药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/04/22 – 2025/04/28
- New acceptances this week
- 396
- Drugs with new generic filings (by drug name, de-duplicated)
- 77
- Accepted this week, now under review
- 49
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
396filings, 97 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 190 |
| Generic | 97 |
| New drug | 61 |
| Import | 33 |
| Unspecified | 11 |
| Import re-registration | 3 |
| 药械组合产品 | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 287 |
| TCM | 59 |
| 治疗用生物制品 | 40 |
| 预防用生物制品 | 7 |
| 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
77 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 佩玛贝特片 | 4 | 4 | 25 |
| 2 | 富马酸伏诺拉生片 | 3 | 2 | 58 |
| 3 | 磷酸芦可替尼片 | 3 | 1 | 27 |
| 4 | 琥珀酸亚铁片 | 2 | 2 | 21 |
| 5 | 草酸艾司西酞普兰口服溶液 | 2 | 2 | 11 |
| 6 | 双氯芬酸钠缓释片 | 2 | 1 | 10 |
| 7 | 富马酸二甲酯肠溶胶囊 | 2 | 1 | 0 |
| 8 | 枸橼酸坦度螺酮片 | 2 | 1 | 2 |
| 9 | 注射用头孢唑肟钠 | 2 | 1 | 6 |
| 10 | 盐酸左布比卡因注射液 | 2 | 1 | 4 |
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
234 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 广州市联瑞制药有限公司 | 16 | 10 | 0 |
| 2 | Eli Lilly and Company | 14 | 2 | 0 |
| 3 | Janssen-Cilag International NV | 9 | 4 | 0 |
| 4 | 百济神州（苏州）生物科技有限公司 | 9 | 3 | 0 |
| 5 | 丹东宏业制药有限公司 | 8 | 8 | 0 |
| 6 | 广东东阳光药业股份有限公司 | 6 | 3 | 0 |
| 7 | 内蒙古福寿堂制药有限公司 | 5 | 5 | 0 |
| 8 | 扬子江药业集团江苏紫龙药业有限公司 | 5 | 5 | 0 |
| 9 | 石家庄四药有限公司 | 5 | 4 | 3 |
| 10 | 山西晋新双鹤药业有限责任公司 | 4 | 4 | 1 |
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
122 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/04/28Import · Class 3.1 | 帕博利珠单抗注射液JXSS2500051 | Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2025/04/28Import · Class 1 | VHB937注射用浓溶液JXSL2500065 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/04/28Generic · Class 3 | 磷酸奥司他韦颗粒CYHS2501595 | 重庆万霖生物医药科技有限公司; 湖南九典制药股份有限公司 |
| 2025/04/28Generic · Class 3 | 富马酸氯马斯汀口服溶液CYHS2501592 | 广东华南药业集团有限公司; 广东众生药业股份有限公司 |
| 2025/04/28Generic · Class 3 | 苯溴马隆片CYHS2501591 | 浙江江北药业有限公司 |
| 2025/04/28Generic · Class 3 | 琥珀酸亚铁片CYHS2501589 | 陕西巨成生物医药生产力促进中心有限公司; 华益药业科技（安徽）有限公司 |
| 2025/04/28Generic · Class 3 | 复方聚乙二醇（3350）电解质口服溶液CYHS2501587 | 澳诺（中国）制药有限公司 |
| 2025/04/28New drug · Class 2.3 | 百令胶囊CXZL2500027 | 杭州中美华东制药有限公司 |
| 2025/04/28New drug · Class 2.3 | 百令胶囊CXZL2500026 | 杭州中美华东制药有限公司 |
| 2025/04/28New drug · Class 2.2 | SHR-8068注射液CXSL2500338 | 苏州盛迪亚生物医药有限公司 |
| 2025/04/28New drug · Class 1 | 注射用DB-1311CXSL2500337 | 映恩生物制药（苏州）有限公司 |
| 2025/04/28New drug · Class 2.2 | 贝伐珠单抗注射液CXSL2500336 | 苏州盛迪亚生物医药有限公司 |
| 2025/04/28New drug · Class 2.2 | 阿得贝利单抗注射液CXSL2500335 | 上海盛迪医药有限公司 |
| 2025/04/28New drug · Class 1 | 注射用SKB518CXSL2500334 | 四川科伦博泰生物医药股份有限公司 |
| 2025/04/28New drug · Class 1 | PM8002注射液CXSL2500333 | 普米斯生物技术（珠海）有限公司; 百欧恩泰（上海）医药有限公司 |
| 2025/04/28New drug · Class 1 | 注射用BL-B01D1CXSL2500332 | 成都百利多特生物药业有限责任公司; 四川百利药业有限责任公司 |
| 2025/04/28New drug · Class 1 | 索托克拉片CXHS2500042 | 百济神州（苏州）生物科技有限公司 |
| 2025/04/28New drug · Class 1 | 索托克拉片CXHS2500041 | 百济神州（苏州）生物科技有限公司 |
| 2025/04/28New drug · Class 1 | 索托克拉片CXHS2500040 | 百济神州（苏州）生物科技有限公司 |
| 2025/04/28New drug · Class 2.3 | 左氨氯地平比索洛尔片（Ⅱ）CXHS2500039 | 施慧达药业集团（吉林）有限公司 |
| 2025/04/28New drug · Class 2.3 | 左氨氯地平比索洛尔片（Ⅰ）CXHS2500038 | 施慧达药业集团（吉林）有限公司 |
| 2025/04/28New drug · Class 2.2 | OLP-210片CXHL2500423 | 深圳奥礼生物科技有限公司 |
| 2025/04/28New drug · Class 2.2 | OLP-210片CXHL2500422 | 深圳奥礼生物科技有限公司 |
| 2025/04/28New drug · Class 2.2 | OLP-210片CXHL2500421 | 深圳奥礼生物科技有限公司 |
| 2025/04/28New drug · Class 2.2 | 雷美替胺双释片CXHL2500420 | 南京三迭纪医药科技有限公司 |
| 2025/04/28New drug · Class 2.4 | 甲磺酸阿帕替尼片CXHL2500419 | 江苏恒瑞医药股份有限公司 |
| 2025/04/28New drug · Class 1 | ABP-745片CXHL2500418 | 杭州新元素药业有限公司 |
| 2025/04/28New drug · Class 1 | ABP-745片CXHL2500417 | 杭州新元素药业有限公司 |
| 2025/04/28New drug · Class 1 | ABP-745片CXHL2500416 | 杭州新元素药业有限公司 |
| 2025/04/28New drug · Class 2.2 | WS-019CXHL2500415 | 湖北午时药业股份有限公司 |
92 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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