药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/04/14 – 2026/04/20
- New acceptances this week
- 347
- Drugs with new generic filings (by drug name, de-duplicated)
- 37
- Accepted this week, now under review
- 86
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
347filings, 47 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 195 |
| New drug | 64 |
| Generic | 47 |
| Import | 17 |
| Unspecified | 12 |
| Import re-registration | 12 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 171 |
| TCM | 113 |
| 治疗用生物制品 | 53 |
| Biologic | 9 |
| 预防用生物制品 | 1 |
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 | 氨溴特罗口服溶液 | 3 | 2 | 23 |
| 2 | 注射用磷酸左奥硝唑酯二钠 | 2 | 2 | 20 |
| 3 | 头孢丙烯干混悬剂 | 2 | 1 | 2 |
| 4 | 注射用亚胺培南西司他丁钠 | 2 | 1 | 6 |
| 5 | 洛索洛芬钠贴剂 | 2 | 1 | 30 |
| 6 | 盐酸乌拉地尔注射液 | 2 | 1 | 5 |
| 7 | 盐酸米那普仑片 | 2 | 1 | 8 |
| 8 | 美阿沙坦钾片 | 2 | 1 | 33 |
| 9 | 西格列汀二甲双胍缓释片 | 2 | 1 | 14 |
| 10 | 丙酸氟替卡松雾化吸入用混悬液 | 1 | 1 | 7 |
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
225 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 江苏修正制药有限公司 | 7 | 4 | 0 |
| 2 | Janssen-Cilag International NV | 7 | 3 | 0 |
| 3 | 百济神州（苏州）生物科技有限公司 | 7 | 2 | 0 |
| 4 | 山西振东制药股份有限公司 | 6 | 6 | 0 |
| 5 | 杭州中美华东制药江东有限公司 | 5 | 1 | 0 |
| 6 | 福州闽海药业有限公司 | 4 | 4 | 0 |
| 7 | 苏州盛迪亚生物医药有限公司 | 4 | 4 | 0 |
| 8 | 西安博爱制药有限责任公司 | 4 | 4 | 0 |
| 9 | Alexion Pharma International Operations Limited Alexion Athlone Manufacturing Facility (AAMF) | 4 | 2 | 0 |
| 10 | 新疆维吾尔药业有限责任公司 | 4 | 2 | 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
97 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/04/20New drug · Class 1 | CMS-F021凝胶CXHL2600472 | 海南德镁医药科技有限责任公司 |
| 2026/04/20New drug · Class 1 | CMS-F021凝胶CXHL2600471 | 海南德镁医药科技有限责任公司 |
| 2026/04/20New drug · Class 1 | CMS-F021凝胶CXHL2600470 | 海南德镁医药科技有限责任公司 |
| 2026/04/20New drug · Class 1 | BG-75202片CXHL2600465 | 百济神州（苏州）生物科技有限公司 |
| 2026/04/20New drug · Class 1 | BG-75202片CXHL2600464 | 百济神州（苏州）生物科技有限公司 |
| 2026/04/20New drug · Class 1 | BG-75202片CXHL2600463 | 百济神州（苏州）生物科技有限公司 |
| 2026/04/18Generic · Class 3 | 美索巴莫注射液CYHS2600895 | 江苏福邦药业有限公司 |
| 2026/04/18Generic · Class 3 | 头孢丙烯干混悬剂CYHS2600894 | 温岭市创新生物医药科技股份有限公司; 万邦德制药集团有限公司 |
| 2026/04/18Generic · Class 3 | 头孢丙烯干混悬剂CYHS2600893 | 温岭市创新生物医药科技股份有限公司; 万邦德制药集团有限公司 |
| 2026/04/18Generic · Class 3 | 福多司坦口服溶液CYHS2600892 | 江苏晨牌邦德药业有限公司 |
| 2026/04/18New drug · Class 2.2 | HKGM-452CXHL2600462 | 天津汉瑞药业有限公司 |
| 2026/04/18New drug · Class 1 | TT-01488片CXHL2600461 | 药捷安康（南京）科技股份有限公司 |
| 2026/04/18New drug · Class 1 | PP011胶囊CXHL2600460 | 沛肽（上海）医药科技有限公司 |
| 2026/04/17Import · Class 2.2 | 特立妥单抗注射液JXSS2600039 | Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd. |
| 2026/04/17Import · Class 2.2 | 特立妥单抗注射液JXSS2600038 | Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd. |
| 2026/04/17Import · Class 2.4 | 那米司特片JXHL2600116 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2026/04/17Import · Class 2.4 | 那米司特片JXHL2600115 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2026/04/17Generic · Class 3 | 富马酸酮替芬口服溶液CYHS2600887 | 西洲医药科技（浙江）有限公司; 浙江北生药业汉生制药有限公司 |
| 2026/04/17Generic · Class 3 | 苯磺贝他斯汀口崩片CYHS2600885 | 南京易亨制药有限公司 |
| 2026/04/17Generic · Class 3 | 盐酸哌罗匹隆片CYHS2600884 | 福安药业集团宁波天衡制药有限公司 |
| 2026/04/17Generic · Class 3 | 西格列汀二甲双胍缓释片CYHS2600882 | 深圳市瑞华制药技术有限公司; 华益泰康药业股份有限公司 |
| 2026/04/17Generic · Class 3 | 西格列汀二甲双胍缓释片CYHS2600881 | 深圳市瑞华制药技术有限公司; 华益泰康药业股份有限公司 |
| 2026/04/17New drug · Class 2.2 | 注射用瑞康曲妥珠单抗CXSL2600426 | 苏州盛迪亚生物医药有限公司 |
| 2026/04/17New drug · Class 1 | SHR-4610注射液CXSL2600425 | 上海盛迪医药有限公司 |
| 2026/04/17New drug · Class 3.2 | ACYW135群脑膜炎球菌多糖结合疫苗CXSL2600424 | 中国医学科学院医学生物学研究所 |
| 2026/04/17New drug · Class 2.2 | 伊匹木单抗N01注射液CXSL2600423 | 信达生物医药科技（杭州）有限公司 |
| 2026/04/17New drug · Class 1 | 注射用SHR-A2009CXSL2600422 | 苏州盛迪亚生物医药有限公司 |
| 2026/04/17New drug · Class 1 | BTL-203注射液CXSL2600421 | 本道生物科技（杭州）有限公司 |
| 2026/04/17New drug · Class 1 | DN002注射用冻干粉针剂CXSL2600420 | 苏州迪新宸科生物科技有限公司 |
| 2026/04/17New drug · Class 2.2 | SHR-8068注射液CXSL2600419 | 苏州盛迪亚生物医药有限公司 |
67 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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