药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/06/01 – 2021/06/07
- New acceptances this week
- 164
- Drugs with new generic filings (by drug name, de-duplicated)
- 25
- 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
164filings, 39 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 82 |
| Generic | 39 |
| New drug | 20 |
| Import | 16 |
| Import re-registration | 4 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 106 |
| 治疗用生物制品 | 28 |
| TCM | 25 |
| 预防用生物制品 | 5 |
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
25 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸厄洛替尼片 | 3 | 2 | 0 |
| 2 | 注射用拉氧头孢钠 | 3 | 1 | 1 |
| 3 | 甲苯磺酸艾多沙班片 | 3 | 1 | 9 |
| 4 | 盐酸帕罗西汀肠溶缓释片 | 3 | 1 | 0 |
| 5 | 盐酸溴己新注射液 | 2 | 2 | 8 |
| 6 | 利奈唑胺葡萄糖注射液 | 2 | 1 | 3 |
| 7 | 玻璃酸钠滴眼液 | 2 | 1 | 29 |
| 8 | 硫酸沙丁胺醇雾化吸入溶液 | 2 | 1 | 0 |
| 9 | 非布司他片 | 2 | 1 | 15 |
| 10 | 骨化三醇软胶囊 | 2 | 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
102 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 北京葆年堂（菏泽）药业有限公司 | 14 | 13 | 0 |
| 2 | 湖北龙辅药业有限公司 | 5 | 5 | 0 |
| 3 | 国药集团容生制药有限公司 | 4 | 3 | 0 |
| 4 | Roche Pharma（Schweiz）AG | 4 | 1 | 0 |
| 5 | 齐鲁制药有限公司 | 3 | 3 | 2 |
| 6 | 瑞阳制药股份有限公司 | 3 | 2 | 0 |
| 7 | Bristol-Myers Squibb Company | 3 | 1 | 0 |
| 8 | 华益泰康药业股份有限公司 | 3 | 1 | 3 |
| 9 | 山东润泽制药有限公司 | 3 | 1 | 3 |
| 10 | 海南先声药业有限公司 | 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
44 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/06/07Import · Class 2.1 | 雷珠单抗注射液JXSL2101039 | F. Hoffmann-La Roche Ltd.; Roche (China) Holding Ltd. |
| 2021/06/07Import · Class 1 | LNP023胶囊JXHL2101079 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2021/06/07Generic · Class 3 | 盐酸溴己新注射液CYHS2101272 | 万邦德制药集团有限公司 |
| 2021/06/07Generic · Class 3 | 呋塞米注射液CYHS2101269 | 广州瑞尔医药科技有限公司; 成都市海通药业有限公司 |
| 2021/06/07Generic · Class 3 | 骨化三醇软胶囊CYHS2101214 | 南京海融制药有限公司; 安士制药（中山）有限公司 |
| 2021/06/07New drug · Class 1 | MRG004ACXSL2101115 | 上海美雅珂生物技术有限责任公司 |
| 2021/06/07New drug · Class 2.2 | 痘苗病毒致炎兔皮提取物注射液CXSL2101107 | 威世药业（如皋）有限公司 |
| 2021/06/07New drug · Class 1 | SS-001CXHL2101180 | 百缮药业（苏州）有限公司 |
| 2021/06/07New drug · Class 1 | SS-001CXHL2101179 | 百缮药业（苏州）有限公司 |
| 2021/06/07New drug · Class 1 | TQA3605片CXHL2101176 | 正大天晴药业集团股份有限公司 |
| 2021/06/07New drug · Class 1 | TQA3605片CXHL2101175 | 正大天晴药业集团股份有限公司 |
| 2021/06/04Import · Class 1 | Nipocalimab注射液JXSL2101038 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2021/06/04Generic · Class 3 | 地塞米松磷酸钠注射液CYHS2101262 | 广州绿十字制药股份有限公司 |
| 2021/06/04Generic · Class 3 | 胞磷胆碱钠注射液CYHS2101242 | 辰欣药业股份有限公司 |
| 2021/06/04Generic · Class 3 | 重酒石酸去甲肾上腺素注射液CYHS2101225 | 合肥亿帆生物制药有限公司 |
| 2021/06/04New drug · Class 2.2 | 替雷利珠单抗注射液CXSS2101004 | 百济神州（上海）生物科技有限公司; 广州百济神州生物制药有限公司 |
| 2021/06/04New drug · Class 1 | T3011疱疹病毒注射液CXSL2101106 | 深圳市亦诺微医药科技有限公司 |
| 2021/06/04New drug · Class 1 | TLZ-16-CL胶囊CXHL2101174 | 北京泰舟利泽医药科技有限公司 |
| 2021/06/04New drug · Class 1 | TLZ-16-CL胶囊CXHL2101173 | 北京泰舟利泽医药科技有限公司 |
| 2021/06/04New drug · Class 2.4 | 盐酸米托蒽醌脂质体注射液CXHL2101172 | 石药集团中诺药业（石家庄）有限公司 |
| 2021/06/03Import · Class 1 | HBM9161(HL161BKN)注射液JXSL2101037 | Harbour BioMed Therapeutics Limited; 和铂医药（苏州）有限公司 |
| 2021/06/03Import · Class 1 | Troriluzole 胶囊JXHL2101078 | Bioshin Limited; BioShin (Shanghai) Co. Ltd. |
| 2021/06/03Import · Class 1 | Troriluzole 胶囊JXHL2101077 | Bioshin Limited; BioShin (Shanghai) Co. Ltd. |
| 2021/06/03Generic · Class 3 | 注射用拉氧头孢钠CYHS2101254 | 山东润泽制药有限公司 |
| 2021/06/03Generic · Class 3 | 注射用拉氧头孢钠CYHS2101253 | 山东润泽制药有限公司 |
| 2021/06/03Generic · Class 3 | 注射用拉氧头孢钠CYHS2101252 | 山东润泽制药有限公司 |
| 2021/06/03Generic · Class 3 | 米力农葡萄糖注射液CYHS2101246 | 广州绿十字制药股份有限公司 |
| 2021/06/03New drug · Class 1 | EMB-06 注射液CXSL2101108 | 上海岸迈生物科技有限公司 |
| 2021/06/03New drug · Class 1 | SYHX1903片CXHL2101171 | 石药集团中奇制药技术（石家庄）有限公司 |
| 2021/06/03New drug · Class 1 | SYHX1903片CXHL2101170 | 石药集团中奇制药技术（石家庄）有限公司 |
14 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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