药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/04/07 – 2026/04/13
- New acceptances this week
- 400
- Drugs with new generic filings (by drug name, de-duplicated)
- 59
- Accepted this week, now under review
- 117
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
400filings, 82 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 213 |
| Generic | 82 |
| New drug | 61 |
| Import | 28 |
| Import re-registration | 10 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 213 |
| TCM | 116 |
| 治疗用生物制品 | 64 |
| Biologic | 4 |
| 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
59 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 奥氮平萨米多芬片 | 4 | 1 | 0 |
| 2 | 布洛芬混悬液 | 3 | 2 | 14 |
| 3 | 双氯芬酸二乙胺乳胶剂 | 3 | 1 | 21 |
| 4 | 吸入用盐酸氨溴索溶液 | 3 | 1 | 10 |
| 5 | 托吡酯缓释胶囊 | 3 | 1 | 0 |
| 6 | 依达拉奉右莰醇注射用浓溶液 | 2 | 2 | 32 |
| 7 | 盐酸毛果芸香碱滴眼液 | 2 | 2 | 5 |
| 8 | 吸入用盐酸溴己新溶液 | 2 | 1 | 1 |
| 9 | 富马酸伏诺拉生片 | 2 | 1 | 58 |
| 10 | 左乙拉西坦氯化钠注射液 | 2 | 1 | 2 |
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
222 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 河北万岁药业有限公司 | 11 | 10 | 0 |
| 2 | Novo Nordisk A/S | 10 | 3 | 0 |
| 3 | 哈药集团生物工程有限公司 | 8 | 6 | 0 |
| 4 | Merck Sharp & Dohme B.V. | 6 | 2 | 0 |
| 5 | 礼来苏州制药有限公司 | 6 | 2 | 0 |
| 6 | 拜耳医药保健有限公司 | 6 | 1 | 0 |
| 7 | 江西科睿药业有限公司 | 5 | 3 | 0 |
| 8 | 百济神州（苏州）生物科技有限公司 | 5 | 3 | 0 |
| 9 | 苏州盛迪亚生物医药有限公司 | 5 | 2 | 0 |
| 10 | Boehringer Ingelheim International GmbH | 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
123 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/04/13Import · Class 2.4 | 塞伐艾替尼片JXHS2600038 | Bayer HealthCare Pharmaceuticals Inc.; Bayer AG; Bayer Healthcare Company Ltd. |
| 2026/04/13Import · Class 2.4 | 盐酸曲恩汀片JXHL2600111 | Orphalan SA; Fortrea Pharmaceutical Research and Development (Beijing) Co. Ltd. |
| 2026/04/13Import · Class 2.4 | 英克司兰钠注射液JXHL2600110 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/04/13Generic · Class 3 | 磷酸二氨基吡啶片CYHS2600850 | 河北一品生物医药有限公司 |
| 2026/04/13Generic · Class 3 | 呋塞米口服溶液CYHS2600849 | 大玮（安徽）药业有限公司; 华益药业科技（安徽）有限公司 |
| 2026/04/13Generic · Class 3 | 酮咯酸氨丁三醇片CYHS2600848 | 山东百诺医药股份有限公司; 山东明仁福瑞达制药股份有限公司 |
| 2026/04/13Generic · Class 3 | 奥氮平萨米多芬片CYHL2600053 | 江苏恩华药业股份有限公司; 苏州恩华生物医药科技有限公司 |
| 2026/04/13Generic · Class 3 | 奥氮平萨米多芬片CYHL2600052 | 江苏恩华药业股份有限公司; 苏州恩华生物医药科技有限公司 |
| 2026/04/13Generic · Class 3 | 奥氮平萨米多芬片CYHL2600051 | 江苏恩华药业股份有限公司; 苏州恩华生物医药科技有限公司 |
| 2026/04/13Generic · Class 3 | 奥氮平萨米多芬片CYHL2600050 | 江苏恩华药业股份有限公司; 苏州恩华生物医药科技有限公司 |
| 2026/04/13Generic · Class 3 | 盐酸毛果芸香碱滴眼液CYHL2600049 | 浙江视方极医药科技有限公司 |
| 2026/04/13Generic · Class 3 | 吸入用盐酸氨溴索溶液CYHL2600048 | 四川普锐特药业有限公司 |
| 2026/04/13Generic · Class 3 | 吸入用盐酸氨溴索溶液CYHL2600047 | 四川普锐特药业有限公司 |
| 2026/04/13Generic · Class 3 | 吸入用盐酸氨溴索溶液CYHL2600046 | 四川普锐特药业有限公司 |
| 2026/04/13New drug · Class 1.1 | 天精泽兰颗粒CXZL2600035 | 雷允上药业集团有限公司; 南京中医药大学 |
| 2026/04/13New drug · Class 2.2 | 注射用泽尼达妥单抗CXSS2600064 | 百济神州（苏州）生物科技有限公司; 无锡药明生物技术股份有限公司 |
| 2026/04/13New drug · Class 1 | STX11101注射液CXSL2600403 | 上海思德克索生物科技有限公司 |
| 2026/04/13New drug · Class 1 | 注射用HWS113CXSL2600402 | 湖北生物医药产业技术研究院有限公司 |
| 2026/04/13New drug · Class 1 | 注射用HDM2005CXSL2600401 | 杭州中美华东制药有限公司 |
| 2026/04/13New drug · Class 1 | HRS-8797片CXHL2600434 | 成都盛迪医药有限公司 |
| 2026/04/13New drug · Class 1 | HRS-8797片CXHL2600433 | 成都盛迪医药有限公司 |
| 2026/04/13New drug · Class 1 | HRS-8797片CXHL2600432 | 成都盛迪医药有限公司 |
| 2026/04/13New drug · Class 2.3 | 海博麦布氨氯地平阿托伐他汀钙片CXHL2600431 | 浙江海正药业股份有限公司 |
| 2026/04/11Import · Class 1 | NNC0487-0111注射液JXSL2600097 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/04/11Import · Class 1 | NNC0487-0111注射液JXSL2600096 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/04/11Import · Class 1 | NNC0487-0111注射液JXSL2600095 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/04/11Import · Class 1 | NNC0487-0111注射液JXSL2600094 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/04/11Import · Class 1 | NNC0487-0111注射液JXSL2600093 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/04/11Import · Class 1 | NNC0487-0111注射液JXSL2600092 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/04/11Generic · Class 3 | 艾地骨化醇片CYHS2600842 | 安徽四环科宝制药有限公司 |
93 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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