药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/07/21 – 2026/07/27
- New acceptances this week
- 499
- Drugs with new generic filings (by drug name, de-duplicated)
- 48
- Accepted this week, now under review
- 199
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
499filings, 62 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 309 |
| New drug | 79 |
| Generic | 62 |
| Import | 29 |
| Unspecified | 17 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 243 |
| TCM | 165 |
| 治疗用生物制品 | 77 |
| Biologic | 8 |
| 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
48 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 达格列净片 | 4 | 2 | 82 |
| 2 | 阿达帕林凝胶 | 3 | 3 | 31 |
| 3 | 磷酸奥司他韦胶囊 | 3 | 1 | 42 |
| 4 | 吸入用盐酸氨溴索溶液 | 2 | 2 | 10 |
| 5 | 多替诺雷片 | 2 | 1 | 49 |
| 6 | 富马酸伏诺拉生片 | 2 | 1 | 58 |
| 7 | 沙库巴曲缬沙坦钠片 | 2 | 1 | 74 |
| 8 | 玻璃酸钠滴眼液 | 2 | 1 | 29 |
| 9 | 盐酸氨溴索口服溶液 | 2 | 1 | 45 |
| 10 | 罗沙司他胶囊 | 2 | 1 | 17 |
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
295 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 21 | 6 | 0 |
| 2 | 江西九连山药业有限公司 | 10 | 9 | 0 |
| 3 | Merck Sharp & Dohme LLC | 8 | 4 | 0 |
| 4 | 百济神州(苏州)生物科技有限公司 | 7 | 2 | 0 |
| 5 | 信达生物制药(苏州)有限公司 | 6 | 3 | 0 |
| 6 | 长春金赛药业有限责任公司 | 6 | 3 | 0 |
| 7 | 陕西东泰制药有限公司 | 5 | 5 | 0 |
| 8 | 李时珍医药集团有限公司 | 5 | 4 | 0 |
| 9 | Pfizer Inc. | 5 | 2 | 0 |
| 10 | 包头中药有限责任公司 | 5 | 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 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
115 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/07/27Import · Class 1 | PF-08653944注射液JXHL2600291 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/07/27Import · Class 1 | PF-08653944注射液JXHL2600290 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/07/27Import · Class 1 | PF-08653944注射液JXHL2600289 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/07/27Import · Class 1 | PF-08653944注射液JXHL2600288 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/07/27Import · Class 1 | RO7568282胶囊JXHL2600287 | F. Hoffmann-La Roche Ltd; Roche R&D Center (China) Ltd. |
| 2026/07/27Import · Class 1 | RO7568282胶囊JXHL2600286 | F. Hoffmann-La Roche Ltd; Roche R&D Center (China) Ltd. |
| 2026/07/27Generic · Class 3 | 乳酸钠林格冲洗液CYHS2601790 | 湖南康源制药有限公司 |
| 2026/07/27Generic · Class 3 | 吸入用盐酸氨溴索溶液CYHS2601788 | 南京华盖制药有限公司 |
| 2026/07/27Generic · Class 3 | 联苯苄唑溶液CYHS2601784 | 苏州高迈药业有限公司; 唐山红星药业有限责任公司 |
| 2026/07/27New drug · Class 1.1 | TDX105颗粒CXZL2600066 | 天士力医药集团股份有限公司 |
| 2026/07/27New drug · Class 2.4 | 注射用重组A型肉毒毒素(Sf9细胞,150 kD天然氨基酸序列)CXSL2600779 | 苏州若弋生物科技有限公司 |
| 2026/07/27New drug · Class 1 | Cizutamig注射液(皮下注射)CXSL2600778 | 上海坦蒂生物医药科技有限公司 |
| 2026/07/27New drug · Class 1 | TGI-10注射液CXSL2600777 | 合肥天港免疫药物有限公司 |
| 2026/07/27New drug · Class 1 | NouvSight001CXSL2600776 | 睿健毅联医药科技(成都)有限公司; 武汉睿健医药科技有限公司 |
| 2026/07/27New drug · Class 1 | GenSci155注射液CXSL2600775 | 长春金赛药业有限责任公司 |
| 2026/07/27New drug · Class 1 | GenSci155注射液CXSL2600774 | 长春金赛药业有限责任公司 |
| 2026/07/27New drug · Class 1 | LDR1259注射液CXHL2600918 | 成都先衍生物技术有限公司 |
| 2026/07/27New drug · Class 1 | IMP1734片CXHL2600917 | 上海瑛派药业有限公司 |
| 2026/07/27New drug · Class 1 | IMP1734片CXHL2600916 | 上海瑛派药业有限公司 |
| 2026/07/27New drug · Class 1 | QX-6胶囊CXHL2600915 | 江西普正制药股份有限公司; 中国医学科学院药用植物研究所 |
| 2026/07/27New drug · Class 1 | QX-6胶囊CXHL2600914 | 江西普正制药股份有限公司; 中国医学科学院药用植物研究所 |
| 2026/07/27New drug · Class 1 | 737NL01注射液CXHL2600913 | 中山万汉制药有限公司 |
| 2026/07/27New drug · Class 1 | 737NL01注射液CXHL2600912 | 中山万汉制药有限公司 |
| 2026/07/27New drug · Class 1 | HSK56630片CXHL2600911 | 海思科医药集团股份有限公司 |
| 2026/07/27New drug · Class 1 | HSK56630片CXHL2600910 | 海思科医药集团股份有限公司 |
| 2026/07/27New drug · Class 2.4 | 复方RY2乳膏CXHL2600909 | 南京睿鹰润泽生物医药科技有限公司; 中国药科大学; 山东润泽紫花药业有限公司 |
| 2026/07/27New drug · Class 2.4 | 复方RY2乳膏CXHL2600908 | 南京睿鹰润泽生物医药科技有限公司; 中国药科大学; 山东润泽紫花药业有限公司 |
| 2026/07/27New drug · Class 2.4 | 复方RY2乳膏CXHL2600907 | 南京睿鹰润泽生物医药科技有限公司; 中国药科大学; 山东润泽紫花药业有限公司 |
| 2026/07/24Import · Class 2.2 | MK-3475A注射液JXSL2600177 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2026/07/24Import · Class 2.2 | MK-3475A注射液JXSL2600176 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
85 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.