药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/06/11 – 2024/06/17
- New acceptances this week
- 320
- Drugs with new generic filings (by drug name, de-duplicated)
- 59
- Accepted this week, now under review
- 3
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
320filings, 77 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 160 |
| Generic | 77 |
| New drug | 56 |
| Import | 12 |
| Unspecified | 9 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 223 |
| TCM | 50 |
| 治疗用生物制品 | 38 |
| Biologic | 5 |
| 预防用生物制品 | 4 |
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 | 注射用青霉素钠 | 5 | 1 | 2 |
| 2 | 氨磺必利注射液 | 3 | 2 | 1 |
| 3 | 西甲硅油乳剂 | 2 | 2 | 3 |
| 4 | 丁酸氯维地平注射用乳剂 | 2 | 1 | 0 |
| 5 | 他克莫司胶囊 | 2 | 1 | 2 |
| 6 | 头孢呋辛酯干混悬剂 | 2 | 1 | 5 |
| 7 | 富马酸比索洛尔片 | 2 | 1 | 6 |
| 8 | 布洛芬混悬液 | 2 | 1 | 14 |
| 9 | 拉考沙胺注射液 | 2 | 1 | 0 |
| 10 | 硫酸阿米卡星注射液 | 2 | 1 | 3 |
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
177 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bracco Imaging S.P.A. | 24 | 1 | 0 |
| 2 | 四川依科制药有限公司 | 8 | 7 | 2 |
| 3 | 神州细胞工程有限公司 | 7 | 4 | 0 |
| 4 | Novartis Pharma Schweiz AG | 7 | 3 | 0 |
| 5 | 广东金城金素制药有限公司 | 7 | 2 | 0 |
| 6 | Boehringer Ingelheim International GmbH | 7 | 1 | 0 |
| 7 | 秦皇岛爱晖药业有限公司 | 6 | 6 | 0 |
| 8 | 河南省百泉制药有限公司 | 5 | 5 | 0 |
| 9 | 西藏金岳医药有限公司 | 5 | 1 | 5 |
| 10 | 海南爱科制药有限公司 | 4 | 4 | 4 |
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 |
|---|---|---|
| 2024/06/17New drug · Class 1.2 | SCTV04C注射液CXSL2400397 | 神州细胞工程有限公司 |
| 2024/06/17New drug · Class 1.2 | SCTV04C注射液CXSL2400396 | 神州细胞工程有限公司 |
| 2024/06/17New drug · Class 1 | SYSA1801注射液CXSL2400395 | 石药集团巨石生物制药有限公司 |
| 2024/06/17New drug · Class 1 | PG-033片CXHL2400607 | 北京普祺医药科技股份有限公司 |
| 2024/06/17New drug · Class 1 | PG-033片CXHL2400606 | 北京普祺医药科技股份有限公司 |
| 2024/06/17New drug · Class 1 | TY751注射液CXHL2400605 | 天津药物研究院有限公司 |
| 2024/06/15Import · Class 1 | BAY 2927088片JXHL2400140 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2024/06/15Import · Class 2.4 | Capivasertib片JXHL2400139 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2024/06/15Import · Class 2.4 | Capivasertib片JXHL2400138 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2024/06/15Import · Class 1 | AZD9833片JXHL2400137 | AstraZeneca AB; AstraZeneca Investment (China) Co. Limited |
| 2024/06/15Generic · Class 3 | 盐酸昂丹司琼片CYHS2401808 | 成都通德药业有限公司 |
| 2024/06/15Generic · Class 3 | 米诺地尔搽剂CYHS2401807 | 贵州瑞和制药有限公司; 中山万汉制药有限公司 |
| 2024/06/15Generic · Class 3 | 米诺地尔搽剂CYHS2401806 | 贵州瑞和制药有限公司; 中山万汉制药有限公司 |
| 2024/06/15Generic · Class 3 | 复方聚乙二醇(3350)电解质散CYHS2401805 | 四川信拓医药技术有限公司; 成都天台山制药股份有限公司 |
| 2024/06/15New drug · Class 3.1 | 五味消毒饮颗粒CXZS2400022 | 瑞阳制药股份有限公司 |
| 2024/06/15New drug · Class 3.3 | 司美格鲁肽注射液CXSL2400394 | 惠升生物制药股份有限公司 |
| 2024/06/15New drug · Class 3.3 | 司美格鲁肽注射液CXSL2400393 | 惠升生物制药股份有限公司 |
| 2024/06/15New drug · Class 1 | GR1802注射液CXSL2400392 | 重庆智翔金泰生物制药股份有限公司 |
| 2024/06/15New drug · Class 1 | GR1802注射液CXSL2400391 | 重庆智翔金泰生物制药股份有限公司 |
| 2024/06/15New drug · Class 1 | SCTB41注射液CXSL2400390 | 神州细胞工程有限公司 |
| 2024/06/14Import · Class 2.2 | Efgartigimod注射液JXSL2400113 | argenx BV; Zai Lab (Shanghai) Co. Ltd. |
| 2024/06/14Generic · Class 3 | 维生素B6注射液CYHS2401798 | 南京思聆医药科技有限公司; 金陵药业股份有限公司南京金陵制药厂 |
| 2024/06/14Generic · Class 3 | 复方聚乙二醇电解质散(儿童型)CYHS2401797 | 亚宝药业集团股份有限公司 |
| 2024/06/14Generic · Class 3 | 瑞加诺生注射液CYHL2400112 | 珠海润都制药股份有限公司 |
| 2024/06/14Generic · Class 3 | 盐酸西替利嗪注射液CYHL2400111 | 中孚药业股份有限公司 |
| 2024/06/14New drug · Class 1.1 | 益智安脑颗粒CXZL2400033 | 北京京师脑力科技有限公司 |
| 2024/06/14New drug · Class 1 | SCT520FF注射液CXSL2400389 | 神州细胞工程有限公司 |
| 2024/06/14New drug · Class 1 | SCT520FF注射液CXSL2400388 | 神州细胞工程有限公司 |
| 2024/06/14New drug · Class 1 | SCT520FF注射液CXSL2400387 | 神州细胞工程有限公司 |
| 2024/06/14New drug · Class 3.3 | 重组抗PD-1人源化单克隆抗体注射液CXSL2400386 | 复星汉霖(深圳)生物技术有限公司; 上海复宏汉霖生物技术股份有限公司 |
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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