药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/03/28 – 2023/04/03
- New acceptances this week
- 251
- Drugs with new generic filings (by drug name, de-duplicated)
- 37
- 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
251filings, 48 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 129 |
| Generic | 48 |
| New drug | 30 |
| Import | 26 |
| Import re-registration | 11 |
| Unspecified | 5 |
| 药械组合产品 | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 178 |
| TCM | 39 |
| 治疗用生物制品 | 26 |
| 预防用生物制品 | 8 |
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
37 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 枸橼酸西地那非片 | 3 | 1 | 12 |
| 2 | 二羟丙茶碱注射液 | 2 | 2 | 7 |
| 3 | 普拉洛芬滴眼液 | 2 | 2 | 7 |
| 4 | 聚乙二醇钠钾散 | 2 | 2 | 3 |
| 5 | 利那洛肽胶囊 | 2 | 1 | 13 |
| 6 | 氨溴特罗口服溶液 | 2 | 1 | 23 |
| 7 | 盐酸多奈哌齐片 | 2 | 1 | 0 |
| 8 | 盐酸昂丹司琼片 | 2 | 1 | 6 |
| 9 | 苯磺酸左氨氯地平片 | 2 | 1 | 47 |
| 10 | 达格列净片 | 2 | 1 | 82 |
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
150 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 武汉香草堂药业有限公司 | 16 | 15 | 0 |
| 2 | Eli Lilly and Company | 6 | 1 | 0 |
| 3 | 上海罗氏制药有限公司 | 5 | 2 | 0 |
| 4 | Celgene Corporation | 5 | 1 | 0 |
| 5 | 先声再明医药有限公司 | 4 | 2 | 0 |
| 6 | 成都康华生物制品股份有限公司 | 4 | 2 | 0 |
| 7 | 石家庄四药有限公司 | 4 | 2 | 2 |
| 8 | 重庆锐恩医药有限公司 | 4 | 2 | 0 |
| 9 | Pfizer Europe MA EEIG | 4 | 1 | 0 |
| 10 | Roche Pharma (Schweiz) AG | 4 | 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
62 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/04/03Generic · Class 3 | 氨溴特罗口服溶液CYHS2300951 | 合肥国高药业有限公司; 扬州市三药制药有限公司 |
| 2023/04/03Generic · Class 3 | 氨溴特罗口服溶液CYHS2300950 | 合肥国高药业有限公司; 扬州市三药制药有限公司 |
| 2023/04/03New drug · Class 1 | TQH2929注射液CXSL2300224 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2023/04/01Import · Class 2.4 | 甲苯磺酸他拉唑帕利胶囊JXHS2300032 | Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd. |
| 2023/04/01Import · Class 2.4 | 甲苯磺酸他拉唑帕利胶囊JXHS2300031 | Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd. |
| 2023/04/01Import · Class 2.4 | 甲苯磺酸他拉唑帕利胶囊JXHS2300030 | Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd. |
| 2023/04/01Import · Class 2.4 | 甲苯磺酸他拉唑帕利胶囊JXHS2300029 | Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd. |
| 2023/04/01Generic · Class 3 | 吡非尼酮片CYHS2300947 | 山东华铂凯盛生物科技有限公司; 安徽泰恩康制药有限公司 |
| 2023/04/01Generic · Class 3 | 羧甲司坦口服溶液CYHS2300946 | 海南斯达制药有限公司 |
| 2023/04/01Generic · Class 3 | 去氧肾上腺素酮咯酸溶液CYHL2300043 | 南京海融医药科技股份有限公司 |
| 2023/04/01New drug · Class 1.1 | 安体威颗粒CXZL2300025 | 天士力医药集团股份有限公司 |
| 2023/04/01New drug · Class 1 | SYH2051片CXHL2300351 | 石药集团中奇制药技术(石家庄)有限公司 |
| 2023/04/01New drug · Class 1 | SYH2051片CXHL2300350 | 石药集团中奇制药技术(石家庄)有限公司 |
| 2023/04/01New drug · Class 1 | JAB-26766片CXHL2300349 | 北京加科思新药研发有限公司 |
| 2023/04/01New drug · Class 1 | JAB-26766片CXHL2300348 | 北京加科思新药研发有限公司 |
| 2023/04/01New drug · Class 1 | ONC201胶囊CXHL2300347 | 华润三九医药股份有限公司 |
| 2023/03/31Import · Class 1 | AMG 509JXSL2300063 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2023/03/31Import · Class 1 | ASP1570片JXHL2300074 | Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd. |
| 2023/03/31Import · Class 1 | ASP1570片JXHL2300073 | Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd. |
| 2023/03/31Generic · Class 3 | 二羟丙茶碱注射液CYHS2300943 | 成都天之翼尚品医药科技有限公司; 太极集团四川太极制药有限公司 |
| 2023/03/31Generic · Class 3 | 二羟丙茶碱注射液CYHS2300942 | 安徽长江药业有限公司; 安徽恒星制药有限公司 |
| 2023/03/31Generic · Class 3 | 普瑞巴林口服溶液CYHS2300936 | 北京海步医药科技有限公司; 北京九龙制药有限公司 |
| 2023/03/31Generic · Class 3 | 酒石酸匹莫范色林胶囊CYHL2300042 | 浙江佰奥医药科技有限公司 |
| 2023/03/31New drug · Class 1.1 | 芎芍止痛颗粒CXZL2300024 | 广东凯仲生物科技有限公司 |
| 2023/03/31New drug · Class 1 | SIM1811-03注射液CXSL2300223 | 江苏先声生物制药有限公司 |
| 2023/03/31New drug · Class 1 | SHR8554注射液CXHL2300346 | 江苏恒瑞医药股份有限公司 |
| 2023/03/31New drug · Class 1 | SHR8554注射液CXHL2300345 | 江苏恒瑞医药股份有限公司 |
| 2023/03/31New drug · Class 2.2;2.4 | 美洛昔康混悬注射液CXHL2300344 | 江苏恒瑞医药股份有限公司 |
| 2023/03/31New drug · Class 1 | 注射用甲磺酸普依司他CXHL2300343 | 成都赜灵生物医药科技有限公司 |
| 2023/03/31New drug · Class 1 | 注射用甲磺酸普依司他CXHL2300342 | 成都赜灵生物医药科技有限公司 |
32 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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