药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/12/10 – 2024/12/16
- New acceptances this week
- 429
- Drugs with new generic filings (by drug name, de-duplicated)
- 83
- Accepted this week, now under review
- 6
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
429filings, 113 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 188 |
| Generic | 113 |
| New drug | 93 |
| Import | 22 |
| Unspecified | 10 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 289 |
| TCM | 70 |
| 治疗用生物制品 | 54 |
| 预防用生物制品 | 9 |
| Biologic | 6 |
| 体外诊断试剂 | 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
83 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 富马酸伏诺拉生片 | 12 | 6 | 58 |
| 2 | 盐酸氨溴索口服溶液 | 5 | 1 | 45 |
| 3 | 醋酸兰瑞肽缓释注射液(预充式) | 3 | 1 | 0 |
| 4 | 乌帕替尼缓释片 | 2 | 2 | 43 |
| 5 | 注射用甲磺酸萘莫司他 | 2 | 2 | 38 |
| 6 | 瑞舒伐他汀依折麦布片(I) | 2 | 2 | 9 |
| 7 | 依折麦布阿托伐他汀钙片 | 2 | 1 | 4 |
| 8 | 利伐沙班口崩片 | 2 | 1 | 4 |
| 9 | 双氯芬酸二乙胺乳胶剂 | 2 | 1 | 21 |
| 10 | 布比卡因脂质体注射液 | 2 | 1 | 7 |
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
277 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 江苏豪森药业集团有限公司 | 9 | 2 | 0 |
| 2 | Novo Nordisk A/S | 7 | 2 | 0 |
| 3 | 亚宝药业集团股份有限公司 | 6 | 6 | 0 |
| 4 | 广州嘉越医药科技有限公司 | 6 | 1 | 0 |
| 5 | 上海君实生物医药科技股份有限公司 | 5 | 5 | 0 |
| 6 | 山西广誉远国药有限公司 | 5 | 5 | 0 |
| 7 | 海南斯达制药有限公司 | 5 | 1 | 5 |
| 8 | 福元药业有限公司 | 4 | 4 | 1 |
| 9 | 通化正源药业有限责任公司 | 4 | 4 | 0 |
| 10 | 广州大光制药有限公司 | 4 | 3 | 2 |
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
146 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/12/16Import · Class 2.1;2.2 | Amivantamab注射液(皮下注射)JXSL2400239 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/12/16Import · Class 2.1;2.2 | Amivantamab注射液(皮下注射)JXSL2400238 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/12/16Generic · Class 3 | 注射用甲磺酸萘莫司他CYHL2400260 | 山东化药医药科技有限公司 |
| 2024/12/14Import · Class 1 | Amycretin注射液JXSL2400237 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2024/12/14Import · Class 2.4 | 替尔泊肽注射液JXHS2400111 | Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/12/14Import · Class 2.4 | 替尔泊肽注射液JXHS2400110 | Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/12/14Import · Class 2.4 | 替尔泊肽注射液JXHS2400109 | Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/12/14Import · Class 2.4 | 替尔泊肽注射液JXHS2400108 | Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/12/14Generic · Class 3 | 小儿复方氨基酸注射液(19AA-Ⅰ)CYHS2404359 | 武汉久安药物研究院有限公司; 四川科伦药业股份有限公司 |
| 2024/12/14Generic · Class 3 | 头孢泊肟酯干混悬剂CYHS2404352 | 石家庄四药有限公司 |
| 2024/12/14Generic · Class 3 | 己酮可可碱缓释片CYHS2404350 | 杭州康恩贝制药有限公司 |
| 2024/12/14Generic · Class 3 | 复方聚乙二醇电解质散(II)CYHS2404347 | 湖南普道医药技术有限公司; 湖南九典制药股份有限公司 |
| 2024/12/14Generic · Class 3 | 阿齐沙坦氨氯地平片CYHL2400259 | 北京百奥药业有限责任公司 |
| 2024/12/14New drug · Class 2.2 | 吸附无细胞百(三组分)白破联合疫苗CXSS2400139 | 康希诺生物股份公司 |
| 2024/12/14New drug · Class 3.3 | 阿达木单抗注射液CXSS2400138 | 浙江华海生物科技有限公司 |
| 2024/12/14New drug · Class 1 | 注射用DXC008CXSL2400868 | 杭州多禧生物科技有限公司 |
| 2024/12/14New drug · Class 2.2 | 阿得贝利单抗注射液CXSL2400867 | 上海盛迪医药有限公司 |
| 2024/12/14New drug · Class 1 | 注射用SHR-A2102CXSL2400866 | 苏州盛迪亚生物医药有限公司; 上海恒瑞医药有限公司 |
| 2024/12/14New drug · Class 1 | 注射用SHR-4602CXSL2400865 | 苏州盛迪亚生物医药有限公司; 上海盛迪医药有限公司 |
| 2024/12/14New drug · Class 1 | 注射用KKD001CXSL2400864 | 上饶市康可得生物科技有限公司 |
| 2024/12/14New drug · Class 1 | 注射用KKD001CXSL2400863 | 上饶市康可得生物科技有限公司 |
| 2024/12/14New drug · Class 1 | IMM01CXSL2400862 | 宜明昂科生物医药技术(上海)股份有限公司 |
| 2024/12/14New drug · Class 1 | IMM2510CXSL2400861 | 宜明昂科生物医药技术(上海)股份有限公司 |
| 2024/12/14New drug · Class 1.2 | 冻干二价呼吸道合胞病毒mRNA疫苗CXSL2400860 | 武汉瑞佶生物科技有限公司; 深圳瑞吉生物科技有限公司 |
| 2024/12/14New drug · Class 1 | 人骨髓间充质干细胞注射液CXSL2400859 | 九芝堂美科(北京)细胞技术有限公司 |
| 2024/12/14New drug · Class 1 | JMT108注射液CXSL2400858 | 上海津曼特生物科技有限公司 |
| 2024/12/14New drug · Class 1 | JYP0015片CXHL2401384 | 广州嘉越医药科技有限公司 |
| 2024/12/14New drug · Class 1 | JYP0015片CXHL2401383 | 广州嘉越医药科技有限公司 |
| 2024/12/14New drug · Class 1 | JYP0015片CXHL2401382 | 广州嘉越医药科技有限公司 |
| 2024/12/14New drug · Class 1 | JYP0015片CXHL2401381 | 广州嘉越医药科技有限公司 |
116 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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