药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/02/09 – 2021/02/15
- New acceptances this week
- 120
- Drugs with new generic filings (by drug name, de-duplicated)
- 19
- 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
120filings, 23 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 46 |
| Import | 25 |
| New drug | 24 |
| Generic | 23 |
| 药械组合产品 | 1 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 91 |
| 治疗用生物制品 | 24 |
| TCM | 3 |
| 药械组合 | 1 |
| 预防用生物制品 | 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
19 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 阿普斯特片 | 3 | 1 | 0 |
| 2 | 盐酸纳洛酮注射液 | 2 | 1 | 1 |
| 3 | 达比加群酯胶囊 | 2 | 1 | 2 |
| 4 | 右酮洛芬氨丁三醇注射液 | 1 | 1 | 6 |
| 5 | 左乙拉西坦片 | 1 | 1 | 6 |
| 6 | 左氧氟沙星注射液 | 1 | 1 | 1 |
| 7 | 氢溴酸伏硫西汀片 | 1 | 1 | 8 |
| 8 | 泊沙康唑注射液 | 1 | 1 | 1 |
| 9 | 注射用生长抑素 | 1 | 1 | 2 |
| 10 | 盐酸去氧肾上腺素注射液 | 1 | 1 | 5 |
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
79 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 河南科伦药业有限公司 | 9 | 2 | 0 |
| 2 | Novartis Pharma Schweiz AG | 3 | 2 | 0 |
| 3 | Allergan Pharmaceuticals Ireland | 3 | 1 | 0 |
| 4 | Merck Europe B.V. | 3 | 1 | 0 |
| 5 | Orion Corporation | 3 | 1 | 0 |
| 6 | Pfizer Inc. | 3 | 1 | 0 |
| 7 | 上海君实生物医药科技股份有限公司 | 3 | 1 | 0 |
| 8 | 四川科伦博泰生物医药股份有限公司 | 3 | 1 | 0 |
| 9 | 广东东阳光药业有限公司 | 3 | 1 | 0 |
| 10 | 江苏正大清江制药有限公司 | 3 | 1 | 3 |
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
51 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/02/11Import · Class 3.3 | 四价流感病毒裂解疫苗JXSS2100009 | Adimmune Corporation |
| 2021/02/11Import · Class 3.1 | 注射用A型肉毒毒素JXSL2100025 | Allergan Pharmaceuticals Ireland |
| 2021/02/11Import · Class 3.1 | 注射用A型肉毒毒素JXSL2100024 | Allergan Pharmaceuticals Ireland |
| 2021/02/11Import · Class 3.1 | 注射用A型肉毒毒素JXSL2100023 | Allergan Pharmaceuticals Ireland |
| 2021/02/11Import · Class 1 | IMG-020注射液JXSL2100022 | Affibody AB |
| 2021/02/11Import · Class 3.1 | 阿替利珠单抗注射液JXSL2100021 | F.Hoffmann-La Roche Ltd |
| 2021/02/11Import · Class 3.1 | Eptinezumab注射用浓溶液JXSL2100019 | Lundbeck |
| 2021/02/11Import · Class 1 | 阿布昔替尼片JXHS2100022 | Pfizer Inc.; Pfizer Manufacturing Deutschland GmbH |
| 2021/02/11Import · Class 1 | 阿布昔替尼片JXHS2100021 | Pfizer Inc.; Pfizer Manufacturing Deutschland GmbH |
| 2021/02/11Import · Class 1 | 阿布昔替尼片JXHS2100020 | Pfizer Inc.; Pfizer Manufacturing Deutschland GmbH |
| 2021/02/11Import · Class 1 | Aramchol片JXHL2100052 | Galmed Research and Development Ltd. |
| 2021/02/11Import · Class 1 | AZD9833片JXHL2100051 | AstraZeneca AB |
| 2021/02/11Import · Class 1 | AZD9833片JXHL2100050 | AstraZeneca AB |
| 2021/02/11Import · Class 2.4 | 达罗他胺片JXHL2100049 | Bayer HealthCare Pharmaceuticals Inc. |
| 2021/02/11Generic · Class 3 | 盐酸去氧肾上腺素注射液CYHS2100194 | 成都苑东生物制药股份有限公司 |
| 2021/02/11New drug · Class 3.3 | 门冬胰岛素30注射液CXSS2100019 | 宜昌东阳光长江药业股份有限公司 |
| 2021/02/11New drug · Class 2.2 | 特瑞普利单抗注射液CXSS2100018 | 上海君实生物医药科技股份有限公司; 苏州众合生物医药科技有限公司 |
| 2021/02/11New drug · Class 2.2 | 特瑞普利单抗注射液CXSS2100017 | 上海君实生物医药科技股份有限公司; 苏州众合生物医药科技有限公司 |
| 2021/02/11New drug · Class 2.2 | 特瑞普利单抗注射液CXSS2100016 | 上海君实生物医药科技股份有限公司; 苏州众合生物医药科技有限公司 |
| 2021/02/11New drug · Class 1 | 注射用间充质干细胞（脐带）CXSL2100056 | 天津昂赛细胞基因工程有限公司 |
| 2021/02/11New drug · Class 2.4 | BAT4706注射液CXSL2100050 | 百奥泰生物制药股份有限公司 |
| 2021/02/11New drug · Class 2.4 | BAT4706注射液CXSL2100049 | 百奥泰生物制药股份有限公司 |
| 2021/02/10Import · Class 1 | PamrevlumabJXSL2100020 | FibroGen Inc |
| 2021/02/09Import · Class 1 | ZN-c3片JXHL2100048 | Zentera Therapeutics HK Limited |
| 2021/02/09Import · Class 1 | ZN-c3片JXHL2100047 | Zentera Therapeutics HK Limited |
| 2021/02/09Import · Class 1 | MK-8189JXHL2100046 | Merck Sharp & Dohme International GmbH |
| 2021/02/09Generic · Class 3 | 右酮洛芬氨丁三醇注射液CYHS2100190 | 南京正科医药股份有限公司 |
| 2021/02/09Generic · Class 3 | 左氧氟沙星注射液CYHS2100189 | 石家庄四药有限公司 |
| 2021/02/09Generic · Class 3 | 阿普斯特片CYHS2100187 | 江苏正大清江制药有限公司 |
| 2021/02/09Generic · Class 3 | 阿普斯特片CYHS2100186 | 江苏正大清江制药有限公司 |
21 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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