药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/10/06 – 2026/10/12
- New acceptances this week
- 413
- Drugs with new generic filings (by drug name, de-duplicated)
- 49
- Accepted this week, now under review
- 395
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
413filings, 73 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 217 |
| New drug | 76 |
| Generic | 73 |
| Import | 21 |
| Import re-registration | 18 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 218 |
| TCM | 118 |
| 治疗用生物制品 | 75 |
| 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
49 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 别嘌醇片 | 3 | 2 | 5 |
| 2 | 枸橼酸伊沙佐米胶囊 | 3 | 1 | 7 |
| 3 | 酒石酸双氢可待因缓释片 | 3 | 1 | 3 |
| 4 | 二硫化硒洗剂 | 2 | 2 | 14 |
| 5 | 硫酸氨基葡萄糖胶囊 | 2 | 2 | 52 |
| 6 | 莫匹罗星软膏 | 2 | 2 | 31 |
| 7 | 多替诺雷片 | 2 | 1 | 49 |
| 8 | 富马酸依美斯汀缓释胶囊 | 2 | 1 | 11 |
| 9 | 布立西坦片 | 2 | 1 | 16 |
| 10 | 替格瑞洛片 | 2 | 1 | 12 |
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
235 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 东阿阿胶股份有限公司 | 11 | 11 | 0 |
| 2 | Pfizer Inc. | 9 | 2 | 0 |
| 3 | 联邦生物科技（珠海横琴）有限公司 | 8 | 2 | 0 |
| 4 | N. V. Organon | 8 | 1 | 0 |
| 5 | 昆明中药厂有限公司 | 7 | 7 | 0 |
| 6 | 广西宝瑞坦制药有限公司 | 6 | 4 | 0 |
| 7 | Upjohn Manufacturing Ireland Unlimited Company | 6 | 1 | 0 |
| 8 | 正大天晴药业集团南京顺欣制药有限公司 | 6 | 1 | 0 |
| 9 | AstraZeneca AB | 5 | 3 | 0 |
| 10 | Merck Europe B.V. | 5 | 2 | 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 no longer on the under-review list whose last snapshot sighting falls in this week, meaning approved or terminated, to be verified. Companies are counted by first applicant.
Class 3 and new-drug acceptances
128 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/10/12Import · Class 2.2 | 法瑞西单抗注射液JXSS2600091 | Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG |
| 2026/10/12Import · Class 2.2 | 法瑞西单抗注射液JXSS2600090 | Roche Pharma (Schweiz) AG; Vetter Pharma-Fertigung GmbH & Co. KG |
| 2026/10/12Import · Class 2.2 | 泰它西普注射液JXSL2600271 | Vor Biopharma Inc.; RemeGen Co. Ltd. |
| 2026/10/12Import · Class 1 | LY888891混悬液JXSL2600270 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/10/12Import · Class 1 | LY5830966片JXHL2600440 | Ajax Therapeutics Inc. (a wholly owned subsidiary of Eli Lilly and Company); Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2026/10/12Import · Class 1 | Fenebrutinib片JXHL2600439 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/10/12Generic · Class 3 | 富马酸依美斯汀缓释胶囊CYHS2602503 | 广州绿十字制药股份有限公司; 广东豪瑞恩制药有限公司 |
| 2026/10/12Generic · Class 3 | 富马酸依美斯汀缓释胶囊CYHS2602502 | 广州绿十字制药股份有限公司; 广东豪瑞恩制药有限公司 |
| 2026/10/12Generic · Class 3 | 别嘌醇片CYHS2602495 | 大桐制药（中国）有限责任公司 |
| 2026/10/12Generic · Class 3 | 马来酸噻吗洛尔滴眼液CYHS2602494 | 成都普什制药有限公司 |
| 2026/10/12Generic · Class 3 | 马来酸噻吗洛尔滴眼液CYHS2602493 | 成都普什制药有限公司 |
| 2026/10/12Generic · Class 3 | 色甘酸钠滴眼液CYHS2602492 | 成都普什制药有限公司 |
| 2026/10/12Generic · Class 3 | 二硫化硒洗剂CYHS2602491 | 山东诺禾康药业有限公司 |
| 2026/10/12Generic · Class 3 | 尿素[14C]胶囊CYHL2600114 | 湖南赛利斯医学生物科技有限公司 |
| 2026/10/12Generic · Class 3 | 美阿沙坦钾氯噻酮片CYHL2600113 | 北京福元医药股份有限公司 |
| 2026/10/12Generic · Class 3 | 美阿沙坦钾氯噻酮片CYHL2600112 | 北京福元医药股份有限公司 |
| 2026/10/12New drug · Class 3.1 | 半夏白术天麻汤颗粒CXZS2600053 | 神威药业集团有限公司 |
| 2026/10/12New drug · Class 2.2 | 消炎解毒合剂CXZL2600098 | 湖北一恩药业有限公司 |
| 2026/10/12New drug · Class 1 | 注射用GB268CXSL2601106 | 亿腾医药（珠海）有限公司 |
| 2026/10/12New drug · Class 1 | QH104A细胞注射液CXSL2601105 | 北京清辉联诺生物科技有限责任公司 |
| 2026/10/12New drug · Class 1 | 抗狂犬病病毒全人源组合抗体注射液CXSL2601104 | 辽宁成大生物股份有限公司; 北京成大天和生物科技有限公司 |
| 2026/10/12New drug · Class 2.2 | 注射用泰它西普CXSL2601103 | 荣昌生物制药（烟台）股份有限公司 |
| 2026/10/12New drug · Class 1 | 注射用LM-338CXSL2601102 | 礼新医药科技（上海）有限公司 |
| 2026/10/12New drug · Class 1 | 注射用QLS5314CXSL2601101 | 上海齐鲁制药研究中心有限公司 |
| 2026/10/12New drug · Class 1 | 注射用HS-20122CXSL2601100 | 上海翰森生物医药科技有限公司; 常州恒邦药业有限公司 |
| 2026/10/12New drug · Class 2.2 | 阿得贝利单抗注射液CXSL2601099 | 上海盛迪医药有限公司 |
| 2026/10/12New drug · Class 1 | SYS6072CXSL2601098 | 石药集团巨石生物制药有限公司 |
| 2026/10/12New drug · Class 1 | 9MW5211注射液CXSL2601097 | 迈威（上海）生物科技股份有限公司 |
| 2026/10/12New drug · Class 2.4 | 盐酸吉卡昔替尼片CXHS2600137 | 苏州泽璟生物制药股份有限公司 |
| 2026/10/12New drug · Class 1 | HP570片CXHL2601261 | 海创药业股份有限公司 |
98 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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