药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/06/03 – 2025/06/09
- New acceptances this week
- 269
- Drugs with new generic filings (by drug name, de-duplicated)
- 53
- Accepted this week, now under review
- 47
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
269filings, 79 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 113 |
| Generic | 79 |
| New drug | 53 |
| Import | 15 |
| Unspecified | 5 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 175 |
| 治疗用生物制品 | 45 |
| TCM | 43 |
| Biologic | 3 |
| 预防用生物制品 | 3 |
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
53 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 甲磺酸沙非胺片 | 4 | 2 | 20 |
| 2 | 达格列净片 | 4 | 2 | 82 |
| 3 | 乙酰半胱氨酸注射液 | 3 | 3 | 53 |
| 4 | 硝普钠注射液 | 3 | 2 | 15 |
| 5 | 米诺地尔搽剂 | 3 | 2 | 49 |
| 6 | 棕榈酸帕利哌酮注射液 | 3 | 1 | 8 |
| 7 | 吡格列酮二甲双胍片 | 2 | 2 | 10 |
| 8 | 碳酸司维拉姆干混悬剂 | 2 | 2 | 3 |
| 9 | 他达拉非片 | 2 | 1 | 23 |
| 10 | 叶酸注射液 | 2 | 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
200 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Eli Lilly Nederland B.V. | 4 | 1 | 0 |
| 2 | 辽宁海神联盛制药有限公司 | 4 | 1 | 0 |
| 3 | 江苏安正制药有限公司 | 3 | 3 | 0 |
| 4 | 贵州德昌祥医药股份有限公司 | 3 | 3 | 0 |
| 5 | Merck Sharp & Dohme B.V. | 3 | 2 | 0 |
| 6 | Novartis Pharma AG | 3 | 2 | 0 |
| 7 | 山西正来制药有限公司 | 3 | 2 | 0 |
| 8 | 贵州益佰制药股份有限公司 | 3 | 2 | 0 |
| 9 | 丽珠集团丽珠制药厂 | 3 | 1 | 3 |
| 10 | 北京中科先行医疗科技有限公司 | 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
94 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/06/09Generic · Class 3 | 吡格列酮二甲双胍片CYHS2502028 | 石家庄市华新药业有限责任公司 |
| 2025/06/09New drug · Class 1.1 | 郁枢达片CXZS2500025 | 国药集团同济堂（贵州）制药有限公司 |
| 2025/06/09New drug · Class 1 | 脐带血巨核细胞注射液CXSL2500465 | 苏州血霁生物科技有限公司 |
| 2025/06/09New drug · Class 1 | 人羊膜间充质干细胞注射液CXSL2500464 | 源品细胞生物科技集团有限公司 |
| 2025/06/09New drug · Class 1 | 盐酸匹米替尼胶囊CXHS2500063 | 默克雪兰诺（北京）医药有限公司; 凯莱英生命科学技术（天津）有限公司 |
| 2025/06/07Import · Class 2.1 | 帕博利珠单抗注射液（皮下注射）JXSS2500073 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/06/07Import · Class 2.1 | 帕博利珠单抗注射液（皮下注射）JXSS2500072 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/06/07Import · Class 1 | Quabodepistat片JXHL2500130 | Otsuka Pharmaceutical Co. Ltd.; Otsuka Beijing Research Institute |
| 2025/06/07Import · Class 1 | JSB462片JXHL2500129 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/06/07Generic · Class 3 | 盐酸异丙肾上腺素注射液CYHS2502023 | 江苏迪赛诺制药有限公司 |
| 2025/06/07Generic · Class 3 | 盐酸异丙肾上腺素注射液CYHS2502022 | 江苏迪赛诺制药有限公司 |
| 2025/06/07Generic · Class 3 | 叶酸注射液CYHS2502020 | 北京远方通达医药技术有限公司; 山西普恒制药有限公司 |
| 2025/06/07Generic · Class 3 | 叶酸注射液CYHS2502019 | 北京远方通达医药技术有限公司; 山西普恒制药有限公司 |
| 2025/06/07Generic · Class 3 | 比拉斯汀口服溶液CYHS2502018 | 嘉亨（珠海横琴）医药科技有限公司; 亚宝药业四川制药有限公司 |
| 2025/06/07Generic · Class 3 | 盐酸溴己新口服溶液CYHS2502016 | 湖南九典制药股份有限公司 |
| 2025/06/07Generic · Class 3 | 盐酸毛果芸香碱滴眼液CYHL2500107 | 浙江莎普健康管理有限公司 |
| 2025/06/07New drug · Class 1.1 | 益胃消瘀颗粒CXZL2500037 | 重庆市中药研究院（重庆市中药博物馆）; 重庆市中医院（重庆市中西医结合医院、重庆市中医研究院、重庆市第一人民医院） |
| 2025/06/07New drug · Class 1.1 | 复方黄杞颗粒CXZL2500036 | 浙江九如医药科技有限公司 |
| 2025/06/07New drug · Class 1 | HJY-ATRQβ-001注射液CXSL2500463 | 武汉华纪元生物技术开发有限公司 |
| 2025/06/07New drug · Class 3.3 | 流感病毒裂解疫苗CXSL2500460 | 武汉生物制品研究所有限责任公司 |
| 2025/06/07New drug · Class 3.3 | 流感病毒裂解疫苗CXSL2500459 | 武汉生物制品研究所有限责任公司 |
| 2025/06/07New drug · Class 1 | 注射用SSS50CXSL2500458 | 沈阳三生制药有限责任公司 |
| 2025/06/07New drug · Class 1 | 注射用LM-24C5CXSL2500457 | 礼新医药科技（上海）有限公司 |
| 2025/06/07New drug · Class 2.4 | 赖诺普利氨氯地平片CXHS2500062 | 四川尚锐生物医药有限公司; 四川美大康药业股份有限公司 |
| 2025/06/07New drug · Class 1 | 注射用HTMC0769CXHL2500546 | 上海壹典医药科技开发有限公司 |
| 2025/06/07New drug · Class 1 | HSK47977片CXHL2500545 | 海思科医药集团股份有限公司 |
| 2025/06/07New drug · Class 1 | HSK47977片CXHL2500544 | 海思科医药集团股份有限公司 |
| 2025/06/06Import · Class 1 | Clesrovimab注射液JXSS2500071 | Merck Sharp & Dohme B.V.; Patheon Manufacturing Services LLC; MSD R&D (China) Co. Ltd. |
| 2025/06/06Import · Class 1 | JSB462片JXHL2500128 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/06/06Import · Class 2.4 | 镥（177Lu）vipivotide tetraxetan注射液JXHL2500127 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
64 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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