药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/09/29 – 2026/10/05
- New acceptances this week
- 125
- Drugs with new generic filings (by drug name, de-duplicated)
- 17
- Accepted this week, now under review
- 107
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
125filings, 19 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 69 |
| New drug | 24 |
| Generic | 19 |
| Import | 8 |
| Import re-registration | 3 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 62 |
| TCM | 41 |
| 治疗用生物制品 | 21 |
| 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
17 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 多替诺雷片 | 2 | 1 | 49 |
| 2 | 阿托伐他汀钙片 | 2 | 1 | 24 |
| 3 | ω-3鱼油脂肪乳注射液 | 1 | 1 | 6 |
| 4 | 乙酰半胱氨酸片 | 1 | 1 | 8 |
| 5 | 伊班膦酸钠注射液 | 1 | 1 | 4 |
| 6 | 依达拉奉右莰醇注射用浓溶液 | 1 | 1 | 32 |
| 7 | 利多卡因丙胺卡因气雾剂 | 1 | 1 | 5 |
| 8 | 多种微量元素注射液（IV） | 1 | 1 | 4 |
| 9 | 夫西地酸乳膏 | 1 | 1 | 16 |
| 10 | 左氧氟沙星注射液 | 1 | 1 | 1 |
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
91 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Pfizer Inc. | 7 | 2 | 0 |
| 2 | 绵阳一康制药有限公司 | 5 | 5 | 0 |
| 3 | 神威药业集团有限公司 | 3 | 3 | 0 |
| 4 | 云南植物药业有限公司 | 3 | 2 | 0 |
| 5 | AbbVie Limited | 3 | 1 | 0 |
| 6 | 山东绿叶制药有限公司 | 3 | 1 | 0 |
| 7 | 四川蜀中药业有限公司 | 2 | 2 | 0 |
| 8 | 长春海外制药集团有限公司 | 2 | 2 | 0 |
| 9 | 上海思璞锐医药科技有限公司 | 2 | 1 | 0 |
| 10 | 先声再明医药股份有限公司 | 2 | 1 | 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
38 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/09/30Import · Class 2.2 | 伊奈利珠单抗注射液JXSL2600262 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2026/09/30Generic · Class 3 | 乙酰半胱氨酸片CYHS2602434 | 广东赛康制药厂有限公司 |
| 2026/09/30Generic · Class 3 | 左氧氟沙星注射液CYHS2602433 | 山西普恒制药有限公司 |
| 2026/09/30New drug · Class 1 | 注射用AST1001CXSL2601080 | 上海艾力斯医药科技股份有限公司 |
| 2026/09/30New drug · Class 1 | RG002-03注射液CXSL2601079 | 仁景（苏州）生物科技有限公司; 中国医学科学院医药生物技术研究所 |
| 2026/09/30New drug · Class 1 | ALXN2220注射液CXSL2601078 | 阿斯利康全球研发（中国）有限公司 |
| 2026/09/30New drug · Class 1 | SI-B037双特异性抗体注射液CXSL2601077 | 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 |
| 2026/09/30New drug · Class 2.2;2.4 | BTS1115CXHL2601220 | 江苏诺和必拓新药研发有限公司; 北京阳光诺和药物研究股份有限公司; 北京百奥药业有限责任公司 |
| 2026/09/30New drug · Class 1 | SPR2015片CXHL2601219 | 上海思璞锐医药科技有限公司 |
| 2026/09/30New drug · Class 1 | SPR2015片CXHL2601218 | 上海思璞锐医药科技有限公司 |
| 2026/09/30New drug · Class 1 | HJY-39注射液CXHL2601217 | 厦门甘宝利生物医药有限公司 |
| 2026/09/29Import · Class 1 | PF-07994525JXHL2600435 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/29Import · Class 1 | PF-07994525JXHL2600434 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/29Import · Class 1 | PF-07994525JXHL2600433 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/29Import · Class 1 | PF-08653944注射液JXHL2600432 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/29Import · Class 1 | PF-08653944注射液JXHL2600431 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/29Import · Class 1 | PF-08653944注射液JXHL2600430 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/29Import · Class 1 | PF-08653944注射液JXHL2600429 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/29Generic · Class 3 | 骨化三醇口服溶液CYHS2602431 | 广西梧州制药（集团）股份有限公司 |
| 2026/09/29Generic · Class 3 | 铝碳酸镁混悬液CYHS2602427 | 重庆世森医药科技有限公司; 陕西汉江药业集团股份有限公司 |
| 2026/09/29Generic · Class 3 | 多种微量元素注射液（IV）CYHS2602425 | 仁合益康汇泽药业河北有限公司 |
| 2026/09/29Generic · Class 3 | 西甲硅油咀嚼片CYHS2602422 | 宏越科技（湖州）有限公司; 浙江莎普爱思药业股份有限公司 |
| 2026/09/29New drug · Class 3.4 | 替瑞奇珠单抗注射液CXSS2600157 | 晟华药业（海南）有限公司; 夏尔巴生物技术(杭州)有限公司 |
| 2026/09/29New drug · Class 1 | HL99自体T细胞注射液CXSL2601076 | 河南省华隆生物技术有限公司 |
| 2026/09/29New drug · Class 1 | SIM0725注射液CXSL2601075 | 江苏先声药业有限公司; 先声药业有限公司 |
| 2026/09/29New drug · Class 1 | 注射用SIM0505CXSL2601074 | 上海先声再明医药生物科技有限公司 |
| 2026/09/29New drug · Class 1 | 注射用BG-T187（皮下注射）CXSL2601073 | 广州百济神州生物制药有限公司 |
| 2026/09/29New drug · Class 1 | 注射用YL413CXSL2601072 | 苏州宜联生物医药有限公司 |
| 2026/09/29New drug · Class 1 | 注射用HCRB001CXSL2601071 | 海口铁树大方生物科技有限公司 |
| 2026/09/29New drug · Class 1 | MK-8748眼内注射溶液CXSL2601070 | 默沙东研发（中国）有限公司 |
8 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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