药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/05/12 – 2026/05/18
- New acceptances this week
- 554
- Drugs with new generic filings (by drug name, de-duplicated)
- 68
- Accepted this week, now under review
- 158
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
554filings, 104 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 305 |
| Generic | 104 |
| New drug | 104 |
| Import | 19 |
| Unspecified | 11 |
| Import re-registration | 11 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 284 |
| TCM | 176 |
| 治疗用生物制品 | 82 |
| Biologic | 10 |
| 预防用生物制品 | 2 |
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 | 沙库巴曲缬沙坦钠片 | 6 | 2 | 74 |
| 2 | 依达拉奉右莰醇注射用浓溶液 | 3 | 3 | 32 |
| 3 | 瑞维那新吸入溶液 | 3 | 3 | 53 |
| 4 | 布瑞哌唑片 | 3 | 1 | 31 |
| 5 | 氢溴酸加兰他敏口服溶液 | 3 | 1 | 5 |
| 6 | 盐酸左米那普仑缓释胶囊 | 3 | 1 | 6 |
| 7 | 乌帕替尼缓释片 | 2 | 2 | 43 |
| 8 | 氧（液态） | 2 | 2 | 14 |
| 9 | 二甲硅油乳剂 | 2 | 1 | 14 |
| 10 | 地氯雷他定口服溶液 | 2 | 1 | 26 |
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
312 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 哈药集团生物工程有限公司 | 26 | 10 | 0 |
| 2 | 太极集团重庆桐君阁药厂有限公司 | 13 | 11 | 0 |
| 3 | Karuna Therapeutics Inc. a Bristol Myers Squibb Company | 8 | 2 | 0 |
| 4 | 辟埃赛医药科技（上海）有限公司 | 6 | 6 | 0 |
| 5 | 包头中药有限责任公司 | 6 | 4 | 0 |
| 6 | 江苏恒瑞医药股份有限公司 | 6 | 3 | 0 |
| 7 | Kyowa Kirin Co. Ltd. | 6 | 1 | 0 |
| 8 | 英百瑞（杭州）生物医药股份有限公司 | 6 | 1 | 0 |
| 9 | 广西玉林制药集团有限责任公司 | 5 | 5 | 0 |
| 10 | 苏州盛迪亚生物医药有限公司 | 5 | 5 | 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 no longer on the under-review list whose last snapshot sighting falls in this week, meaning approved or terminated, to be verified. Companies are counted by first applicant.
Class 3 and new-drug acceptances
156 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/05/18Generic · Class 3 | 盐酸多西环素片CYHS2601168 | 安徽杰玺医药有限公司 |
| 2026/05/18Generic · Class 3 | 盐酸多西环素片CYHS2601167 | 安徽杰玺医药有限公司 |
| 2026/05/18Generic · Class 3 | 瑞卢戈利片CYHS2601163 | 上海汇伦医药股份有限公司; 上海汇伦江苏药业有限公司 |
| 2026/05/18Generic · Class 3 | 马沙骨化醇注射液CYHL2600061 | 南京泽恒医药技术开发有限公司 |
| 2026/05/18New drug · Class 3.3 | 司美格鲁肽注射液CXSS2600085 | 丽珠集团新北江制药股份有限公司 |
| 2026/05/18New drug · Class 3.3 | 司美格鲁肽注射液CXSS2600084 | 丽珠集团新北江制药股份有限公司 |
| 2026/05/18New drug · Class 2.2 | 阿得贝利单抗注射液CXSL2600544 | 上海盛迪医药有限公司 |
| 2026/05/18New drug · Class 2.2 | SHR-8068注射液CXSL2600543 | 苏州盛迪亚生物医药有限公司 |
| 2026/05/18New drug · Class 1 | 注射用TL001CXSL2600542 | 上海糖岭生物医药有限责任公司; 中国科学院上海药物研究所 |
| 2026/05/18New drug · Class 1 | LM-168注射液CXSL2600541 | 礼新医药科技（上海）有限公司 |
| 2026/05/18New drug · Class 1 | SHR-4610注射液CXSL2600540 | 上海盛迪医药有限公司 |
| 2026/05/18New drug · Class 1 | 注射用SHR-1826CXSL2600539 | 苏州盛迪亚生物医药有限公司 |
| 2026/05/18New drug · Class 1 | 注射用SHR-9839（sc）CXSL2600538 | 苏州盛迪亚生物医药有限公司; 上海恒瑞医药有限公司 |
| 2026/05/18New drug · Class 2.2 | 贝伐珠单抗注射液CXSL2600537 | 苏州盛迪亚生物医药有限公司 |
| 2026/05/18New drug · Class 1 | 注射用FH-006CXSL2600536 | 江苏恒瑞医药股份有限公司; 上海甫弘生物医药有限公司 |
| 2026/05/18New drug · Class 1 | 注射用HB0043（皮下注射）CXSL2600535 | 上海华奥泰生物药业股份有限公司; 华博生物医药技术(上海)有限公司 |
| 2026/05/18New drug · Class 1 | 人脐带间充质干细胞注射液CXSL2600534 | 千石生物科技（上海）有限公司 |
| 2026/05/18New drug · Class 1 | QT-019B细胞注射液CXSL2600533 | 杭州启函生物科技有限公司 |
| 2026/05/18New drug · Class 1 | LY01620CXSL2600532 | 南京吉迈生物技术有限公司 |
| 2026/05/18New drug · Class 1 | HRS-7172片CXHL2600589 | 江苏恒瑞医药股份有限公司; 上海恒瑞医药有限公司 |
| 2026/05/18New drug · Class 1 | HRS-7172片CXHL2600588 | 江苏恒瑞医药股份有限公司; 上海恒瑞医药有限公司 |
| 2026/05/18New drug · Class 1 | HRS-7172片CXHL2600587 | 江苏恒瑞医药股份有限公司; 上海恒瑞医药有限公司 |
| 2026/05/18New drug · Class 1 | CVL218片CXHL2600586 | 甫康（湖北省）生物科技开发有限公司 |
| 2026/05/18New drug · Class 1 | HRS-4642注射液CXHL2600585 | 上海恒瑞医药有限公司; 江苏恒瑞医药股份有限公司 |
| 2026/05/18New drug · Class 1 | HRS-4642注射液CXHL2600584 | 上海恒瑞医药有限公司; 江苏恒瑞医药股份有限公司 |
| 2026/05/18New drug · Class 1 | H029片CXHL2600583 | 江苏柯菲平医药股份有限公司 |
| 2026/05/18New drug · Class 1 | HRS-6093片CXHL2600582 | 江苏恒瑞医药股份有限公司 |
| 2026/05/18New drug · Class 1 | HRS-6093片CXHL2600581 | 江苏恒瑞医药股份有限公司 |
| 2026/05/18New drug · Class 1 | HRS-7058胶囊CXHL2600580 | 山东盛迪医药有限公司 |
| 2026/05/18New drug · Class 1 | HRS-7058胶囊CXHL2600579 | 山东盛迪医药有限公司 |
126 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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