药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/07/13 – 2021/07/19
- New acceptances this week
- 192
- 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
192filings, 21 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 105 |
| New drug | 40 |
| Generic | 21 |
| Import | 13 |
| Unspecified | 10 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 128 |
| 治疗用生物制品 | 38 |
| TCM | 21 |
| Biologic | 4 |
| 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 | 盐酸依匹斯汀颗粒 | 2 | 1 | 0 |
| 2 | 盐酸罗哌卡因注射液 | 2 | 1 | 5 |
| 3 | 丙戊酸钠口服溶液 | 1 | 1 | 1 |
| 4 | 利斯的明透皮贴剂 | 1 | 1 | 1 |
| 5 | 吸入用硫酸沙丁胺醇溶液 | 1 | 1 | 2 |
| 6 | 地高辛注射液 | 1 | 1 | 3 |
| 7 | 奥美拉唑碳酸氢钠干混悬剂（II） | 1 | 1 | 0 |
| 8 | 奥美沙坦酯片 | 1 | 1 | 1 |
| 9 | 左乙拉西坦缓释片 | 1 | 1 | 0 |
| 10 | 枸橼酸西地那非片 | 1 | 1 | 12 |
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
121 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 合肥立方制药股份有限公司 | 10 | 10 | 0 |
| 2 | Actelion Pharmaceuticals Ltd | 8 | 1 | 0 |
| 3 | Novartis Pharma Schweiz AG | 7 | 1 | 0 |
| 4 | 四川远大蜀阳药业有限责任公司 | 6 | 2 | 0 |
| 5 | 广州一品红制药有限公司 | 5 | 3 | 5 |
| 6 | 山东绿叶制药有限公司 | 4 | 1 | 0 |
| 7 | 贝达药业股份有限公司 | 4 | 1 | 0 |
| 8 | 苏州盛迪亚生物医药有限公司 | 3 | 2 | 0 |
| 9 | Eli Lilly and Company | 3 | 1 | 0 |
| 10 | Loxo Oncology Inc. | 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
57 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/07/19Generic · Class 3 | 盐酸左布比卡因注射液CYHS2101449 | 山东百诺医药股份有限公司; 山西诺成制药有限公司 |
| 2021/07/19New drug · Class 2.3 | 滋肾育胎丸CXZL2101019 | 广州白云山中一药业有限公司 |
| 2021/07/19New drug · Class 1 | 重组抗VEGFR2全人源单克隆抗体注射液CXSL2101203 | 北京东方百泰生物科技股份有限公司 |
| 2021/07/19New drug · Class 1 | 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液CXSL2101191 | 江苏康宁杰瑞生物制药有限公司 |
| 2021/07/19New drug · Class 1 | 注射用RC118CXSL2101189 | 荣昌生物制药（烟台）股份有限公司 |
| 2021/07/19New drug · Class 2.2 | 依达拉奉舌下片CXHS2101030 | 南京百鑫愉医药有限公司; 药源生物科技（启东）有限公司 |
| 2021/07/19New drug · Class 1 | LPM3770164缓释片CXHL2101302 | 山东绿叶制药有限公司 |
| 2021/07/19New drug · Class 1 | LPM3770164缓释片CXHL2101301 | 山东绿叶制药有限公司 |
| 2021/07/19New drug · Class 1 | LPM3770164缓释片CXHL2101300 | 山东绿叶制药有限公司 |
| 2021/07/19New drug · Class 1 | LPM3770164缓释片CXHL2101299 | 山东绿叶制药有限公司 |
| 2021/07/16Import · Class 1 | LOXO-305片JXHL2101139 | Loxo Oncology Inc.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2021/07/16Import · Class 1 | LOXO-305片JXHL2101138 | Loxo Oncology Inc.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2021/07/16Import · Class 1 | LOXO-305片JXHL2101137 | Loxo Oncology Inc.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2021/07/16Import · Class 1 | 非奈利酮片JXHL2101136 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2021/07/16Import · Class 1 | 非奈利酮片JXHL2101135 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2021/07/16Generic · Class 3 | 氨甲环酸注射液CYHS2101442 | 广州一品红制药有限公司; 成都百裕制药股份有限公司 |
| 2021/07/16New drug · Class 1 | SHR-1701注射液CXSL2101202 | 苏州盛迪亚生物医药有限公司 |
| 2021/07/16New drug · Class 1 | 恩沃利单抗注射液CXSL2101201 | 四川思路康瑞药业有限公司 |
| 2021/07/16New drug · Class 2.2 | BH002注射液CXHL2101297 | 珠海贝海生物技术有限公司 |
| 2021/07/15Import · Class 2.4 | 硫酸阿托品滴眼液JXHL2101133 | ZHAOKE (HONG KONG) OPHTHALMOLOGY PHARMACEUTICAL LIMITED; ZHAOKE (GUANG ZHOU) OPHTHALMOLOGY PHARMACEUTICAL LIMITED |
| 2021/07/15Import · Class 2.4 | 硫酸阿托品滴眼液JXHL2101132 | ZHAOKE (HONG KONG) OPHTHALMOLOGY PHARMACEUTICAL LIMITED; ZHAOKE (GUANG ZHOU) OPHTHALMOLOGY PHARMACEUTICAL LIMITED |
| 2021/07/15Generic · Class 3 | 盐酸氨溴索口服溶液CYHS2101438 | 山东盛迪医药有限公司 |
| 2021/07/15Generic · Class 3 | 地高辛注射液CYHS2101427 | 上海旭东海普药业有限公司 |
| 2021/07/15Generic · Class 3 | 左乙拉西坦缓释片CYHS2101407 | 越洋医药开发（广州）有限公司; 常州制药厂有限公司 |
| 2021/07/15New drug · Class 1 | 注射用TJ011133CXSL2101200 | 天境生物科技（上海）有限公司 |
| 2021/07/15New drug · Class 1 | SynOV1.1腺病毒注射液CXSL2101198 | 北京合生基因科技有限公司 |
| 2021/07/15New drug · Class 3.3 | LY05008注射液CXSL2101197 | 山东博安生物技术股份有限公司 |
| 2021/07/15New drug · Class 3.3 | LY05008注射液CXSL2101196 | 山东博安生物技术股份有限公司 |
| 2021/07/15New drug · Class 1 | CM355CXSL2101185 | 北京天诺健成医药科技有限公司 |
| 2021/07/15New drug · Class 1 | 注射用HS-20089CXSL2101180 | 上海翰森生物医药科技有限公司 |
27 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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