药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/11/26 – 2024/12/02
- New acceptances this week
- 392
- Drugs with new generic filings (by drug name, de-duplicated)
- 67
- Accepted this week, now under review
- 11
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
392filings, 89 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 198 |
| Generic | 89 |
| New drug | 50 |
| Import re-registration | 27 |
| Import | 18 |
| Unspecified | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 265 |
| TCM | 81 |
| 治疗用生物制品 | 40 |
| Biologic | 5 |
| 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
67 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 美阿沙坦钾片 | 4 | 2 | 33 |
| 2 | 氧 | 3 | 3 | 15 |
| 3 | 富马酸伏诺拉生片 | 3 | 2 | 58 |
| 4 | 布美他尼注射液 | 3 | 2 | 16 |
| 5 | 沙库巴曲缬沙坦钠片 | 3 | 1 | 72 |
| 6 | 枸橼酸西地那非口崩片 | 2 | 2 | 8 |
| 7 | 注射用硫酸艾沙康唑 | 2 | 2 | 15 |
| 8 | 硫酸氢氯吡格雷片 | 2 | 2 | 6 |
| 9 | 硫酸氨基葡萄糖胶囊 | 2 | 2 | 50 |
| 10 | 硫酸镁钠钾口服用浓溶液 | 2 | 2 | 8 |
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
221 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Fresenius Kabi Deutschland GmbH | 18 | 1 | 0 |
| 2 | 百济神州(苏州)生物科技有限公司 | 14 | 4 | 0 |
| 3 | 哈药集团世一堂制药厂 | 12 | 12 | 0 |
| 4 | AstraZeneca AB | 7 | 4 | 0 |
| 5 | The Wellcome Foundation Limited | 7 | 2 | 0 |
| 6 | 湖南洞庭药业股份有限公司 | 6 | 4 | 0 |
| 7 | 广东东阳光药业股份有限公司 | 6 | 1 | 0 |
| 8 | 广西河丰药业有限责任公司 | 5 | 5 | 0 |
| 9 | 内蒙古库伦蒙药有限公司 | 5 | 4 | 0 |
| 10 | 成都地奥集团天府药业股份有限公司 | 5 | 3 | 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
92 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/12/02Generic · Class 3 | 布美他尼注射液CYHS2404137 | 石家庄四药有限公司 |
| 2024/12/02Generic · Class 3 | 草酸艾司西酞普兰口服溶液CYHS2404136 | 海南广升誉制药有限公司; 江苏欧歌制药有限公司 |
| 2024/12/02Generic · Class 3 | 钠钾镁钙注射用浓溶液CYHS2404135 | 成都欣捷高新技术开发股份有限公司; 山东华鲁制药有限公司 |
| 2024/12/02Generic · Class 3 | 磷酸奥司他韦干混悬剂CYHS2404133 | 江西药都仁和制药有限公司 |
| 2024/12/02New drug · Class 1.2 | 冻干呼吸道合胞病毒(RSV)mRNA疫苗CXSL2400812 | 北京科兴中维生物技术有限公司 |
| 2024/12/02New drug · Class 1 | JYB1904注射液CXSL2400811 | 江苏济烨生物制药有限公司 |
| 2024/11/30Import · Class 1 | 镥[177Lu]Lu-NeoB注射液JXHL2400281 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/11/30Import · Class 1 | 用于制备放射性药物[68Ga]Ga-NeoB注射液的药盒JXHL2400280 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/11/30Import · Class 1 | 注射用JX10JXHL2400279 | Corxel Pharmaceuticals Inc.; Corxel Pharmaceuticals (Shanghai) Co. Ltd |
| 2024/11/30Generic · Class 3 | 铝碳酸镁混悬液CYHS2404126 | 合肥远志医药科技开发有限公司; 安徽永生堂药业有限责任公司 |
| 2024/11/30Generic · Class 3 | 盐酸美金刚口崩片CYHS2404125 | 重庆苯立方医药科技有限公司; 山西同达药业有限公司 |
| 2024/11/30Generic · Class 3 | 碳酸镧颗粒CYHS2404124 | 海南皇隆制药股份有限公司 |
| 2024/11/30Generic · Class 3 | 马来酸依那普利口服溶液CYHS2404123 | 北京海一药业有限公司; 江苏欧歌制药有限公司 |
| 2024/11/30Generic · Class 3 | 酮咯酸氨丁三醇注射液CYHS2404122 | 广东南国药业有限公司 |
| 2024/11/30Generic · Class 3 | 对乙酰氨基酚颗粒(直接服用)CYHS2404121 | 上海上药信谊药厂有限公司 |
| 2024/11/30Generic · Class 3 | 吲哚美辛凝胶贴膏CYHL2400238 | 深圳珐玛易药品科技有限公司 |
| 2024/11/30Generic · Class 3 | 利多卡因丙胺卡因气雾剂CYHL2400237 | 北京中泰邦医药科技有限公司 |
| 2024/11/30New drug · Class 1 | LYN101注射液CXSL2400810 | 上海才致药成生物科技有限公司 |
| 2024/11/30New drug · Class 1 | NKC007细胞注射液CXSL2400809 | 广州蒽恺赛生物科技有限公司 |
| 2024/11/30New drug · Class 1 | KYS202002A注射液CXSL2400808 | 江苏康缘药业股份有限公司 |
| 2024/11/30New drug · Class 1 | Sonrotoclax薄膜包衣片CXHL2401304 | 百济神州(苏州)生物科技有限公司 |
| 2024/11/30New drug · Class 1 | Sonrotoclax薄膜包衣片CXHL2401303 | 百济神州(苏州)生物科技有限公司 |
| 2024/11/30New drug · Class 1 | Sonrotoclax薄膜包衣片CXHL2401302 | 百济神州(苏州)生物科技有限公司 |
| 2024/11/30New drug · Class 1 | Sonrotoclax薄膜包衣片CXHL2401301 | 百济神州(苏州)生物科技有限公司 |
| 2024/11/30New drug · Class 1 | HS-10502片CXHL2401300 | 江苏豪森药业集团有限公司; 上海翰森生物医药科技有限公司 |
| 2024/11/30New drug · Class 1 | HS-10502片CXHL2401299 | 江苏豪森药业集团有限公司; 上海翰森生物医药科技有限公司 |
| 2024/11/30New drug · Class 2.4 | 泽布替尼胶囊CXHL2401298 | 百济神州(苏州)生物科技有限公司 |
| 2024/11/30New drug · Class 2.4 | 泽布替尼胶囊CXHL2401297 | 百济神州(苏州)生物科技有限公司 |
| 2024/11/30New drug · Class 1 | F1F3软膏CXHL2401296 | 中奥生物医药技术(广东)有限公司 |
| 2024/11/30New drug · Class 1 | F1F3软膏CXHL2401295 | 中奥生物医药技术(广东)有限公司 |
62 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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