药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/06/09 – 2026/06/15
- New acceptances this week
- 431
- Drugs with new generic filings (by drug name, de-duplicated)
- 53
- Accepted this week, now under review
- 134
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
431filings, 77 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 268 |
| Generic | 77 |
| New drug | 63 |
| Import | 16 |
| Import re-registration | 4 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 229 |
| TCM | 145 |
| 治疗用生物制品 | 55 |
| 预防用生物制品 | 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
53 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 注射用甲磺酸萘莫司他 | 5 | 3 | 38 |
| 2 | 苯磺酸美洛加巴林片 | 5 | 2 | 58 |
| 3 | 多替诺雷片 | 3 | 1 | 49 |
| 4 | 西诺氨酯片 | 3 | 1 | 21 |
| 5 | 乌帕替尼缓释片 | 2 | 2 | 43 |
| 6 | 布瑞哌唑片 | 2 | 1 | 31 |
| 7 | 布美他尼注射液 | 2 | 1 | 16 |
| 8 | 帕拉米韦氯化钠注射液 | 2 | 1 | 17 |
| 9 | 曲安奈德益康唑乳膏 | 2 | 1 | 3 |
| 10 | 氨基酸（15）腹膜透析液 | 2 | 1 | 3 |
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
258 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Eli Lilly and Company | 8 | 3 | 0 |
| 2 | Pfizer Inc. | 6 | 3 | 0 |
| 3 | 辽宁鑫善源药业有限公司 | 6 | 2 | 3 |
| 4 | Amgen Inc. | 6 | 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 | 华润双鹤湘中药业（湖南）有限公司 | 5 | 5 | 0 |
| 7 | 信达生物制药（苏州）有限公司 | 5 | 2 | 0 |
| 8 | 百济神州（苏州）生物科技有限公司 | 5 | 2 | 0 |
| 9 | 包头中药有限责任公司 | 4 | 4 | 0 |
| 10 | 北京同仁堂制药有限公司 | 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
108 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/06/15Generic · Class 3 | 琥珀酸美托洛尔缓释胶囊CYHS2601415 | 山东华素制药有限公司 |
| 2026/06/15Generic · Class 3 | 琥珀酸美托洛尔缓释胶囊CYHS2601414 | 山东华素制药有限公司 |
| 2026/06/15Generic · Class 3 | 维生素K1注射液CYHS2601413 | 深圳欣祺医药科技有限公司; 广东星昊药业有限公司 |
| 2026/06/15Generic · Class 3 | 头孢克肟胶囊CYHS2601412 | 湖南状元制药有限公司; 山东淄博新达制药有限公司 |
| 2026/06/15Generic · Class 3 | 盐酸甲氧氯普胺口服溶液CYHS2601409 | 江苏瑜兴医药科技有限公司 |
| 2026/06/15Generic · Class 3 | 注射用甲磺酸萘莫司他CYHS2601408 | 成都苑东生物制药股份有限公司; 成都通德药业有限公司 |
| 2026/06/15New drug · Class 1 | 注射用AMT-116CXSL2600638 | 普众发现医药科技（上海）股份有限公司 |
| 2026/06/15New drug · Class 1 | 注射用HY07121（皮下注射）CXSL2600637 | 四川汇宇海玥医药科技有限公司 |
| 2026/06/15New drug · Class 1 | BG-75202片CXHL2600714 | 百济神州（苏州）生物科技有限公司 |
| 2026/06/15New drug · Class 1 | BG-75202片CXHL2600713 | 百济神州（苏州）生物科技有限公司 |
| 2026/06/15New drug · Class 1 | BG-75202片CXHL2600712 | 百济神州（苏州）生物科技有限公司 |
| 2026/06/15New drug · Class 1 | FXR0906注射液CXHL2600711 | 复星医药产业发展（深圳）有限公司 |
| 2026/06/12Import · Class 1 | AZD2936JXSL2600141 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/06/12Import · Class 2.4 | BMS-986510胶囊JXHL2600218 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/06/12Import · Class 2.4 | BMS-986510胶囊JXHL2600217 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/06/12Import · Class 2.4 | BMS-986510胶囊JXHL2600216 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/06/12Generic · Class 3 | 注射用甲磺酸萘莫司他CYHS2601406 | 重庆华邦制药有限公司 |
| 2026/06/12Generic · Class 3 | 注射用甲磺酸萘莫司他CYHS2601405 | 重庆华邦制药有限公司 |
| 2026/06/12Generic · Class 3 | 环磷酰胺注射液CYHS2601403 | 上海创诺制药有限公司 |
| 2026/06/12Generic · Class 3 | 米诺地尔搽剂CYHS2601401 | 湖北康正药业有限公司 |
| 2026/06/12Generic · Class 3 | 米诺地尔搽剂CYHS2601400 | 湖北康正药业有限公司 |
| 2026/06/12Generic · Class 3 | 盐酸西替利嗪注射液CYHS2601399 | 山东新时代药业有限公司 |
| 2026/06/12New drug · Class 2.2 | 皮内注射用重组卡介苗CXSL2600636 | 成都安永鼎业生物技术有限公司 |
| 2026/06/12New drug · Class 1 | 重组抗IL-4Rα人源化单克隆抗体注射液CXSL2600635 | 三生国健药业（上海）股份有限公司 |
| 2026/06/12New drug · Class 1 | AZD5863CXSL2600634 | 阿斯利康全球研发（中国）有限公司 |
| 2026/06/12New drug · Class 1 | GC012F注射液CXSL2600633 | 亘喜生物科技（上海）有限公司; 阿斯利康投资（中国）有限公司; 苏州亘喜生物科技有限公司 |
| 2026/06/12New drug · Class 1 | 注射用Efimosfermin alfaCXSL2600632 | 葛兰素史克（中国）投资有限公司 |
| 2026/06/12New drug · Class 1 | IBI3040CXHL2600710 | 信达生物制药（苏州）有限公司 |
| 2026/06/12New drug · Class 1 | IBI3032CXHL2600709 | 信达生物科技有限公司 |
| 2026/06/12New drug · Class 1 | IBI3032CXHL2600708 | 信达生物科技有限公司 |
78 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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