药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/11/15 – 2022/11/21
- New acceptances this week
- 332
- Drugs with new generic filings (by drug name, de-duplicated)
- 41
- 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
332filings, 51 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 215 |
| Generic | 51 |
| New drug | 38 |
| Import | 16 |
| Import re-registration | 7 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 250 |
| TCM | 50 |
| 治疗用生物制品 | 32 |
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
41 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 哌柏西利胶囊 | 3 | 1 | 0 |
| 2 | 磷酸西格列汀片 | 3 | 1 | 2 |
| 3 | 他达拉非片 | 2 | 1 | 23 |
| 4 | 拉莫三嗪片 | 2 | 1 | 0 |
| 5 | 注射用艾司奥美拉唑钠 | 2 | 1 | 1 |
| 6 | 盐酸丙卡特罗口服溶液 | 2 | 1 | 12 |
| 7 | 达格列净片 | 2 | 1 | 82 |
| 8 | 达比加群酯胶囊 | 2 | 1 | 2 |
| 9 | 6-[18F]氟-L-多巴注射液 | 1 | 1 | 0 |
| 10 | 利丙双卡因乳膏 | 1 | 1 | 25 |
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
162 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 吉林省尚城药业有限公司 | 50 | 44 | 0 |
| 2 | 河南双鹤华利药业有限公司 | 12 | 3 | 0 |
| 3 | 江西人可医药科技有限公司 | 9 | 9 | 0 |
| 4 | 合肥华方医药科技有限公司 | 7 | 7 | 0 |
| 5 | GE Healthcare AS | 7 | 1 | 0 |
| 6 | Boehringer Ingelheim International GmbH | 6 | 1 | 0 |
| 7 | 深圳信立泰药业股份有限公司 | 6 | 1 | 0 |
| 8 | 华润三九(郴州)制药有限公司 | 5 | 5 | 0 |
| 9 | 四川宏明博思药业有限公司 | 5 | 4 | 0 |
| 10 | UCB Pharma SA | 5 | 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
61 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/11/21Import · Class 3.1 | 托珠单抗注射液(皮下注射)JXSS2200037 | Roche Registration GmbH; Vetter Pharma-Fertigung GmbH & Co. KG; Roche(China)Holding Ltd. |
| 2022/11/21Import · Class 1 | RO7200220 注射液JXSL2200203 | F. Hoffmann-La Roche Ltd |
| 2022/11/21Import · Class 1 | RO7200220 注射液JXSL2200202 | F. Hoffmann-La Roche Ltd |
| 2022/11/21Generic · Class 3 | 琥珀酸呋罗曲坦片CYHS2202020 | 正大制药(青岛)有限公司 |
| 2022/11/21Generic · Class 3 | 吸入用格隆溴铵溶液CYHL2200106 | 仁合益康集团有限公司 |
| 2022/11/21New drug · Class 1 | 洛奈利单抗注射液CXSL2200584 | 山东新时代药业有限公司 |
| 2022/11/19Import · Class 1 | BAY 2433334片JXHL2200339 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2022/11/19Generic · Class 3 | 注射用泮托拉唑钠(Ⅰ)CYHS2202017 | 广东金城金素制药有限公司; 广东隆赋药业股份有限公司 |
| 2022/11/19New drug · Class 1 | SAL0119片CXHL2200915 | 深圳信立泰药业股份有限公司 |
| 2022/11/19New drug · Class 1 | SAL0119片CXHL2200914 | 深圳信立泰药业股份有限公司 |
| 2022/11/19New drug · Class 1 | SAL0119片CXHL2200913 | 深圳信立泰药业股份有限公司 |
| 2022/11/19New drug · Class 1 | SAL0119片CXHL2200912 | 深圳信立泰药业股份有限公司 |
| 2022/11/19New drug · Class 1 | SAL0119片CXHL2200911 | 深圳信立泰药业股份有限公司 |
| 2022/11/19New drug · Class 1 | SAL0119片CXHL2200910 | 深圳信立泰药业股份有限公司 |
| 2022/11/19New drug · Class 1 | BR1733片CXHL2200909 | 上海青煜医药科技有限公司 |
| 2022/11/19New drug · Class 1 | BR1733片CXHL2200908 | 上海青煜医药科技有限公司 |
| 2022/11/19New drug · Class 1 | KF-0210片CXHL2200907 | 凯复(苏州)生物医药有限公司 |
| 2022/11/19New drug · Class 1 | KF-0210片CXHL2200906 | 凯复(苏州)生物医药有限公司 |
| 2022/11/18Generic · Class 3 | 盐酸纳洛酮注射液CYHS2202015 | 重庆莱美药业股份有限公司 |
| 2022/11/18Generic · Class 3 | 头孢克肟颗粒CYHS2201935 | 合肥恩瑞特药业有限公司; 安徽安科恒益药业有限公司 |
| 2022/11/18New drug · Class 3.4 | 人凝血酶原复合物CXSS2200091 | 深圳市卫光生物制品股份有限公司 |
| 2022/11/18New drug · Class 1 | 注射用IMM0306CXSL2200583 | 宜明昂科生物医药技术(上海)股份有限公司 |
| 2022/11/18New drug · Class 1 | 注射用PRO1184CXSL2200582 | 普方生物制药(苏州)有限公司 |
| 2022/11/18New drug · Class 1 | ELPIS人脐带间充质干细胞注射液CXSL2200581 | 华夏源(上海)生物科技有限公司 |
| 2022/11/17Generic · Class 3 | 地高辛注射液CYHS2202003 | 杭州沐源生物医药科技有限公司; 成都市海通药业有限公司 |
| 2022/11/17Generic · Class 3 | 富马酸福莫特罗吸入溶液CYHS2202000 | 上海奥科达医药科技股份有限公司; 山东华鲁制药有限公司 |
| 2022/11/17New drug · Class 1.1 | 金连消风颗粒CXZL2200052 | 盈科瑞(天津)创新医药研究有限公司 |
| 2022/11/17New drug · Class 1 | 注射用BB-1709CXSL2200580 | 百力司康生物医药(杭州)有限公司 |
| 2022/11/17New drug · Class 2.2 | 普特利单抗注射液CXSL2200578 | 乐普生物科技股份有限公司 |
| 2022/11/17New drug · Class 1 | GC012F注射液CXSL2200577 | 苏州亘喜生物科技有限公司; 亘喜生物科技(上海)有限公司 |
31 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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