3.1 | 重组人促卵泡激素δ注射液JXSS2100012 | Ferring Pharmaceuticals A/S; Vetter Pharma-Fertigung GmbH & Co.KG |
| 2021/02/08Generic · Class 3 | 硫酸特布他林注射液CYHS2100174 | 福安药业集团宁波天衡制药有限公司 |
| 2021/02/08Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液CYHS2100173 | 四川普锐特药业有限公司 |
| 2021/02/08Generic · Class 3 | 苯溴马隆片CYHS2100172 | 成都倍特药业股份有限公司 |
| 2021/02/08New drug · Class 1.1 | 天杏咳喘贴CXZS2100003 | 湖北佑尔盛药业有限公司 |
| 2021/02/08New drug · Class 1.1 | 天杏咳喘贴CXZS2100002 | 湖北佑尔盛药业有限公司 |
| 2021/02/08New drug · Class 1.1 | 天杏咳喘贴CXZS2100001 | 湖北佑尔盛药业有限公司 |
| 2021/02/08New drug · Class 1 | 注射用SG12473CXSL2101000 | 杭州尚健生物技术有限公司 |
| 2021/02/08New drug · Class 1 | GR1802注射液CXSL2100048 | 智翔（上海）医药科技有限公司 |
| 2021/02/08New drug · Class 1 | 西奥罗尼胶囊CXHL2101001 | 深圳微芯生物科技股份有限公司 |
| 2021/02/08New drug · Class 1 | 西奥罗尼胶囊CXHL2101000 | 深圳微芯生物科技股份有限公司 |
| 2021/02/08New drug · Class 1 | HY1770乳膏CXHL2100099 | 苏州沪云新药研发股份有限公司 |
| 2021/02/08New drug · Class 1 | HY1770乳膏CXHL2100098 | 苏州沪云新药研发股份有限公司 |
| 2021/02/08New drug · Class 1 | HY1770乳膏CXHL2100097 | 苏州沪云新药研发股份有限公司 |
| 2021/02/08New drug · Class 1 | HY1770乳膏CXHL2100096 | 苏州沪云新药研发股份有限公司 |
| 2021/02/08New drug · Class 1 | HY1770乳膏CXHL2100095 | 苏州沪云新药研发股份有限公司 |
| 2021/02/06Import · Class 3.1 | 注射用罗特西普JXSS2100011 | Celgene Corporation; Patheon Italia S.p.A. |
| 2021/02/06Import · Class 3.1 | 注射用罗特西普JXSS2100010 | Celgene Corporation; Patheon Italia S.p.A. |
| 2021/02/06New drug · Class 1 | EMB-02注射液CXSL2100047 | 上海岸迈生物科技有限公司 |
| 2021/02/06New drug · Class 1 | GR1802注射液CXSL2100045 | 智翔（上海）医药科技有限公司 |
| 2021/02/06New drug · Class 1 | GR1802注射液CXSL2100044 | 智翔（上海）医药科技有限公司 |
| 2021/02/06New drug · Class 2.4 | 环泊酚注射液CXHS2100003 | 辽宁海思科制药有限公司 |
| 2021/02/06New drug · Class 1 | SHR1459片CXHL2100094 | 江苏恒瑞医药股份有限公司 |
| 2021/02/06New drug · Class 1 | SHR1459片CXHL2100093 | 江苏恒瑞医药股份有限公司 |
| 2021/02/06New drug · Class 1 | SHR1459片CXHL2100092 | 江苏恒瑞医药股份有限公司 |
| 2021/02/06New drug · Class 1 | YY-20394片CXHL2100091 | 上海璎黎药业有限公司 |
| 2021/02/05Import · Class 2.2 | Benralizumab注射液JXSL2100018 | AstraZeneca AB |
| 2021/02/05Import · Class 1 | TK216注射液JXHL2100045 | Shanghai Pharmaceutical (USA) Inc. |
54 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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