药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/08/30 – 2022/09/05
- New acceptances this week
- 273
- Drugs with new generic filings (by drug name, de-duplicated)
- 37
- 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
273filings, 46 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 139 |
| Generic | 46 |
| New drug | 44 |
| Import | 26 |
| Import re-registration | 12 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 190 |
| 治疗用生物制品 | 49 |
| TCM | 31 |
| 预防用生物制品 | 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
37 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 磷酸西格列汀片 | 3 | 1 | 2 |
| 2 | 地夸磷索钠滴眼液 | 2 | 2 | 5 |
| 3 | 注射用氯诺昔康 | 2 | 2 | 2 |
| 4 | 吡仑帕奈片 | 2 | 1 | 2 |
| 5 | 奥扎格雷钠注射液 | 2 | 1 | 3 |
| 6 | 奥硝唑注射液 | 2 | 1 | 0 |
| 7 | 盐酸帕洛诺司琼注射液 | 2 | 1 | 1 |
| 8 | 达格列净片 | 2 | 1 | 82 |
| 9 | 丙戊酸钠口服溶液 | 1 | 1 | 1 |
| 10 | 吡拉西坦注射液 | 1 | 1 | 9 |
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
157 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Roche Pharma (Schweiz) AG | 9 | 2 | 0 |
| 2 | 国九堂山东阿胶有限公司 | 8 | 8 | 0 |
| 3 | Eli Lilly and Company | 7 | 2 | 0 |
| 4 | 达嘉维康生物制药有限公司 | 6 | 6 | 0 |
| 5 | Janssen Research & Development LLC | 6 | 3 | 0 |
| 6 | 百济神州（苏州）生物科技有限公司 | 6 | 2 | 0 |
| 7 | 海南广升誉制药有限公司 | 6 | 1 | 0 |
| 8 | 广西圣民制药有限公司 | 5 | 5 | 0 |
| 9 | 成都弘基生物科技有限公司 | 5 | 1 | 0 |
| 10 | 广西胜合制药有限公司 | 4 | 4 | 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
77 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/09/05New drug · Class 1 | LM-101注射液CXSL2200438 | 礼新医药科技（上海）有限公司 |
| 2022/09/05New drug · Class 1 | KP104注射液CXSL2200437 | 科越医药（苏州）有限公司 |
| 2022/09/05New drug · Class 1 | AB-218 胶囊CXHL2200649 | 葆元生物医药科技（杭州）有限公司 |
| 2022/09/05New drug · Class 2.2;2.4 | TML-023软膏CXHL2200648 | 武汉科福新药有限责任公司 |
| 2022/09/04New drug · Class 1 | AK0707胶囊CXHL2200647 | 苏州爱科百发生物医药技术有限公司 |
| 2022/09/04New drug · Class 1 | AK0707胶囊CXHL2200646 | 苏州爱科百发生物医药技术有限公司 |
| 2022/09/03Import · Class 2.4 | INC280JXHL2200274 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2022/09/03Import · Class 2.4 | INC280JXHL2200273 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2022/09/03Import · Class 2.4 | 镥（177Lu）vipivotide tetraxetan注射液JXHL2200271 | Advanced Accelerator Applications USA Inc. A Novartis Company; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2022/09/03Generic · Class 3 | 甘露醇山梨醇注射液CYHS2201452 | 南京赛瑞谱顿制药有限公司; 江苏大红鹰恒顺药业有限公司 |
| 2022/09/03Generic · Class 3 | 奥扎格雷钠注射液CYHS2201446 | 本溪恒康制药有限公司 |
| 2022/09/03Generic · Class 3 | 奥扎格雷钠注射液CYHS2201445 | 本溪恒康制药有限公司 |
| 2022/09/03Generic · Class 3 | 左乙拉西坦缓释片CYHS2201443 | 越洋医药开发（广州）有限公司; 常州制药厂有限公司 |
| 2022/09/03New drug · Class 1 | TC-N201注射液CXSL2200436 | 广东天科雅生物医药科技有限公司 |
| 2022/09/02Import · Class 1 | BIIB059JXSL2200154 | Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd |
| 2022/09/02Generic · Class 3 | 盐酸奥普力农注射液CYHS2201442 | 山西德元堂药业有限公司 |
| 2022/09/02Generic · Class 3 | 美索巴莫注射液CYHS2201436 | 南京恩泰医药科技有限公司; 江苏大红鹰恒顺药业有限公司 |
| 2022/09/02Generic · Class 3 | 奥硝唑注射液CYHS2201425 | 山西德元堂药业有限公司 |
| 2022/09/02Generic · Class 3 | 奥硝唑注射液CYHS2201424 | 山西德元堂药业有限公司 |
| 2022/09/02New drug · Class 1.1 | 芪黄明目胶囊CXZS2200007 | 石家庄以岭药业股份有限公司 |
| 2022/09/02New drug · Class 1 | 注射用ZW25CXSL2200435 | 百济神州（苏州）生物科技有限公司 |
| 2022/09/02New drug · Class 1 | 注射用ZW25CXSL2200434 | 百济神州（苏州）生物科技有限公司 |
| 2022/09/02New drug · Class 1 | 注射用QLF32101CXSL2200433 | 齐鲁制药有限公司 |
| 2022/09/02New drug · Class 1 | GC304腺相关病毒注射液CXSL2200432 | 北京锦篮基因科技有限公司 |
| 2022/09/02New drug · Class 1 | 注射用LM-305CXSL2200431 | 礼新医药科技（上海）有限公司 |
| 2022/09/02New drug · Class 1 | WS016干混悬剂CXHL2200645 | 中美华世通生物医药科技（武汉）股份有限公司 |
| 2022/09/02New drug · Class 1 | IMG-004胶囊CXHL2200644 | 英脉生物医药（杭州）有限公司 |
| 2022/09/02New drug · Class 1 | IMG-004胶囊CXHL2200643 | 英脉生物医药（杭州）有限公司 |
| 2022/09/02New drug · Class 1 | ASC61片CXHL2200642 | 歌礼生物科技（杭州）有限公司 |
| 2022/09/02New drug · Class 1 | PA9159吸入气雾剂CXHL2200641 | 安徽柏拉阿图医药科技有限公司 |
47 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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