药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/03/30 – 2021/04/05
- New acceptances this week
- 156
- Drugs with new generic filings (by drug name, de-duplicated)
- 12
- 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
156filings, 20 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 86 |
| New drug | 22 |
| Generic | 20 |
| Import | 15 |
| Import re-registration | 12 |
| Unspecified | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 117 |
| 治疗用生物制品 | 29 |
| TCM | 6 |
| 预防用生物制品 | 3 |
| 体外诊断试剂 | 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
12 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸美金刚片 | 4 | 1 | 2 |
| 2 | 奥氮平片 | 2 | 1 | 4 |
| 3 | 左氧氟沙星片 | 2 | 1 | 8 |
| 4 | 达格列净片 | 2 | 1 | 82 |
| 5 | 酒石酸美托洛尔片 | 2 | 1 | 3 |
| 6 | 雷诺嗪缓释片 | 2 | 1 | 3 |
| 7 | 丙泊酚乳状注射液 | 1 | 1 | 2 |
| 8 | 富马酸丙酚替诺福韦片 | 1 | 1 | 0 |
| 9 | 托拉塞米注射液 | 1 | 1 | 1 |
| 10 | 格隆溴铵新斯的明注射液 | 1 | 1 | 3 |
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
96 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Fresenius Kabi Austria GmbH | 6 | 1 | 0 |
| 2 | Janssen-Cilag International NV | 6 | 1 | 0 |
| 3 | 保定九汇医药制造有限公司 | 5 | 5 | 0 |
| 4 | Janssen Research & Development LLC | 4 | 2 | 0 |
| 5 | Pfizer Europe MA EEIG | 4 | 2 | 0 |
| 6 | 四川科伦药业股份有限公司 | 4 | 1 | 0 |
| 7 | 安徽金太阳生化药业有限公司 | 4 | 1 | 4 |
| 8 | 同方药业集团有限公司 | 3 | 2 | 0 |
| 9 | Novo Nordisk A/S | 3 | 1 | 0 |
| 10 | 优时比（珠海）制药有限公司 | 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
40 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/04/03New drug · Class 1.1 | 六合丹软膏CXZL2100003 | 四川大学华西医院 |
| 2021/04/03New drug · Class 1 | 注射用重组人源化抗Muc1单抗-Tub201偶联剂CXSL2100114 | 杭州多禧生物科技有限公司 |
| 2021/04/03New drug · Class 3.3 | 流感病毒裂解疫苗CXSL2100113 | 山西培森生物科技有限公司 |
| 2021/04/03New drug · Class 2.2 | 阿地溴铵吸入粉雾剂CXHL2100218 | 健康元药业集团股份有限公司 |
| 2021/04/02Import · Class 3.3 | 注射用英夫利西单抗JXSS2100022 | CELLTRION Inc. |
| 2021/04/02Import · Class 1 | 注射用阿帕拉格鲁肽JXHL2100112 | VectivBio AG |
| 2021/04/02Generic · Class 3 | 托拉塞米注射液CYHS2100309 | 扬子江药业集团南京海陵药业有限公司; 扬子江药业集团有限公司 |
| 2021/04/02Generic · Class 3 | 格隆溴铵新斯的明注射液CYHL2100018 | 瑞阳制药股份有限公司 |
| 2021/04/02New drug · Class 1.1 | 川芎定痛颗粒CXZL2100004 | 北京阳光合和中医药科技开发有限公司 |
| 2021/04/02New drug · Class 3.3 | 德谷门冬双胰岛素注射液CXSL2100112 | 吉林惠升生物制药有限公司 |
| 2021/04/02New drug · Class 1 | LM-102 注射液CXSL2100111 | 上海礼新医药研发有限公司 |
| 2021/04/02New drug · Class 1 | HS-10374片CXHL2100217 | 常州恒邦药业有限公司 |
| 2021/04/02New drug · Class 1 | HS-10374片CXHL2100216 | 常州恒邦药业有限公司 |
| 2021/04/02New drug · Class 1 | PG-011凝胶CXHL2100215 | 北京普祺医药科技有限公司 |
| 2021/04/02New drug · Class 1 | PG-011凝胶CXHL2100214 | 北京普祺医药科技有限公司 |
| 2021/04/01Import · Class 3.1 | 贝伐珠单抗注射液JXSS2100021 | Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH |
| 2021/04/01Import · Class 1 | Teclistamab 注射液JXSL2101003 | Janssen Research & Development LLC; Johnson & Jonson （China）Investment Ltd. |
| 2021/04/01Import · Class 1 | Teclistamab 注射液JXSL2101002 | Janssen Research & Development， LLC; Johnson & Johnson （China）Investment Ltd |
| 2021/04/01Import · Class 3.1 | Nonacog beta pegolJXSL2100050 | Novo Nordisk A/S |
| 2021/04/01Import · Class 3.1 | Nonacog beta pegolJXSL2100049 | Novo Nordisk A/S |
| 2021/04/01Import · Class 3.1 | Nonacog beta pegolJXSL2100048 | Novo Nordisk A/S |
| 2021/04/01Import · Class 1 | 注射用LNA043JXSL2100047 | Novartis Pharma AG |
| 2021/04/01Import · Class 2.2 | ACZ885注射液JXSL2100046 | Novartis Pharma AG |
| 2021/04/01Import · Class 2.4 | 注射用TrilaciclibJXHL2100110 | G1 THERAPEUTICS INC. |
| 2021/04/01Generic · Class 3 | 雷诺嗪缓释片CYHL2100020 | 扬子江药业集团有限公司 |
| 2021/04/01Generic · Class 3 | 雷诺嗪缓释片CYHL2100019 | 扬子江药业集团有限公司 |
| 2021/04/01New drug · Class 1.1 | 小儿连花清感颗粒CXZL2101003 | 石家庄以岭药业股份有限公司 |
| 2021/04/01New drug · Class 2.3 | 痰热清胶囊CXZL2101002 | 上海凯宝药业股份有限公司 |
| 2021/04/01New drug · Class 3.3 | 吸附破伤风疫苗CXSL2101008 | 北京科兴中维生物技术有限公司 |
| 2021/04/01New drug · Class 1 | JS007注射液CXSL2100110 | 上海君实生物医药科技股份有限公司 |
10 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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