药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/07/04 – 2023/07/10
- New acceptances this week
- 310
- Drugs with new generic filings (by drug name, de-duplicated)
- 52
- 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
310filings, 66 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 169 |
| Generic | 66 |
| New drug | 42 |
| Import | 18 |
| Unspecified | 9 |
| Import re-registration | 4 |
| 药械组合产品 | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 231 |
| TCM | 52 |
| 治疗用生物制品 | 24 |
| 预防用生物制品 | 2 |
| Biologic | 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
52 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 钆特酸葡胺注射液 | 3 | 1 | 1 |
| 2 | 阿普米司特片 | 3 | 1 | 3 |
| 3 | 地诺孕素片 | 2 | 2 | 2 |
| 4 | 玻璃酸钠滴眼液 | 2 | 2 | 29 |
| 5 | 美索巴莫注射液 | 2 | 2 | 3 |
| 6 | 他达拉非片 | 2 | 1 | 23 |
| 7 | 复方奥美拉唑干混悬剂 | 2 | 1 | 0 |
| 8 | 头孢羟氨苄片 | 2 | 1 | 0 |
| 9 | 左氧氟沙星片 | 2 | 1 | 8 |
| 10 | 艾司奥美拉唑镁肠溶胶囊 | 2 | 1 | 4 |
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
183 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 修正药业集团天汉药业有限公司 | 19 | 19 | 0 |
| 2 | 河南双鹤华利药业有限公司 | 16 | 3 | 0 |
| 3 | 黑龙江参鸽药业有限公司 | 8 | 8 | 0 |
| 4 | AstraZeneca AB | 6 | 3 | 0 |
| 5 | 百济神州（苏州）生物科技有限公司 | 6 | 2 | 0 |
| 6 | 华仁药业股份有限公司 | 5 | 5 | 0 |
| 7 | AbbVie Inc. | 4 | 3 | 0 |
| 8 | 山东新时代药业有限公司 | 4 | 2 | 3 |
| 9 | 安徽誉恒生物科技有限公司 | 4 | 1 | 0 |
| 10 | 上海信谊万象药业股份有限公司 | 3 | 3 | 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 |
|---|---|---|
| 2023/07/10Generic · Class 3 | 复方奥美拉唑干混悬剂CYHS2301849 | 杭州沐源生物医药科技有限公司; 四川科伦药业股份有限公司 |
| 2023/07/10Generic · Class 3 | 复方奥美拉唑干混悬剂CYHS2301848 | 杭州沐源生物医药科技有限公司; 四川科伦药业股份有限公司 |
| 2023/07/08Import · Class 3.1 | 艾加莫德α注射液（皮下注射）JXSS2300054 | argenx BV; Patheon Italia S.p.A.; Zai Lab (Shanghai) Co. Ltd. |
| 2023/07/08Import · Class 1 | MBG453JXSL2300126 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2023/07/08Generic · Class 3 | 氢溴酸依他佐辛注射液CYHS2301841 | 合肥亿帆生物制药有限公司 |
| 2023/07/08Generic · Class 3 | 尼莫地平口服溶液CYHS2301838 | 南京泽恒医药技术开发有限公司; 南京海纳制药有限公司 |
| 2023/07/08Generic · Class 3 | 酒石酸阿福特罗雾化吸入用溶液CYHL2300082 | 山东京卫制药有限公司 |
| 2023/07/08New drug · Class 1 | 注射用SIBP-A13CXSL2300458 | 上海生物制品研究所有限责任公司 |
| 2023/07/08New drug · Class 1 | 注射用HS-20105CXSL2300457 | 上海翰森生物医药科技有限公司; 常州恒邦药业有限公司 |
| 2023/07/08New drug · Class 1 | 重组人nsIL12溶瘤腺病毒注射液CXSL2300456 | 北京锤特生物科技有限公司 |
| 2023/07/08New drug · Class 1 | 重组抗IL-4Rα人源化单克隆抗体注射液CXSL2300455 | 三生国健药业（上海）股份有限公司 |
| 2023/07/08New drug · Class 1 | LF0315片CXHL2300759 | 无锡瓴方生物医药科技有限公司 |
| 2023/07/08New drug · Class 1 | LV232胶囊CXHL2300758 | 苏州旺山旺水生物医药股份有限公司; 南通和风连旺医药科技有限公司 |
| 2023/07/08New drug · Class 1 | LV232胶囊CXHL2300757 | 苏州旺山旺水生物医药股份有限公司; 南通和风连旺医药科技有限公司 |
| 2023/07/08New drug · Class 1 | BGB-30813片CXHL2300756 | 百济神州（苏州）生物科技有限公司 |
| 2023/07/08New drug · Class 1 | BGB-30813片CXHL2300755 | 百济神州（苏州）生物科技有限公司 |
| 2023/07/08New drug · Class 1 | BGB-30813片CXHL2300754 | 百济神州（苏州）生物科技有限公司 |
| 2023/07/08New drug · Class 1 | BGB-30813片CXHL2300753 | 百济神州（苏州）生物科技有限公司 |
| 2023/07/08New drug · Class 1 | HJ787软膏CXHL2300752 | 成都华健未来科技有限公司 |
| 2023/07/08New drug · Class 1 | HJ787软膏CXHL2300751 | 成都华健未来科技有限公司 |
| 2023/07/08New drug · Class 2.2 | LN006干混悬剂CXHL2300750 | 上海惠永制药有限公司 |
| 2023/07/08New drug · Class 1 | 炔丙基半胱氨酸胶囊CXHL2300749 | 依诺医药（广东）有限公司; 珠海澳科大科技研究院 |
| 2023/07/08New drug · Class 1 | 炔丙基半胱氨酸胶囊CXHL2300748 | 依诺医药（广东）有限公司; 珠海澳科大科技研究院 |
| 2023/07/07Generic · Class 3 | 艾司奥美拉唑镁肠溶胶囊CYHS2301835 | 广州新济药业科技有限公司; 宜昌人福药业有限责任公司 |
| 2023/07/07Generic · Class 3 | 艾司奥美拉唑镁肠溶胶囊CYHS2301834 | 广州新济药业科技有限公司; 宜昌人福药业有限责任公司 |
| 2023/07/07Generic · Class 3 | 马来酸噻吗洛尔滴眼液CYHS2301833 | 合肥立方制药股份有限公司; 安徽省双科药业有限公司 |
| 2023/07/07Generic · Class 3 | 头孢羟氨苄片CYHS2301830 | 海南广升誉制药有限公司; 浙江莎普爱思药业股份有限公司 |
| 2023/07/07Generic · Class 3 | 头孢羟氨苄片CYHS2301829 | 海南广升誉制药有限公司; 浙江莎普爱思药业股份有限公司 |
| 2023/07/07Generic · Class 3 | 美索巴莫注射液CYHS2301827 | 杭州端本医药科技有限公司; 浙江赛默制药有限公司 |
| 2023/07/07Generic · Class 3 | 美索巴莫注射液CYHS2301826 | 江苏艾立康医药科技有限公司; 江苏悦兴药业有限公司 |
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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