药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/07/07 – 2026/07/13
- New acceptances this week
- 460
- Drugs with new generic filings (by drug name, de-duplicated)
- 54
- Accepted this week, now under review
- 150
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
460filings, 65 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 253 |
| New drug | 85 |
| Generic | 65 |
| Import | 31 |
| Unspecified | 17 |
| Import re-registration | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 232 |
| TCM | 134 |
| 治疗用生物制品 | 81 |
| Biologic | 7 |
| 预防用生物制品 | 6 |
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
54 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 氧 | 3 | 3 | 15 |
| 2 | 玻璃酸钠滴眼液 | 2 | 2 | 29 |
| 3 | 多替诺雷片 | 2 | 1 | 49 |
| 4 | 头孢托仑匹酯颗粒 | 2 | 1 | 18 |
| 5 | 注射用氢化可的松琥珀酸钠 | 2 | 1 | 18 |
| 6 | 洛索洛芬钠贴剂 | 2 | 1 | 30 |
| 7 | 瑞舒伐他汀钙片 | 2 | 1 | 18 |
| 8 | 盐酸溴己新口服溶液 | 2 | 1 | 23 |
| 9 | 那屈肝素钙注射液 | 2 | 1 | 4 |
| 10 | 雌二醇凝胶 | 2 | 1 | 6 |
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
292 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 福建盛迪医药有限公司 | 8 | 1 | 0 |
| 2 | 陕西东泰制药有限公司 | 7 | 6 | 0 |
| 3 | Novo Nordisk A/S | 7 | 2 | 0 |
| 4 | 山西澳迩药业有限公司 | 6 | 6 | 0 |
| 5 | 海思科医药集团股份有限公司 | 6 | 3 | 0 |
| 6 | Amgen Inc. | 6 | 1 | 0 |
| 7 | Liquidia Technologies Inc. | 6 | 1 | 0 |
| 8 | 杭州百新生物医药科技有限公司 | 6 | 1 | 0 |
| 9 | 桂林三金药业股份有限公司 | 5 | 4 | 0 |
| 10 | Patheon France | 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 no longer on the under-review list whose last snapshot sighting falls in this week, meaning approved or terminated, to be verified. Companies are counted by first applicant.
Class 3 and new-drug acceptances
141 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/07/13Import · Class 3.1 | 帕博利珠单抗注射液JXSS2600062 | MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd. |
| 2026/07/13Import · Class 1 | AMG 133JXSL2600162 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2026/07/13Import · Class 1 | AMG 133JXSL2600161 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2026/07/13Import · Class 1 | AMG 133JXSL2600160 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2026/07/13Import · Class 1 | AMG 133JXSL2600159 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2026/07/13Import · Class 1 | AMG 133JXSL2600158 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2026/07/13Import · Class 1 | AMG 133JXSL2600157 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2026/07/13Import · Class 1 | PF-08653944注射液JXHL2600272 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/07/13Import · Class 1 | PF-08653944注射液JXHL2600271 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/07/13Import · Class 1 | PF-08653944注射液JXHL2600270 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/07/13Import · Class 1 | PF-08653944注射液JXHL2600269 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/07/13Generic · Class 3 | 盐酸奥洛他定口崩片CYHS2601670 | 海南科进生物制药有限公司 |
| 2026/07/13Generic · Class 3 | 富马酸氯马斯汀注射液CYHS2601666 | 江苏润恒制药有限公司 |
| 2026/07/13Generic · Class 3 | 盐酸溴己新口服溶液CYHS2601664 | 河北山姆士药业有限公司 |
| 2026/07/13Generic · Class 3 | 盐酸溴己新口服溶液CYHS2601663 | 河北山姆士药业有限公司 |
| 2026/07/13Generic · Class 3 | 唑尼沙胺胶囊CYHS2601662 | 湖南尚众合生物医药有限公司; 天地恒一制药股份有限公司 |
| 2026/07/13Generic · Class 3 | 吡非尼酮片CYHS2601659 | 山东朗诺制药有限公司 |
| 2026/07/13New drug · Class 3.1 | 当归饮子颗粒CXZS2600036 | 海南斯达制药有限公司; 安徽宏信药业发展有限公司 |
| 2026/07/13New drug · Class 1.1 | 糖宁通络乳膏CXZL2600060 | 百灵毓秀(珠海)医药有限公司 |
| 2026/07/13New drug · Class 1 | Sac002注射液CXSL2600735 | 中美赛尔生物科技(广东)有限公司 |
| 2026/07/13New drug · Class 1 | HS-20117-2注射液CXSL2600734 | 上海翰森生物医药科技有限公司; 常州恒邦药业有限公司 |
| 2026/07/13New drug · Class 1 | 注射用AK158D1CXSL2600733 | 中山康方生物医药有限公司 |
| 2026/07/13New drug · Class 1 | BNT317注射液CXSL2600732 | 百欧恩泰(上海)医药有限公司 |
| 2026/07/13New drug · Class 1 | Cizutamig注射液(皮下注射)CXSL2600731 | 上海坦蒂生物医药科技有限公司 |
| 2026/07/13New drug · Class 2.4 | 苯磺酸克利加巴林胶囊CXHS2600102 | 海思科医药集团股份有限公司; 四川海思科制药有限公司 |
| 2026/07/13New drug · Class 2.4 | 镥[177Lu]氧奥曲肽注射液CXHL2600846 | 北京先通国际医药科技股份有限公司 |
| 2026/07/13New drug · Class 1 | ABP-745缓释片ACXHL2600845 | 杭州新元素药业股份有限公司 |
| 2026/07/13New drug · Class 1 | ABP-745缓释片BCXHL2600844 | 杭州新元素药业股份有限公司 |
| 2026/07/13New drug · Class 2.3 | EP-0229TCXHL2600843 | 成都硕德药业有限公司 |
| 2026/07/13New drug · Class 1 | BCR-0008片CXHL2600842 | 杭州百新生物医药科技有限公司 |
111 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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