药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/07/15 – 2025/07/21
- New acceptances this week
- 336
- Drugs with new generic filings (by drug name, de-duplicated)
- 80
- Accepted this week, now under review
- 70
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
336filings, 99 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 148 |
| Generic | 99 |
| New drug | 58 |
| Import | 12 |
| Unspecified | 10 |
| Import re-registration | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 233 |
| TCM | 57 |
| 治疗用生物制品 | 30 |
| 预防用生物制品 | 11 |
| Biologic | 5 |
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
80 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 恩格列净二甲双胍缓释片 | 3 | 1 | 12 |
| 2 | 乌帕替尼缓释片 | 2 | 2 | 43 |
| 3 | 乙酰半胱氨酸注射液 | 2 | 2 | 53 |
| 4 | 甘油磷酸钠注射液 | 2 | 2 | 7 |
| 5 | 维生素K1滴剂 | 2 | 2 | 3 |
| 6 | 伏立康唑片 | 2 | 1 | 0 |
| 7 | 低钙腹膜透析液(乳酸盐-G1.5%) | 2 | 1 | 3 |
| 8 | 低钙腹膜透析液(乳酸盐-G2.5%) | 2 | 1 | 4 |
| 9 | 低钙腹膜透析液(乳酸盐-G4.25%) | 2 | 1 | 3 |
| 10 | 呋喃妥因胶囊 | 2 | 1 | 4 |
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
214 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 江西青峰药业有限公司 | 8 | 8 | 0 |
| 2 | 北京民海生物科技有限公司 | 6 | 5 | 0 |
| 3 | 四川青山利康药业有限公司 | 6 | 3 | 6 |
| 4 | Bracco Imaging S.P.A. | 6 | 1 | 0 |
| 5 | 宁波天益药业科技有限公司 | 5 | 5 | 5 |
| 6 | 长春海外制药集团有限公司 | 5 | 5 | 0 |
| 7 | 江苏博创园生物医药科技有限公司 | 5 | 1 | 0 |
| 8 | Revance Therapeutics Inc. | 4 | 4 | 0 |
| 9 | 株洲千金药业股份有限公司 | 4 | 4 | 0 |
| 10 | 石药集团欧意药业有限公司 | 4 | 2 | 3 |
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
105 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/07/21New drug · Class 1.1 | 重组金黄色葡萄球菌四组分疫苗(大肠杆菌)CXSL2500611 | 江苏坤力生物制药有限责任公司 |
| 2025/07/21New drug · Class 3.2 | 三价流感病毒裂解疫苗(BK-01佐剂)CXSL2500608 | 长春百克生物科技股份公司 |
| 2025/07/21New drug · Class 1 | CMS-D002胶囊CXHL2500728 | 深圳市康哲生物科技有限公司 |
| 2025/07/21New drug · Class 1 | CMS-D002胶囊CXHL2500727 | 深圳市康哲生物科技有限公司 |
| 2025/07/19Generic · Class 3 | 生理氯化钠溶液CYHS2502610 | 山东华茂药业有限公司 |
| 2025/07/19Generic · Class 3 | 吲哚美辛凝胶贴膏CYHL2500130 | 海南回元堂药业有限公司 |
| 2025/07/19New drug · Class 2.2 | AKZ001直服颗粒CXHL2500726 | 海南爱科制药有限公司 |
| 2025/07/19New drug · Class 1 | CKBA乳膏CXHL2500725 | 江苏博创园生物医药科技有限公司 |
| 2025/07/19New drug · Class 1 | CKBA乳膏CXHL2500724 | 江苏博创园生物医药科技有限公司 |
| 2025/07/19New drug · Class 1 | CKBA乳膏CXHL2500723 | 江苏博创园生物医药科技有限公司 |
| 2025/07/19New drug · Class 1 | CKBA乳膏CXHL2500722 | 江苏博创园生物医药科技有限公司 |
| 2025/07/19New drug · Class 1 | CKBA乳膏CXHL2500721 | 江苏博创园生物医药科技有限公司 |
| 2025/07/19New drug · Class 1 | YUQ-A1007片CXHL2500720 | 元启(苏州)生物制药有限公司 |
| 2025/07/19New drug · Class 1 | YUQ-A1007片CXHL2500719 | 元启(苏州)生物制药有限公司 |
| 2025/07/18Import · Class 1 | BMS-986504片JXHL2500189 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2025/07/18Import · Class 1 | BMS-986504片JXHL2500188 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2025/07/18Import · Class 1 | BMS-986504片JXHL2500187 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2025/07/18Generic · Class 3 | 碳酸氢钠血滤置换液(无钾、无钙、0.6 mmol/L镁)CYHS2502596 | 宁波天益药业科技有限公司 |
| 2025/07/18Generic · Class 3 | 碳酸氢钠血滤置换液(无钾)CYHS2502595 | 宁波天益药业科技有限公司 |
| 2025/07/18Generic · Class 3 | 碳酸氢钠血滤置换液(钾4mmol/L无钙)CYHS2502592 | 宁波天益药业科技有限公司 |
| 2025/07/18Generic · Class 3 | 布美他尼注射液CYHS2502591 | 海南普利制药股份有限公司 |
| 2025/07/18Generic · Class 3 | 维生素B6注射液CYHS2502590 | 海南普利制药股份有限公司 |
| 2025/07/18Generic · Class 3 | 碳酸氢钠血滤置换液(钾4mmol/L)CYHS2502589 | 宁波天益药业科技有限公司 |
| 2025/07/18Generic · Class 3 | 碳酸氢钠血滤置换液(钾2mmol/L无钙)CYHS2502587 | 宁波天益药业科技有限公司 |
| 2025/07/18Generic · Class 3 | 盐酸溴己新口服溶液CYHS2502586 | 石家庄四药有限公司; 湖南科伦制药有限公司 |
| 2025/07/18Generic · Class 3 | 头孢羟氨苄干混悬剂CYHS2502583 | 苏州第三制药厂有限责任公司 |
| 2025/07/18Generic · Class 3 | 头孢羟氨苄干混悬剂CYHS2502582 | 苏州第三制药厂有限责任公司 |
| 2025/07/18Generic · Class 3 | 盐酸克林霉素棕榈酸酯颗粒CYHS2502578 | 安徽省先锋制药有限公司 |
| 2025/07/18Generic · Class 3 | 异烟肼口服溶液CYHS2502577 | 江苏润恒制药有限公司 |
| 2025/07/18New drug · Class 3.2 | 人血管性血友病因子/凝血因子Ⅷ复合物CXSS2500076 | 山东泰邦生物制品有限公司 |
75 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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