药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/12/24 – 2024/12/30
- New acceptances this week
- 502
- Drugs with new generic filings (by drug name, de-duplicated)
- 120
- Accepted this week, now under review
- 15
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
502filings, 171 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 182 |
| Generic | 171 |
| New drug | 104 |
| Import | 25 |
| Unspecified | 14 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 368 |
| TCM | 73 |
| 治疗用生物制品 | 60 |
| 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
120 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 乳果糖口服溶液 | 6 | 3 | 40 |
| 2 | 甲磺酸沙非胺片 | 5 | 3 | 20 |
| 3 | 富马酸伏诺拉生片 | 4 | 2 | 58 |
| 4 | 罗沙司他胶囊 | 4 | 2 | 17 |
| 5 | 氨溴特罗口服溶液 | 3 | 3 | 23 |
| 6 | 西咪替丁注射液 | 3 | 3 | 5 |
| 7 | 布美他尼注射液 | 3 | 2 | 16 |
| 8 | 甲氧氯普胺片 | 3 | 2 | 4 |
| 9 | 米诺地尔搽剂 | 3 | 2 | 49 |
| 10 | 利丙双卡因乳膏 | 3 | 1 | 25 |
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
309 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 山东齐都药业有限公司 | 9 | 4 | 1 |
| 2 | 成都地奥集团天府药业股份有限公司 | 8 | 8 | 0 |
| 3 | AstraZeneca AB | 8 | 5 | 0 |
| 4 | 石家庄四药有限公司 | 7 | 5 | 3 |
| 5 | 内蒙古大唐药业股份有限公司 | 6 | 6 | 0 |
| 6 | 恒昌（广州）新药研究有限公司 | 6 | 6 | 0 |
| 7 | Bracco Imaging S.P.A. | 6 | 1 | 0 |
| 8 | 上海齐鲁制药研究中心有限公司 | 6 | 1 | 0 |
| 9 | 南京艾美斐生物医药科技有限公司 | 6 | 1 | 0 |
| 10 | 昆明南疆制药有限公司 | 5 | 3 | 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
209 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/12/30Import · Class 3.1 | 注射用sotaterceptJXSL2400258 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2024/12/30Import · Class 3.1 | 注射用sotaterceptJXSL2400257 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2024/12/30Import · Class 1 | Rilzabrutinib片JXHS2400121 | Genzyme Corporation; Sanofi S.r.l; Sanofi (China) Investment Co. Ltd. |
| 2024/12/30Generic · Class 3 | 吡格列酮二甲双胍片（15mg/500mg）CYHS2404618 | 安徽杰玺医药有限公司; 华益药业科技（安徽）有限公司 |
| 2024/12/28Import · Class 1 | PF-08046054 (注射用冻干粉针)JXSL2400256 | Seagen Inc.; Pfizer Investment CO. Ltd. |
| 2024/12/28Import · Class 2.4 | 乌帕替尼缓释片JXHS2400119 | AbbVie Deutschland GmbH & Co.KG; AbbVie Ireland NL B.V. |
| 2024/12/28Generic · Class 3 | 硫酸阿托品注射液CYHS2404615 | 烟台万润药业有限公司; 烟台鲁银药业有限公司 |
| 2024/12/28Generic · Class 3 | 重酒石酸去甲肾上腺素注射液CYHS2404614 | 山西振东泰盛制药有限公司 |
| 2024/12/28Generic · Class 3 | 盐酸多沙普仑注射液CYHS2404612 | 江苏九旭药业有限公司 |
| 2024/12/28Generic · Class 3 | 盐酸多沙普仑注射液CYHS2404611 | 湖北简诚博泰医药有限公司; 湖北津药药业股份有限公司 |
| 2024/12/28Generic · Class 3 | 氯硝西泮注射液CYHS2404609 | 国药集团工业有限公司廊坊分公司 |
| 2024/12/28Generic · Class 3 | 甲氧氯普胺片CYHS2404607 | 石家庄四药有限公司 |
| 2024/12/28Generic · Class 3 | 西咪替丁注射液CYHS2404606 | 石家庄四药有限公司 |
| 2024/12/28Generic · Class 3 | 西咪替丁注射液CYHS2404605 | 江西科为制药有限公司; 亚邦医药股份有限公司 |
| 2024/12/28Generic · Class 3 | 维生素B？注射液CYHS2404604 | 广东君康药业有限公司; 珠海润都制药股份有限公司 |
| 2024/12/28Generic · Class 3 | 马来酸曲美布汀片CYHS2404603 | 浙江昂利康制药股份有限公司; 浙江赛默制药有限公司 |
| 2024/12/28Generic · Class 3 | 马来酸曲美布汀片CYHS2404602 | 浙江昂利康制药股份有限公司; 浙江赛默制药有限公司 |
| 2024/12/28Generic · Class 3 | 对乙酰氨基酚维生素C泡腾片CYHS2404600 | 江苏和晨药业有限公司 |
| 2024/12/28Generic · Class 3 | 维生素B6注射液CYHS2404599 | 江苏九旭药业有限公司 |
| 2024/12/28Generic · Class 3 | 阿瑞匹坦注射液CYHS2404598 | 山东齐都药业有限公司 |
| 2024/12/28Generic · Class 3 | 氨茶碱注射液CYHS2404595 | 湖南赛隆药业（长沙）有限公司 |
| 2024/12/28Generic · Class 3 | 氨茶碱注射液CYHS2404594 | 湖南赛隆药业（长沙）有限公司 |
| 2024/12/28Generic · Class 3 | 盐酸利多卡因眼用凝胶CYHL2400281 | 深圳珐玛易药品科技有限公司 |
| 2024/12/28Generic · Class 3 | 富马酸卢帕他定口服溶液CYHL2400280 | 广州市桐晖药业有限公司 |
| 2024/12/28Generic · Class 3 | 注射用盐酸米诺环素CYHL2400279 | 广东金城金素制药有限公司 |
| 2024/12/28New drug · Class 3.1 | 半夏白术天麻汤颗粒CXZS2400040 | 安徽华润金蟾药业有限公司 |
| 2024/12/28New drug · Class 1 | XP-001-V2CXSL2400922 | 上海信谱生物医药科技有限公司 |
| 2024/12/28New drug · Class 1 | 注射用MHB036CCXSL2400921 | 明慧医药（杭州）有限公司 |
| 2024/12/28New drug · Class 1 | 注射用MHB039ACXSL2400920 | 明慧医药（杭州）有限公司 |
| 2024/12/28New drug · Class 1 | CD-001注射液CXSL2400919 | 乘典（苏州）生物医药有限公司 |
179 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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