药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/10/12 – 2021/10/18
- New acceptances this week
- 224
- Drugs with new generic filings (by drug name, de-duplicated)
- 18
- 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
224filings, 27 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 133 |
| New drug | 45 |
| Generic | 27 |
| Import | 8 |
| Import re-registration | 6 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 105 |
| TCM | 89 |
| 治疗用生物制品 | 27 |
| Biologic | 3 |
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
18 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 阿普米司特片 | 6 | 2 | 3 |
| 2 | 磷酸西格列汀片 | 3 | 1 | 2 |
| 3 | 磷酸奥司他韦干糖浆 | 2 | 1 | 0 |
| 4 | 艾司奥美拉唑镁肠溶胶囊 | 2 | 1 | 4 |
| 5 | 依托咪酯乳状注射液 | 1 | 1 | 1 |
| 6 | 地奈德乳膏 | 1 | 1 | 0 |
| 7 | 多索茶碱注射液 | 1 | 1 | 5 |
| 8 | 左氧氟沙星片 | 1 | 1 | 8 |
| 9 | 恩曲他滨丙酚替诺福韦片 | 1 | 1 | 0 |
| 10 | 氟哌啶醇口服溶液 | 1 | 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
100 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 山西万辉制药有限公司 | 64 | 48 | 0 |
| 2 | 正大天晴药业集团股份有限公司 | 8 | 4 | 0 |
| 3 | 江苏恒瑞医药股份有限公司 | 7 | 4 | 0 |
| 4 | Novo Nordisk A/S | 5 | 4 | 0 |
| 5 | 佛山德芮可制药有限公司 | 5 | 1 | 0 |
| 6 | 河北药王集团股份有限公司 | 4 | 2 | 0 |
| 7 | 安徽安科生物工程（集团）股份有限公司 | 4 | 1 | 0 |
| 8 | 陕西安远堂药业有限公司 | 3 | 3 | 0 |
| 9 | 远大生命科学（武汉）有限公司 | 3 | 2 | 1 |
| 10 | 兆科药业（广州）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
59 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/10/15Generic · Class 3 | 米诺膦酸片CYHL2101030 | 南京海纳医药科技股份有限公司 |
| 2021/10/15New drug · Class 1.1 | 巴蜀颗粒CXZL2101030 | 新疆华世丹药物研究有限责任公司 |
| 2021/10/15New drug · Class 1.1 | 清肠温中片CXZL2101029 | 扬子江药业集团江苏龙凤堂中药有限公司 |
| 2021/10/15New drug · Class 1 | HRS-3738片CXHL2101572 | 江苏恒瑞医药股份有限公司 |
| 2021/10/15New drug · Class 1 | HRS-3738片CXHL2101571 | 江苏恒瑞医药股份有限公司 |
| 2021/10/15New drug · Class 1 | HRS-3738片CXHL2101570 | 江苏恒瑞医药股份有限公司 |
| 2021/10/15New drug · Class 1 | HRS5685片CXHL2101569 | 瑞可迪（上海）生物医药有限公司 |
| 2021/10/15New drug · Class 1 | HRS5685片CXHL2101568 | 瑞可迪（上海）生物医药有限公司 |
| 2021/10/15New drug · Class 1 | IN10018 片CXHL2101567 | 应世生物科技（上海）有限公司 |
| 2021/10/15New drug · Class 1 | IN10018片CXHL2101566 | 应世生物科技（上海）有限公司 |
| 2021/10/15New drug · Class 2.3 | HRG2005吸入剂CXHL2101565 | 江苏恒瑞医药股份有限公司 |
| 2021/10/15New drug · Class 1 | IMP4297胶囊CXHL2101564 | 上海君派英实药业有限公司 |
| 2021/10/15New drug · Class 2.4 | 盐酸氨酮戊酸外用散CXHL2101563 | 上海复旦张江生物医药股份有限公司 |
| 2021/10/15New drug · Class 1 | 注射用MB07133CXHL2101561 | 西安新通药物研究股份有限公司 |
| 2021/10/14Import · Class 1 | Rozanolixizumab注射液JXSL2101117 | UCB Pharma SA; UCB Trading (Shanghai) Co. Ltd |
| 2021/10/14Import · Class 1 | TAK-935片JXHL2101200 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd. |
| 2021/10/14Import · Class 1 | TAK-935片JXHL2101199 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd. |
| 2021/10/14Generic · Class 3 | 地奈德乳膏CYHS2101866 | 海思科制药（眉山）有限公司 |
| 2021/10/14Generic · Class 3 | 氟哌啶醇口服溶液CYHS2101865 | 新疆特丰药业股份有限公司 |
| 2021/10/14Generic · Class 3 | 艾司奥美拉唑镁肠溶胶囊CYHS2101861 | 浙江华海药业股份有限公司 |
| 2021/10/14Generic · Class 3 | 艾司奥美拉唑镁肠溶胶囊CYHS2101860 | 浙江华海药业股份有限公司 |
| 2021/10/14Generic · Class 3 | 磷酸奥司他韦干混悬剂CYHS2101856 | 齐鲁制药（海南）有限公司 |
| 2021/10/14Generic · Class 3 | 氨甲环酸注射液CYHS2101833 | 广州绿十字制药股份有限公司; 成都天台山制药有限公司 |
| 2021/10/14New drug · Class 3.3 | 地舒单抗注射液CXSS2101033 | 山东博安生物技术股份有限公司 |
| 2021/10/14New drug · Class 1 | 注射用DNV3CXSL2101369 | 浙江时迈药业有限公司 |
| 2021/10/14New drug · Class 1 | Ociperlimab注射液CXSL2101368 | 广州百济神州生物制药有限公司 |
| 2021/10/14New drug · Class 2.2 | 替雷利珠单抗注射液CXSL2101367 | 百济神州（上海）生物科技有限公司 |
| 2021/10/14New drug · Class 3.2 | 静注人免疫球蛋白（10%）CXSL2101366 | 博雅生物制药集团股份有限公司 |
| 2021/10/14New drug · Class 1 | SSGJ-706注射液CXSL2101365 | 三生国健药业（上海）股份有限公司 |
| 2021/10/14New drug · Class 1 | SSGJ-706注射液CXSL2101364 | 三生国健药业（上海）股份有限公司 |
29 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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