药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/05/14 – 2024/05/20
- New acceptances this week
- 301
- Drugs with new generic filings (by drug name, de-duplicated)
- 56
- 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
301filings, 75 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 121 |
| Generic | 75 |
| New drug | 68 |
| Import re-registration | 15 |
| Import | 14 |
| Unspecified | 5 |
| 药械组合产品 | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 202 |
| 治疗用生物制品 | 54 |
| TCM | 34 |
| 预防用生物制品 | 8 |
| 药械 | 3 |
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
56 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 富马酸伏诺拉生片 | 3 | 2 | 58 |
| 2 | 他达拉非片 | 3 | 1 | 23 |
| 3 | 复方聚乙二醇(3350)电解质散 | 2 | 2 | 5 |
| 4 | 洛索洛芬钠凝胶贴膏 | 2 | 2 | 8 |
| 5 | 盐酸去氧肾上腺素注射液 | 2 | 2 | 5 |
| 6 | 二甲双胍格列本脲片 | 2 | 1 | 0 |
| 7 | 他克莫司缓释胶囊 | 2 | 1 | 6 |
| 8 | 利伐沙班干混悬剂 | 2 | 1 | 2 |
| 9 | 利格列汀二甲双胍缓释片 | 2 | 1 | 4 |
| 10 | 孟鲁司特钠口崩片 | 2 | 1 | 0 |
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
190 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Pfizer Inc. | 6 | 3 | 0 |
| 2 | 深圳信立泰药业股份有限公司 | 6 | 1 | 0 |
| 3 | 四川安可康生物医药有限公司 | 5 | 1 | 0 |
| 4 | 广州一品红制药有限公司 | 5 | 1 | 0 |
| 5 | 北京百奥药业有限责任公司 | 4 | 3 | 4 |
| 6 | 上海和誉生物医药科技有限公司 | 4 | 2 | 0 |
| 7 | Fresenius Kabi AB | 4 | 1 | 0 |
| 8 | Sanofi Winthrop Industrie | 4 | 1 | 0 |
| 9 | 凯思凯迪(上海)医药科技有限公司 | 4 | 1 | 0 |
| 10 | 广西馨海药业科技有限公司 | 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
108 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/05/18Import · Class 2.4 | 甲磺酸贝舒地尔片JXHL2400115 | Kadmon Pharmaceuticals LLC; Sanofi (China) Investment Co. Ltd. |
| 2024/05/18Import · Class 2.4 | Fezolinetant片JXHL2400114 | Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd. |
| 2024/05/18Generic · Class 3 | 乙酰半胱氨酸注射液CYHS2401507 | 湖南华纳大药厂股份有限公司 |
| 2024/05/18Generic · Class 3 | 乌苯美司胶囊CYHS2401505 | 西安万隆制药股份有限公司 |
| 2024/05/18Generic · Class 3 | 洛索洛芬钠口服溶液CYHS2401502 | 合肥诚志生物制药有限公司 |
| 2024/05/18Generic · Class 3 | 利格列汀二甲双胍缓释片CYHS2401498 | 湖北广辰药业有限公司 |
| 2024/05/18Generic · Class 3 | 利格列汀二甲双胍缓释片CYHS2401497 | 湖北广辰药业有限公司 |
| 2024/05/18Generic · Class 3 | 丁酸氯维地平注射用乳剂CYHS2401496 | 齐鲁制药(海南)有限公司 |
| 2024/05/18Generic · Class 3 | 葡萄糖酸钙氯化钠注射液CYHS2401493 | 石家庄四药有限公司 |
| 2024/05/18Generic · Class 3 | 复方聚乙二醇(3350)电解质散CYHS2401489 | 湖北莱康医疗技术有限公司; 广东华南药业集团有限公司 |
| 2024/05/18Generic · Class 3 | 右酮洛芬氨丁三醇注射液CYHL2400098 | 北京百奥药业有限责任公司 |
| 2024/05/18New drug · Class 1.2 | JKN2303CXZL2400029 | 江西中医药大学; 广西馨海药业科技有限公司 |
| 2024/05/18New drug · Class 1.2 | JKN2303吸入溶液CXZL2400028 | 广西馨海药业科技有限公司; 健康元药业集团股份有限公司 |
| 2024/05/18New drug · Class 1.2 | JKN2303吸入溶液CXZL2400027 | 广西馨海药业科技有限公司; 健康元药业集团股份有限公司 |
| 2024/05/18New drug · Class 1.2 | JKN2303吸入溶液CXZL2400026 | 广西馨海药业科技有限公司; 健康元药业集团股份有限公司 |
| 2024/05/18New drug · Class 1.2 | JKN2303吸入溶液CXZL2400025 | 广西馨海药业科技有限公司; 健康元药业集团股份有限公司 |
| 2024/05/18New drug · Class 3.3 | 四价流感病毒裂解疫苗CXSL2400331 | 深圳康泰生物制品股份有限公司 |
| 2024/05/18New drug · Class 1 | PM1032注射液CXSL2400330 | 普米斯生物技术(珠海)有限公司 |
| 2024/05/18New drug · Class 2.2 | SL001CXHL2400511 | 四川省三星堆制药有限公司 |
| 2024/05/17Import · Class 1 | 注射用M9140JXSL2400096 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd. |
| 2024/05/17Import · Class 2.2 | Dostarlimab注射液JXSL2400095 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. LTD |
| 2024/05/17Import · Class 2.2 | Dostarlimab注射液JXSL2400094 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd. |
| 2024/05/17Import · Class 1 | Amlitelimab注射液JXSL2400093 | Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD |
| 2024/05/17Generic · Class 3 | 氨磺必利注射液CYHS2401488 | 南京正科医药股份有限公司 |
| 2024/05/17Generic · Class 3 | 氨磺必利注射液CYHS2401487 | 南京正科医药股份有限公司 |
| 2024/05/17Generic · Class 3 | 布美他尼注射液CYHS2401480 | 四川奥邦古得药业有限公司; 成都利尔药业有限公司 |
| 2024/05/17Generic · Class 3 | 盐酸纳美芬注射液CYHS2401479 | 海南爱科制药有限公司 |
| 2024/05/17Generic · Class 3 | 重酒石酸间羟胺注射液CYHS2401477 | 广州惠沣德生物技术有限公司; 博瑞制药(苏州)有限公司 |
| 2024/05/17Generic · Class 3 | 二甲双胍格列本脲片CYHS2401476 | 通化万通药业股份有限公司 |
| 2024/05/17Generic · Class 3 | 二甲双胍格列本脲片CYHS2401475 | 通化万通药业股份有限公司 |
78 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.