药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/05/28 – 2024/06/03
- New acceptances this week
- 263
- Drugs with new generic filings (by drug name, de-duplicated)
- 55
- 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
263filings, 73 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 122 |
| Generic | 73 |
| New drug | 47 |
| Import | 18 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 182 |
| 治疗用生物制品 | 40 |
| TCM | 37 |
| 预防用生物制品 | 3 |
| 体外诊断试剂 | 1 |
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
55 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 乳果糖口服溶液 | 7 | 3 | 40 |
| 2 | 二甲硅油乳剂 | 3 | 1 | 14 |
| 3 | 阿普米司特片 | 3 | 1 | 3 |
| 4 | 布美他尼注射液 | 2 | 1 | 16 |
| 5 | 盐酸米诺环素胶囊 | 2 | 1 | 19 |
| 6 | 硫辛酸片 | 2 | 1 | 4 |
| 7 | 碘佛醇注射液 | 2 | 1 | 9 |
| 8 | 磷酸西格列汀片 | 2 | 1 | 2 |
| 9 | 维生素K1注射液 | 2 | 1 | 6 |
| 10 | 罗沙司他胶囊 | 2 | 1 | 17 |
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
164 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 河南华峰制药有限公司 | 9 | 9 | 0 |
| 2 | 江苏恒瑞医药股份有限公司 | 8 | 4 | 0 |
| 3 | CHEPLAPHARM Registration GmbH | 7 | 2 | 0 |
| 4 | Eli Lilly and Company | 6 | 1 | 0 |
| 5 | 海南广升誉制药有限公司 | 6 | 1 | 0 |
| 6 | 百济神州(苏州)生物科技有限公司 | 5 | 2 | 0 |
| 7 | 湘北威尔曼制药股份有限公司 | 5 | 1 | 0 |
| 8 | 浙江百代医药科技有限公司 | 4 | 4 | 4 |
| 9 | 山东博安生物技术股份有限公司 | 4 | 1 | 0 |
| 10 | Novartis Europharm Limited | 3 | 2 | 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
82 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/06/03Import · Class 1 | 伊那利塞片JXHS2400038 | Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG; Roche (China) Holding Ltd. |
| 2024/06/03Import · Class 1 | 伊那利塞片JXHS2400037 | Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG; Roche (China) Holding Ltd. |
| 2024/06/01Import · Class 3.1 | 呼吸道合胞病毒疫苗JXSL2400107 | Pfizer Inc.; Pfizer Investment CO Ltd. |
| 2024/06/01Import · Class 2.2;2.4 | 克拉屈滨胶囊JXHL2400125 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd |
| 2024/06/01Import · Class 2.2;2.4 | 克拉屈滨胶囊JXHL2400124 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd |
| 2024/06/01Generic · Class 3 | 依帕司他片CYHS2401651 | 中美华世通生物医药科技(武汉)股份有限公司; 湖北华世通生物医药科技有限公司 |
| 2024/06/01Generic · Class 3 | 氯化钾颗粒CYHS2401648 | 山东普瑞曼药业有限公司 |
| 2024/06/01Generic · Class 3 | 维生素B6注射液CYHS2401646 | 北京远方通达医药技术有限公司; 河南科伦药业有限公司 |
| 2024/06/01Generic · Class 3 | 布美他尼注射液CYHS2401641 | 北京民康百草医药科技有限公司; 山西诺成制药有限公司 |
| 2024/06/01Generic · Class 3 | 布美他尼注射液CYHS2401640 | 北京民康百草医药科技有限公司; 山西诺成制药有限公司 |
| 2024/06/01New drug · Class 1 | CS060380片CXHL2400553 | 凯思凯迪(上海)医药科技有限公司 |
| 2024/06/01New drug · Class 1 | CS060380片CXHL2400552 | 凯思凯迪(上海)医药科技有限公司 |
| 2024/06/01New drug · Class 1 | CS060380片CXHL2400551 | 凯思凯迪(上海)医药科技有限公司 |
| 2024/05/31Import · Class 2.2 | Dostarlimab注射液JXSL2400106 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd. |
| 2024/05/31Import · Class 1 | VAY736注射液JXSL2400105 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/05/31Generic · Class 3 | 氨磺必利口服溶液CYHS2401638 | 常州四药制药有限公司 |
| 2024/05/31Generic · Class 3 | 氯化钙注射液CYHS2401634 | 河北千康医药科技有限责任公司; 山东齐都药业有限公司 |
| 2024/05/31Generic · Class 3 | 异烟肼注射液CYHS2401633 | 漯河市汇创医药有限公司; 裕松源药业有限公司 |
| 2024/05/31Generic · Class 3 | 维生素K1注射液CYHS2401632 | 合肥亿帆生物制药有限公司 |
| 2024/05/31Generic · Class 3 | 维生素K1注射液CYHS2401631 | 合肥亿帆生物制药有限公司 |
| 2024/05/31New drug · Class 1 | 夫那奇珠单抗注射液CXSL2400363 | 苏州盛迪亚生物医药有限公司 |
| 2024/05/31New drug · Class 1 | 夫那奇珠单抗注射液CXSL2400362 | 苏州盛迪亚生物医药有限公司 |
| 2024/05/31New drug · Class 1 | 夫那奇珠单抗注射液CXSL2400361 | 苏州盛迪亚生物医药有限公司 |
| 2024/05/31New drug · Class 1 | 注射用LNF2007双特异性抗体CXSL2400360 | 山东新时代药业有限公司 |
| 2024/05/31New drug · Class 1 | SHR-2106注射液CXSL2400359 | 广东恒瑞医药有限公司 |
| 2024/05/31New drug · Class 1 | 注射用HS-20093CXSL2400358 | 上海翰森生物医药科技有限公司; 常州恒邦药业有限公司 |
| 2024/05/31New drug · Class 1 | 注射用HS-20093CXSL2400357 | 上海翰森生物医药科技有限公司; 常州恒邦药业有限公司 |
| 2024/05/31New drug · Class 1 | HS-20117注射液CXSL2400356 | 上海翰森生物医药科技有限公司; 常州恒邦药业有限公司 |
| 2024/05/31New drug · Class 1 | XMVA09注射液CXSL2400355 | 合肥星眸生物科技有限公司 |
| 2024/05/31New drug · Class 1 | BGB-45035片CXHL2400550 | 百济神州(苏州)生物科技有限公司 |
52 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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