药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/04/18 – 2023/04/24
- New acceptances this week
- 410
- Drugs with new generic filings (by drug name, de-duplicated)
- 68
- 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
410filings, 90 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 214 |
| Generic | 90 |
| New drug | 72 |
| Import | 18 |
| Unspecified | 9 |
| Import re-registration | 6 |
| 药械组合产品 | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 299 |
| TCM | 59 |
| 治疗用生物制品 | 44 |
| 预防用生物制品 | 3 |
| Biologic | 2 |
| 体外诊断试剂 | 1 |
| 药械 | 1 |
| 药械组合 | 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
68 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 乳果糖口服溶液 | 3 | 2 | 36 |
| 2 | 恩那度司他片 | 3 | 1 | 0 |
| 3 | 西格列汀二甲双胍缓释片 | 3 | 1 | 14 |
| 4 | 二羟丙茶碱注射液 | 2 | 2 | 7 |
| 5 | 普瑞巴林口服溶液 | 2 | 2 | 5 |
| 6 | 氧 | 2 | 2 | 15 |
| 7 | 注射用氯诺昔康 | 2 | 2 | 2 |
| 8 | 硝酸异山梨酯注射液 | 2 | 2 | 0 |
| 9 | 黄体酮注射液 | 2 | 2 | 5 |
| 10 | 吸入用盐酸丙卡特罗溶液 | 2 | 1 | 2 |
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 | 长沙爱贝高药业有限公司 | 31 | 26 | 0 |
| 2 | 江西南昌济生制药有限责任公司 | 14 | 12 | 0 |
| 3 | 黑龙江华玺生物医药科技有限公司 | 9 | 9 | 0 |
| 4 | 浙江国镜药业有限公司 | 9 | 2 | 0 |
| 5 | 江苏恒瑞医药股份有限公司 | 7 | 3 | 0 |
| 6 | Celgene Corporation | 6 | 1 | 0 |
| 7 | 烟台创和生物科技有限公司 | 6 | 1 | 0 |
| 8 | 石家庄四药有限公司 | 5 | 4 | 5 |
| 9 | 山东罗欣药业集团股份有限公司 | 5 | 2 | 0 |
| 10 | 内蒙古白医制药股份有限公司 | 5 | 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
136 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/04/24Generic · Class 3 | 复方醋酸钠林格注射液CYHS2301149 | 赤峰源生药业有限公司 |
| 2023/04/24Generic · Class 3 | 复方醋酸钠林格注射液CYHS2301148 | 赤峰源生药业有限公司 |
| 2023/04/24Generic · Class 3 | 西格列汀二甲双胍缓释片CYHS2301143 | 南通联亚药业股份有限公司 |
| 2023/04/24Generic · Class 3 | 西格列汀二甲双胍缓释片CYHS2301142 | 南通联亚药业股份有限公司 |
| 2023/04/24Generic · Class 3 | 西格列汀二甲双胍缓释片CYHS2301141 | 南通联亚药业股份有限公司 |
| 2023/04/24Generic · Class 3 | 吸入用盐酸丙卡特罗溶液CYHS2301140 | 浙江百代医药科技有限公司; 浙江赛默制药有限公司 |
| 2023/04/24Generic · Class 3 | 吸入用盐酸丙卡特罗溶液CYHS2301139 | 浙江百代医药科技有限公司; 浙江赛默制药有限公司 |
| 2023/04/24Generic · Class 3 | 盐酸多巴酚丁胺注射液CYHS2301138 | 南京泽恒医药技术开发有限公司; 江苏神龙药业有限公司 |
| 2023/04/24Generic · Class 3 | 膦甲酸钠注射液CYHS2301137 | 华仁药业股份有限公司 |
| 2023/04/24Generic · Class 3 | 氯化钾注射液CYHS2301136 | 重庆药谷制药有限公司; 哈尔滨三联药业股份有限公司 |
| 2023/04/24Generic · Class 3 | 氯化钾注射液CYHS2301135 | 重庆药谷制药有限公司; 哈尔滨三联药业股份有限公司 |
| 2023/04/24New drug · Class 1.1 | HYZ2001胶囊CXZL2300030 | 天地恒一制药股份有限公司 |
| 2023/04/24New drug · Class 3.3 | 冻干人用狂犬病疫苗（Vero细胞）CXSS2300020 | 长春卓谊生物股份有限公司 |
| 2023/04/24New drug · Class 1 | IN10018片CXHL2300424 | 应世生物科技（上海）有限公司 |
| 2023/04/24New drug · Class 1 | IN10018片CXHL2300423 | 应世生物科技（上海）有限公司 |
| 2023/04/24New drug · Class 1 | LPM7100328胶囊CXHL2300422 | 烟台创和生物科技有限公司 |
| 2023/04/24New drug · Class 1 | LPM7100328胶囊CXHL2300421 | 烟台创和生物科技有限公司 |
| 2023/04/24New drug · Class 1 | LPM7100328胶囊CXHL2300420 | 烟台创和生物科技有限公司 |
| 2023/04/24New drug · Class 1 | LPM7100328胶囊CXHL2300419 | 烟台创和生物科技有限公司 |
| 2023/04/24New drug · Class 1 | LPM7100328胶囊CXHL2300418 | 烟台创和生物科技有限公司 |
| 2023/04/24New drug · Class 1 | LPM7100328胶囊CXHL2300417 | 烟台创和生物科技有限公司 |
| 2023/04/22Import · Class 1 | IMG-020注射液JXSL2300076 | INMAGENE PTE. LTD.; Inmagene Biopharmaceuticals (Hangzhou) Co. Ltd. |
| 2023/04/22Import · Class 1 | MEDI5752JXSL2300075 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/04/22Import · Class 1 | AZD2936JXSL2300074 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/04/22Import · Class 1 | ASP2138 注射液JXSL2300073 | Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd. |
| 2023/04/22Generic · Class 3 | 二羟丙茶碱注射液CYHS2301131 | 安徽金太阳生化药业有限公司 |
| 2023/04/22Generic · Class 3 | 醋酸去氨加压素口服溶液CYHS2301129 | 合肥恩瑞特药业有限公司 |
| 2023/04/22Generic · Class 3 | 硫酸沙丁胺醇注射液CYHS2301128 | 浙江华海药业股份有限公司 |
| 2023/04/22Generic · Class 3 | 氯化钾颗粒CYHS2301126 | 山西普德药业有限公司 |
| 2023/04/22Generic · Class 3 | 氨溴特罗口服溶液CYHS2301124 | 北京韩美生物科技有限公司; 北京韩美药品有限公司 |
106 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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