药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/12/09 – 2025/12/15
- New acceptances this week
- 311
- Drugs with new generic filings (by drug name, de-duplicated)
- 58
- Accepted this week, now under review
- 96
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
311filings, 75 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 132 |
| Generic | 75 |
| New drug | 73 |
| Unspecified | 12 |
| Import re-registration | 12 |
| Import | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 192 |
| TCM | 68 |
| 治疗用生物制品 | 37 |
| Biologic | 8 |
| 预防用生物制品 | 6 |
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
58 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 | 4 | 2 | 40 |
| 2 | 米诺地尔搽剂 | 4 | 2 | 49 |
| 3 | 非奈利酮片 | 3 | 2 | 71 |
| 4 | 普瑞巴林胶囊 | 3 | 1 | 12 |
| 5 | 复方醋酸钠葡萄糖注射液 | 2 | 1 | 8 |
| 6 | 帕拉米韦氯化钠注射液 | 2 | 1 | 17 |
| 7 | 注射用头孢他啶阿维巴坦钠 | 2 | 1 | 12 |
| 8 | 注射用托伐普坦磷酸钠 | 2 | 1 | 15 |
| 9 | 美沙拉秦肠溶缓释颗粒 | 2 | 1 | 3 |
| 10 | 美阿沙坦钾片 | 2 | 1 | 33 |
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
200 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Fresenius Kabi Austria GmbH | 6 | 1 | 0 |
| 2 | 标新生物医药科技（上海）有限公司 | 6 | 1 | 0 |
| 3 | 津药达仁堂集团股份有限公司达仁堂制药厂 | 5 | 3 | 0 |
| 4 | AstraZeneca AB | 5 | 2 | 0 |
| 5 | 哈尔滨美君制药有限公司 | 4 | 4 | 0 |
| 6 | 哈药集团世一堂制药厂 | 4 | 4 | 0 |
| 7 | 沂南力诺制药有限责任公司 | 4 | 4 | 3 |
| 8 | 甘肃天水岐黄药业有限责任公司 | 4 | 4 | 0 |
| 9 | 苏州盛迪亚生物医药有限公司 | 4 | 3 | 0 |
| 10 | Amgen Manufacturing Limited LLC | 4 | 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 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
104 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/12/15Generic · Class 3 | 醋酸钠林格葡萄糖注射液CYHS2504283 | 江苏淮安双鹤药业有限责任公司 |
| 2025/12/15Generic · Class 3 | 贝派度酸片CYHL2500221 | 石药集团欧意药业有限公司 |
| 2025/12/15New drug · Class 1 | GB19注射液CXSL2501081 | 深圳科兴药业有限公司 |
| 2025/12/15New drug · Class 1 | GB19注射液CXSL2501080 | 深圳科兴药业有限公司 |
| 2025/12/15New drug · Class 2.3 | 阿瑞匹坦帕洛诺司琼乳状注射液CXHS2500156 | 齐鲁制药（海南）有限公司 |
| 2025/12/13Import · Class 1 | GIA632注射液JXSL2500238 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/12/13Generic · Class 3 | 美沙拉秦肠溶缓释颗粒CYHS2504277 | 广州市联瑞制药有限公司 |
| 2025/12/13Generic · Class 3 | 美沙拉秦肠溶缓释颗粒CYHS2504276 | 广州市联瑞制药有限公司 |
| 2025/12/13Generic · Class 3 | 盐酸替扎尼定片CYHS2504272 | 康哲（湖南）制药有限公司; 江苏和晨药业有限公司 |
| 2025/12/13Generic · Class 3 | 多种微量元素注射液（I）CYHS2504271 | 石家庄四药有限公司 |
| 2025/12/13New drug · Class 1.1 | 小儿润通糖浆CXZL2500128 | 苏州玉森新药开发有限公司 |
| 2025/12/13New drug · Class 3.3 | ACYW135群脑膜炎球菌结合疫苗CXSL2501077 | 成都康华生物制品股份有限公司 |
| 2025/12/13New drug · Class 2.2 | 盐酸多塞平口颊膜CXHS2500155 | 力品药业（厦门）股份有限公司; 厦门力卓药业有限公司 |
| 2025/12/13New drug · Class 1 | BGB-58067片CXHL2501385 | 百济神州（苏州）生物科技有限公司 |
| 2025/12/13New drug · Class 1 | BGB-58067片CXHL2501384 | 百济神州（苏州）生物科技有限公司 |
| 2025/12/12Generic · Class 3 | 复方醋酸钠葡萄糖注射液CYHS2504267 | 江苏淮安双鹤药业有限责任公司 |
| 2025/12/12Generic · Class 3 | 复方醋酸钠葡萄糖注射液CYHS2504266 | 江苏淮安双鹤药业有限责任公司 |
| 2025/12/12Generic · Class 3 | 注射用吲哚菁绿CYHS2504265 | 浙江杭康药业有限公司 |
| 2025/12/12Generic · Class 3 | 硝苯地平缓释片（Ⅱ）CYHS2504263 | 四川依科制药有限公司 |
| 2025/12/12New drug · Class 2.2 | 斯鲁利单抗注射液CXSS2500141 | 上海复宏瑞霖生物技术有限公司; 上海复宏汉霖生物制药有限公司 |
| 2025/12/12New drug · Class 2.2 | SHR-8068注射液CXSL2501076 | 苏州盛迪亚生物医药有限公司 |
| 2025/12/12New drug · Class 2.2 | 阿得贝利单抗注射液CXSL2501075 | 上海盛迪医药有限公司 |
| 2025/12/12New drug · Class 1 | SM17单克隆抗体注射液（皮下注射）CXSL2501074 | 杏联药业（苏州）有限公司 |
| 2025/12/12New drug · Class 1 | 注射用洛贝米柳CXHS2500154 | 南京宁丹新药技术股份有限公司; 广东星昊药业有限公司 |
| 2025/12/12New drug · Class 2.4 | 戈利昔替尼胶囊CXHL2501383 | 迪哲（江苏）医药股份有限公司 |
| 2025/12/11Generic · Class 3 | 注射用右雷佐生CYHS2504264 | 浙江华海药业股份有限公司 |
| 2025/12/11Generic · Class 3 | 苯溴马隆片CYHS2504255 | 浙江皓格药业有限公司; 华益药业科技（安徽）有限公司 |
| 2025/12/11Generic · Class 3 | 米诺地尔搽剂CYHS2504247 | 保定天浩制药有限公司 |
| 2025/12/11Generic · Class 3 | 米诺地尔搽剂CYHS2504246 | 保定天浩制药有限公司 |
| 2025/12/11Generic · Class 3 | 左氧氟沙星滴耳液CYHS2504245 | 云南傣药有限公司 |
74 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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