药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/04/23 – 2024/04/29
- New acceptances this week
- 330
- Drugs with new generic filings (by drug name, de-duplicated)
- 72
- Accepted this week, now under review
- 4
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
330filings, 103 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 166 |
| Generic | 103 |
| New drug | 44 |
| Import re-registration | 8 |
| Import | 6 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 222 |
| TCM | 61 |
| 治疗用生物制品 | 38 |
| 预防用生物制品 | 7 |
| Biologic | 2 |
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
72 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 他达拉非片 | 5 | 2 | 23 |
| 2 | 马来酸氟伏沙明片 | 4 | 3 | 0 |
| 3 | 米诺地尔搽剂 | 4 | 2 | 49 |
| 4 | 吸入用盐酸氨溴索溶液 | 3 | 1 | 10 |
| 5 | 盐酸布比卡因注射液 | 3 | 1 | 4 |
| 6 | 乙酰半胱氨酸注射液 | 2 | 2 | 53 |
| 7 | 腺苷钴胺胶囊 | 2 | 2 | 8 |
| 8 | 丙氨酰谷氨酰胺注射液 | 2 | 1 | 4 |
| 9 | 乳果糖口服溶液 | 2 | 1 | 40 |
| 10 | 依折麦布阿托伐他汀钙片 | 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
191 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 湖北第六制药有限公司 | 24 | 23 | 0 |
| 2 | Bristol-Myers Squibb Pharma EEIG | 7 | 3 | 0 |
| 3 | 河南华峰制药有限公司 | 6 | 6 | 0 |
| 4 | 江苏恒瑞医药股份有限公司 | 6 | 3 | 0 |
| 5 | 河南省百泉制药有限公司 | 5 | 5 | 0 |
| 6 | 宸寰医药集团有限公司 | 5 | 4 | 0 |
| 7 | 石家庄四药有限公司 | 5 | 4 | 4 |
| 8 | 北京福元医药股份有限公司 | 5 | 3 | 5 |
| 9 | 深圳市天道医药有限公司 | 5 | 1 | 0 |
| 10 | 四川天杏汇医药科技有限公司 | 4 | 4 | 4 |
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
92 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/04/29Generic · Class 3 | 盐酸甲氧氯普胺注射液CYHS2401300 | 仁合益康汇泽药业河北有限公司; 河北仁合益康药业有限公司 |
| 2024/04/29Generic · Class 3 | 硫酸镁注射液CYHS2401298 | 山东齐都药业有限公司 |
| 2024/04/29Generic · Class 3 | 腺苷钴胺胶囊CYHS2401296 | 桂林华信制药有限公司 |
| 2024/04/29Generic · Class 3 | 复方聚乙二醇（3350）电解质散CYHS2401295 | 哈尔滨葵花药业有限公司; 葵花药业集团（唐山）生物制药有限公司 |
| 2024/04/29Generic · Class 3 | 氯化钾颗粒CYHS2401287 | 四川天杏汇医药科技有限公司; 成都天台山制药股份有限公司 |
| 2024/04/29New drug · Class 1 | 司普奇拜单抗注射液CXSS2400045 | 成都康诺行生物医药科技有限公司 |
| 2024/04/29New drug · Class 1 | ART001注射液CXSL2400271 | 锐正基因（苏州）有限公司 |
| 2024/04/29New drug · Class 2.2 | 聚乙二醇干扰素α-2b注射液CXSL2400270 | 厦门特宝生物工程股份有限公司 |
| 2024/04/29New drug · Class 1 | 注射用TRS005CXSL2400269 | 浙江特瑞思药业股份有限公司 |
| 2024/04/29New drug · Class 1 | AFN0328注射液CXSL2400268 | 合肥阿法纳生物科技有限公司; 安徽安科生物工程（集团）股份有限公司; 合肥阿法纳安科生物科技有限公司 |
| 2024/04/28New drug · Class 1.4 | 四价流感病毒亚单位疫苗（佐剂）CXSL2400267 | 江苏中慧元通生物科技股份有限公司; 易慧生物技术（上海）有限公司 |
| 2024/04/27New drug · Class 1.1 | 百苓止咳颗粒CXZL2400021 | 苏州中药研究所有限公司 |
| 2024/04/27New drug · Class 1 | ZHB110舌下片CXSL2400266 | 江苏众红生物工程创药研究院有限公司 |
| 2024/04/27New drug · Class 1 | ZHB110舌下片CXSL2400265 | 江苏众红生物工程创药研究院有限公司 |
| 2024/04/27New drug · Class 1 | HS-10370片CXHL2400420 | 江苏豪森药业集团有限公司; 上海翰森生物医药科技有限公司 |
| 2024/04/27New drug · Class 1 | TYK-01054胶囊CXHL2400419 | 浙江同源康医药股份有限公司 |
| 2024/04/27New drug · Class 1 | TYK-01054胶囊CXHL2400418 | 浙江同源康医药股份有限公司 |
| 2024/04/27New drug · Class 2.2 | 注射用IPGCXHL2400417 | 浙江仙琚制药股份有限公司 |
| 2024/04/26Import · Class 1 | AZD8205JXSL2400082 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/04/26Import · Class 1 | AZD2936JXSL2400081 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/04/26Generic · Class 3 | 米诺地尔搽剂CYHS2401276 | 江苏天士力帝益药业有限公司; 河南天地药业股份有限公司 |
| 2024/04/26Generic · Class 3 | 米诺地尔搽剂CYHS2401275 | 江苏天士力帝益药业有限公司; 河南天地药业股份有限公司 |
| 2024/04/26Generic · Class 3 | 西咪替丁注射液CYHS2401262 | 四川汇宇制药股份有限公司; 成都天台山制药股份有限公司 |
| 2024/04/26Generic · Class 3 | 氯化钾口服溶液CYHS2401260 | 四川天杏汇医药科技有限公司; 四川先通药业有限责任公司 |
| 2024/04/26New drug · Class 3.3 | 吸附破伤风疫苗CXSS2400044 | 北京科兴中维生物技术有限公司 |
| 2024/04/26New drug · Class 3.3 | 司美格鲁肽注射液CXSL2400264 | 重庆宸安生物制药有限公司 |
| 2024/04/26New drug · Class 3.3 | 司美格鲁肽注射液CXSL2400263 | 重庆宸安生物制药有限公司 |
| 2024/04/26New drug · Class 2.2 | 艾司奥美拉唑镁碳酸氢钠干混悬剂（Ⅰ）CXHL2400416 | 海南灵康制药有限公司 |
| 2024/04/26New drug · Class 2.2 | 艾司奥美拉唑镁碳酸氢钠干混悬剂（Ⅰ）CXHL2400415 | 海南灵康制药有限公司 |
| 2024/04/26New drug · Class 2.3 | CP006吸入粉雾剂CXHL2400414 | 上海新黄河制药有限公司 |
62 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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