药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/01/16 – 2024/01/22
- New acceptances this week
- 306
- Drugs with new generic filings (by drug name, de-duplicated)
- 59
- Accepted this week, now under review
- 2
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
306filings, 77 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 156 |
| Generic | 77 |
| New drug | 51 |
| Import | 14 |
| Unspecified | 4 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 203 |
| TCM | 56 |
| 治疗用生物制品 | 42 |
| 预防用生物制品 | 3 |
| Biologic | 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
59 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 注射用头孢唑肟钠 | 4 | 1 | 6 |
| 2 | 亚叶酸钙注射液 | 3 | 1 | 4 |
| 3 | 地夸磷索钠滴眼液 | 2 | 2 | 5 |
| 4 | 他达拉非片 | 2 | 1 | 23 |
| 5 | 克唑替尼胶囊 | 2 | 1 | 7 |
| 6 | 吡拉西坦注射液 | 2 | 1 | 9 |
| 7 | 复方聚乙二醇电解质散(Ⅱ) | 2 | 1 | 4 |
| 8 | 富马酸伏诺拉生片 | 2 | 1 | 58 |
| 9 | 沙库巴曲缬沙坦钠片 | 2 | 1 | 70 |
| 10 | 注射用美罗培南 | 2 | 1 | 5 |
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
179 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 甘肃雍合堂药业有限公司 | 16 | 16 | 0 |
| 2 | 吉林恒星科技制药有限公司 | 10 | 9 | 0 |
| 3 | Boehringer Ingelheim International GmbH | 9 | 3 | 0 |
| 4 | 上海恒瑞医药有限公司 | 5 | 4 | 0 |
| 5 | 广东科伦药业有限公司 | 5 | 1 | 0 |
| 6 | 吉林吴太感康药业有限公司 | 4 | 4 | 0 |
| 7 | 江西南昌济生制药有限责任公司 | 4 | 4 | 0 |
| 8 | 河南省百泉制药有限公司 | 4 | 4 | 0 |
| 9 | 苏州盛迪亚生物医药有限公司 | 4 | 4 | 0 |
| 10 | AstraZeneca AB | 4 | 3 | 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
95 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/01/22Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液CYHS2400291 | 江苏康缘药业股份有限公司 |
| 2024/01/22New drug · Class 2.2 | SHR-8068注射液CXSL2400050 | 苏州盛迪亚生物医药有限公司 |
| 2024/01/22New drug · Class 1 | 注射用SHR-A2102CXSL2400049 | 上海恒瑞医药有限公司 |
| 2024/01/22New drug · Class 2.2 | 阿得贝利单抗注射液CXSL2400048 | 上海盛迪医药有限公司 |
| 2024/01/22New drug · Class 2.4 | 羟乙磺酸达尔西利片CXHL2400093 | 江苏恒瑞医药股份有限公司 |
| 2024/01/22New drug · Class 2.4 | 羟乙磺酸达尔西利片CXHL2400092 | 江苏恒瑞医药股份有限公司 |
| 2024/01/22New drug · Class 1 | HRS8807片CXHL2400091 | 上海恒瑞医药有限公司 |
| 2024/01/22New drug · Class 1 | HRS8807片CXHL2400090 | 上海恒瑞医药有限公司 |
| 2024/01/22New drug · Class 2.4 | 羟乙磺酸达尔西利片CXHL2400089 | 江苏恒瑞医药股份有限公司 |
| 2024/01/20Import · Class 2.2 | 佩索利单抗注射液(皮下注射)JXSL2400021 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2024/01/20Import · Class 2.2 | 佩索利单抗注射液JXSL2400020 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2024/01/20Generic · Class 3 | 硫酸沙丁胺醇注射液CYHS2400290 | 湖南华纳大药厂股份有限公司 |
| 2024/01/20Generic · Class 3 | 西格列汀二甲双胍缓释片CYHS2400288 | 平光制药股份有限公司 |
| 2024/01/20Generic · Class 3 | 西格列汀二甲双胍缓释片CYHS2400287 | 平光制药股份有限公司 |
| 2024/01/20Generic · Class 3 | 依巴斯汀口服溶液CYHS2400286 | 山西同达药业有限公司 |
| 2024/01/20Generic · Class 3 | 复方聚乙二醇电解质散(Ⅱ)CYHS2400285 | 杨凌科森生物制药有限责任公司 |
| 2024/01/20Generic · Class 3 | 复方聚乙二醇电解质散(Ⅱ)CYHS2400284 | 杨凌科森生物制药有限责任公司 |
| 2024/01/20Generic · Class 3 | 盐酸曲唑酮片CYHS2400283 | 西安远大科创医药科技有限公司; 西安远大德天药业股份有限公司 |
| 2024/01/20Generic · Class 3 | 无水甜菜碱散剂CYHS2400282 | 北京斯利安药业有限公司 |
| 2024/01/20Generic · Class 3 | 二羟丙茶碱注射液CYHS2400281 | 安徽美来药业股份有限公司; 马鞍山丰原制药有限公司 |
| 2024/01/20Generic · Class 3 | 盐酸美金刚口服溶液CYHS2400280 | 沈阳天邦药业有限公司 |
| 2024/01/20New drug · Class 3.1 | 枇杷清肺颗粒CXZS2400004 | 仲景宛西制药股份有限公司 |
| 2024/01/20New drug · Class 3.3 | b型流感嗜血杆菌结合疫苗CXSS2400014 | 罗益(无锡)生物制药有限公司 |
| 2024/01/20New drug · Class 2.2 | 注射用卡瑞利珠单抗CXSL2400047 | 苏州盛迪亚生物医药有限公司 |
| 2024/01/20New drug · Class 1 | 注射用BL-M07D1CXSL2400046 | 成都百利多特生物药业有限责任公司; 四川百利药业有限责任公司 |
| 2024/01/20New drug · Class 1 | 注射用BL-M07D1CXSL2400045 | 成都百利多特生物药业有限责任公司; 四川百利药业有限责任公司 |
| 2024/01/20New drug · Class 1 | XNW5004片CXHL2400088 | 苏州信诺维医药科技股份有限公司 |
| 2024/01/20New drug · Class 1 | XNW5004片CXHL2400087 | 苏州信诺维医药科技股份有限公司 |
| 2024/01/20New drug · Class 2.4 | 盐酸伊立替康脂质体注射液CXHL2400086 | 石药集团欧意药业有限公司 |
| 2024/01/19Import · Class 1 | BI 456906 注射液JXHL2400020 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
65 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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