药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/08/06 – 2024/08/12
- New acceptances this week
- 390
- Drugs with new generic filings (by drug name, de-duplicated)
- 81
- Accepted this week, now under review
- 1
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
390filings, 123 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 165 |
| Generic | 123 |
| New drug | 54 |
| Import | 19 |
| Unspecified | 18 |
| Import re-registration | 11 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 291 |
| TCM | 46 |
| 治疗用生物制品 | 37 |
| Biologic | 10 |
| 预防用生物制品 | 6 |
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
81 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 生理氯化钠溶液 | 5 | 1 | 17 |
| 2 | 苯磺酸左氨氯地平片 | 4 | 2 | 47 |
| 3 | 比索洛尔氨氯地平片 | 3 | 3 | 8 |
| 4 | 氯化钙注射液 | 3 | 3 | 6 |
| 5 | 米诺地尔搽剂 | 3 | 2 | 49 |
| 6 | 沙库巴曲缬沙坦钠片 | 3 | 1 | 72 |
| 7 | 注射用头孢哌酮钠舒巴坦钠 | 3 | 1 | 14 |
| 8 | 盐酸二甲双胍缓释片 | 3 | 1 | 11 |
| 9 | 盐酸拉贝洛尔注射液 | 3 | 1 | 4 |
| 10 | 吡格列酮二甲双胍片 | 2 | 2 | 10 |
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
229 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Boehringer Ingelheim International GmbH | 14 | 1 | 0 |
| 2 | 华北制药金坦生物技术股份有限公司 | 8 | 1 | 0 |
| 3 | 沈阳红药集团股份有限公司 | 7 | 7 | 0 |
| 4 | Novo Nordisk A/S | 7 | 3 | 0 |
| 5 | 山东盛迪医药有限公司 | 7 | 3 | 0 |
| 6 | 江苏神龙药业有限公司 | 5 | 2 | 5 |
| 7 | 河北道恩药业有限公司 | 5 | 1 | 5 |
| 8 | 山东齐都药业有限公司 | 4 | 4 | 4 |
| 9 | 黑龙江亿达鸿药业有限公司 | 4 | 4 | 0 |
| 10 | Pfizer Inc. | 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
135 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/08/12Generic · Class 3 | 米诺地尔外用溶液CYHS2402603 | 江苏济茗医药有限公司; 江苏万高药业股份有限公司 |
| 2024/08/12Generic · Class 3 | 米诺地尔外用溶液CYHS2402602 | 江苏济茗医药有限公司; 江苏万高药业股份有限公司 |
| 2024/08/12Generic · Class 3 | 盐酸拉贝洛尔注射液CYHS2402599 | 江苏神龙药业有限公司; 西安安健药业有限公司 |
| 2024/08/12Generic · Class 3 | 盐酸拉贝洛尔注射液CYHS2402598 | 江苏神龙药业有限公司; 西安安健药业有限公司 |
| 2024/08/12Generic · Class 3 | 盐酸拉贝洛尔注射液CYHS2402597 | 江苏神龙药业有限公司; 西安安健药业有限公司 |
| 2024/08/12New drug · Class 2.2 | 特瑞普利单抗注射液CXSS2400085 | 上海君实生物医药科技股份有限公司; 苏州众合生物医药科技有限公司; 上海君实生物工程有限公司 |
| 2024/08/12New drug · Class 2.2 | 特瑞普利单抗注射液CXSS2400084 | 上海君实生物医药科技股份有限公司; 苏州众合生物医药科技有限公司; 上海君实生物工程有限公司 |
| 2024/08/12New drug · Class 1 | TG-1000胶囊CXHS2400073 | 健康元药业集团股份有限公司; 凯莱英生命科学技术(天津)有限公司 |
| 2024/08/10Import · Class 1 | ALPN-303注射液JXSL2400147 | Alpine Immune Sciences Inc.; —— |
| 2024/08/10Generic · Class 3 | 尼美舒利片CYHS2402594 | 上海理想制药有限公司 |
| 2024/08/10Generic · Class 3 | 米诺地尔搽剂CYHS2402593 | 山东鲁抗医药集团赛特有限责任公司 |
| 2024/08/10Generic · Class 3 | 米诺地尔搽剂CYHS2402592 | 山东鲁抗医药集团赛特有限责任公司 |
| 2024/08/10Generic · Class 3 | 吡格列酮二甲双胍片(15mg/850mg)CYHS2402591 | 安徽杰玺医药有限公司; 华益药业科技(安徽)有限公司 |
| 2024/08/10Generic · Class 3 | 己酮可可碱缓释片CYHS2402588 | 广州市联瑞制药有限公司 |
| 2024/08/10Generic · Class 3 | 二羟丙茶碱注射液CYHS2402586 | 江西亿友药业有限公司; 裕松源药业有限公司 |
| 2024/08/10Generic · Class 3 | 氯化钙注射液CYHS2402585 | 湖南埃威格林医药科技有限公司; 浙江赛默制药有限公司 |
| 2024/08/10New drug · Class 3.3 | 地舒单抗注射液CXSL2400532 | 华兰基因工程(河南)有限公司; 华兰基因工程有限公司 |
| 2024/08/10New drug · Class 1 | HC022注射液CXSL2400531 | 上海宏成药业有限公司 |
| 2024/08/10New drug · Class 3.3 | 精蛋白人胰岛素混合注射液 (30R)CXSL2400530 | 恒敬合创生物医药(浙江)有限公司 |
| 2024/08/10New drug · Class 2.2 | SHR-8068注射液CXSL2400529 | 苏州盛迪亚生物医药有限公司 |
| 2024/08/10New drug · Class 2.2 | BIOS2210CXHL2400815 | 杭州百诚医药科技股份有限公司 |
| 2024/08/10New drug · Class 2.2 | BIOS2210CXHL2400814 | 杭州百诚医药科技股份有限公司 |
| 2024/08/10New drug · Class 2.2 | 司美格鲁肽注射液CXHL2400813 | 山西嘉源生物医药有限公司 |
| 2024/08/10New drug · Class 2.2 | 司美格鲁肽注射液CXHL2400812 | 山西嘉源生物医药有限公司 |
| 2024/08/10New drug · Class 2.2 | BM2216缓释片CXHL2400811 | 南京佰麦生物技术有限公司 |
| 2024/08/10New drug · Class 2.2 | BM2216缓释片CXHL2400810 | 南京佰麦生物技术有限公司 |
| 2024/08/10New drug · Class 2.2 | BM2216缓释片CXHL2400809 | 南京佰麦生物技术有限公司 |
| 2024/08/09Import · Class 2.4 | 艾伏尼布片JXHL2400198 | Institut de Recherches Internationales Servier; Servier (Beijing) Pharmaceutical Research & Development Co. LTD |
| 2024/08/09Generic · Class 3 | 盐酸去氧肾上腺素注射液CYHS2402578 | 上海炫鑫医药科技有限公司; 山东方明药业集团股份有限公司 |
| 2024/08/09Generic · Class 3 | 枸橼酸西地那非口溶膜CYHS2402577 | 四川科伦药业股份有限公司 |
105 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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