药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/03/02 – 2021/03/08
- New acceptances this week
- 200
- Drugs with new generic filings (by drug name, de-duplicated)
- 15
- 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
200filings, 21 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 104 |
| New drug | 35 |
| Import | 28 |
| Generic | 21 |
| Unspecified | 9 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 150 |
| 治疗用生物制品 | 28 |
| TCM | 19 |
| Biologic | 2 |
| 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
15 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 阿普司特片 | 3 | 1 | 0 |
| 2 | 盐酸右美托咪定注射液 | 2 | 2 | 0 |
| 3 | 左氧氟沙星注射液 | 2 | 1 | 1 |
| 4 | 盐酸托莫西汀胶囊 | 2 | 1 | 6 |
| 5 | 盐酸美金刚片 | 2 | 1 | 2 |
| 6 | 他达拉非片 | 1 | 1 | 23 |
| 7 | 头孢地尼胶囊 | 1 | 1 | 0 |
| 8 | 枸橼酸托法替布片 | 1 | 1 | 1 |
| 9 | 注射用奥美拉唑钠（静脉滴注） | 1 | 1 | 0 |
| 10 | 盐酸二甲双胍缓释片 | 1 | 1 | 11 |
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
115 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 中玉制药（海口）有限公司 | 8 | 5 | 0 |
| 2 | 北京广为医药科技有限公司 | 8 | 1 | 0 |
| 3 | 甘肃奇正藏药有限公司 | 6 | 6 | 0 |
| 4 | 西安京西双鹤药业有限公司 | 6 | 1 | 0 |
| 5 | 大连天山药业有限公司 | 5 | 5 | 0 |
| 6 | 百济神州（苏州）生物科技有限公司 | 5 | 2 | 0 |
| 7 | Fresenius Kabi Austria GmbH | 4 | 2 | 0 |
| 8 | 成都倍特药业股份有限公司 | 4 | 2 | 0 |
| 9 | 上海凯茂生物医药有限公司 | 4 | 1 | 0 |
| 10 | 吉林四环澳康药业有限公司 | 4 | 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
64 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/03/08Generic · Class 3 | 左氧氟沙星注射液CYHS2101016 | 山东齐都药业有限公司 |
| 2021/03/08Generic · Class 3 | 左氧氟沙星注射液CYHS2101015 | 山东齐都药业有限公司 |
| 2021/03/06New drug · Class 1 | YH003注射液CXSL2101002 | 祐和医药科技（北京）有限公司 |
| 2021/03/05Import · Class 1 | Tanezumab注射液JXSL2100037 | Pfizer Inc. |
| 2021/03/05Import · Class 2.2 | 注射用LuspaterceptJXSL2100036 | Celgene Corporation |
| 2021/03/05Import · Class 2.2 | 注射用LuspaterceptJXSL2100035 | Celgene Corporation |
| 2021/03/05Import · Class 1 | ATG-016片JXHL2100082 | Karyopharm Therapeutics Inc. |
| 2021/03/05Import · Class 1 | ATG-016片JXHL2100081 | Karyopharm Therapeutics Inc. |
| 2021/03/05Import · Class 1 | 注射用EC-DGJXHL2100080 | Cell>Point L.C.C. |
| 2021/03/05New drug · Class 2.2 | 替雷利珠单抗注射液CXSS2100030 | 百济神州（上海）生物科技有限公司; 勃林格殷格翰生物药业（中国）有限公司 |
| 2021/03/05New drug · Class 1 | JS103注射液CXSL2100083 | 上海君实生物医药科技股份有限公司 |
| 2021/03/05New drug · Class 2.2 | 盐酸罗哌卡因脂质体混悬注射液CXHL2100170 | 南京绿叶制药有限公司 |
| 2021/03/04Import · Class 1 | CG0070注射液JXSL2100029 | CG Oncology Inc. |
| 2021/03/04Import · Class 1 | MB-102注射液JXHL2100079 | MediBeacon Inc. |
| 2021/03/04Import · Class 1 | ALG-010133注射液JXHL2100075 | Aligos Therapeutics Inc. |
| 2021/03/04Import · Class 1 | JNJ-67856633 硬胶囊JXHL2100074 | Janssen Research & Development LLC |
| 2021/03/04Import · Class 1 | JNJ-67856633 硬胶囊JXHL2100073 | Janssen Research & Development LLC |
| 2021/03/04Import · Class 2.4 | ATG-010片JXHL2100072 | Karyopharm Therapeutics Inc. |
| 2021/03/04Import · Class 1 | ZN-c3片JXHL2100071 | Zentera Therapeutics HK Limited |
| 2021/03/04Import · Class 1 | ZN-c3片JXHL2100070 | Zentera Therapeutics HK Limited |
| 2021/03/04Import · Class 1 | 注射用LY3437943JXHL2100069 | Eli Lilly and Company |
| 2021/03/04Generic · Class 3 | 羧甲司坦口服溶液CYHS2100254 | 广东品晟医药科技有限公司; 广州一品红制药有限公司 |
| 2021/03/04Generic · Class 3 | 盐酸右美托咪定注射液CYHS2100252 | 河北仁合益康药业有限公司 |
| 2021/03/04New drug · Class 1 | AK104注射液CXSL2100082 | 康方药业有限公司 |
| 2021/03/04New drug · Class 1 | IBI321CXSL2100081 | 信达生物制药（苏州）有限公司 |
| 2021/03/04New drug · Class 1 | 甲磺酸贝福替尼胶囊CXHS2100009 | 贝达药业股份有限公司 |
| 2021/03/04New drug · Class 1 | 甲磺酸贝福替尼胶囊CXHS2100008 | 贝达药业股份有限公司 |
| 2021/03/04New drug · Class 1 | YY-20394片CXHL2100169 | 上海璎黎药业有限公司 |
| 2021/03/04New drug · Class 1 | GW117胶囊CXHL2100168 | 北京广为医药科技有限公司 |
| 2021/03/04New drug · Class 1 | GW117胶囊CXHL2100167 | 北京广为医药科技有限公司 |
34 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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