药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/10/10 – 2023/10/16
- New acceptances this week
- 463
- Drugs with new generic filings (by drug name, de-duplicated)
- 82
- Accepted this week, now under review
- 1
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
463filings, 118 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 219 |
| Generic | 118 |
| New drug | 87 |
| Import | 26 |
| Import re-registration | 7 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 332 |
| TCM | 70 |
| 治疗用生物制品 | 53 |
| 预防用生物制品 | 7 |
| 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
82 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 地夸磷索钠滴眼液 | 6 | 5 | 5 |
| 2 | 甲苯磺酸艾多沙班片 | 6 | 2 | 9 |
| 3 | 磷酸奥司他韦干混悬剂 | 4 | 2 | 2 |
| 4 | 乳果糖口服溶液 | 3 | 2 | 40 |
| 5 | 法莫替丁注射液 | 3 | 2 | 8 |
| 6 | 注射用尼可地尔 | 3 | 2 | 1 |
| 7 | 米诺地尔搽剂 | 3 | 2 | 49 |
| 8 | 小儿复方氨基酸注射液（19AA-I） | 3 | 1 | 2 |
| 9 | 盐酸左沙丁胺醇雾化吸入溶液 | 3 | 1 | 2 |
| 10 | 依折麦布片 | 2 | 2 | 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
262 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 广西金兴制药有限责任公司 | 19 | 18 | 0 |
| 2 | 山西阳和医药技术有限公司 | 8 | 3 | 0 |
| 3 | 正大天晴药业集团股份有限公司 | 8 | 2 | 0 |
| 4 | 四川森科制药有限公司 | 6 | 5 | 0 |
| 5 | 四川科伦药业股份有限公司 | 6 | 3 | 2 |
| 6 | 津药和平（天津）制药有限公司 | 6 | 3 | 6 |
| 7 | 齐鲁制药有限公司 | 5 | 3 | 5 |
| 8 | Boehringer Ingelheim International GmbH | 5 | 2 | 0 |
| 9 | 江苏正大丰海制药有限公司 | 5 | 2 | 1 |
| 10 | 江苏新元素医药科技有限公司 | 5 | 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
156 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/10/16Import · Class 1 | DS-7011aJXSL2300185 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2023/10/16New drug · Class 1 | KAL-002CXSL2300703 | 四川厌氧生物科技有限责任公司 |
| 2023/10/16New drug · Class 1 | KAL-002CXSL2300702 | 四川厌氧生物科技有限责任公司 |
| 2023/10/14Import · Class 1 | TarlatamabJXSL2300184 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2023/10/14Import · Class 1 | TarlatamabJXSL2300183 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2023/10/14Import · Class 1 | TarlatamabJXSL2300182 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2023/10/14Generic · Class 3 | 氟[18F]化钠注射液CYHS2302776 | 南京江原安迪科正电子研究发展有限公司 |
| 2023/10/14Generic · Class 3 | 碳酸镧颗粒CYHS2302774 | 湖南明瑞制药股份有限公司 |
| 2023/10/14Generic · Class 3 | 磷酸奥司他韦干混悬剂CYHS2302769 | 遂成药业股份有限公司; 郑州致和药业有限公司 |
| 2023/10/14Generic · Class 3 | 磷酸奥司他韦干混悬剂CYHS2302768 | 遂成药业股份有限公司; 郑州致和药业有限公司 |
| 2023/10/14Generic · Class 3 | 磷酸奥司他韦干混悬剂CYHS2302767 | 遂成药业股份有限公司; 郑州致和药业有限公司 |
| 2023/10/14Generic · Class 3 | 马来酸噻吗洛尔滴眼液CYHS2302766 | 扬州中宝药业股份有限公司 |
| 2023/10/14Generic · Class 3 | 小儿复方氨基酸注射液（19AA-I）CYHS2302763 | 津药和平（天津）制药有限公司 |
| 2023/10/14Generic · Class 3 | 小儿复方氨基酸注射液（19AA-I）CYHS2302762 | 津药和平（天津）制药有限公司 |
| 2023/10/14Generic · Class 3 | 小儿复方氨基酸注射液（19AA-I）CYHS2302761 | 津药和平（天津）制药有限公司 |
| 2023/10/14Generic · Class 3 | 米诺地尔搽剂CYHS2302758 | 广东伊康纳斯生物医药科技股份有限公司; 中山万汉制药有限公司 |
| 2023/10/14Generic · Class 3 | 米诺地尔搽剂CYHS2302757 | 广东伊康纳斯生物医药科技股份有限公司; 中山万汉制药有限公司 |
| 2023/10/14New drug · Class 2.1 | 万通筋骨巴布膏CXZS2300021 | 通化万通药业股份有限公司 |
| 2023/10/14New drug · Class 1 | 注射用ZHB114CXSL2300701 | 江苏众红生物工程创药研究院有限公司; 常州千红生化制药股份有限公司 |
| 2023/10/14New drug · Class 1 | IBI343CXSL2300700 | 信达生物制药（苏州）有限公司 |
| 2023/10/14New drug · Class 1 | KL003细胞注射液CXSL2300699 | 康霖生物科技（杭州）有限公司 |
| 2023/10/14New drug · Class 1 | ZX2010注射液CXSL2300698 | 江苏中新医药有限公司 |
| 2023/10/14New drug · Class 1 | SC0011片CXHL2301118 | 无锡瓴方生物医药科技有限公司 |
| 2023/10/14New drug · Class 2.2 | LPC-013口溶膜CXHL2301117 | 海南中旺医疗科技开发有限公司 |
| 2023/10/14New drug · Class 2.2 | LPC-013口溶膜CXHL2301116 | 海南中旺医疗科技开发有限公司 |
| 2023/10/14New drug · Class 1 | BT-114143注射液CXHL2301115 | 赛诺哈勃药业（成都）有限公司 |
| 2023/10/14New drug · Class 1 | TNP-2092软膏CXHL2301114 | 丹诺医药（中山）有限公司 |
| 2023/10/14New drug · Class 1 | BT-114143注射液CXHL2301113 | 赛诺哈勃药业（成都）有限公司 |
| 2023/10/14New drug · Class 1 | DA818胶囊CXHL2301112 | 成都地奥九泓制药厂 |
| 2023/10/14New drug · Class 1 | DA818胶囊CXHL2301111 | 成都地奥九泓制药厂 |
126 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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