药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/12/30 – 2026/01/05
- New acceptances this week
- 404
- Drugs with new generic filings (by drug name, de-duplicated)
- 75
- Accepted this week, now under review
- 125
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
404filings, 109 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 164 |
| Generic | 109 |
| New drug | 104 |
| Import | 14 |
| Unspecified | 8 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 244 |
| TCM | 92 |
| 治疗用生物制品 | 63 |
| Biologic | 4 |
| 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
75 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 瑞维那新吸入溶液 | 4 | 4 | 53 |
| 2 | 依伏卡塞片 | 4 | 2 | 9 |
| 3 | 乌帕替尼缓释片 | 3 | 3 | 43 |
| 4 | 丙酸氟替卡松乳膏 | 3 | 2 | 12 |
| 5 | 磷酸奥司他韦胶囊 | 3 | 2 | 42 |
| 6 | 他达拉非片 | 3 | 1 | 23 |
| 7 | 普瑞巴林胶囊 | 3 | 1 | 12 |
| 8 | 二甲硅油乳剂 | 2 | 2 | 14 |
| 9 | 盐酸毛果芸香碱滴眼液 | 2 | 2 | 5 |
| 10 | 西甲硅油乳剂 | 2 | 2 | 3 |
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 | 内蒙古大唐药业股份有限公司 | 33 | 31 | 0 |
| 2 | 四川天德制药有限公司 | 9 | 9 | 0 |
| 3 | Janssen-Cilag International NV | 8 | 1 | 0 |
| 4 | 广东万年青制药股份有限公司 | 6 | 6 | 0 |
| 5 | 恒济医药（上海）有限公司 | 6 | 1 | 0 |
| 6 | 南京瑞初医药有限公司 | 5 | 2 | 0 |
| 7 | 北京福元医药股份有限公司 | 4 | 4 | 3 |
| 8 | 浙江昂利康制药股份有限公司 | 4 | 4 | 4 |
| 9 | 神威药业（张家口）有限公司 | 4 | 4 | 0 |
| 10 | Janssen Research & Development LLC | 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
144 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/01/05Import · Class 2.1 | 仑卡奈单抗注射液（皮下注射）JXSS2600001 | Eisai Inc.; Terumo Corporation Kofu Factory; Eisai China Inc. |
| 2026/01/05Import · Class 2.1 | 注射用贝林妥欧单抗（皮下注射）JXSL2600001 | Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd. |
| 2026/01/05Generic · Class 3 | 地氯雷他定口服溶液CYHS2600030 | 江苏贝佳制药有限公司 |
| 2026/01/05Generic · Class 3 | 地氯雷他定口服溶液CYHS2600029 | 江苏贝佳制药有限公司 |
| 2026/01/05Generic · Class 3 | 复方匹可硫酸钠颗粒CYHS2600022 | 山东济坤生物制药有限公司; 寿光富康制药有限公司 |
| 2026/01/05Generic · Class 3 | 伏格列波糖口崩片CYHS2600017 | 山东百诺医药股份有限公司; 锦州奥鸿药业有限责任公司 |
| 2026/01/05Generic · Class 3 | 普罗布考片CYHS2600014 | 北京福元医药股份有限公司 |
| 2026/01/05Generic · Class 3 | 枸橼酸西地那非口溶膜CYHS2600013 | 广州白云山医药集团股份有限公司白云山制药总厂; 博志研新泰州药物技术有限公司 |
| 2026/01/05Generic · Class 3 | 盐酸甲氧氯普胺口服溶液CYHS2600005 | 北京远方通达医药技术有限公司; 山西同达药业有限公司 |
| 2026/01/05New drug · Class 1 | 注射用HMPL-A580CXSL2600011 | 和记黄埔医药（上海）有限公司 |
| 2026/01/05New drug · Class 1 | CT0596 CAR T细胞注射液CXSL2600004 | 优恺泽生物医药（上海）有限公司 |
| 2026/01/05New drug · Class 1 | CT0596 CAR T细胞注射液CXSL2600003 | 优恺泽生物医药（上海）有限公司 |
| 2026/01/05New drug · Class 1 | 注射用IN30758CXSL2600002 | 应世生物科技（深圳）有限公司 |
| 2026/01/05New drug · Class 3.3 | 重组抗PD-1人源化单克隆抗体注射液CXSL2600001 | 复星汉霖（成都）生物技术有限公司; 上海复宏汉霖生物医药有限公司 |
| 2026/01/05New drug · Class 2.3 | 西格列他钠二甲双胍缓释片CXHL2600017 | 深圳微芯生物科技股份有限公司; 成都微芯药业有限公司 |
| 2026/01/05New drug · Class 2.3 | 西格列他钠二甲双胍缓释片CXHL2600016 | 深圳微芯生物科技股份有限公司; 成都微芯药业有限公司 |
| 2026/01/05New drug · Class 2.2 | CBT-009眼用乳液CXHL2600011 | 拨康视云生物医药科技（苏州）有限公司 |
| 2026/01/05New drug · Class 2.4 | 注射用盐酸伊吡诺司他CXHL2600010 | 广州必贝特医药股份有限公司 |
| 2026/01/05New drug · Class 1 | FH001片CXHL2600009 | 恒济医药（上海）有限公司 |
| 2026/01/05New drug · Class 1 | FH001片CXHL2600008 | 恒济医药（上海）有限公司 |
| 2026/01/05New drug · Class 1 | FH001片CXHL2600007 | 恒济医药（上海）有限公司 |
| 2026/01/05New drug · Class 1 | FH001片CXHL2600006 | 恒济医药（上海）有限公司 |
| 2026/01/05New drug · Class 1 | FH001片CXHL2600005 | 恒济医药（上海）有限公司 |
| 2026/01/05New drug · Class 1 | FH001片CXHL2600004 | 恒济医药（上海）有限公司 |
| 2026/01/05New drug · Class 1 | FXS0683片CXHL2600003 | 上海复星医药产业发展有限公司 |
| 2026/01/05New drug · Class 1 | FXS0683片CXHL2600002 | 上海复星医药产业发展有限公司 |
| 2026/01/05New drug · Class 1 | FXS0683片CXHL2600001 | 上海复星医药产业发展有限公司 |
| 2026/01/04Import · Class 2.4 | 盐酸芬氟拉明口服溶液JXHL2600001 | UCB Pharma S.A.; UCB Trading (Shanghai) Co. Ltd |
| 2026/01/04Generic · Class 3 | 尿素[14C]胶囊CYHL2500237 | 深圳市福瑞康科技有限公司 |
| 2026/01/04New drug · Class 1 | QLH2405注射液CXSL2600006 | 齐鲁制药有限公司 |
114 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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