药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/09/22 – 2026/09/28
- New acceptances this week
- 345
- Drugs with new generic filings (by drug name, de-duplicated)
- 37
- Accepted this week, now under review
- 287
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
345filings, 47 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 183 |
| New drug | 54 |
| Generic | 47 |
| Import | 34 |
| Import re-registration | 16 |
| Unspecified | 11 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 185 |
| TCM | 91 |
| 治疗用生物制品 | 62 |
| Biologic | 5 |
| 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
37 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 巴瑞替尼片 | 3 | 2 | 32 |
| 2 | 依达拉奉右莰醇注射用浓溶液 | 2 | 2 | 32 |
| 3 | 盐酸西替利嗪滴眼液 | 2 | 2 | 3 |
| 4 | 酒石酸溴莫尼定滴眼液 | 2 | 2 | 4 |
| 5 | 枸橼酸西地那非片 | 2 | 1 | 12 |
| 6 | 注射用甲磺酸萘莫司他 | 2 | 1 | 38 |
| 7 | 瑞格列奈片 | 2 | 1 | 8 |
| 8 | 达格列净片 | 2 | 1 | 82 |
| 9 | 阿昔替尼片 | 2 | 1 | 5 |
| 10 | 右酮洛芬氨丁三醇注射液 | 1 | 1 | 5 |
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
219 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bayer Vital GmbH | 9 | 1 | 0 |
| 2 | Pfizer Inc. | 9 | 1 | 0 |
| 3 | 北京康诺亚生物医药有限公司 | 8 | 1 | 0 |
| 4 | 陕西欧珂药业有限公司 | 6 | 6 | 0 |
| 5 | 西安万隆制药股份有限公司 | 5 | 5 | 0 |
| 6 | 江西品信药业股份有限公司 | 5 | 2 | 0 |
| 7 | Boehringer Ingelheim International GmbH | 5 | 1 | 0 |
| 8 | 山西旺龙药业集团有限公司 | 4 | 4 | 0 |
| 9 | 远大碑林(西安)药业有限公司 | 4 | 4 | 0 |
| 10 | 特一药业集团股份有限公司 | 4 | 2 | 2 |
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
102 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/09/28Import · Class 1 | AMG 732JXSL2600261 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2026/09/28Import · Class 1 | PF-07220060JXHL2600428 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2026/09/28Import · Class 1 | PF-07220060JXHL2600427 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2026/09/28Import · Class 1 | PF-07220060JXHL2600426 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2026/09/28Import · Class 1 | Giredestrant胶囊JXHL2600425 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/09/28Import · Class 1 | PF-07220060JXHL2600424 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2026/09/28Import · Class 1 | Giredestrant胶囊JXHL2600423 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2026/09/28Import · Class 1 | PF-07220060JXHL2600422 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2026/09/28Import · Class 1 | PF-07220060JXHL2600421 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2026/09/28Import · Class 1 | PF-07220060JXHL2600420 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2026/09/28Import · Class 1 | PF-07220060JXHL2600419 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2026/09/28Import · Class 1 | PF-07220060JXHL2600418 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2026/09/28Generic · Class 3 | 溴吡斯的明口服溶液CYHS2602419 | 宿州亿帆药业有限公司 |
| 2026/09/28Generic · Class 3 | 对乙酰氨基酚布洛芬片CYHS2602416 | 济南景笙科技有限公司; 潍坊中狮制药有限公司 |
| 2026/09/28Generic · Class 3 | 右酮洛芬氨丁三醇注射液CYHS2602415 | 山东达冠医药科技有限公司; 山东辉成制药有限公司 |
| 2026/09/28New drug · Class 1.1 | 消肿颗粒CXZL2600095 | 盈科瑞(天津)创新医药研究有限公司 |
| 2026/09/28New drug · Class 2.4 | 注射用重组A型肉毒毒素(150 kD)CXSS2600156 | 君合盟生物制药(通化)有限公司 |
| 2026/09/28New drug · Class 1 | 注射用AP308CXSL2601066 | 上海礼邦医药科技有限公司 |
| 2026/09/28New drug · Class 1 | 9MW2821CXSL2601065 | 迈威(上淘)生物科技股份有限公司 |
| 2026/09/28New drug · Class 1 | YYSW001片CXHL2601211 | 一又生物(上海)有限公司; 中国药科大学; 梦阳药业(上海)有限公司 |
| 2026/09/28New drug · Class 1 | 注射用TNP-2092CXHL2601210 | 丹诺医药(苏州)股份有限公司 |
| 2026/09/28New drug · Class 1 | BG-92505片CXHL2601209 | 百济神州(苏州)生物科技有限公司 |
| 2026/09/28New drug · Class 1 | BG-92505片CXHL2601208 | 百济神州(苏州)生物科技有限公司 |
| 2026/09/28New drug · Class 1 | 注射用莱古比星CXHL2601207 | 上海亲合力生物医药科技股份有限公司 |
| 2026/09/28New drug · Class 1 | YKYY018雾化吸入剂CXHL2601206 | 北京悦康科创医药科技股份有限公司 |
| 2026/09/28New drug · Class 1 | YKYY018雾化吸入剂CXHL2601205 | 北京悦康科创医药科技股份有限公司 |
| 2026/09/24Import · Class 1 | Duvakitug注射液JXSL2600260 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2026/09/24Import · Class 2.4 | 甲磺酸仑伐替尼胶囊JXHS2600123 | Eisai Europe Limited; Eisai Co. Ltd. |
| 2026/09/24Import · Class 2.4 | 甲磺酸仑伐替尼胶囊JXHS2600122 | Eisai Europe Limited; Eisai Co. Ltd. |
| 2026/09/24Import · Class 2.4 | 赛沃替尼片JXHL2600417 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
72 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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