药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/07/25 – 2023/07/31
- New acceptances this week
- 338
- Drugs with new generic filings (by drug name, de-duplicated)
- 55
- Accepted this week, now under review
- 0
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
338filings, 70 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 186 |
| Generic | 70 |
| New drug | 52 |
| Import | 20 |
| Import re-registration | 6 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 236 |
| TCM | 50 |
| 治疗用生物制品 | 46 |
| 预防用生物制品 | 5 |
| Biologic | 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
55 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 托吡司特片 | 4 | 2 | 0 |
| 2 | 注射用盐酸罗沙替丁醋酸酯 | 2 | 2 | 5 |
| 3 | 硫酸镁钠钾口服用浓溶液 | 2 | 2 | 8 |
| 4 | 他克莫司缓释胶囊 | 2 | 1 | 6 |
| 5 | 普伐他汀钠片 | 2 | 1 | 2 |
| 6 | 注射用卡非佐米 | 2 | 1 | 0 |
| 7 | 注射用头孢呋辛钠 | 2 | 1 | 8 |
| 8 | 盐酸纳洛酮注射液 | 2 | 1 | 1 |
| 9 | 硫辛酸片 | 2 | 1 | 4 |
| 10 | 米拉贝隆缓释片 | 2 | 1 | 1 |
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
182 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 四川核力欣健药业有限公司 | 15 | 14 | 0 |
| 2 | 贵州天地药业有限责任公司 | 12 | 3 | 0 |
| 3 | 湖北潜江制药股份有限公司 | 9 | 9 | 0 |
| 4 | Bayer AG | 9 | 2 | 0 |
| 5 | BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED | 7 | 2 | 0 |
| 6 | 鸿祥（黑龙江）制药有限公司 | 6 | 6 | 0 |
| 7 | 辽宁华瑞联合制药有限公司 | 6 | 4 | 0 |
| 8 | Sanofi Winthrop Industrie | 5 | 1 | 0 |
| 9 | 石家庄四药有限公司 | 4 | 4 | 2 |
| 10 | 长沙新林制药有限公司 | 4 | 4 | 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
101 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/07/31Generic · Class 3 | 前列地尔注射液CYHL2300094 | 石家庄四药有限公司 |
| 2023/07/31Generic · Class 3 | 托吡司特片CYHL2300093 | 湖南先施制药有限公司 |
| 2023/07/31Generic · Class 3 | 托吡司特片CYHL2300092 | 湖南先施制药有限公司 |
| 2023/07/31New drug · Class 1 | LVGN7409单克隆抗体注射液CXSL2300528 | 礼进生物医药科技（上海）有限公司 |
| 2023/07/31New drug · Class 3.4 | 马破伤风免疫球蛋白F(ab')2CXSL2300527 | 兰州生物制品研究所有限责任公司 |
| 2023/07/31New drug · Class 1 | ND-003片CXHL2300836 | 深圳市新樾生物科技有限公司; 深圳市小分子新药创新中心有限公司 |
| 2023/07/31New drug · Class 1 | ND-003片CXHL2300835 | 深圳市新樾生物科技有限公司; 深圳市小分子新药创新中心有限公司 |
| 2023/07/29Import · Class 1 | AZD2936JXSL2300145 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/07/29Generic · Class 3 | 硫辛酸片CYHS2302036 | 湖南先施制药有限公司; 浙江赛默制药有限公司 |
| 2023/07/29Generic · Class 3 | 硫辛酸片CYHS2302035 | 湖南先施制药有限公司; 浙江赛默制药有限公司 |
| 2023/07/29Generic · Class 3 | 盐酸利多卡因注射液CYHS2302033 | 江苏长江药业有限公司; 江苏华阳制药有限公司 |
| 2023/07/29Generic · Class 3 | 布美他尼注射液CYHS2302028 | 新乡市常乐制药有限责任公司 |
| 2023/07/29Generic · Class 3 | 托吡司特片CYHL2300090 | 山东新华制药股份有限公司 |
| 2023/07/29Generic · Class 3 | 托吡司特片CYHL2300089 | 山东新华制药股份有限公司 |
| 2023/07/29New drug · Class 1 | 注射用SG2918CXSL2300526 | 杭州尚健生物技术有限公司 |
| 2023/07/29New drug · Class 1 | 注射用LM-302CXSL2300525 | 礼新医药（浙江）有限公司 |
| 2023/07/29New drug · Class 1 | JMKX000197注射液CXHL2300834 | 浙江杭煜制药有限公司 |
| 2023/07/29New drug · Class 1 | JMKX000197注射液CXHL2300833 | 浙江杭煜制药有限公司 |
| 2023/07/29New drug · Class 1 | IMP1734片CXHL2300832 | 上海瑛派药业有限公司 |
| 2023/07/29New drug · Class 1 | IMP1734片CXHL2300831 | 上海瑛派药业有限公司 |
| 2023/07/29New drug · Class 2.1 | HDM3010CXHL2300830 | 杭州中美华东制药有限公司 |
| 2023/07/29New drug · Class 1 | ENC0364胶囊CXHL2300829 | 轶诺（浙江）药业有限公司 |
| 2023/07/29New drug · Class 1 | ENC0364胶囊CXHL2300828 | 轶诺（浙江）药业有限公司 |
| 2023/07/29New drug · Class 1 | ENC0364胶囊CXHL2300827 | 轶诺（浙江）药业有限公司 |
| 2023/07/28Import · Class 3.1 | 奥瑞利珠单抗注射液JXSS2300065 | Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH |
| 2023/07/28Import · Class 3.1 | 奥瑞利珠单抗注射液JXSS2300064 | Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH |
| 2023/07/28Import · Class 3.1 | 重组人促卵泡激素δ注射液JXSL2300144 | Ferring Pharmaceuticals A/S; Ferring Pharmaceuticals (Asia) Company Limited |
| 2023/07/28Import · Class 3.1 | 重组人促卵泡激素δ注射液JXSL2300143 | Ferring Pharmaceuticals A/S; Ferring Pharmaceuticals (Asia) Company Limited |
| 2023/07/28Import · Class 3.1 | 重组人促卵泡激素δ注射液JXSL2300142 | Ferring Pharmaceuticals A/S; Ferring Pharmaceuticals (Asia) Company Limited |
| 2023/07/28Import · Class 2.4 | ABL001片JXHL2300179 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
71 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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