药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/06/20 – 2023/06/26
- New acceptances this week
- 194
- Drugs with new generic filings (by drug name, de-duplicated)
- 33
- 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
194filings, 39 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 76 |
| New drug | 46 |
| Generic | 39 |
| Import | 16 |
| Import re-registration | 11 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 141 |
| TCM | 26 |
| 治疗用生物制品 | 26 |
| 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
33 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 卡络磺钠注射液 | 2 | 1 | 1 |
| 2 | 左氧氟沙星滴眼液 | 2 | 1 | 16 |
| 3 | 注射用卡非佐米 | 2 | 1 | 0 |
| 4 | 盐酸纳布啡注射液 | 2 | 1 | 11 |
| 5 | 罗库溴铵注射液 | 2 | 1 | 1 |
| 6 | 马来酸曲美布汀片 | 2 | 1 | 4 |
| 7 | 乙酰半胱氨酸注射液 | 1 | 1 | 53 |
| 8 | 乳果糖口服溶液 | 1 | 1 | 36 |
| 9 | 复合磷酸氢钾注射液 | 1 | 1 | 2 |
| 10 | 富马酸福莫特罗吸入溶液 | 1 | 1 | 7 |
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
127 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 杭州安道药业有限公司 | 6 | 1 | 0 |
| 2 | Dr. Reddy's Laboratories Ltd. | 5 | 2 | 0 |
| 3 | 海南倍特药业有限公司 | 5 | 2 | 1 |
| 4 | Hetero Labs Limited | 4 | 2 | 0 |
| 5 | 广州嘉越医药科技有限公司 | 4 | 1 | 0 |
| 6 | 修正药业集团天汉药业有限公司 | 3 | 3 | 0 |
| 7 | AbbVie Inc. | 3 | 1 | 0 |
| 8 | AbbVie Limited | 3 | 1 | 0 |
| 9 | Organon Pharma (UK) Limited | 3 | 1 | 0 |
| 10 | 广西金康药业有限公司 | 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
72 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/06/26Import · Class 1 | RO7565020注射液JXSL2300114 | F. Hoffmann-La Roche Ltd; Roche R&D Center (China) Ltd. |
| 2023/06/26Generic · Class 3 | 卡络磺钠注射液CYHS2301684 | 南京海科瑞医药科技有限公司; 江苏九旭药业有限公司 |
| 2023/06/26Generic · Class 3 | 卡络磺钠注射液CYHS2301683 | 南京海科瑞医药科技有限公司; 江苏九旭药业有限公司 |
| 2023/06/26Generic · Class 3 | 盐酸万古霉素胶囊CYHS2301681 | 时森海（杭州）医药科技有限公司; 杨凌步长制药有限公司 |
| 2023/06/26New drug · Class 1.1 | 小儿佛芍和中颗粒CXZL2300044 | 江苏康缘药业股份有限公司 |
| 2023/06/26New drug · Class 1 | CM310重组人源化单克隆抗体注射液CXSL2300430 | 康诺亚生物医药科技（成都）有限公司 |
| 2023/06/26New drug · Class 1 | CM310重组人源化单克隆抗体注射液CXSL2300429 | 康诺亚生物医药科技（成都）有限公司 |
| 2023/06/26New drug · Class 1 | MK-1084片CXHL2300693 | 默沙东研发（中国）有限公司 |
| 2023/06/26New drug · Class 1 | MK-1084片CXHL2300692 | 默沙东研发（中国）有限公司 |
| 2023/06/26New drug · Class 2.2;2.4 | 醋酸阿比特龙片（Ⅰ）CXHL2300691 | 成都盛迪医药有限公司 |
| 2023/06/26New drug · Class 1 | AC-201片CXHL2300690 | 爱科诺生物医药（苏州）有限公司 |
| 2023/06/26New drug · Class 1 | AC-201片CXHL2300689 | 爱科诺生物医药（苏州）有限公司 |
| 2023/06/26New drug · Class 1 | LIT-00814片CXHL2300688 | 上海辉启生物医药科技有限公司 |
| 2023/06/26New drug · Class 1 | LIT-00814片CXHL2300687 | 上海辉启生物医药科技有限公司 |
| 2023/06/22Import · Class 1 | MK-0616 片JXHL2300146 | Merck Sharp & Dohme LLC; 不适用 |
| 2023/06/22Generic · Class 3 | 盐酸艾司洛尔注射液CYHS2301678 | 海南倍特药业有限公司 |
| 2023/06/22New drug · Class 1 | 注射用D3L-001CXSL2300428 | 德昇济医药（无锡）有限公司 |
| 2023/06/22New drug · Class 1 | 重组抗CD20人源化单克隆抗体皮下注射液CXSL2300427 | 上海上药交联医药科技有限公司 |
| 2023/06/22New drug · Class 1 | 注射用NCB003CXSL2300426 | 浙江新码生物医药有限公司 |
| 2023/06/22New drug · Class 1 | VV119胶囊CXHL2300686 | 苏州旺山旺水生物医药股份有限公司 |
| 2023/06/22New drug · Class 1 | VV119胶囊CXHL2300685 | 苏州旺山旺水生物医药股份有限公司 |
| 2023/06/22New drug · Class 1 | VV119胶囊CXHL2300684 | 苏州旺山旺水生物医药股份有限公司 |
| 2023/06/22New drug · Class 1 | JYP0061片CXHL2300683 | 广州嘉越医药科技有限公司 |
| 2023/06/22New drug · Class 1 | JYP0061片CXHL2300682 | 广州嘉越医药科技有限公司 |
| 2023/06/22New drug · Class 1 | JYP0061片CXHL2300681 | 广州嘉越医药科技有限公司 |
| 2023/06/22New drug · Class 1 | JYP0061片CXHL2300680 | 广州嘉越医药科技有限公司 |
| 2023/06/21Import · Class 1 | LEO 138559 注射液JXSL2300113 | LEO Pharma A/S; LEO Pharma Consultancy (Shanghai) Company Limited |
| 2023/06/21Import · Class 1 | Sisunatovir 胶囊JXHL2300145 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2023/06/21Generic · Class 3 | 己酮可可碱注射液CYHS2301677 | 河北一品生物医药有限公司; 河北一品制药股份有限公司 |
| 2023/06/21Generic · Class 3 | 复合磷酸氢钾注射液CYHS2301676 | 石家庄四药有限公司 |
42 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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