药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/04/30 – 2024/05/06
- New acceptances this week
- 110
- Drugs with new generic filings (by drug name, de-duplicated)
- 23
- 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
110filings, 31 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 47 |
| Generic | 31 |
| New drug | 24 |
| Import re-registration | 4 |
| Unspecified | 2 |
| Import | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 64 |
| TCM | 23 |
| 治疗用生物制品 | 23 |
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
23 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 普瑞巴林口服溶液 | 3 | 1 | 5 |
| 2 | 乳果糖口服溶液 | 2 | 1 | 40 |
| 3 | 培哚普利氨氯地平片（Ⅰ） | 2 | 1 | 3 |
| 4 | 复方聚乙二醇电解质散（Ⅱ） | 2 | 1 | 4 |
| 5 | 盐酸莫西沙星滴眼液 | 2 | 1 | 5 |
| 6 | 达比加群酯胶囊 | 2 | 1 | 2 |
| 7 | 阿伐那非片 | 2 | 1 | 2 |
| 8 | 培哚普利氨氯地平片（Ⅱ） | 1 | 1 | 0 |
| 9 | 培哚普利氨氯地平片（Ⅲ） | 1 | 1 | 3 |
| 10 | 头孢克肟颗粒 | 1 | 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
70 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 湖北炎黄本草药业有限公司 | 12 | 12 | 0 |
| 2 | 沈阳兴齐眼药股份有限公司 | 8 | 1 | 0 |
| 3 | 江西施美药业股份有限公司 | 4 | 3 | 4 |
| 4 | 北京远方通达医药技术有限公司 | 3 | 3 | 0 |
| 5 | Takeda Pharmaceuticals International AG Ireland Branch | 3 | 1 | 0 |
| 6 | 海南斯达制药有限公司 | 3 | 1 | 3 |
| 7 | BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED | 2 | 2 | 0 |
| 8 | 安徽金马药业股份有限公司 | 2 | 2 | 0 |
| 9 | 普米斯生物技术（珠海）有限公司 | 2 | 2 | 0 |
| 10 | Janssen-Cilag International NV | 2 | 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
41 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/05/06Generic · Class 3 | 阿伐那非片CYHS2401333 | 昆明积大制药股份有限公司 |
| 2024/05/06Generic · Class 3 | 阿伐那非片CYHS2401332 | 昆明积大制药股份有限公司 |
| 2024/05/06New drug · Class 1 | TAL-T细胞注射液CXSL2400285 | 广州泛恩生物科技有限公司 |
| 2024/05/01Import · Class 2.2 | 帕博利珠单抗注射液JXSL2400084 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2024/05/01New drug · Class 1 | CNK-UT002细胞注射液CXSL2400284 | 羿尊生物医药（浙江）有限公司 |
| 2024/05/01New drug · Class 1 | 注射用sacituzumab tirumotecanCXSL2400283 | 默沙东研发（中国）有限公司 |
| 2024/05/01New drug · Class 1 | 酒石酸泰贝西利胶囊CXHS2400039 | 贝达药业股份有限公司 |
| 2024/05/01New drug · Class 1 | SGB-3908注射液CXHL2400426 | 苏州圣因生物医药有限公司 |
| 2024/05/01New drug · Class 2.2 | HZ031口溶膜CXHL2400425 | 浙江和泽医药科技股份有限公司 |
| 2024/04/30Import · Class 1 | ASP2138注射液JXSL2400083 | Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd. |
| 2024/04/30Generic · Class 3 | 头孢克肟颗粒CYHS2401322 | 浙江昂利康制药股份有限公司 |
| 2024/04/30Generic · Class 3 | 盐酸利多卡因注射液CYHS2401319 | 南京泽恒医药技术开发有限公司; 亚邦医药股份有限公司 |
| 2024/04/30Generic · Class 3 | 盐酸氨溴索滴剂CYHS2401318 | 南京海纳制药有限公司 |
| 2024/04/30Generic · Class 3 | 硫酸沙丁胺醇糖浆CYHS2401315 | 海南万玮制药有限公司 |
| 2024/04/30Generic · Class 3 | 普瑞巴林口服溶液CYHS2401314 | 海南斯达制药有限公司 |
| 2024/04/30Generic · Class 3 | 比拉斯汀口服溶液CYHS2401313 | 深圳市贝美药业有限公司; 华益药业科技（安徽）有限公司 |
| 2024/04/30Generic · Class 3 | 普瑞巴林口服溶液CYHS2401312 | 海南斯达制药有限公司 |
| 2024/04/30Generic · Class 3 | 普瑞巴林口服溶液CYHS2401311 | 海南斯达制药有限公司 |
| 2024/04/30Generic · Class 3 | 肾上腺素注射液（预充式）CYHS2401310 | 武汉久安药物研究院有限公司; 武汉久安药业有限公司 |
| 2024/04/30Generic · Class 3 | 盐酸溴己新注射液CYHS2401309 | 辰欣药业股份有限公司 |
| 2024/04/30Generic · Class 3 | 复方聚乙二醇电解质散（Ⅱ）CYHS2401308 | 陕西丽彩药业有限公司; 杨凌科森生物制药有限责任公司 |
| 2024/04/30Generic · Class 3 | 复方聚乙二醇电解质散（Ⅱ）CYHS2401307 | 陕西丽彩药业有限公司; 杨凌科森生物制药有限责任公司 |
| 2024/04/30Generic · Class 3 | 阿奇霉素滴眼液CYHL2400080 | 深圳欣祺医药科技有限公司 |
| 2024/04/30New drug · Class 1.1 | 清降和胃颗粒CXZL2400022 | 黑龙江珍宝岛药业股份有限公司 |
| 2024/04/30New drug · Class 1 | SQ-22031滴眼液CXSL2400282 | 沈阳兴齐眼药股份有限公司 |
| 2024/04/30New drug · Class 1 | SQ-22031滴眼液CXSL2400281 | 沈阳兴齐眼药股份有限公司 |
| 2024/04/30New drug · Class 1 | 注射用sacituzumab tirumotecanCXSL2400280 | 默沙东研发（中国）有限公司 |
| 2024/04/30New drug · Class 1 | SQ-22031滴眼液CXSL2400279 | 沈阳兴齐眼药股份有限公司 |
| 2024/04/30New drug · Class 1 | SQ-22031滴眼液CXSL2400278 | 沈阳兴齐眼药股份有限公司 |
| 2024/04/30New drug · Class 1 | PM8002注射液CXSL2400277 | 普米斯生物技术（珠海）有限公司 |
11 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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