药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/11/11 – 2025/11/17
- New acceptances this week
- 384
- Drugs with new generic filings (by drug name, de-duplicated)
- 50
- Accepted this week, now under review
- 77
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
384filings, 67 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 212 |
| Generic | 67 |
| New drug | 67 |
| Import | 24 |
| Import re-registration | 9 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 240 |
| TCM | 106 |
| 治疗用生物制品 | 29 |
| 预防用生物制品 | 8 |
| 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
50 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 奥氮平萨米多芬片 | 3 | 1 | 0 |
| 2 | 布瑞哌唑片 | 3 | 1 | 31 |
| 3 | 二甲硅油乳剂 | 2 | 2 | 14 |
| 4 | 氧 | 2 | 2 | 15 |
| 5 | 瑞维那新吸入溶液 | 2 | 2 | 53 |
| 6 | 盐酸莫西沙星片 | 2 | 2 | 11 |
| 7 | 乙酰半胱氨酸口服溶液 | 2 | 1 | 11 |
| 8 | 依伏卡塞片 | 2 | 1 | 9 |
| 9 | 头孢托仑匹酯颗粒 | 2 | 1 | 18 |
| 10 | 氨溴特罗口服溶液 | 2 | 1 | 23 |
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
205 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bayer Vital GmbH | 14 | 1 | 0 |
| 2 | Takeda Development Center Americas Inc. | 8 | 3 | 0 |
| 3 | 四川蜀中药业有限公司 | 7 | 7 | 0 |
| 4 | 湖南诺纳医药科技有限公司 | 7 | 7 | 0 |
| 5 | Boehringer Ingelheim International GmbH | 7 | 3 | 0 |
| 6 | 青海春天药用资源科技股份有限公司 | 6 | 6 | 0 |
| 7 | 信达生物制药(苏州)有限公司 | 6 | 3 | 0 |
| 8 | 湖南科伦制药有限公司 | 6 | 2 | 0 |
| 9 | Bracco Imaging S.P.A. | 6 | 1 | 0 |
| 10 | 津药达仁堂集团股份有限公司达仁堂制药厂 | 5 | 5 | 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
115 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/11/17New drug · Class 1 | JNJ-95597528注射液CXSL2500974 | 强生(中国)投资有限公司 |
| 2025/11/17New drug · Class 1 | YKYY032注射液CXHL2501263 | 北京悦康科创医药科技股份有限公司; 杭州天龙药业有限公司 |
| 2025/11/17New drug · Class 2.1;2.4 | AP-2202片CXHL2501262 | 杭州安元生物医药科技有限公司 |
| 2025/11/15Import · Class 1 | EPX-100口服溶液JXHL2500354 | Epygenix Therapeutics Inc.; Tenacia Biotechnology (Shanghai) Co. Ltd |
| 2025/11/15Generic · Class 3 | 呋塞米片CYHS2503971 | 珠海润都制药股份有限公司 |
| 2025/11/15Generic · Class 3 | 注射用拉氧头孢钠CYHS2503970 | 山东鲁抗三叶制药有限公司 |
| 2025/11/15New drug · Class 1 | SYS6010CXSL2500973 | 石药集团巨石生物制药有限公司 |
| 2025/11/15New drug · Class 2.5 | 冻干人用狂犬病疫苗(人二倍体细胞)CXSL2500972 | 浙江普康生物技术股份有限公司 |
| 2025/11/15New drug · Class 1 | JMT108注射液CXSL2500971 | 上海津曼特生物科技有限公司 |
| 2025/11/15New drug · Class 1 | HLX701注射液CXSL2500970 | 上海复宏瑞霖生物技术有限公司; 上海市复宏汉霖生物医药有限公司 |
| 2025/11/15New drug · Class 1 | ASN-8639片CXHL2501257 | 江苏亚虹医药科技股份有限公司 |
| 2025/11/15New drug · Class 1 | ASN-8639片CXHL2501256 | 江苏亚虹医药科技股份有限公司 |
| 2025/11/14Import · Class 2.2 | Mirikizumab注射液JXSL2500223 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/11/14Import · Class 2.2 | Mirikizumab注射液JXSL2500222 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/11/14Import · Class 1 | LY4268989胶囊JXHL2500353 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/11/14Generic · Class 3 | 氨溴特罗口服溶液CYHS2503967 | 江西远盛药业有限公司; 湖南九典制药股份有限公司 |
| 2025/11/14Generic · Class 3 | 氨溴特罗口服溶液CYHS2503966 | 江西远盛药业有限公司; 湖南九典制药股份有限公司 |
| 2025/11/14Generic · Class 3 | 右酮洛芬氨丁三醇注射液CYHS2503963 | 中润药业有限公司; 山西普德药业有限公司 |
| 2025/11/14Generic · Class 3 | 二羟丙茶碱注射液CYHS2503961 | 大玮(安徽)药业有限公司; 安徽威尔曼制药有限公司 |
| 2025/11/14Generic · Class 3 | 盐酸奥洛他定颗粒CYHS2503958 | 海南赛立克药业有限公司 |
| 2025/11/14Generic · Class 3 | 复方聚乙二醇(3350)电解质口服溶液CYHS2503955 | 赤峰源生药业有限公司 |
| 2025/11/14New drug · Class 2.4 | YFZ-003CXZL2500116 | 四川凯京制药有限公司 |
| 2025/11/14New drug · Class 2.4 | YFZ-003CXZL2500115 | 四川凯京制药有限公司 |
| 2025/11/14New drug · Class 2.4 | YFZ-003CXZL2500114 | 四川凯京制药有限公司 |
| 2025/11/14New drug · Class 2.4 | YFZ-003CXZL2500113 | 四川凯京制药有限公司 |
| 2025/11/14New drug · Class 2.2 | B群脑膜炎球菌OMV疫苗CXSL2500969 | 上海羽冠生物技术有限公司 |
| 2025/11/14New drug · Class 2.2 | B群脑膜炎球菌OMV疫苗CXSL2500968 | 上海羽冠生物技术有限公司 |
| 2025/11/14New drug · Class 2.2 | B群脑膜炎球菌OMV疫苗CXSL2500967 | 上海羽冠生物技术有限公司 |
| 2025/11/14New drug · Class 1 | IBI343CXSL2500966 | 信达生物制药(苏州)有限公司 |
| 2025/11/14New drug · Class 2.2 | 玛舒拉沙韦干混悬剂CXHS2500136 | 江西科睿药业有限公司 |
85 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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