药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/07/30 – 2024/08/05
- New acceptances this week
- 355
- Drugs with new generic filings (by drug name, de-duplicated)
- 75
- Accepted this week, now under review
- 12
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
355filings, 100 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 179 |
| Generic | 100 |
| New drug | 50 |
| Import | 14 |
| Unspecified | 8 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 228 |
| TCM | 63 |
| 治疗用生物制品 | 56 |
| 预防用生物制品 | 6 |
| 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
75 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 美阿沙坦钾片 | 4 | 2 | 33 |
| 2 | 氯化钾口服溶液 | 3 | 2 | 12 |
| 3 | 盐酸溴己新口服溶液 | 3 | 2 | 22 |
| 4 | 甲硫酸新斯的明注射液 | 3 | 1 | 4 |
| 5 | 硫酸镁注射液 | 3 | 1 | 7 |
| 6 | 地夸磷索钠滴眼液 | 2 | 2 | 5 |
| 7 | 小儿法罗培南钠颗粒 | 2 | 2 | 2 |
| 8 | 注射用硫酸艾沙康唑 | 2 | 2 | 15 |
| 9 | 维生素B6注射液 | 2 | 2 | 13 |
| 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
230 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 湖南三学药业有限公司 | 14 | 11 | 0 |
| 2 | 哈药集团制药总厂 | 11 | 2 | 0 |
| 3 | 神威药业集团有限公司 | 5 | 5 | 0 |
| 4 | 广东科泓药业有限公司 | 5 | 1 | 0 |
| 5 | 杭州中美华东制药有限公司 | 5 | 1 | 0 |
| 6 | 上海万仕诚药业有限公司 | 4 | 4 | 0 |
| 7 | Janssen Research & Development LLC | 4 | 2 | 0 |
| 8 | 西洲医药科技(浙江)有限公司 | 4 | 2 | 3 |
| 9 | Eli Lilly and Company | 4 | 1 | 0 |
| 10 | 北京质肽生物医药科技有限公司 | 4 | 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
105 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/08/03Import · Class 2.2 | 佩索利单抗注射液JXSL2400145 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2024/08/03Import · Class 1 | HDP-101JXSL2400144 | Heidelberg Pharma AG; Hangzhou Zhongmei HuaDong Pharmaceutical Co. Ltd. |
| 2024/08/03Import · Class 1 | ASP2138注射液JXSL2400143 | Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd. |
| 2024/08/03Import · Class 1 | JNJ-78278343注射液JXSL2400142 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/08/03Import · Class 1 | JNJ-78278343注射液JXSL2400141 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/08/03Generic · Class 3 | 昂丹司琼口溶膜CYHS2402479 | 上海欣峰制药有限公司 |
| 2024/08/03Generic · Class 3 | 昂丹司琼口溶膜CYHS2402478 | 上海欣峰制药有限公司 |
| 2024/08/03Generic · Class 3 | 磷酸奥司他韦干混悬剂CYHS2402477 | 安徽济人药业股份有限公司 |
| 2024/08/03Generic · Class 3 | 氯化钾口服溶液CYHS2402475 | 浙江领创优品药业有限公司; 浙江凯润药业股份有限公司 |
| 2024/08/03Generic · Class 3 | 氯化钾口服溶液CYHS2402474 | 浙江领创优品药业有限公司; 浙江凯润药业股份有限公司 |
| 2024/08/03Generic · Class 3 | 头孢地尼干混悬剂CYHS2402472 | 上海金城素智药业有限公司 |
| 2024/08/03Generic · Class 3 | 依托泊苷注射液CYHS2402468 | 成都瑞尔医药科技有限公司; 山东新时代药业有限公司 |
| 2024/08/03Generic · Class 3 | 阿巴帕肽注射液CYHL2400159 | 齐鲁制药有限公司 |
| 2024/08/03New drug · Class 1 | GQ1005注射液CXSL2400522 | 启德医药科技(苏州)有限公司 |
| 2024/08/03New drug · Class 1 | 注射用PTX-912CXSL2400521 | 博致生物科技(上海)有限公司 |
| 2024/08/03New drug · Class 3.3 | 司美格鲁肽注射液CXSL2400520 | 北京质肽生物医药科技有限公司; 北京诺博特生物科技有限公司 |
| 2024/08/03New drug · Class 3.3 | 司美格鲁肽注射液CXSL2400519 | 北京质肽生物医药科技有限公司; 北京诺博特生物科技有限公司 |
| 2024/08/03New drug · Class 3.3 | 司美格鲁肽注射液CXSL2400518 | 北京质肽生物医药科技有限公司; 北京诺博特生物科技有限公司 |
| 2024/08/03New drug · Class 3.3 | 司美格鲁肽注射液CXSL2400517 | 北京质肽生物医药科技有限公司; 北京诺博特生物科技有限公司 |
| 2024/08/03New drug · Class 1 | YFQLXB-UC01注射液CXSL2400516 | 山东省齐鲁细胞治疗工程技术有限公司 |
| 2024/08/03New drug · Class 1 | ZM001注射液CXSL2400515 | 厦门再妙生物科技有限公司 |
| 2024/08/02Import · Class 3.1 | elranatamabJXSL2400140 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2024/08/02Import · Class 3.1 | 注射用sotaterceptJXSL2400139 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2024/08/02Import · Class 3.1 | 注射用sotaterceptJXSL2400138 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2024/08/02Generic · Class 3 | 膦甲酸钠注射液CYHS2402461 | 赤峰源生药业有限公司 |
| 2024/08/02Generic · Class 3 | 氨磺必利口服溶液CYHS2402458 | 万特制药(海南)有限公司 |
| 2024/08/02Generic · Class 3 | 盐酸溴己新注射液CYHS2402451 | 北京双鹭药业股份有限公司 |
| 2024/08/02Generic · Class 3 | 布美他尼片CYHS2402450 | 新乡市常乐制药有限责任公司 |
| 2024/08/02New drug · Class 1.2 | 冻干带状疱疹mRNA疫苗CXSL2400514 | 武汉瑞佶生物科技有限公司; 深圳瑞吉生物科技有限公司 |
| 2024/08/02New drug · Class 1 | IHS002赋能人脐带间充质干细胞注射液CXSL2400513 | 无锡华泰创新药技术研究院有限公司 |
75 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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