药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/11/25 – 2025/12/01
- New acceptances this week
- 338
- Drugs with new generic filings (by drug name, de-duplicated)
- 56
- Accepted this week, now under review
- 88
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
338filings, 70 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 166 |
| Generic | 70 |
| New drug | 61 |
| Import | 24 |
| Unspecified | 14 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 196 |
| TCM | 86 |
| 治疗用生物制品 | 50 |
| Biologic | 5 |
| 预防用生物制品 | 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
56 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 复方电解质醋酸钠葡萄糖注射液 | 3 | 2 | 22 |
| 2 | 棕榈酸帕利哌酮注射液 | 3 | 1 | 8 |
| 3 | 氢溴酸加兰他敏口崩片 | 3 | 1 | 3 |
| 4 | 克立硼罗软膏 | 2 | 2 | 28 |
| 5 | 他克莫司软膏 | 2 | 1 | 8 |
| 6 | 左炔诺孕酮片 | 2 | 1 | 5 |
| 7 | 恩格列净片 | 2 | 1 | 20 |
| 8 | 洛索洛芬钠贴剂 | 2 | 1 | 30 |
| 9 | 盐酸左西替利嗪口服溶液 | 2 | 1 | 3 |
| 10 | 磷苯妥英钠注射用浓溶液 | 2 | 1 | 6 |
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
199 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 河南合智医药科技有限公司 | 9 | 9 | 0 |
| 2 | 信达生物制药(苏州)有限公司 | 7 | 2 | 0 |
| 3 | 湖南科伦制药有限公司 | 7 | 2 | 1 |
| 4 | 天方药业有限公司 | 6 | 5 | 2 |
| 5 | 沈阳三生制药有限责任公司 | 6 | 3 | 0 |
| 6 | 瑞丽市畹町民鑫制药有限公司 | 6 | 2 | 0 |
| 7 | Novo Nordisk A/S | 6 | 1 | 0 |
| 8 | 广东雷允上药业有限公司 | 5 | 5 | 0 |
| 9 | 西安乐析医疗科技有限公司 | 5 | 5 | 0 |
| 10 | 津药达仁堂集团股份有限公司乐仁堂制药厂 | 5 | 4 | 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
107 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/12/01Generic · Class 3 | 复方电解质醋酸钠注射液CYHS2504127 | 山东齐都药业有限公司 |
| 2025/12/01Generic · Class 3 | 盐酸西替利嗪滴眼液CYHL2500210 | 南京海纳制药有限公司 |
| 2025/11/29Import · Class 2.2 | 利妥昔单抗注射液JXSS2500147 | Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH |
| 2025/11/29Import · Class 2.2 | 利妥昔单抗注射液JXSS2500146 | Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH |
| 2025/11/29Import · Class 1 | JNJ-88545223片JXHL2500367 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2025/11/29Import · Class 1 | JNJ-88545223片JXHL2500366 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2025/11/29Generic · Class 3 | 乙酰半胱氨酸片CYHS2504115 | 浙江皓格药业有限公司; 成都通德药业有限公司 |
| 2025/11/29Generic · Class 3 | 盐酸左西替利嗪口服溶液CYHS2504113 | 重庆和平制药有限公司 |
| 2025/11/29Generic · Class 3 | 盐酸左西替利嗪口服溶液CYHS2504112 | 重庆和平制药有限公司 |
| 2025/11/29Generic · Class 3 | 盐酸溴己新片CYHS2504110 | 四川依科制药有限公司 |
| 2025/11/29Generic · Class 3 | 复方聚乙二醇电解质散(II)CYHS2504109 | 重庆仁泽医药科技有限公司; 成都通德药业有限公司 |
| 2025/11/29Generic · Class 3 | ω-3甘油三酯(2%)中/长链脂肪乳/氨基酸(16)/葡萄糖(16%)注射液CYHS2504108 | 浙江国镜药业有限公司; 四川科伦药业股份有限公司 |
| 2025/11/29New drug · Class 2.1;2.2 | 泰它西普注射液CXSL2501028 | 荣昌生物制药(烟台)股份有限公司 |
| 2025/11/29New drug · Class 1 | 注射用SSS57CXSL2501027 | 沈阳三生制药有限责任公司 |
| 2025/11/29New drug · Class 1 | AK139注射液CXSL2501026 | 中山康方生物医药有限公司 |
| 2025/11/29New drug · Class 1 | AK139注射液CXSL2501025 | 中山康方生物医药有限公司 |
| 2025/11/29New drug · Class 1 | AK139注射液CXSL2501024 | 中山康方生物医药有限公司 |
| 2025/11/29New drug · Class 1 | AK139注射液CXSL2501023 | 中山康方生物医药有限公司 |
| 2025/11/29New drug · Class 1 | AK139注射液CXSL2501022 | 中山康方生物医药有限公司 |
| 2025/11/29New drug · Class 1 | 人自体多克隆调节性T细胞注射液CXSL2501020 | 上海赛尔欣生物医疗科技有限公司 |
| 2025/11/29New drug · Class 1 | 注射用SSS57CXSL2501019 | 沈阳三生制药有限责任公司 |
| 2025/11/29New drug · Class 1 | CMS-D017胶囊CXHL2501314 | 深圳市康哲生物科技有限公司 |
| 2025/11/29New drug · Class 1 | CMS-D017胶囊CXHL2501313 | 深圳市康哲生物科技有限公司 |
| 2025/11/29New drug · Class 1 | CMS-D017胶囊CXHL2501312 | 深圳市康哲生物科技有限公司 |
| 2025/11/29New drug · Class 1 | CMS-D017胶囊CXHL2501311 | 深圳市康哲生物科技有限公司 |
| 2025/11/29New drug · Class 1 | RG002C0106注射液CXHL2501310 | 北京炫景瑞医药科技有限公司; 苏州炫景生物科技有限公司 |
| 2025/11/29New drug · Class 1 | 注射用SJ001CXHL2501309 | 上海施江生物科技有限公司 |
| 2025/11/29New drug · Class 1 | BEBT-701注射液CXHL2501308 | 广州必贝特医药股份有限公司 |
| 2025/11/29New drug · Class 2.2 | DP22001口服乳CXHL2501307 | 中国科学院上海药物研究所 |
| 2025/11/29New drug · Class 1 | UBT251注射液CXHL2501306 | 联邦生物科技(珠海横琴)有限公司 |
77 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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