药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/05/13 – 2025/05/19
- New acceptances this week
- 360
- Drugs with new generic filings (by drug name, de-duplicated)
- 74
- Accepted this week, now under review
- 56
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
360filings, 102 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 180 |
| Generic | 102 |
| New drug | 52 |
| Import | 18 |
| Unspecified | 5 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 241 |
| 治疗用生物制品 | 60 |
| TCM | 53 |
| 预防用生物制品 | 4 |
| Biologic | 2 |
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
74 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 复方电解质醋酸钠葡萄糖注射液 | 4 | 2 | 22 |
| 2 | 利培酮口服溶液 | 4 | 1 | 6 |
| 3 | 醋酸钙口服溶液 | 4 | 1 | 1 |
| 4 | 阿立哌唑口服溶液 | 4 | 1 | 5 |
| 5 | 盐酸屈他维林注射液 | 2 | 2 | 3 |
| 6 | 盐酸甲氧氯普胺注射液 | 2 | 2 | 6 |
| 7 | 维生素B12注射液 | 2 | 2 | 6 |
| 8 | 奥卡西平片 | 2 | 1 | 4 |
| 9 | 富马酸伏诺拉生片 | 2 | 1 | 58 |
| 10 | 左氧氟沙星氯化钠注射液 | 2 | 1 | 14 |
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
217 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 安徽四环科宝制药有限公司 | 13 | 4 | 13 |
| 2 | 齐鲁制药有限公司 | 7 | 3 | 0 |
| 3 | 红桃开药业股份有限公司 | 6 | 6 | 0 |
| 4 | 津药达仁堂集团股份有限公司达仁堂制药厂 | 6 | 5 | 0 |
| 5 | Sanofi Winthrop Industrie | 6 | 1 | 0 |
| 6 | 广东星昊药业有限公司 | 5 | 2 | 2 |
| 7 | 神州细胞工程有限公司 | 5 | 2 | 0 |
| 8 | 江苏中新医药有限公司 | 5 | 1 | 0 |
| 9 | 西藏奥斯必秀医药有限公司 | 5 | 1 | 0 |
| 10 | 海南海力制药有限公司 | 4 | 4 | 1 |
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
118 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/05/19Generic · Class 3 | 氯化钙注射液CYHS2501810 | 山西普恒制药有限公司 |
| 2025/05/19New drug · Class 1 | CM512注射液CXSL2500397 | 康诺亚生物医药科技(成都)有限公司 |
| 2025/05/19New drug · Class 1 | SCTB14注射液CXSL2500396 | 神州细胞工程有限公司 |
| 2025/05/19New drug · Class 1 | SCTB14注射液CXSL2500395 | 神州细胞工程有限公司 |
| 2025/05/19New drug · Class 1 | SM17单克隆抗体注射液(皮下注射)CXSL2500394 | 杏联药业(苏州)有限公司 |
| 2025/05/19New drug · Class 1 | CM512注射液CXSL2500391 | 康诺亚生物医药科技(成都)有限公司 |
| 2025/05/19New drug · Class 2.2 | QLM2012CXHL2500489 | 齐鲁制药有限公司 |
| 2025/05/19New drug · Class 2.2 | QLM2012CXHL2500488 | 齐鲁制药有限公司 |
| 2025/05/17Import · Class 1 | AMG 890JXHL2500115 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd. |
| 2025/05/17Import · Class 1 | AMG 890JXHL2500114 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd. |
| 2025/05/17Import · Class 2.4 | 匹妥布替尼片JXHL2500113 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/05/17Import · Class 1 | Rilzabrutinib片JXHL2500112 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2025/05/17Generic · Class 3 | 布立西坦片CYHS2501808 | 浙江和泽医药科技股份有限公司; 浙江京新药业股份有限公司 |
| 2025/05/17Generic · Class 3 | 布立西坦片CYHS2501807 | 浙江和泽医药科技股份有限公司; 浙江京新药业股份有限公司 |
| 2025/05/17Generic · Class 3 | 氯化钾口服溶液CYHS2501803 | 安徽杰玺医药有限公司; 合肥诚志生物制药有限公司 |
| 2025/05/17Generic · Class 3 | 维生素B12注射液CYHS2501802 | 海南海和制药有限公司; 海南灵康制药有限公司 |
| 2025/05/17Generic · Class 3 | 硝酸咪康唑乳膏CYHS2501801 | 苏州高迈药业有限公司; 药源生物科技(启东)有限公司 |
| 2025/05/17Generic · Class 3 | 唑尼沙胺口服混悬液CYHS2501795 | 山东朗诺制药有限公司 |
| 2025/05/17Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G2.5%)CYHS2501794 | 石家庄四药有限公司 |
| 2025/05/17Generic · Class 3 | 硫酸阿米卡星注射液CYHS2501791 | 吉林敖东药业集团延吉股份有限公司 |
| 2025/05/17Generic · Class 3 | 叶酸片CYHS2501789 | 安徽圣鹰药业有限公司 |
| 2025/05/17Generic · Class 3 | 硫酸阿米卡星注射液CYHS2501788 | 吉林敖东药业集团延吉股份有限公司 |
| 2025/05/17New drug · Class 2.2 | 菖麻熄风颗粒CXZS2500020 | 黑龙江省济仁药业有限公司 |
| 2025/05/17New drug · Class 1 | SCTB14注射液CXSL2500393 | 神州细胞工程有限公司 |
| 2025/05/17New drug · Class 1 | SCTB14注射液CXSL2500392 | 神州细胞工程有限公司 |
| 2025/05/17New drug · Class 1 | 重组人IL12/15单纯疱疹I型双调控溶瘤病毒注射液(Vero细胞)CXSL2500390 | 上海复诺健生物科技有限公司; 深圳复诺健生物科技有限公司 |
| 2025/05/17New drug · Class 1 | SCT640C注射液CXSL2500389 | 神州细胞工程有限公司 |
| 2025/05/17New drug · Class 2.2 | 1536ACXHL2500484 | 北京康联智汇科技有限公司 |
| 2025/05/16Generic · Class 3 | 复方聚乙二醇(3350)电解质散CYHS2501787 | 重庆赛诺生物药业股份有限公司 |
| 2025/05/16Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液CYHS2501786 | 浙江高跖医药科技股份有限公司; 浙江赛默制药有限公司 |
88 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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