药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/07/27 – 2021/08/02
- New acceptances this week
- 173
- Drugs with new generic filings (by drug name, de-duplicated)
- 17
- 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
173filings, 20 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 83 |
| New drug | 34 |
| Import | 21 |
| Generic | 20 |
| Unspecified | 9 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 118 |
| 治疗用生物制品 | 29 |
| TCM | 24 |
| Biologic | 2 |
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
17 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 恩格列净片 | 2 | 1 | 18 |
| 2 | 普瑞巴林胶囊 | 2 | 1 | 12 |
| 3 | 注射用醋酸卡泊芬净 | 2 | 1 | 8 |
| 4 | 依诺肝素钠注射液 | 1 | 1 | 16 |
| 5 | 多索茶碱注射液 | 1 | 1 | 5 |
| 6 | 富马酸丙酚替诺福韦片 | 1 | 1 | 0 |
| 7 | 布洛芬混悬液 | 1 | 1 | 14 |
| 8 | 布洛芬混悬滴剂 | 1 | 1 | 0 |
| 9 | 氯法拉滨注射液 | 1 | 1 | 0 |
| 10 | 盐酸氨溴索口服溶液 | 1 | 1 | 45 |
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
109 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 黑龙江林海雪原药业有限公司 | 5 | 5 | 0 |
| 2 | 正大天晴药业集团股份有限公司 | 5 | 2 | 0 |
| 3 | 江苏豪森药业集团有限公司 | 5 | 2 | 0 |
| 4 | 石家庄四药有限公司 | 4 | 4 | 2 |
| 5 | Janssen-Cilag International NV | 3 | 2 | 0 |
| 6 | 三生国健药业（上海）股份有限公司 | 3 | 2 | 0 |
| 7 | 瑞阳制药股份有限公司 | 3 | 2 | 0 |
| 8 | Bristol-Myers Squibb Pharma EEIG | 3 | 1 | 0 |
| 9 | Pfizer Europe MA EEIG | 3 | 1 | 0 |
| 10 | 内蒙古京新药业有限公司 | 3 | 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
52 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/07/30Import · Class 1 | RilzabrutinibJXHL2101147 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2021/07/30Generic · Class 3 | 氯法拉滨注射液CYHS2101502 | 合肥亿帆生物制药有限公司 |
| 2021/07/30New drug · Class 1.1 | 芪红固本颗粒CXZL2101021 | 广州如源生物科技有限公司 |
| 2021/07/30New drug · Class 2.2 | 特瑞普利单抗注射液CXSS2101015 | 上海君实生物医药科技股份有限公司; 苏州众合生物医药科技有限公司 |
| 2021/07/30New drug · Class 2.2 | 特瑞普利单抗注射液CXSS2101014 | 上海君实生物医药科技股份有限公司; 苏州众合生物医药科技有限公司 |
| 2021/07/30New drug · Class 1 | 重组抗PD-1人源化单克隆抗体注射液CXSL2101226 | 三生国健药业（上海）股份有限公司 |
| 2021/07/30New drug · Class 1 | ELPIS人脐带间充质干细胞注射液CXSL2101224 | 华夏源细胞工程集团股份有限公司 |
| 2021/07/30New drug · Class 2.4 | 盐酸安罗替尼胶囊CXHL2101347 | 正大天晴药业集团股份有限公司 |
| 2021/07/30New drug · Class 2.4 | 盐酸安罗替尼胶囊CXHL2101346 | 正大天晴药业集团股份有限公司 |
| 2021/07/30New drug · Class 2.4 | 盐酸安罗替尼胶囊CXHL2101345 | 正大天晴药业集团股份有限公司 |
| 2021/07/30New drug · Class 1 | NB005胶囊CXHL2101344 | 宁波新湾科技发展有限公司 |
| 2021/07/30New drug · Class 1 | NB005胶囊CXHL2101343 | 宁波新湾科技发展有限公司 |
| 2021/07/29Import · Class 1 | TJ107注射液JXSL2101083 | I-MAB Biopharma US Limited; I-MAB Biopharma Co. Ltd. |
| 2021/07/29Import · Class 1 | Bermekimab注射液JXSL2101082 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2021/07/29Import · Class 1 | DS-1062aJXSL2101081 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2021/07/29Generic · Class 3 | 盐酸氨溴索口服溶液CYHS2101495 | 杭州元素医药有限公司; 浙江凯润药业股份有限公司 |
| 2021/07/29Generic · Class 3 | 布洛芬混悬滴剂CYHS2101494 | 北京百奥药业有限责任公司; 吉林益民堂制药有限公司 |
| 2021/07/29Generic · Class 3 | 硫酸镁注射液CYHS2101489 | 广州瑞尔医药科技有限公司; 成都市海通药业有限公司 |
| 2021/07/29New drug · Class 2.2 | 注射用伊尼妥单抗CXSL2101223 | 三生国健药业（上海）股份有限公司 |
| 2021/07/29New drug · Class 1 | PB-201片CXHL2101333 | 派格生物医药（苏州）股份有限公司 |
| 2021/07/29New drug · Class 1 | PB-201片CXHL2101332 | 派格生物医药（苏州）股份有限公司 |
| 2021/07/28Import · Class 1 | MK-4280A注射液JXSL2101080 | Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd. |
| 2021/07/28Import · Class 2.4 | 甲磺酸仑伐替尼胶囊JXHL2101144 | Eisai Europe Ltd. |
| 2021/07/28Import · Class 2.4 | 甲磺酸仑伐替尼胶囊JXHL2101143 | Eisai Europe Ltd. |
| 2021/07/28Generic · Class 3 | 胞磷胆碱钠注射液CYHS2101492 | 广州绿十字制药股份有限公司; 成都市海通药业有限公司 |
| 2021/07/28New drug · Class 1 | 重组抗PD-1人源化单克隆抗体注射液CXSL2101221 | 三生国健药业（上海）股份有限公司 |
| 2021/07/28New drug · Class 1 | 注射用QLF32004CXSL2101220 | 齐鲁制药有限公司 |
| 2021/07/28New drug · Class 1 | HS-10375片CXHL2101340 | 江苏豪森药业集团有限公司 |
| 2021/07/28New drug · Class 1 | HS-10375片CXHL2101339 | 江苏豪森药业集团有限公司 |
| 2021/07/28New drug · Class 1 | ICP-189片CXHL2101338 | 北京诺诚健华医药科技有限公司 |
22 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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