药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/03/14 – 2023/03/20
- New acceptances this week
- 275
- Drugs with new generic filings (by drug name, de-duplicated)
- 50
- 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
275filings, 70 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 108 |
| Generic | 70 |
| New drug | 42 |
| Import re-registration | 35 |
| Import | 13 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 214 |
| 治疗用生物制品 | 31 |
| TCM | 24 |
| Biologic | 5 |
| 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
50 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸胺碘酮注射液 | 4 | 2 | 0 |
| 2 | 硫酸氨基葡萄糖胶囊 | 3 | 3 | 51 |
| 3 | 头孢氨苄干混悬剂 | 3 | 1 | 0 |
| 4 | 丙戊酸钠注射用浓溶液 | 2 | 1 | 0 |
| 5 | 他克莫司软膏 | 2 | 1 | 8 |
| 6 | 兰索拉唑肠溶胶囊 | 2 | 1 | 4 |
| 7 | 利斯的明透皮贴剂 | 2 | 1 | 1 |
| 8 | 奥利司他胶囊 | 2 | 1 | 8 |
| 9 | 氨氯地平阿托伐他汀钙片 | 2 | 1 | 2 |
| 10 | 氯雷他定糖浆 | 2 | 1 | 7 |
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
166 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bracco Imaging Italia S.r.L. | 24 | 1 | 0 |
| 2 | 黑龙江亿达鸿药业有限公司 | 5 | 4 | 0 |
| 3 | MSD Pharma (Singapore) Pte. Ltd | 4 | 2 | 0 |
| 4 | 上海长征富民金山制药有限公司 | 3 | 3 | 0 |
| 5 | 广西吉民堂药业有限公司 | 3 | 3 | 0 |
| 6 | 广西裕源药业有限公司 | 3 | 3 | 0 |
| 7 | AstraZeneca AB | 3 | 2 | 0 |
| 8 | 正大天晴药业集团南京顺欣制药有限公司 | 3 | 2 | 0 |
| 9 | 正大天晴药业集团股份有限公司 | 3 | 2 | 0 |
| 10 | 江苏恒瑞医药股份有限公司 | 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
73 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/03/20Generic · Class 3 | 头孢氨苄干混悬剂CYHS2300841 | 上海金城素智药业有限公司 |
| 2023/03/20Generic · Class 3 | 头孢氨苄干混悬剂CYHS2300840 | 上海金城素智药业有限公司 |
| 2023/03/20Generic · Class 3 | 头孢氨苄干混悬剂CYHS2300839 | 上海金城素智药业有限公司 |
| 2023/03/20Generic · Class 3 | 二羟丙茶碱注射液CYHS2300838 | 东阳祥昇医药科技有限公司; 浙江北生药业汉生制药有限公司 |
| 2023/03/20New drug · Class 1 | 人骨髓间充质干细胞注射液CXSL2300202 | 九芝堂美科（北京）细胞技术有限公司 |
| 2023/03/18Generic · Class 3 | 盐酸氟西汀口服溶液CYHS2300837 | 常州四药制药有限公司 |
| 2023/03/18Generic · Class 3 | 丙戊酸钠注射用浓溶液CYHS2300830 | 慧禹康成（浙江）医药科技有限公司; 辽宁药联制药有限公司 |
| 2023/03/18Generic · Class 3 | 丙戊酸钠注射用浓溶液CYHS2300829 | 慧禹康成（浙江）医药科技有限公司; 辽宁药联制药有限公司 |
| 2023/03/18Generic · Class 3 | 盐酸西替利嗪注射液CYHS2300827 | 沈阳达善医药科技有限公司; 中孚药业股份有限公司 |
| 2023/03/18New drug · Class 1 | SDT-T002细胞注射液CXSL2300201 | 赛德特（北京）生物工程有限公司 |
| 2023/03/18New drug · Class 2.2;2.4 | SHR8028滴眼液CXHS2300039 | 成都盛迪医药有限公司 |
| 2023/03/18New drug · Class 2.4 | 醋酸阿比特龙片CXHL2300322 | 正大天晴药业集团股份有限公司 |
| 2023/03/18New drug · Class 1 | TQB3823片CXHL2300321 | 正大天晴药业集团股份有限公司 |
| 2023/03/18New drug · Class 1 | TQB3823片CXHL2300320 | 正大天晴药业集团股份有限公司 |
| 2023/03/18New drug · Class 2.2;2.4 | SBK011口服溶液CXHL2300319 | 成都施贝康生物医药科技有限公司 |
| 2023/03/17Generic · Class 3 | 法莫替丁注射液CYHS2300825 | 云南药科院生物医药股份有限公司; 楚雄和创药业有限责任公司 |
| 2023/03/17Generic · Class 3 | 盐酸左西替利嗪口服溶液CYHS2300824 | 湖北唯森制药有限公司 |
| 2023/03/17New drug · Class 1 | 注射用DB-1310CXSL2300200 | 映恩生物制药（苏州）有限公司 |
| 2023/03/17New drug · Class 1 | UCMYM802CXSL2300199 | 上海优替济生生物医药有限公司 |
| 2023/03/17New drug · Class 1 | TQB3455片CXHL2300318 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2023/03/17New drug · Class 1 | TQB3455片CXHL2300317 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2023/03/17New drug · Class 2.2 | BTP0611CXHL2300316 | 江苏诺和必拓新药研发有限公司; 北京百奥药业有限责任公司 |
| 2023/03/17New drug · Class 2.2 | BTP0611CXHL2300315 | 江苏诺和必拓新药研发有限公司; 北京百奥药业有限责任公司 |
| 2023/03/16Generic · Class 3 | 盐酸去氧肾上腺素注射液CYHS2300808 | 南京恒道医药科技股份有限公司; 江苏大红鹰恒顺药业有限公司 |
| 2023/03/16Generic · Class 3 | 羧甲司坦口服溶液CYHS2300805 | 浙江易泽达医药科技有限公司; 浙江赛默制药有限公司 |
| 2023/03/16Generic · Class 3 | 羧甲司坦口服溶液CYHS2300804 | 浙江易泽达医药科技有限公司; 浙江赛默制药有限公司 |
| 2023/03/16Generic · Class 3 | 己酮可可碱注射液CYHS2300803 | 河南欣泰药业有限公司; 新乡市常乐制药有限责任公司 |
| 2023/03/16Generic · Class 3 | 左乙拉西坦缓释片CYHS2300802 | 湖南洞庭药业股份有限公司 |
| 2023/03/16Generic · Class 3 | 注射用拉氧头孢钠CYHS2300800 | 山东蓝晶生物技术有限公司; 山东润泽制药有限公司 |
| 2023/03/16Generic · Class 3 | 注射用拉氧头孢钠CYHS2300799 | 山东蓝晶生物技术有限公司; 山东润泽制药有限公司 |
43 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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