药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/04/29 – 2025/05/05
- New acceptances this week
- 199
- Drugs with new generic filings (by drug name, de-duplicated)
- 41
- Accepted this week, now under review
- 20
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
199filings, 43 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 113 |
| Generic | 43 |
| New drug | 27 |
| Import | 6 |
| Import re-registration | 6 |
| Unspecified | 3 |
| 药械组合 | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 119 |
| TCM | 58 |
| 治疗用生物制品 | 19 |
| Biologic | 3 |
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
41 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 二甲双胍恩格列净片（Ⅰ） | 2 | 2 | 7 |
| 2 | 阿达帕林凝胶 | 2 | 2 | 31 |
| 3 | 二十碳五烯酸乙酯软胶囊 | 1 | 1 | 25 |
| 4 | 佩玛贝特片 | 1 | 1 | 25 |
| 5 | 倍氯米松福莫特罗吸入气雾剂 | 1 | 1 | 0 |
| 6 | 利丙双卡因乳膏 | 1 | 1 | 25 |
| 7 | 厄贝沙坦氢氯噻嗪片 | 1 | 1 | 5 |
| 8 | 双氯芬酸二乙胺乳胶剂 | 1 | 1 | 21 |
| 9 | 坎地氢噻片 | 1 | 1 | 2 |
| 10 | 复合磷酸氢钾注射液 | 1 | 1 | 2 |
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
117 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 沈阳东新药业有限公司 | 41 | 34 | 0 |
| 2 | 广东星昊药业有限公司 | 5 | 1 | 0 |
| 3 | Takeda Development Center Americas Inc. | 4 | 2 | 0 |
| 4 | 南京毓浠医药技术有限公司 | 4 | 1 | 0 |
| 5 | 迈英诺医药科技（珠海）有限公司 | 4 | 1 | 0 |
| 6 | 湖南科伦制药有限公司 | 3 | 2 | 1 |
| 7 | 百济神州（苏州）生物科技有限公司 | 3 | 2 | 0 |
| 8 | Janssen-Cilag International NV | 3 | 1 | 0 |
| 9 | 上海博志研新药物研究有限公司 | 3 | 1 | 0 |
| 10 | 上海药苑生物科技有限公司 | 3 | 1 | 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
44 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/05/01Import · Class 1 | 177Lu-HuJ591单抗注射液JXSL2500069 | Telix Pharmaceuticals (Innovations) Pty Ltd; GrandPharma (China) Co. Ltd. |
| 2025/05/01Generic · Class 3 | 碳酸司维拉姆干混悬剂CYHS2501638 | 金陵药业股份有限公司南京金陵制药厂 |
| 2025/05/01Generic · Class 3 | 美洛昔康注射液CYHS2501635 | 浙江圣兆药物科技股份有限公司; 杭州澳亚生物技术股份有限公司 |
| 2025/05/01Generic · Class 3 | 硫代硫酸钠注射液CYHS2501634 | 海南卓科制药有限公司; 四川科伦药业股份有限公司 |
| 2025/05/01New drug · Class 1 | FL115注射液CXSL2500350 | 苏州复融生物技术有限公司 |
| 2025/05/01New drug · Class 1 | BAT4406F注射液CXSL2500349 | 百奥泰生物制药股份有限公司 |
| 2025/05/01New drug · Class 1 | 人脐带间充质干细胞注射液CXSL2500348 | 深圳市北科生物科技有限公司 |
| 2025/05/01New drug · Class 1 | 注射用BGB-B3227CXSL2500347 | 广州百济神州生物制药有限公司 |
| 2025/05/01New drug · Class 1 | 注射用重组病毒巨噬细胞炎性蛋白CXSL2500346 | 广州弘润生物科技有限公司 |
| 2025/05/01New drug · Class 2.2 | 依沃西单抗注射液CXSL2500345 | 康方赛诺医药有限公司 |
| 2025/05/01New drug · Class 1 | 注射用HRS8179CXHL2500436 | 北京盛迪医药有限公司 |
| 2025/05/01New drug · Class 1 | MDI-1228_mesylate凝胶CXHL2500435 | 迈英诺医药科技（珠海）有限公司 |
| 2025/05/01New drug · Class 1 | MDI-1228_mesylate凝胶CXHL2500434 | 迈英诺医药科技（珠海）有限公司 |
| 2025/05/01New drug · Class 1 | MDI-1228_mesylate凝胶CXHL2500433 | 迈英诺医药科技（珠海）有限公司 |
| 2025/05/01New drug · Class 1 | MDI-1228_mesylate凝胶CXHL2500432 | 迈英诺医药科技（珠海）有限公司 |
| 2025/05/01New drug · Class 1 | HRS-1893片CXHL2500431 | 山东盛迪医药有限公司 |
| 2025/05/01New drug · Class 1 | SYN608片CXHL2500430 | 杭州圣域生物医药科技有限公司 |
| 2025/05/01New drug · Class 1 | SYN608片CXHL2500429 | 杭州圣域生物医药科技有限公司 |
| 2025/04/30Generic · Class 3 | 复方电解质醋酸钠注射液CYHS2501623 | 浙江赛默制药有限公司 |
| 2025/04/30Generic · Class 3 | 法莫替丁注射液CYHS2501619 | 山东新华制药股份有限公司; 杭州民生药业股份有限公司 |
| 2025/04/30Generic · Class 3 | 坎地氢噻片CYHS2501617 | 桂林华信制药有限公司 |
| 2025/04/30New drug · Class 1 | 靶向CD19和CD22 的嵌合抗原受体自体T细胞注射液CXSL2500344 | 上海医药集团生物治疗技术有限公司 |
| 2025/04/30New drug · Class 1 | 注射用YL242CXSL2500343 | 苏州宜联生物医药有限公司 |
| 2025/04/30New drug · Class 1 | DF-003胶囊CXHL2500428 | 上海药苑生物科技有限公司 |
| 2025/04/30New drug · Class 1 | DF-003胶囊CXHL2500427 | 上海药苑生物科技有限公司 |
| 2025/04/30New drug · Class 1 | DF-003胶囊CXHL2500426 | 上海药苑生物科技有限公司 |
| 2025/04/30New drug · Class 1 | G201-Na胶囊CXHL2500425 | 石家庄以岭药业股份有限公司 |
| 2025/04/30New drug · Class 1 | G201-Na胶囊CXHL2500424 | 石家庄以岭药业股份有限公司 |
| 2025/04/29Import · Class 1 | Mezagitamab注射剂JXSL2500067 | Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited |
| 2025/04/29Import · Class 1 | Mezagitamab注射剂JXSL2500066 | Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited |
14 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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