药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/04/13 – 2021/04/19
- New acceptances this week
- 186
- Drugs with new generic filings (by drug name, de-duplicated)
- 17
- 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
186filings, 23 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 115 |
| Generic | 23 |
| New drug | 22 |
| Import re-registration | 12 |
| Import | 10 |
| Unspecified | 3 |
| 药械组合产品 | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 162 |
| 治疗用生物制品 | 15 |
| TCM | 5 |
| 预防用生物制品 | 3 |
| 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
17 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 马来酸阿法替尼片 | 3 | 2 | 2 |
| 2 | 哌柏西利胶囊 | 3 | 1 | 0 |
| 3 | 拉考沙胺片 | 2 | 1 | 0 |
| 4 | 普瑞巴林胶囊 | 2 | 1 | 12 |
| 5 | 地氯雷他定片 | 1 | 1 | 0 |
| 6 | 富马酸丙酚替诺福韦片 | 1 | 1 | 0 |
| 7 | 左氧氟沙星氯化钠注射液 | 1 | 1 | 14 |
| 8 | 布比卡因脂质体注射液 | 1 | 1 | 7 |
| 9 | 度他雄胺软胶囊 | 1 | 1 | 0 |
| 10 | 来氟米特片 | 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
78 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 齐鲁安替制药有限公司 | 53 | 25 | 0 |
| 2 | 天津信谊津津药业有限公司 | 9 | 8 | 0 |
| 3 | Boehringer Ingelheim International GmbH | 6 | 2 | 0 |
| 4 | AstraZeneca AB | 5 | 2 | 0 |
| 5 | Janssen-Cilag International NV | 5 | 2 | 0 |
| 6 | 江苏恒瑞医药股份有限公司 | 4 | 3 | 1 |
| 7 | 扬子江药业集团有限公司 | 3 | 3 | 1 |
| 8 | 华北制药河北华民药业有限责任公司 | 3 | 1 | 0 |
| 9 | 四川科伦药物研究院有限公司 | 3 | 1 | 3 |
| 10 | 杭州默沙东制药有限公司 | 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
32 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/04/19Import · Class 1 | BRII-179 (VBI-2601) 注射液JXSL2101011 | Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited |
| 2021/04/19Import · Class 1 | BRII-835 (VIR-2218) 注射液JXHL2101011 | Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited |
| 2021/04/19Import · Class 2.2;2.4 | 盐酸二甲双胍迟释片JXHL2101009 | Anji Pharma (US) LLC; Anji Pharma (Shanghai) Limited |
| 2021/04/19New drug · Class 1 | BR101注射液CXSL2101026 | 海正生物制药有限公司; 浙江博锐生物制药有限公司 |
| 2021/04/19New drug · Class 1 | SHR7280片CXHL2101045 | 江苏恒瑞医药股份有限公司 |
| 2021/04/19New drug · Class 1 | SHR7280片CXHL2101044 | 江苏恒瑞医药股份有限公司 |
| 2021/04/19New drug · Class 1 | ICP-033片CXHL2101043 | 北京诺诚健华医药科技有限公司 |
| 2021/04/19New drug · Class 1 | ICP-033片CXHL2101042 | 北京诺诚健华医药科技有限公司 |
| 2021/04/19New drug · Class 1 | TQB3820片CXHL2101040 | 正大天晴药业集团股份有限公司 |
| 2021/04/19New drug · Class 1 | TQB3820片CXHL2101039 | 正大天晴药业集团股份有限公司 |
| 2021/04/16Generic · Class 3 | 氨溴特罗口服溶液CYHS2101069 | 海南万玮制药有限公司 |
| 2021/04/16Generic · Class 3 | 布比卡因脂质体注射液CYHS2101068 | 江苏恒瑞医药股份有限公司 |
| 2021/04/16New drug · Class 1.1 | 芪连降糖片CXZL2101006 | 首都医科大学附属北京世纪坛医院 |
| 2021/04/16New drug · Class 2.3 | 散风通窍滴丸CXZL2101005 | 扬子江药业集团有限公司 |
| 2021/04/16New drug · Class 1 | GB5005嵌合抗原受体T细胞注射液CXSL2101024 | 上海吉倍生物技术有限公司 |
| 2021/04/16New drug · Class 1 | YR-1702注射液CXHL2101038 | 扬子江药业集团有限公司 |
| 2021/04/16New drug · Class 2.4 | HR19034滴眼液CXHL2101037 | 成都盛迪医药有限公司 |
| 2021/04/16New drug · Class 2.4 | HR19034滴眼液CXHL2101036 | 成都盛迪医药有限公司 |
| 2021/04/16New drug · Class 2.2 | 巯嘌呤咀嚼片CXHL2101035 | 南京泽恒医药技术开发有限公司 |
| 2021/04/16New drug · Class 2.4 | 西达本胺片CXHL2100224 | 深圳微芯生物科技股份有限公司 |
| 2021/04/15New drug · Class 1 | UB-421注射液CXSL2101027 | 联药（上海）生物科技有限公司 |
| 2021/04/15New drug · Class 1 | SHR-1701注射液CXSL2101025 | 苏州盛迪亚生物医药有限公司 |
| 2021/04/15New drug · Class 1 | 注射用HRS3658CXHL2101034 | 福建盛迪医药有限公司 |
| 2021/04/15New drug · Class 1 | 赛沃替尼片CXHL2101033 | 和记黄埔医药（上海）有限公司 |
| 2021/04/15New drug · Class 1 | 赛沃替尼片CXHL2101032 | 和记黄埔医药（上海）有限公司 |
| 2021/04/15New drug · Class 2.3 | 阿利沙坦酯吲达帕胺缓释片CXHL2101031 | 深圳信立泰药业股份有限公司 |
| 2021/04/14Import · Class 1 | Efgartigimod注射液JXSL2101010 | argenx BV; Zai Lab (Shanghai) Co. Ltd. |
| 2021/04/14Import · Class 1 | Efgartigimod注射液JXSL2101009 | argenx BV; Zai Lab (Shanghai) Co. Ltd. |
| 2021/04/14Import · Class 2.2 | Benralizumab注射液JXSL2101008 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2021/04/14Generic · Class 3 | 磷酸奥司他韦干混悬剂CYHS2101059 | 广州南新制药有限公司; 北京百奥药业有限责任公司 |
2 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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