药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/05/27 – 2025/06/02
- New acceptances this week
- 335
- Drugs with new generic filings (by drug name, de-duplicated)
- 66
- Accepted this week, now under review
- 47
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
335filings, 89 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 165 |
| Generic | 89 |
| New drug | 51 |
| Import | 13 |
| Unspecified | 8 |
| Import re-registration | 8 |
| 药械组合 | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 203 |
| TCM | 72 |
| 治疗用生物制品 | 47 |
| 预防用生物制品 | 9 |
| Biologic | 4 |
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
66 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 乙酰半胱氨酸注射液 | 7 | 7 | 53 |
| 2 | 盐酸尼卡地平注射液 | 3 | 2 | 12 |
| 3 | 布瑞哌唑片 | 3 | 1 | 31 |
| 4 | 硫酸氨基葡萄糖胶囊 | 2 | 2 | 50 |
| 5 | 维生素B6注射液 | 2 | 2 | 13 |
| 6 | 利伐沙班口崩片 | 2 | 1 | 4 |
| 7 | 利伐沙班颗粒 | 2 | 1 | 2 |
| 8 | 复方氨基酸注射液(20AA-Ⅱ) | 2 | 1 | 2 |
| 9 | 左甲状腺素钠片 | 2 | 1 | 9 |
| 10 | 洛索洛芬钠贴剂 | 2 | 1 | 30 |
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
212 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 陕西盘龙药业集团股份有限公司 | 13 | 11 | 0 |
| 2 | 吉林菲诺制药有限公司 | 9 | 5 | 0 |
| 3 | 广州大光制药有限公司 | 6 | 5 | 6 |
| 4 | 贵州益佰制药股份有限公司 | 5 | 5 | 0 |
| 5 | 哈尔滨同一堂药业有限公司 | 4 | 4 | 0 |
| 6 | 泉州中侨药业有限公司 | 4 | 4 | 0 |
| 7 | 贵州盛世龙方制药股份有限公司 | 4 | 4 | 0 |
| 8 | 百济神州(苏州)生物科技有限公司 | 4 | 2 | 0 |
| 9 | 辰欣药业股份有限公司 | 4 | 2 | 0 |
| 10 | UCB Pharma S.A. | 4 | 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 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
90 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/05/31Generic · Class 3 | 利伐沙班颗粒CYHS2501949 | 广州大光制药有限公司 |
| 2025/05/31Generic · Class 3 | 利伐沙班颗粒CYHS2501948 | 广州大光制药有限公司 |
| 2025/05/31Generic · Class 3 | 硫酸沙丁胺醇注射液CYHS2501947 | 亚邦医药股份有限公司 |
| 2025/05/31Generic · Class 3 | 氟比洛芬贴剂CYHS2501944 | 湖南九典制药股份有限公司 |
| 2025/05/31Generic · Class 3 | 硫酸妥布霉素注射液CYHS2501943 | 湖北华鸿医药有限公司; 湖北津药药业股份有限公司 |
| 2025/05/31Generic · Class 3 | 辅酶Q10片CYHS2501942 | 海南元盈医药科技有限公司; 天津汉瑞药业有限公司 |
| 2025/05/31Generic · Class 3 | 硫酸特布他林注射液CYHL2500102 | 广东万泰科创药业有限公司 |
| 2025/05/31Generic · Class 3 | 氨苯砜凝胶CYHL2500101 | 深圳珐玛易药品科技有限公司 |
| 2025/05/31New drug · Class 3.1 | 桃红四物汤颗粒CXZS2500023 | 瑞阳制药股份有限公司 |
| 2025/05/31New drug · Class 1 | 注射用STSP-0601CXSS2500057 | 江苏贝捷泰生物科技有限公司; 舒泰神(北京)生物制药股份有限公司 |
| 2025/05/31New drug · Class 3.2 | ACYW???群脑膜炎球菌多糖结合疫苗CXSS2500056 | 北京智飞绿竹生物制药有限公司 |
| 2025/05/31New drug · Class 1 | SM2275注射液CXSL2500443 | 珠海烁星生物医药科技有限公司 |
| 2025/05/31New drug · Class 3.3 | 冻干b型流感嗜血杆菌结合疫苗CXSL2500442 | 艾美坚持生物制药有限公司 |
| 2025/05/31New drug · Class 1 | 注射用YL201CXSL2500441 | 苏州宜联生物医药有限公司 |
| 2025/05/31New drug · Class 1 | 注射用BAT8008CXSL2500440 | 百奥泰生物制药股份有限公司 |
| 2025/05/31New drug · Class 2.4 | BAT4706注射液CXSL2500439 | 百奥泰生物制药股份有限公司 |
| 2025/05/31New drug · Class 1 | BAT1308注射液CXSL2500438 | 百奥泰生物制药股份有限公司 |
| 2025/05/31New drug · Class 1 | 伊托法替布软膏CXHS2500058 | 明慧医药(杭州)有限公司; 广州玻思韬控释药业有限公司 |
| 2025/05/31New drug · Class 2.2 | HEC20002胶囊CXHL2500527 | 广东东阳光药业股份有限公司 |
| 2025/05/30Import · Class 2.2 | 伊奈利珠单抗注射液JXSS2500070 | Horizon Therapeutics Ireland DAC; AstraZeneca Nijmegen B.V.; Changzhou Hansoh Pharmaceutical Co. Ltd. |
| 2025/05/30Import · Class 1 | PF-08046047JXSL2500085 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2025/05/30Import · Class 2.1 | Mosunetuzumab Injection (Subcutaneous Injection)JXSL2500084 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2025/05/30Import · Class 2.1 | Mosunetuzumab Injection (Subcutaneous Injection)JXSL2500083 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2025/05/30Generic · Class 3 | 维生素B6注射液CYHS2501936 | 上海禾丰制药有限公司 |
| 2025/05/30Generic · Class 3 | 复方氨基酸注射液(20AA-Ⅱ)CYHS2501930 | 内蒙古白医制药股份有限公司 |
| 2025/05/30Generic · Class 3 | 复方氨基酸注射液(20AA-Ⅱ)CYHS2501929 | 内蒙古白医制药股份有限公司 |
| 2025/05/30Generic · Class 3 | 维生素B6注射液CYHS2501927 | 南京海鲸药业股份有限公司; 山西诺成制药有限公司 |
| 2025/05/30Generic · Class 3 | 盐酸氨溴索滴剂CYHS2501926 | 浙江赛默制药有限公司 |
| 2025/05/30Generic · Class 3 | 盐酸氨溴索滴剂CYHS2501925 | 浙江赛默制药有限公司 |
| 2025/05/30New drug · Class 3.3 | 雷珠单抗注射液CXSS2500055 | 杭州中美华东制药有限公司 |
60 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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