药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/08/03 – 2021/08/09
- New acceptances this week
- 279
- Drugs with new generic filings (by drug name, de-duplicated)
- 32
- 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
279filings, 43 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 123 |
| New drug | 65 |
| Generic | 43 |
| Import re-registration | 21 |
| Import | 19 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 189 |
| TCM | 44 |
| 治疗用生物制品 | 44 |
| 体外诊断试剂 | 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
32 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 卡马西平缓释片 | 3 | 1 | 0 |
| 2 | 丙氨酰谷氨酰胺注射液 | 2 | 1 | 4 |
| 3 | 依诺肝素钠注射液 | 2 | 1 | 16 |
| 4 | 卡络磺钠注射液 | 2 | 1 | 1 |
| 5 | 托拉塞米注射液 | 2 | 1 | 1 |
| 6 | 氨甲环酸注射液 | 2 | 1 | 11 |
| 7 | 盐酸多奈哌齐片 | 2 | 1 | 0 |
| 8 | 磷苯妥英钠注射液 | 2 | 1 | 5 |
| 9 | 磷酸奥司他韦胶囊 | 2 | 1 | 42 |
| 10 | 非布司他片 | 2 | 1 | 15 |
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
154 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 山西辅仁恒峰药业有限公司 | 20 | 20 | 0 |
| 2 | 江苏恒瑞医药股份有限公司 | 13 | 6 | 0 |
| 3 | 山东二叶制药有限公司 | 11 | 3 | 0 |
| 4 | 陕西安远堂药业有限公司 | 6 | 6 | 0 |
| 5 | Novartis Pharma Schweiz AG | 6 | 2 | 0 |
| 6 | 杭州邦顺制药有限公司 | 6 | 2 | 0 |
| 7 | Eli Lilly and Company | 6 | 1 | 0 |
| 8 | Fresenius Kabi Deutschland GmbH | 6 | 1 | 0 |
| 9 | 陕西步长制药有限公司 | 4 | 4 | 0 |
| 10 | 三生国健药业（上海）股份有限公司 | 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
103 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/08/09Import · Class 1 | ES104JXSL2101090 | Elpiscience Biopharmaceuticals Co. Limited; Elpiscience (Suzhou) Biopharma Ltd. |
| 2021/08/09Import · Class 2.4 | 环硅酸锆钠散JXHL2101157 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2021/08/09Import · Class 2.4 | 环硅酸锆钠散JXHL2101156 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2021/08/09Import · Class 1 | CPI-818片JXHL2101155 | Corvus Pharmaceuticals Inc.; Angel Pharmaceuticals |
| 2021/08/09Import · Class 1 | CPI-818片JXHL2101154 | Corvus Pharmaceuticals Inc.; Angel Pharmaceuticals |
| 2021/08/09Import · Class 1 | BI 1701963片JXHL2101153 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/08/09Import · Class 1 | BI 1701963片JXHL2101152 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/08/09Import · Class 1 | TAK-981 注射液JXHL2101151 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd |
| 2021/08/09Generic · Class 3 | 非洛地平片CYHS2101538 | 湖南九典制药股份有限公司 |
| 2021/08/09Generic · Class 3 | 托拉塞米注射液CYHS2101536 | 云南龙海天然植物药业有限公司 |
| 2021/08/09Generic · Class 3 | 托拉塞米注射液CYHS2101533 | 云南龙海天然植物药业有限公司 |
| 2021/08/09Generic · Class 3 | 唑来膦酸注射液CYHS2101520 | 仁合益康集团有限公司; 河北仁合益康药业有限公司 |
| 2021/08/09Generic · Class 3 | 利多卡因丁卡因乳膏CYHL2101021 | 北京诺博特生物科技有限公司 |
| 2021/08/09Generic · Class 3 | 丙酸氟替卡松吸入粉雾剂CYHL2101020 | 润生药业有限公司 |
| 2021/08/09New drug · Class 1.1 | 柏金颗粒CXZL2101022 | 中南民族大学 |
| 2021/08/09New drug · Class 1 | THZ0104注射液CXSL2101245 | 天境生物科技（杭州）有限公司 |
| 2021/08/09New drug · Class 2.2 | 注射用卡瑞利珠单抗CXSL2101244 | 苏州盛迪亚生物医药有限公司 |
| 2021/08/09New drug · Class 3.3 | 注射用HZBio2CXSL2101243 | 杭州远大生物制药有限公司 |
| 2021/08/09New drug · Class 1 | 重组人源化抗表皮生长因子受体单克隆抗体注射液CXSL2101242 | 上海津曼特生物科技有限公司 |
| 2021/08/09New drug · Class 1 | CX1440胶囊CXHL2101383 | 杭州邦顺制药有限公司 |
| 2021/08/09New drug · Class 1 | CX1440胶囊CXHL2101382 | 杭州邦顺制药有限公司 |
| 2021/08/09New drug · Class 1 | CX1440胶囊CXHL2101381 | 杭州邦顺制药有限公司 |
| 2021/08/09New drug · Class 1 | CX1440胶囊CXHL2101380 | 杭州邦顺制药有限公司 |
| 2021/08/09New drug · Class 2.2 | HL231吸入溶液CXHL2101379 | 四川海思科制药有限公司 |
| 2021/08/09New drug · Class 2.2 | HL231吸入溶液CXHL2101378 | 四川海思科制药有限公司 |
| 2021/08/09New drug · Class 1 | HRS9531注射液CXHL2101377 | 福建盛迪医药有限公司 |
| 2021/08/09New drug · Class 1 | 苹果酸法米替尼胶囊CXHL2101376 | 江苏恒瑞医药股份有限公司 |
| 2021/08/09New drug · Class 1 | 苹果酸法米替尼胶囊CXHL2101375 | 江苏恒瑞医药股份有限公司 |
| 2021/08/09New drug · Class 1 | 苹果酸法米替尼胶囊CXHL2101374 | 江苏恒瑞医药股份有限公司 |
| 2021/08/09New drug · Class 1 | 注射用罗替戈汀山嵛酸酯缓释微球CXHL2101373 | 山东绿叶制药有限公司 |
73 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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