药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/09/13 – 2022/09/19
- New acceptances this week
- 282
- Drugs with new generic filings (by drug name, de-duplicated)
- 44
- 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
282filings, 60 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 155 |
| Generic | 60 |
| New drug | 45 |
| Unspecified | 8 |
| Import | 8 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 208 |
| TCM | 40 |
| 治疗用生物制品 | 33 |
| Biologic | 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
44 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 达格列净二甲双胍缓释片 | 5 | 1 | 0 |
| 2 | 磷酸奥司他韦干混悬剂 | 3 | 2 | 2 |
| 3 | 复方聚乙二醇电解质散（Ⅲ） | 2 | 2 | 1 |
| 4 | 乙磺酸尼达尼布软胶囊 | 2 | 1 | 6 |
| 5 | 吲哚布芬片 | 2 | 1 | 7 |
| 6 | 枸橼酸坦度螺酮片 | 2 | 1 | 2 |
| 7 | 氨甲环酸注射液 | 2 | 1 | 11 |
| 8 | 注射用替考拉宁 | 2 | 1 | 6 |
| 9 | 注射用氢化可的松琥珀酸钠 | 2 | 1 | 16 |
| 10 | 盐酸多柔比星脂质体注射液 | 2 | 1 | 2 |
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
164 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 广西金兴实业有限责任公司 | 10 | 6 | 0 |
| 2 | 山东孔圣堂制药有限公司 | 6 | 6 | 0 |
| 3 | 达嘉维康生物制药有限公司 | 6 | 4 | 0 |
| 4 | 江西科睿药业有限公司 | 5 | 5 | 0 |
| 5 | 锦州福寿堂医药科技有限公司 | 5 | 5 | 0 |
| 6 | Boehringer Ingelheim International GmbH | 5 | 1 | 0 |
| 7 | Sanofi -aventis France | 5 | 1 | 0 |
| 8 | 上海宣泰医药科技股份有限公司 | 5 | 1 | 5 |
| 9 | 海南美兰史克制药有限公司 | 5 | 1 | 0 |
| 10 | 上海皇象铁力蓝天制药有限公司 | 4 | 4 | 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
85 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/09/19Import · Class 1 | OMTX705注射用浓溶液JXSL2200167 | InxMed (Hong Kong) Limited; InxMed (Nanjing) Co. Ltd |
| 2022/09/19Generic · Class 3 | 地高辛注射液CYHS2201563 | 河北坤安药业有限公司; 河北凯威制药有限责任公司 |
| 2022/09/19Generic · Class 3 | 盐酸多柔比星脂质体注射液CYHS2201562 | 常州吾合生物医药有限责任公司; 无锡紫杉药业股份有限公司 |
| 2022/09/19Generic · Class 3 | 盐酸多柔比星脂质体注射液CYHS2201561 | 常州吾合生物医药有限责任公司; 无锡紫杉药业股份有限公司 |
| 2022/09/19Generic · Class 3 | 注射用氢化可的松琥珀酸钠CYHS2201560 | 津药和平（天津）制药有限公司 |
| 2022/09/19Generic · Class 3 | 注射用氢化可的松琥珀酸钠CYHS2201559 | 津药和平（天津）制药有限公司 |
| 2022/09/19Generic · Class 3 | 米诺地尔外用溶液CYHS2201558 | 浙江鼎泰药业股份有限公司 |
| 2022/09/19Generic · Class 3 | 注射用奥氮平CYHL2200080 | 齐鲁制药有限公司 |
| 2022/09/19New drug · Class 1 | UB-221 皮下注射剂CXSL2200466 | 联生药（扬州）生物医药有限公司 |
| 2022/09/19New drug · Class 1 | 注射用BG136CXHL2200705 | 青岛海洋生物医药研究院; 中国海洋大学; 正大制药（青岛）有限公司 |
| 2022/09/19New drug · Class 1 | 注射用BG136CXHL2200704 | 青岛海洋生物医药研究院; 中国海洋大学; 正大制药（青岛）有限公司 |
| 2022/09/19New drug · Class 1 | 注射用JK0004CXHL2200703 | 深圳嘉科生物科技有限公司 |
| 2022/09/19New drug · Class 1 | 注射用JK0004CXHL2200702 | 深圳嘉科生物科技有限公司 |
| 2022/09/19New drug · Class 1 | XTYW001胶囊CXHL2200701 | 西安新通药物研究股份有限公司 |
| 2022/09/19New drug · Class 1 | XTYW001胶囊CXHL2200700 | 西安新通药物研究股份有限公司 |
| 2022/09/19New drug · Class 1 | 注射用WXWH0075CXHL2200699 | 卓和药业集团股份有限公司 |
| 2022/09/19New drug · Class 1 | 注射用WXWH0075CXHL2200698 | 卓和药业集团股份有限公司 |
| 2022/09/18New drug · Class 1 | DZD9008片CXHL2200697 | 迪哲（江苏）医药股份有限公司 |
| 2022/09/18New drug · Class 1 | DZD9008片CXHL2200696 | 迪哲（江苏）医药股份有限公司 |
| 2022/09/17Generic · Class 3 | 吲哚布芬片CYHS2201555 | 浙江恒研医药科技有限公司; 浙江赛默制药有限公司 |
| 2022/09/17Generic · Class 3 | 吲哚布芬片CYHS2201553 | 浙江恒研医药科技有限公司; 浙江赛默制药有限公司 |
| 2022/09/17New drug · Class 3.3 | 甘精胰岛素注射液CXSS2200079 | 合肥天麦生物科技发展有限公司 |
| 2022/09/17New drug · Class 1 | 靶向 CD19 非病毒 PD1 定点整合 CAR-T 细胞注射液CXSL2200465 | 上海邦耀生物科技有限公司 |
| 2022/09/17New drug · Class 1 | AP-306胶囊CXHL2200695 | 上海礼邦医药科技有限公司 |
| 2022/09/17New drug · Class 1 | AP-306胶囊CXHL2200694 | 上海礼邦医药科技有限公司 |
| 2022/09/17New drug · Class 1 | AR882胶囊CXHL2200693 | 广州瑞安博医药科技有限公司 |
| 2022/09/17New drug · Class 1 | AR882胶囊CXHL2200692 | 广州瑞安博医药科技有限公司 |
| 2022/09/17New drug · Class 1 | LNK01002胶囊CXHL2200691 | 凌科药业（杭州）有限公司 |
| 2022/09/17New drug · Class 1 | LNK01002胶囊CXHL2200690 | 凌科药业（杭州）有限公司 |
| 2022/09/16Import · Class 1 | DS-1062aJXSL2200166 | Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited |
55 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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