药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/11/04 – 2025/11/10
- New acceptances this week
- 362
- Drugs with new generic filings (by drug name, de-duplicated)
- 44
- Accepted this week, now under review
- 83
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
362filings, 59 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 194 |
| Generic | 59 |
| New drug | 50 |
| Import | 22 |
| Import re-registration | 19 |
| Unspecified | 18 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 194 |
| TCM | 91 |
| 治疗用生物制品 | 63 |
| Biologic | 11 |
| 预防用生物制品 | 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
44 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 非奈利酮片 | 3 | 2 | 71 |
| 2 | 氟比洛芬凝胶贴膏 | 2 | 2 | 16 |
| 3 | 利伐沙班干混悬剂 | 2 | 1 | 2 |
| 4 | 卡铂注射液 | 2 | 1 | 11 |
| 5 | 头孢托仑匹酯颗粒 | 2 | 1 | 18 |
| 6 | 富马酸伏诺拉生片 | 2 | 1 | 58 |
| 7 | 拉莫三嗪分散片 | 2 | 1 | 2 |
| 8 | 氯化钾氯化钠注射液 | 2 | 1 | 4 |
| 9 | 注射用头孢曲松钠/氯化钠注射液 | 2 | 1 | 3 |
| 10 | 盐酸达泊西汀片 | 2 | 1 | 20 |
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
220 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 8 | 2 | 0 |
| 2 | 四川依科制药有限公司 | 7 | 7 | 0 |
| 3 | 江苏豪森药业集团有限公司 | 6 | 2 | 0 |
| 4 | 宝龙药业有限公司 | 5 | 5 | 0 |
| 5 | 重庆科瑞南海制药有限责任公司 | 5 | 5 | 0 |
| 6 | Eisai Co. Ltd. | 5 | 1 | 0 |
| 7 | Sanofi-Aventis Recherche & Développement | 4 | 4 | 0 |
| 8 | Merck Sharp & Dohme LLC | 4 | 2 | 0 |
| 9 | Sanofi Winthrop Industrie | 4 | 2 | 0 |
| 10 | 上海和黄药业有限公司 | 4 | 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
90 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/11/10New drug · Class 1 | SPGL008注射液CXSL2500957 | 深圳赛保尔生物药业有限公司 |
| 2025/11/08Import · Class 1 | ABBV-706注射用冻干粉JXSL2500213 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2025/11/08Import · Class 1 | CID-103注射液JXSL2500212 | CASI Pharmaceuticals Inc.; CASI Pharmaceuticals (China) Co. Ltd. |
| 2025/11/08Import · Class 1 | Frexalimab注射液JXSL2500211 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2025/11/08Generic · Class 3 | 美沙拉秦缓释颗粒CYHS2503907 | 石药集团中诺药业(石家庄)有限公司 |
| 2025/11/08Generic · Class 3 | 美沙拉秦缓释颗粒CYHS2503906 | 石药集团中诺药业(石家庄)有限公司 |
| 2025/11/08New drug · Class 1 | SHR-1049注射液CXSL2500956 | 江苏恒瑞医药股份有限公司 |
| 2025/11/08New drug · Class 3.3 | 度普利尤单抗注射液CXSL2500955 | 江苏景行医药科技有限公司 |
| 2025/11/08New drug · Class 1 | IBI343CXSL2500954 | 信达生物制药(苏州)有限公司 |
| 2025/11/08New drug · Class 3.3 | KH816注射液CXSL2500953 | 成都康弘生物科技有限公司 |
| 2025/11/08New drug · Class 1 | OB756片CXHL2501223 | 杭州邦顺制药股份有限公司 |
| 2025/11/07Import · Class 1 | CagriSema注射液JXSL2500218 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2025/11/07Import · Class 1 | CagriSema注射液JXSL2500217 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2025/11/07Import · Class 1 | CagriSema注射液JXSL2500216 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2025/11/07Import · Class 1 | CagriSema注射液JXSL2500215 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2025/11/07Import · Class 1 | CagriSema注射液JXSL2500214 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2025/11/07Import · Class 2.4 | 左炔诺孕酮宫内释放系统JXHL2500344 | Bayer Yakuhin Ltd. |
| 2025/11/07Generic · Class 3 | 盐酸昂丹司琼口服溶液CYHS2503895 | 北京柏雅联合药物研究所有限公司; 广东众生药业股份有限公司 |
| 2025/11/07Generic · Class 3 | 注射用德拉沙星CYHL2500197 | 成都明德至远医药科技有限公司 |
| 2025/11/07New drug · Class 3.3 | 司美格鲁肽注射液CXSS2500122 | 复星万邦(江苏)医药集团有限公司 |
| 2025/11/07New drug · Class 3.3 | 司美格鲁肽注射液CXSS2500121 | 复星万邦(江苏)医药集团有限公司 |
| 2025/11/07New drug · Class 3.3 | 司美格鲁肽注射液CXSS2500120 | 复星万邦(江苏)医药集团有限公司 |
| 2025/11/07New drug · Class 3.3 | 司美格鲁肽注射液CXSS2500119 | 复星万邦(江苏)医药集团有限公司 |
| 2025/11/07New drug · Class 1 | 注射用重组酰化胰高血糖素样肽2类似物CXSL2500952 | 重庆派金生物科技有限公司 |
| 2025/11/07New drug · Class 1 | 人脐带间充质干细胞注射液CXSL2500951 | 杭州易文赛生物技术有限公司 |
| 2025/11/07New drug · Class 1 | 注射用YKYY031CXSL2500950 | 北京悦康科创医药科技股份有限公司; 杭州天龙药业有限公司 |
| 2025/11/07New drug · Class 1 | IPG11406片CXHL2501222 | 南京艾美斐生物医药科技股份有限公司 |
| 2025/11/07New drug · Class 1 | IPG11406片CXHL2501221 | 南京艾美斐生物医药科技股份有限公司 |
| 2025/11/07New drug · Class 1 | IPG11406片CXHL2501220 | 南京艾美斐生物医药科技股份有限公司 |
| 2025/11/07New drug · Class 1 | 西奥罗尼胶囊CXHL2501219 | 深圳微芯生物科技股份有限公司; 成都微芯药业有限公司 |
60 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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