药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/05/06 – 2025/05/12
- New acceptances this week
- 289
- Drugs with new generic filings (by drug name, de-duplicated)
- 52
- Accepted this week, now under review
- 25
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
289filings, 76 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 139 |
| Generic | 76 |
| New drug | 56 |
| Import | 12 |
| Unspecified | 5 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 181 |
| TCM | 59 |
| 治疗用生物制品 | 43 |
| 预防用生物制品 | 4 |
| 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
52 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 米诺地尔搽剂 | 6 | 3 | 49 |
| 2 | 注射用青霉素钠 | 6 | 1 | 2 |
| 3 | 利奥西呱片 | 3 | 1 | 4 |
| 4 | 布瑞哌唑片 | 3 | 1 | 31 |
| 5 | 硫酸氨基葡萄糖胶囊 | 2 | 2 | 50 |
| 6 | 黄体酮注射液（Ⅱ） | 2 | 2 | 2 |
| 7 | 乙磺酸尼达尼布软胶囊 | 2 | 1 | 6 |
| 8 | 卡铂注射液 | 2 | 1 | 11 |
| 9 | 奥利司他胶囊 | 2 | 1 | 8 |
| 10 | 巴瑞替尼片 | 2 | 1 | 32 |
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
171 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 沈阳东新药业有限公司 | 12 | 12 | 0 |
| 2 | 江西青峰药业有限公司 | 10 | 9 | 0 |
| 3 | AstraZeneca AB | 7 | 6 | 0 |
| 4 | 内蒙古福寿堂制药有限公司 | 6 | 6 | 0 |
| 5 | 武汉海特生物制药股份有限公司 | 6 | 5 | 0 |
| 6 | 百济神州（苏州）生物科技有限公司 | 6 | 2 | 0 |
| 7 | 成都晶富医药科技有限公司 | 6 | 1 | 6 |
| 8 | 山西黄河中药有限公司 | 5 | 5 | 0 |
| 9 | 信达生物制药（苏州）有限公司 | 5 | 3 | 0 |
| 10 | 陕西盘龙药业集团股份有限公司 | 4 | 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
97 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/05/12Import · Class 3.1 | 司库奇尤单抗注射液JXSS2500054 | Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Novartis Pharmaceutical Manufacturing GmbH; Beijing Novartis Pharma Co. Ltd. |
| 2025/05/12Import · Class 1 | AZD9833片JXHL2500107 | AstraZeneca AB; AstraZeneca Investment (China) Co. Limited |
| 2025/05/12Generic · Class 3 | 米诺地尔搽剂CYHS2501714 | 广东科泓药业有限公司 |
| 2025/05/12Generic · Class 3 | 米诺地尔搽剂CYHS2501713 | 广东科泓药业有限公司 |
| 2025/05/12Generic · Class 3 | 米诺地尔搽剂CYHS2501712 | 山东诺明康药物研究院有限公司; 烟台鲁银药业有限公司 |
| 2025/05/12Generic · Class 3 | 米诺地尔搽剂CYHS2501711 | 山东诺明康药物研究院有限公司; 烟台鲁银药业有限公司 |
| 2025/05/12New drug · Class 1 | EXG202注射液CXSL2500375 | 杭州嘉因生物科技有限公司 |
| 2025/05/12New drug · Class 1 | 自体天然肿瘤浸润淋巴细胞注射液CXSL2500374 | 上海君赛生物药业有限公司; 上海君赛生物科技有限公司 |
| 2025/05/12New drug · Class 1 | 索托克拉片CXHS2500050 | 百济神州（苏州）生物科技有限公司 |
| 2025/05/12New drug · Class 1 | 索托克拉片CXHS2500049 | 百济神州（苏州）生物科技有限公司 |
| 2025/05/12New drug · Class 1 | 索托克拉片CXHS2500048 | 百济神州（苏州）生物科技有限公司 |
| 2025/05/12New drug · Class 1 | 索托克拉片CXHS2500047 | 百济神州（苏州）生物科技有限公司 |
| 2025/05/12New drug · Class 1 | 盐酸吉卡昔替尼片CXHS2500046 | 苏州泽璟生物制药股份有限公司 |
| 2025/05/12New drug · Class 1 | SP-101注射液CXHL2500460 | 斯莱普泰（上海）生物医药科技有限公司 |
| 2025/05/10Import · Class 1 | SAR402663注射液JXSL2500074 | Sanofi-Aventis Recherche & Développement; SANOFI (CHINA) INVESTMENT CO. LTD |
| 2025/05/10Import · Class 1 | AZD0780薄膜衣片JXHL2500106 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/05/10Generic · Class 3 | 盐酸苯海拉明注射液CYHS2501704 | 安徽长江药业有限公司 |
| 2025/05/10Generic · Class 3 | 酮康唑乳膏CYHS2501702 | 宝龙药业有限公司 |
| 2025/05/10Generic · Class 3 | 硫酸沙丁胺醇口服溶液CYHS2501700 | 石家庄康力药业有限公司 |
| 2025/05/10Generic · Class 3 | 盐酸甲氧氯普胺注射液CYHS2501699 | 苏州弘森药业股份有限公司 |
| 2025/05/10Generic · Class 3 | 呋塞米口服溶液CYHS2501698 | 海南全星制药有限公司 |
| 2025/05/10Generic · Class 3 | 维生素B6注射液CYHS2501697 | 江苏开元药业有限公司; 康普药业股份有限公司 |
| 2025/05/10New drug · Class 1 | 人脐带间充质干细胞注射液CXSL2500373 | 天津华域药业有限公司 |
| 2025/05/10New drug · Class 1 | 注射用GB268CXSL2500372 | 嘉和生物药业有限公司 |
| 2025/05/10New drug · Class 1.3 | 重组带状疱疹疫苗（CHO细胞）CXSL2500371 | 桓科（河北）生物技术有限公司; 华普石家庄医药有限公司 |
| 2025/05/10New drug · Class 3.3 | 德谷门冬双胰岛素注射液CXSL2500370 | 亿帆医药（上海）有限公司 |
| 2025/05/10New drug · Class 1 | IBI3011CXSL2500369 | 信达生物制药（苏州）有限公司 |
| 2025/05/10New drug · Class 1 | 玛仕度肽注射液CXHL2500459 | 信达生物制药（苏州）有限公司 |
| 2025/05/10New drug · Class 1 | 玛仕度肽注射液CXHL2500458 | 信达生物制药（苏州）有限公司 |
| 2025/05/10New drug · Class 1 | 玛仕度肽注射液CXHL2500457 | 信达生物制药（苏州）有限公司 |
67 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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