药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/04/21 – 2026/04/27
- New acceptances this week
- 403
- Drugs with new generic filings (by drug name, de-duplicated)
- 65
- Accepted this week, now under review
- 124
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
403filings, 77 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 226 |
| Generic | 77 |
| New drug | 68 |
| Unspecified | 12 |
| Import re-registration | 11 |
| Import | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 211 |
| TCM | 125 |
| 治疗用生物制品 | 52 |
| Biologic | 10 |
| 预防用生物制品 | 5 |
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
65 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 阿布昔替尼片 | 3 | 1 | 12 |
| 2 | 依达拉奉右莰醇注射用浓溶液 | 2 | 2 | 32 |
| 3 | 布瑞哌唑口崩片 | 2 | 1 | 10 |
| 4 | 沙库巴曲缬沙坦钠片 | 2 | 1 | 72 |
| 5 | 盐酸利多卡因凝胶 | 2 | 1 | 8 |
| 6 | 盐酸氢吗啡酮片 | 2 | 1 | 0 |
| 7 | 艾司奥美拉唑镁肠溶胶囊 | 2 | 1 | 4 |
| 8 | 苯磺酸氨氯地平片 | 2 | 1 | 8 |
| 9 | 达格列净二甲双胍缓释片(I) | 2 | 1 | 5 |
| 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
251 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 8 | 4 | 0 |
| 2 | 哈药集团制药总厂 | 7 | 2 | 0 |
| 3 | 湖南九典诺纳医药科技有限公司 | 6 | 3 | 0 |
| 4 | AstraZeneca UK Limited | 6 | 2 | 0 |
| 5 | 哈药集团生物工程有限公司 | 6 | 2 | 0 |
| 6 | 中山市恒生药业有限公司 | 5 | 5 | 0 |
| 7 | 信合援生制药股份有限公司 | 5 | 4 | 0 |
| 8 | 正大天晴药业集团股份有限公司 | 4 | 4 | 0 |
| 9 | 齐鲁制药有限公司 | 4 | 4 | 0 |
| 10 | Bayer AG | 4 | 3 | 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
104 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/04/27Import · Class 1 | PF-08046876JXSL2600107 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/04/27Generic · Class 3 | 盐酸毛果芸香碱滴眼液CYHS2600985 | 北京福元医药股份有限公司; 安徽省双科药业有限公司 |
| 2026/04/27Generic · Class 3 | 盐酸利多卡因凝胶CYHS2600969 | 江苏欣力元生物制药有限公司; 同方药业集团有限公司 |
| 2026/04/27Generic · Class 3 | 盐酸利多卡因凝胶CYHS2600968 | 江苏欣力元生物制药有限公司; 美药星（南京）制药有限公司 |
| 2026/04/27New drug · Class 1 | CPD704吸入喷雾剂CXHL2600506 | 北京泰德制药股份有限公司; 中国医学科学院药物研究所 |
| 2026/04/25Import · Class 1 | LY4298445注射液JXSL2600103 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2026/04/25Generic · Class 3 | 注射用硫酸多黏菌素BCYHS2600966 | 河北圣雪大成制药有限责任公司; 华北制药股份有限公司 |
| 2026/04/25New drug · Class 3.1 | 芍药甘草汤颗粒CXZS2600022 | 安徽协和成制药有限公司 |
| 2026/04/25New drug · Class 1 | 注射用MST-168单抗CXSL2600444 | 慕宝盛科生物医药（广东横琴）有限公司 |
| 2026/04/25New drug · Class 1.3 | 重组带状疱疹疫苗（CHO细胞）CXSL2600443 | 四川明瑞佳生物科技有限公司 |
| 2026/04/25New drug · Class 2.2 | HL231吸入溶液CXHS2600060 | 四川海思科制药有限公司; 罗欣安若维他药业（成都）有限公司 |
| 2026/04/25New drug · Class 1 | BW-50920注射液CXHL2600504 | 上海舶望制药有限公司 |
| 2026/04/25New drug · Class 1 | DZ-002注射液CXHL2600502 | 深圳市伟航奕宁生物科技有限公司 |
| 2026/04/25New drug · Class 1 | HRS-1780 片CXHL2600501 | 山东盛迪医药有限公司 |
| 2026/04/25New drug · Class 1 | HRS-1780 片CXHL2600500 | 山东盛迪医药有限公司 |
| 2026/04/24Import · Class 2.1 | Tarlatamab（皮下注射）JXSL2600102 | Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd. |
| 2026/04/24Generic · Class 3 | 盐酸伐地那非口崩片CYHS2600958 | 安徽圣鹰药业有限公司 |
| 2026/04/24Generic · Class 3 | 米诺地尔泡沫剂（男用）CYHS2600956 | 山西振东安欣生物制药有限公司 |
| 2026/04/24Generic · Class 3 | 重酒石酸去甲肾上腺素注射液CYHS2600955 | 河北科源药业有限公司; 河北仁合益康药业有限公司 |
| 2026/04/24Generic · Class 3 | 琥珀酸亚铁片CYHS2600954 | 昆明源瑞制药有限公司 |
| 2026/04/24Generic · Class 3 | 硝普钠注射液CYHS2600947 | 扬州中宝药业股份有限公司 |
| 2026/04/24Generic · Class 3 | 二羟丙茶碱注射液CYHS2600944 | 江苏福邦药业有限公司 |
| 2026/04/24Generic · Class 3 | 度米芬含片CYHS2600940 | 合肥启旸生物医药科技有限公司; 安徽安科恒益药业有限公司 |
| 2026/04/24Generic · Class 3 | 盐酸奥昔布宁洗剂CYHL2600056 | 湖南派格兰药业有限公司 |
| 2026/04/24New drug · Class 1.2 | 筋骨草总环烯醚萜苷片CXZS2600021 | 北京康辰药业股份有限公司; 辽宁沃华康辰医药有限公司 |
| 2026/04/24New drug · Class 1.2 | 筋骨草总环烯醚萜苷CXZS2600020 | 辽宁沃华康辰医药有限公司 |
| 2026/04/24New drug · Class 2.2 | 艾帕洛利托沃瑞利单抗注射液CXSS2600072 | 齐鲁制药有限公司 |
| 2026/04/24New drug · Class 3.2 | 人血管性血友病因子CXSL2600442 | 华润博雅生物制药集团股份有限公司 |
| 2026/04/24New drug · Class 2.2 | LY01015注射液CXSL2600441 | 山东博安生物技术股份有限公司 |
| 2026/04/24New drug · Class 2.2 | LY01015注射液CXSL2600440 | 山东博安生物技术股份有限公司 |
74 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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