药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/05/19 – 2026/05/25
- New acceptances this week
- 331
- Drugs with new generic filings (by drug name, de-duplicated)
- 18
- Accepted this week, now under review
- 38
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
331filings, 23 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 218 |
| New drug | 66 |
| Generic | 23 |
| Import | 10 |
| Unspecified | 7 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| TCM | 164 |
| Chemical drug | 118 |
| 治疗用生物制品 | 48 |
| Biologic | 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
18 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 阿达帕林过氧苯甲酰凝胶 | 3 | 2 | 30 |
| 2 | 复方醋酸钠葡萄糖注射液 | 2 | 1 | 8 |
| 3 | 左氧氟沙星氯化钠注射液 | 2 | 1 | 14 |
| 4 | 盐酸丙卡特罗口服溶液 | 2 | 1 | 12 |
| 5 | 乌帕替尼缓释片 | 1 | 1 | 43 |
| 6 | 克立硼罗软膏 | 1 | 1 | 28 |
| 7 | 卡贝缩宫素注射液 | 1 | 1 | 6 |
| 8 | 双氯芬酸钠盐酸利多卡因注射液 | 1 | 1 | 8 |
| 9 | 噻托溴铵奥达特罗吸入喷雾剂 | 1 | 1 | 2 |
| 10 | 布洛芬混悬液 | 1 | 1 | 14 |
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
204 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 西安大唐制药集团有限公司 | 10 | 10 | 0 |
| 2 | 哈药集团生物工程有限公司 | 10 | 5 | 0 |
| 3 | 通化金马药业集团股份有限公司 | 8 | 7 | 0 |
| 4 | 苏州沪云新药研发股份有限公司 | 7 | 1 | 0 |
| 5 | 北京同仁堂科技发展股份有限公司制药厂 | 5 | 5 | 0 |
| 6 | 湖南德康制药股份有限公司 | 5 | 5 | 0 |
| 7 | EUROAPI Germany GmbH | 4 | 4 | 0 |
| 8 | 修正药业集团（湖南）药业有限公司 | 4 | 4 | 0 |
| 9 | 山西广誉远国药有限公司 | 4 | 4 | 0 |
| 10 | 湖北东信药业有限公司 | 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 no longer on the under-review list whose last snapshot sighting falls in this week, meaning approved or terminated, to be verified. Companies are counted by first applicant.
Class 3 and new-drug acceptances
80 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/05/25Import · Class 2.2 | 伊奈利珠单抗注射液JXSL2600120 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2026/05/25Import · Class 1 | PFL-721片JXHL2600184 | PIERRE FABRE MEDICAMENT; Pierre Fabre (Shanghai) Medical Co. Ltd. |
| 2026/05/25Import · Class 1 | PFL-721片JXHL2600183 | PIERRE FABRE MEDICAMENT; Pierre Fabre (Shanghai) Medical Co. Ltd. |
| 2026/05/25New drug · Class 3.1 | 清心莲子饮颗粒CXZS2600027 | 云南白药集团股份有限公司 |
| 2026/05/25New drug · Class 1 | NK细胞注射液CXSL2600569 | 京东方再生医学科技有限公司 |
| 2026/05/25New drug · Class 1 | RJK-RT2831注射液CXSL2600568 | 南京融捷康生物科技有限公司 |
| 2026/05/25New drug · Class 1 | Tvac001新抗原反应性T细胞注射液CXSL2600567 | 广州润生细胞医药科技有限责任公司 |
| 2026/05/25New drug · Class 1 | SGC001注射液CXSL2600566 | 北京舜景生物医药技术有限公司 |
| 2026/05/25New drug · Class 1 | 炔丙基半胱氨酸胶囊CXHL2600625 | 依诺医药（广东）有限公司 |
| 2026/05/25New drug · Class 1 | 炔丙基半胱氨酸胶囊CXHL2600624 | 依诺医药（广东）有限公司 |
| 2026/05/25New drug · Class 1 | 炔丙基半胱氨酸胶囊CXHL2600623 | 依诺医药（广东）有限公司 |
| 2026/05/25New drug · Class 1 | 炔丙基半胱氨酸胶囊CXHL2600622 | 依诺医药（广东）有限公司 |
| 2026/05/25New drug · Class 1 | 注射用Tvac001个性化肿瘤新抗原多肽CXHL2600621 | 广州润生细胞医药科技有限责任公司 |
| 2026/05/25New drug · Class 1 | HZ-V055胶囊CXHL2600620 | 杭州和正医药有限公司; 中国科学院上海药物研究所 |
| 2026/05/25New drug · Class 1 | HZ-V055胶囊CXHL2600619 | 杭州和正医药有限公司; 中国科学院上海药物研究所 |
| 2026/05/25New drug · Class 1 | HZ-V055胶囊CXHL2600618 | 杭州和正医药有限公司; 中国科学院上海药物研究所 |
| 2026/05/22Import · Class 1 | DDY391片JXHL2600182 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/05/22Import · Class 1 | DDY391片JXHL2600181 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/05/22Import · Class 1 | BMS-986458片JXHL2600180 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2026/05/22Import · Class 1 | BMS-986458片JXHL2600179 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2026/05/22New drug · Class 1.1 | 黄氏止咳润喉散CXZL2600048 | 黄氏喉康中医药有限公司 |
| 2026/05/22New drug · Class 1 | 注射用BL-B01D1（皮下注射）CXSL2600565 | 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 |
| 2026/05/22New drug · Class 1 | HH160注射液CXSL2600564 | 华辉安健（北京）生物科技有限公司 |
| 2026/05/22New drug · Class 1 | GEB-101CXSL2600563 | 北京引正基因科技有限公司 |
| 2026/05/22New drug · Class 1 | 注射用3SC009CXSL2600562 | 沈阳三生制药有限责任公司 |
| 2026/05/22New drug · Class 1 | QX027N 注射液CXSL2600561 | 江苏荃信生物医药股份有限公司 |
| 2026/05/22New drug · Class 1 | QX027N 注射液CXSL2600560 | 江苏荃信生物医药股份有限公司 |
| 2026/05/22New drug · Class 1 | GenSci144片CXHL2600617 | 长春金赛药业有限责任公司 |
| 2026/05/22New drug · Class 1 | GenSci144片CXHL2600616 | 长春金赛药业有限责任公司 |
| 2026/05/22New drug · Class 1 | BIOS0635-048片CXHL2600615 | 杭州百诚医药科技股份有限公司 |
50 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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