药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/07/16 – 2024/07/22
- New acceptances this week
- 415
- Drugs with new generic filings (by drug name, de-duplicated)
- 81
- Accepted this week, now under review
- 4
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
415filings, 128 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 170 |
| Generic | 128 |
| New drug | 72 |
| Import | 16 |
| Unspecified | 15 |
| Import re-registration | 14 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 279 |
| TCM | 63 |
| 治疗用生物制品 | 55 |
| 预防用生物制品 | 13 |
| Biologic | 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
81 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 布瑞哌唑片 | 11 | 4 | 31 |
| 2 | 非布司他片 | 6 | 3 | 15 |
| 3 | 布美他尼注射液 | 5 | 3 | 16 |
| 4 | 盐酸尼卡地平注射液 | 3 | 3 | 12 |
| 5 | 布瑞哌唑口崩片 | 3 | 1 | 10 |
| 6 | 恩那度司他片 | 3 | 1 | 0 |
| 7 | 注射用尼可地尔 | 3 | 1 | 1 |
| 8 | 盐酸卡利拉嗪胶囊 | 3 | 1 | 3 |
| 9 | 多巴丝肼片 | 2 | 2 | 2 |
| 10 | 丁酸氯维地平注射用乳剂 | 2 | 1 | 0 |
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
268 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 齐鲁制药有限公司 | 10 | 4 | 6 |
| 2 | 百济神州(苏州)生物科技有限公司 | 7 | 2 | 0 |
| 3 | 海南卓泰制药有限公司 | 6 | 2 | 0 |
| 4 | Nitto Denko Corporation | 6 | 1 | 0 |
| 5 | Novo Nordisk A/S | 5 | 1 | 0 |
| 6 | 云南特安呐制药股份有限公司 | 4 | 4 | 0 |
| 7 | 山西黄河中药有限公司 | 4 | 4 | 0 |
| 8 | 远大医学营养科学(武汉)有限公司 | 4 | 4 | 0 |
| 9 | 成都瑞尔医药科技有限公司 | 4 | 3 | 4 |
| 10 | 苏州朗科生物技术股份有限公司 | 4 | 3 | 4 |
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
137 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/07/22Generic · Class 3 | 盐酸丙卡特罗口服溶液CYHS2402298 | 安徽瑞旗药业有限公司; 安徽新世纪药业有限公司 |
| 2024/07/22New drug · Class 3.2 | MVA株猴痘减毒活疫苗CXSL2400473 | 上海生物制品研究所有限责任公司 |
| 2024/07/22New drug · Class 1 | 镓[68Ga]PSMA-0057注射液CXHL2400742 | 苏州瑞核医药科技有限公司 |
| 2024/07/22New drug · Class 1 | 镥[177Lu]PSMA-0057注射液CXHL2400741 | 苏州瑞核医药科技有限公司 |
| 2024/07/20Import · Class 1 | 注射用BRII-693JXHL2400182 | Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited |
| 2024/07/20Generic · Class 3 | 硝酸甘油注射液CYHS2402294 | 成都瑞尔医药科技有限公司; 四川汇宇制药股份有限公司 |
| 2024/07/20Generic · Class 3 | 硝酸甘油注射液CYHS2402293 | 成都瑞尔医药科技有限公司; 四川汇宇制药股份有限公司 |
| 2024/07/20Generic · Class 3 | 醋酸钙口服溶液CYHS2402291 | 沈阳欣瑞制药有限公司 |
| 2024/07/20Generic · Class 3 | 对乙酰氨基酚片CYHS2402290 | 江苏贝佳制药有限公司 |
| 2024/07/20Generic · Class 3 | 丁酸氯维地平注射用乳剂CYHS2402285 | 上海上药第一生化药业有限公司; 上海医药集团(本溪)北方药业有限公司 |
| 2024/07/20Generic · Class 3 | 丁酸氯维地平注射用乳剂CYHS2402284 | 上海上药第一生化药业有限公司; 上海医药集团(本溪)北方药业有限公司 |
| 2024/07/20Generic · Class 3 | 氨磺必利口服溶液CYHS2402279 | 江苏长泰药业股份有限公司 |
| 2024/07/20New drug · Class 1 | 普基仑赛注射液CXSS2400076 | 重庆精准生物技术有限公司 |
| 2024/07/20New drug · Class 1 | 普基仑赛注射液CXSS2400075 | 重庆精准生物技术有限公司 |
| 2024/07/20New drug · Class 1 | QL1706注射液CXSL2400472 | 齐鲁制药有限公司 |
| 2024/07/20New drug · Class 1 | 注射用XTL6001CXSL2400471 | 上海西泰利生物医药科技有限公司 |
| 2024/07/20New drug · Class 3.2 | 人抗凝血酶ⅢCXSL2400470 | 四川远大蜀阳药业有限责任公司 |
| 2024/07/20New drug · Class 1 | GD-N1801外用溶液CXHL2400740 | 四川好医生攀西药业有限责任公司 |
| 2024/07/20New drug · Class 1 | GD-N1801外用溶液CXHL2400739 | 四川好医生攀西药业有限责任公司 |
| 2024/07/20New drug · Class 1 | BGB-26808片CXHL2400738 | 百济神州(苏州)生物科技有限公司 |
| 2024/07/20New drug · Class 1 | BGB-26808片CXHL2400737 | 百济神州(苏州)生物科技有限公司 |
| 2024/07/20New drug · Class 1 | BGB-26808片CXHL2400736 | 百济神州(苏州)生物科技有限公司 |
| 2024/07/20New drug · Class 1 | 富马酸奥比特嗪肠溶微丸胶囊CXHL2400735 | 深圳市真兴医药技术有限公司 |
| 2024/07/20New drug · Class 1 | HY-1608注射液CXHL2400734 | 北京君科华元医药科技有限公司 |
| 2024/07/19Import · Class 2.2 | 纳武利尤单抗注射液JXSS2400062 | Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2024/07/19Import · Class 2.2 | 纳武利尤单抗注射液JXSS2400061 | Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2024/07/19Generic · Class 3 | 氨氯地平贝那普利胶囊CYHS2402277 | 江西施美药业股份有限公司 |
| 2024/07/19Generic · Class 3 | 氨溴特罗口服溶液CYHS2402269 | 翎耀生物科技(上海)有限公司; 安徽新世纪药业有限公司 |
| 2024/07/19Generic · Class 3 | 盐酸布比卡因注射液CYHS2402267 | 广州合和医药有限公司; 扬州中宝药业股份有限公司 |
| 2024/07/19Generic · Class 3 | 盐酸布比卡因注射液CYHS2402266 | 广州合和医药有限公司; 扬州中宝药业股份有限公司 |
107 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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