药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/02/14 – 2023/02/20
- New acceptances this week
- 361
- Drugs with new generic filings (by drug name, de-duplicated)
- 68
- Accepted this week, now under review
- 0
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
361filings, 98 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 166 |
| Generic | 98 |
| New drug | 48 |
| Import re-registration | 26 |
| Import | 16 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 268 |
| TCM | 52 |
| 治疗用生物制品 | 39 |
| Biologic | 1 |
| 预防用生物制品 | 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
68 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 氨溴特罗口服溶液 | 4 | 3 | 23 |
| 2 | 利丙双卡因乳膏 | 3 | 3 | 25 |
| 3 | 乳果糖口服溶液 | 3 | 2 | 36 |
| 4 | 氨甲环酸注射液 | 3 | 1 | 11 |
| 5 | 琥珀酸美托洛尔缓释胶囊 | 3 | 1 | 4 |
| 6 | 复方匹可硫酸钠颗粒 | 2 | 2 | 4 |
| 7 | 氧 | 2 | 2 | 15 |
| 8 | 注射用盐酸罗沙替丁醋酸酯 | 2 | 2 | 5 |
| 9 | 瑞巴派特片 | 2 | 2 | 4 |
| 10 | 甘露醇山梨醇注射液 | 2 | 2 | 1 |
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 | 北京瑞璟医药有限公司 | 9 | 7 | 0 |
| 2 | 安庆回音必制药股份有限公司 | 6 | 5 | 0 |
| 3 | NAPP PHARMACEUTICALS LIMITED | 6 | 1 | 0 |
| 4 | 石家庄御泽堂制药有限公司 | 5 | 5 | 0 |
| 5 | 石家庄四药有限公司 | 5 | 4 | 2 |
| 6 | 哈尔滨珍宝制药有限公司 | 4 | 4 | 0 |
| 7 | 白银振亚卫生材料有限公司 | 4 | 3 | 0 |
| 8 | Actelion Pharmaceuticals Ltd | 4 | 1 | 0 |
| 9 | BIOTON S.A. | 4 | 1 | 0 |
| 10 | Novartis Pharma Schweiz AG | 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
98 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/02/20New drug · Class 1 | ZT002注射液CXSL2300142 | 北京质肽生物医药科技有限公司 |
| 2023/02/20New drug · Class 2.4 | 替戈拉生片CXHS2300034 | 山东罗欣药业集团股份有限公司 |
| 2023/02/18Import · Class 2.3 | IBD98-M缓释胶囊JXHL2300028 | Holy Stone Healthcare Co. Ltd.; Clinical Service Center Co. Ltd |
| 2023/02/18Generic · Class 3 | 甲氨蝶呤片CYHS2300574 | 江苏百奥信康医药科技有限公司; 浙江浙北药业有限公司 |
| 2023/02/18Generic · Class 3 | 氨溴特罗口服溶液CYHS2300572 | 亚宝药业四川制药有限公司 |
| 2023/02/18Generic · Class 3 | 氨溴特罗口服溶液CYHS2300568 | 南京卡文迪许生物工程技术有限公司; 江苏云阳集团药业有限公司 |
| 2023/02/18Generic · Class 3 | 左乙拉西坦缓释片CYHS2300567 | 山东丹红制药有限公司; 陕西步长制药有限公司 |
| 2023/02/18Generic · Class 3 | 左乙拉西坦缓释片CYHS2300565 | 山东丹红制药有限公司; 陕西步长制药有限公司 |
| 2023/02/18Generic · Class 3 | 异烟肼注射液CYHS2300564 | 湖北美林药业有限公司; 天津金耀药业有限公司 |
| 2023/02/18Generic · Class 3 | 注射用吲哚菁绿CYHS2300560 | 南京亚东启天药业有限公司; 南京海纳制药有限公司 |
| 2023/02/18Generic · Class 3 | 氨溴特罗口服溶液CYHS2300557 | 湖北午时医药研究院有限公司; 湖北午时药业股份有限公司 |
| 2023/02/18Generic · Class 3 | 氨溴特罗口服溶液CYHS2300556 | 湖北午时医药研究院有限公司; 湖北午时药业股份有限公司 |
| 2023/02/18Generic · Class 3 | 注射用盐酸罗沙替丁醋酸酯CYHS2300554 | 海南紫程众投生物科技有限公司; 山西普德药业有限公司 |
| 2023/02/18New drug · Class 1 | 个性化树突状细胞注射液CXSL2300141 | 中生康元生物科技（北京）有限公司 |
| 2023/02/18New drug · Class 1 | 注射用人源抗IL-17A单克隆抗体冻干粉针CXSL2300140 | 山东方坦思生物制药有限公司 |
| 2023/02/18New drug · Class 2.3 | 盐酸左旋沙丁胺醇异丙托溴铵雾化吸入溶液CXHL2300232 | 盈科瑞（天津）创新医药研究有限公司 |
| 2023/02/18New drug · Class 1 | AC-003胶囊CXHL2300231 | 爱科诺生物医药（苏州）有限公司 |
| 2023/02/18New drug · Class 1 | AC-003胶囊CXHL2300230 | 爱科诺生物医药（苏州）有限公司 |
| 2023/02/18New drug · Class 1 | SHR7280干混悬剂CXHL2300229 | 江苏恒瑞医药股份有限公司 |
| 2023/02/17Import · Class 1 | PF-07220060JXHL2300027 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2023/02/17Import · Class 1 | PF-07220060JXHL2300026 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2023/02/17Import · Class 1 | PF-07248144片JXHL2300025 | 235 East 42nd Street New York N.Y. 10017 USA; Pfizer Investment CO. Ltd. |
| 2023/02/17Import · Class 1 | PF-07248144片JXHL2300024 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2023/02/17Generic · Class 3 | 甘露醇山梨醇注射液CYHS2300551 | 北京柏雅联合药物研究所有限公司; 山东华鲁制药有限公司 |
| 2023/02/17Generic · Class 3 | 美沙拉秦肠溶缓释颗粒CYHS2300548 | 江苏安必生制药有限公司 |
| 2023/02/17Generic · Class 3 | 阿昔洛韦钠注射液CYHS2300547 | 海南普利制药股份有限公司 |
| 2023/02/17Generic · Class 3 | 注射用盐酸罗沙替丁醋酸酯CYHS2300546 | 山西普德药业有限公司 |
| 2023/02/17Generic · Class 3 | 美沙拉秦肠溶缓释颗粒CYHS2300545 | 江苏安必生制药有限公司 |
| 2023/02/17Generic · Class 3 | 己酮可可碱注射液CYHS2300543 | 江苏慧聚药业股份有限公司; 山西普德药业有限公司 |
| 2023/02/17Generic · Class 3 | 注射用阿莫西林钠CYHS2300540 | 海南广升誉制药有限公司; 中孚药业股份有限公司 |
68 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.