药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/04/12 – 2022/04/18
- New acceptances this week
- 179
- Drugs with new generic filings (by drug name, de-duplicated)
- 29
- 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
179filings, 45 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 89 |
| Generic | 45 |
| New drug | 20 |
| Import | 14 |
| Import re-registration | 6 |
| Unspecified | 4 |
| 药械组合产品 | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 138 |
| TCM | 22 |
| 治疗用生物制品 | 15 |
| 预防用生物制品 | 4 |
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
29 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 利伐沙班片 | 5 | 2 | 3 |
| 2 | 磷酸奥司他韦干混悬剂 | 3 | 3 | 2 |
| 3 | 他达拉非片 | 3 | 1 | 23 |
| 4 | 哌柏西利片 | 3 | 1 | 2 |
| 5 | 哌柏西利胶囊 | 3 | 1 | 0 |
| 6 | 左氧氟沙星滴眼液 | 2 | 1 | 16 |
| 7 | 氟马西尼注射液 | 2 | 1 | 2 |
| 8 | 注射用奥美拉唑钠 | 2 | 1 | 1 |
| 9 | 舒更葡糖钠注射液 | 2 | 1 | 6 |
| 10 | 乙酰半胱氨酸颗粒 | 1 | 1 | 4 |
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
113 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 齐鲁制药有限公司 | 9 | 3 | 3 |
| 2 | 贵州威利德制药有限公司 | 6 | 6 | 0 |
| 3 | 正大天晴药业集团股份有限公司 | 5 | 2 | 3 |
| 4 | Boehringer Ingelheim International GmbH | 5 | 1 | 0 |
| 5 | Sanofi -aventis France | 5 | 1 | 0 |
| 6 | MSN Laboratories Private Limited | 4 | 2 | 0 |
| 7 | 株洲千金药业股份有限公司 | 4 | 2 | 0 |
| 8 | Fresenius Kabi Austria GmbH | 4 | 1 | 0 |
| 9 | 浙江恒研医药科技有限公司 | 3 | 2 | 3 |
| 10 | 中美华世通生物医药科技（武汉）股份有限公司 | 3 | 1 | 3 |
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
39 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/04/18Generic · Class 3 | 盐酸美金刚口服溶液CYHS2200605 | 南京瑞捷医药科技有限公司; 浙江杭康药业有限公司 |
| 2022/04/18Generic · Class 3 | 盐酸奥普力农注射液CYHS2200601 | 瑞阳制药股份有限公司 |
| 2022/04/18Generic · Class 3 | 哌柏西利片CYHS2200586 | 齐鲁制药有限公司 |
| 2022/04/18Generic · Class 3 | 哌柏西利片CYHS2200585 | 齐鲁制药有限公司 |
| 2022/04/18Generic · Class 3 | 哌柏西利片CYHS2200584 | 齐鲁制药有限公司 |
| 2022/04/18New drug · Class 3.3 | 德谷门冬双胰岛素注射液CXSL2200172 | 联邦生物科技（珠海横琴）有限公司 |
| 2022/04/18New drug · Class 2.2 | 磷酸奥司他韦口溶膜CXHL2200241 | 齐鲁制药有限公司 |
| 2022/04/18New drug · Class 2.2 | 磷酸奥司他韦口溶膜CXHL2200240 | 齐鲁制药有限公司 |
| 2022/04/18New drug · Class 2.2 | 磷酸奥司他韦口溶膜CXHL2200239 | 齐鲁制药有限公司 |
| 2022/04/18New drug · Class 1 | D-2570片CXHL2200238 | 益方生物科技（上海）股份有限公司 |
| 2022/04/15Import · Class 3.1 | 达雷妥尤单抗注射液（皮下注射）JXSS2200013 | Janssen-Cilag International NV; Cilag AG; Xian-Janssen Pharmaceutical Ltd. |
| 2022/04/15Generic · Class 3 | 依巴斯汀口服溶液CYHS2200600 | 湖南普道医药技术有限公司; 湖南九典制药股份有限公司 |
| 2022/04/15Generic · Class 3 | 羧甲司坦口服溶液CYHS2200595 | 宁波卓仑医药科技有限公司; 浙江凯润药业有限公司 |
| 2022/04/15New drug · Class 2.2 | 苏龙嘎-4颗粒CXZL2200019 | 内蒙古自治区国际蒙医医院 |
| 2022/04/15New drug · Class 1 | MN-08片CXHL2200237 | 广州喜鹊医药有限公司 |
| 2022/04/15New drug · Class 1 | HNC664胶囊CXHL2200236 | 广州市恒诺康医药科技有限公司 |
| 2022/04/15New drug · Class 1 | GFH018 片CXHL2200235 | 浙江劲方药业有限公司 |
| 2022/04/15New drug · Class 1 | GFH018 片CXHL2200234 | 浙江劲方药业有限公司 |
| 2022/04/14Generic · Class 3 | 磷酸奥司他韦干混悬剂CYHS2200593 | 江苏万高药业股份有限公司 |
| 2022/04/14Generic · Class 3 | 磷酸奥司他韦干混悬剂CYHS2200589 | 宏越科技（湖州）有限公司; 山西同达药业有限公司 |
| 2022/04/14Generic · Class 3 | 磷酸奥司他韦干混悬剂CYHS2200580 | 北京诚济制药股份有限公司 |
| 2022/04/14New drug · Class 1.1 | ZY002妇科凝胶CXZL2200018 | 江苏正阳药业有限公司 |
| 2022/04/14New drug · Class 1 | NRT6003注射液CXHL2200233 | 成都纽瑞特医疗科技股份有限公司 |
| 2022/04/14New drug · Class 1 | 68Ga-HX01注射液CXHL2200232 | 核欣（苏州）医药科技有限公司 |
| 2022/04/13Import · Class 1 | Relatlimab/Nivolumab固定剂量复方注射液JXSL2200046 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2022/04/13Generic · Class 3 | 依替巴肽注射液CYHS2200579 | 沈阳双鼎制药有限公司 |
| 2022/04/13Generic · Class 3 | 氟马西尼注射液CYHS2200578 | 北京世桥生物制药有限公司 |
| 2022/04/13Generic · Class 3 | 氟马西尼注射液CYHS2200577 | 北京世桥生物制药有限公司 |
| 2022/04/13New drug · Class 1 | LBL-007注射液CXSL2200169 | 南京维立志博生物科技有限公司 |
| 2022/04/12Import · Class 1 | TremelimumabJXSL2200045 | MedImmune LLC; AstraZeneca Global R&D (China) Co. Ltd. |
9 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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