药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/09/17 – 2024/09/23
- New acceptances this week
- 156
- Drugs with new generic filings (by drug name, de-duplicated)
- 29
- Accepted this week, now under review
- 2
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
156filings, 38 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 63 |
| Generic | 38 |
| New drug | 30 |
| Import | 9 |
| Import re-registration | 8 |
| Unspecified | 7 |
| 药械组合 | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 103 |
| TCM | 26 |
| 治疗用生物制品 | 16 |
| Biologic | 8 |
| 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
29 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸氨溴索口服溶液 | 4 | 1 | 45 |
| 2 | 布瑞哌唑片 | 3 | 1 | 31 |
| 3 | 盐酸左沙丁胺醇雾化吸入溶液 | 2 | 1 | 2 |
| 4 | 舒林酸片 | 2 | 1 | 5 |
| 5 | 贝前列素钠片 | 2 | 1 | 0 |
| 6 | 青霉素V钾片 | 2 | 1 | 2 |
| 7 | ω-3鱼油中长链脂肪乳/氨基酸（16）/葡萄糖（16%）注射液 | 1 | 1 | 0 |
| 8 | 丙酸氟替卡松雾化吸入用混悬液 | 1 | 1 | 7 |
| 9 | 地夸磷索钠滴眼液 | 1 | 1 | 5 |
| 10 | 培哚普利氨氯地平片（III） | 1 | 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
107 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 7 | 3 | 0 |
| 2 | 广东科泓药业有限公司 | 5 | 1 | 0 |
| 3 | AbbVie Inc. | 4 | 2 | 0 |
| 4 | 北京四环科宝制药股份有限公司 | 4 | 1 | 4 |
| 5 | 马应龙药业集团股份有限公司 | 4 | 1 | 0 |
| 6 | Dr. Willmar Schwabe GmbH & Co. KG | 3 | 2 | 0 |
| 7 | 山东丹红制药有限公司 | 3 | 1 | 0 |
| 8 | 山东安信制药有限公司 | 3 | 1 | 0 |
| 9 | 浙江普利药业有限公司 | 3 | 1 | 3 |
| 10 | 特科罗生物科技（成都）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
50 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/09/23New drug · Class 1 | HSK21542注射液CXHS2400097 | 辽宁海思科制药有限公司 |
| 2024/09/21Import · Class 1 | NNC0519-0130注射液JXHL2400222 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2024/09/21Import · Class 2.4 | Acalabrutinib Maleate片JXHL2400221 | AstraZeneca Pty Ltd; AstraZeneca Investment (China) Co. Ltd. |
| 2024/09/21Generic · Class 3 | 盐酸普萘洛尔注射液CYHS2403145 | 广州合和医药有限公司; 湖南赛隆药业（长沙）有限公司 |
| 2024/09/21New drug · Class 3.3 | 达雷妥尤单抗注射液CXSL2400635 | 石药集团巨石生物制药有限公司 |
| 2024/09/21New drug · Class 1 | 注射用DM005CXSL2400634 | 多玛医药科技（苏州）有限公司 |
| 2024/09/20Import · Class 1 | AZD2936JXSL2400172 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/20Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液CYHS2403139 | 重庆中创科医药有限公司; 山东华鲁制药有限公司 |
| 2024/09/20Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液CYHS2403138 | 重庆中创科医药有限公司; 山东华鲁制药有限公司 |
| 2024/09/20Generic · Class 3 | 盐酸艾司氯胺酮注射液CYHS2403135 | 国药集团国瑞药业有限公司 |
| 2024/09/20Generic · Class 3 | ω-3鱼油中长链脂肪乳/氨基酸（16）/葡萄糖（16%）注射液CYHS2403133 | 湖北一半天制药有限公司 |
| 2024/09/20Generic · Class 3 | 盐酸甲氧氯普胺注射液CYHS2403129 | 上海葆隆生物科技有限公司; 亚邦医药股份有限公司 |
| 2024/09/20Generic · Class 3 | 水合氯醛灌肠剂CYHS2403128 | 宏越科技（湖州）有限公司; 浙江康恩贝制药股份有限公司 |
| 2024/09/20New drug · Class 1.1 | MYL软膏CXZL2400059 | 马应龙药业集团股份有限公司 |
| 2024/09/20New drug · Class 1.1 | MYL软膏CXZL2400058 | 马应龙药业集团股份有限公司 |
| 2024/09/20New drug · Class 1.1 | MYL软膏CXZL2400057 | 马应龙药业集团股份有限公司 |
| 2024/09/20New drug · Class 1.1 | MYL软膏CXZL2400056 | 马应龙药业集团股份有限公司 |
| 2024/09/20New drug · Class 1 | 瑞拉芙普-α注射液CXSS2400101 | 苏州盛迪亚生物医药有限公司 |
| 2024/09/20New drug · Class 3.4 | 注射用重组人B型利钠肽CXSL2400633 | 江苏景泽生物制药有限公司 |
| 2024/09/19Import · Class 1 | Volixibat胶囊JXHL2400220 | Mirum Pharmaceuticals Inc.; Syneos Health（Beijing）Inc. Ltd. |
| 2024/09/19Import · Class 1 | Volixibat胶囊JXHL2400219 | Mirum Pharmaceuticals Inc.; Syneos Health（Beijing）Inc. Ltd. |
| 2024/09/19Generic · Class 3 | 复方匹可硫酸钠口服溶液CYHS2403122 | 浙江同伍生物医药有限公司; 湖南九典制药股份有限公司 |
| 2024/09/19Generic · Class 3 | 硫酸特布他林口服溶液CYHS2403117 | 北京民康百草医药科技有限公司; 湖南九典制药股份有限公司 |
| 2024/09/19Generic · Class 3 | 舒林酸片CYHS2403116 | 甘正（海南）生物药业有限公司; 海南科进生物制药有限公司 |
| 2024/09/19Generic · Class 3 | 舒林酸片CYHS2403115 | 甘正（海南）生物药业有限公司; 海南科进生物制药有限公司 |
| 2024/09/19Generic · Class 3 | 注射用硫酸多黏菌素BCYHS2403113 | 齐鲁制药（海南）有限公司 |
| 2024/09/19Generic · Class 3 | 瑞卢戈利片CYHL2400191 | 齐鲁制药有限公司 |
| 2024/09/19Generic · Class 3 | 米诺地尔泡沫剂CYHL2400190 | 浙江三生蔓迪药业有限公司 |
| 2024/09/19Generic · Class 3 | 盐酸毛果芸香碱滴眼液CYHL2400189 | 湖北远大天天明制药有限公司 |
| 2024/09/19New drug · Class 3.1 | 桃红四物颗粒CXZS2400031 | 株洲千金药业股份有限公司 |
20 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.