药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/06/17 – 2025/06/23
- New acceptances this week
- 369
- Drugs with new generic filings (by drug name, de-duplicated)
- 81
- Accepted this week, now under review
- 69
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
369filings, 120 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 155 |
| Generic | 120 |
| New drug | 53 |
| Import | 34 |
| Unspecified | 4 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 216 |
| TCM | 81 |
| 治疗用生物制品 | 70 |
| 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
81 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 乙酰半胱氨酸注射液 | 6 | 6 | 53 |
| 2 | 二十碳五烯酸乙酯软胶囊 | 4 | 3 | 25 |
| 3 | 注射用甲苯磺酸奥马环素 | 3 | 3 | 9 |
| 4 | 瑞维那新吸入溶液 | 3 | 3 | 53 |
| 5 | 硝普钠注射液 | 3 | 3 | 15 |
| 6 | 硫酸氨基葡萄糖胶囊 | 3 | 3 | 50 |
| 7 | 苯磺酸左氨氯地平片 | 3 | 2 | 47 |
| 8 | 他达拉非片 | 3 | 1 | 23 |
| 9 | 草酸艾司西酞普兰片 | 3 | 1 | 6 |
| 10 | 溴芬酸钠滴眼液 | 2 | 2 | 7 |
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
235 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Amgen Inc. | 14 | 2 | 0 |
| 2 | Novo Nordisk A/S | 8 | 2 | 0 |
| 3 | 广州大光制药有限公司 | 5 | 5 | 5 |
| 4 | 石家庄四药有限公司 | 5 | 5 | 4 |
| 5 | 莱阳司邦得制药有限公司 | 5 | 5 | 0 |
| 6 | 云南金柯制药有限公司 | 5 | 4 | 0 |
| 7 | Pfizer Inc. | 5 | 3 | 0 |
| 8 | 华益药业科技(安徽)有限公司 | 5 | 3 | 5 |
| 9 | 温州海鹤药业有限公司 | 4 | 3 | 0 |
| 10 | 湖南千金湘江药业股份有限公司 | 4 | 2 | 4 |
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 |
|---|---|---|
| 2025/06/23Generic · Class 3 | 注射用赖氨匹林CYHS2502249 | 南京黄龙生物科技有限公司; 山西普德药业有限公司 |
| 2025/06/23Generic · Class 3 | 注射用赖氨匹林CYHS2502248 | 南京黄龙生物科技有限公司; 山西普德药业有限公司 |
| 2025/06/23Generic · Class 3 | 盐酸普拉格雷片CYHL2500120 | 重庆医药(集团)股份有限公司 |
| 2025/06/23Generic · Class 3 | 盐酸普拉格雷片CYHL2500119 | 重庆医药(集团)股份有限公司 |
| 2025/06/23New drug · Class 1 | 异体人成纤维细胞注射液CXSL2500513 | 椎元医学技术(上海)有限公司 |
| 2025/06/23New drug · Class 1 | VUM02注射液CXSL2500507 | 武汉光谷中源药业有限公司 |
| 2025/06/23New drug · Class 2.2 | 阿得贝利单抗注射液CXSL2500506 | 上海盛迪医药有限公司 |
| 2025/06/23New drug · Class 2.2 | 贝伐珠单抗注射液CXSL2500505 | 苏州盛迪亚生物医药有限公司 |
| 2025/06/23New drug · Class 1 | 注射用SHR-1826CXSL2500504 | 苏州盛迪亚生物医药有限公司 |
| 2025/06/23New drug · Class 1 | HS-10241片CXHL2500608 | 江苏豪森药业集团有限公司; 上海翰森生物医药科技有限公司 |
| 2025/06/23New drug · Class 1 | HS-10241片CXHL2500607 | 江苏豪森药业集团有限公司; 上海翰森生物医药科技有限公司 |
| 2025/06/23New drug · Class 1 | JMKX003002片CXHL2500606 | 浙江杭煜制药有限公司 |
| 2025/06/23New drug · Class 1 | JMKX003002片CXHL2500605 | 浙江杭煜制药有限公司 |
| 2025/06/23New drug · Class 1 | JMKX003002片CXHL2500604 | 浙江杭煜制药有限公司 |
| 2025/06/21Import · Class 1 | AMG 133JXSL2500109 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2025/06/21Import · Class 1 | AMG 133JXSL2500108 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2025/06/21Import · Class 1 | AMG 133JXSL2500107 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2025/06/21Import · Class 1 | AMG 133JXSL2500106 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2025/06/21Import · Class 1 | AMG 133JXSL2500105 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2025/06/21Import · Class 1 | AMG 133JXSL2500104 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2025/06/21Import · Class 1 | AZD8205JXSL2500103 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/06/21Generic · Class 3 | 小儿多种维生素注射液(13)CYHS2502241 | 亚宝药业集团股份有限公司 |
| 2025/06/21Generic · Class 3 | 比拉斯汀口崩片CYHS2502229 | 四川科伦药业股份有限公司 |
| 2025/06/21Generic · Class 3 | 噁拉戈利片CYHL2500118 | 金陵药业股份有限公司南京金陵制药厂 |
| 2025/06/21Generic · Class 3 | 噁拉戈利片CYHL2500117 | 金陵药业股份有限公司南京金陵制药厂 |
| 2025/06/21Generic · Class 3 | 左甲状腺素钠口服溶液CYHL2500116 | 江苏贝美制药有限公司 |
| 2025/06/21New drug · Class 1 | T3011疱疹病毒注射液CXSL2500502 | 苏州亦诺微医药科技有限公司 |
| 2025/06/21New drug · Class 1 | CX1440胶囊CXHL2500603 | 杭州邦顺制药有限公司 |
| 2025/06/21New drug · Class 1 | CX1440胶囊CXHL2500602 | 杭州邦顺制药有限公司 |
| 2025/06/21New drug · Class 1 | HSK47388片CXHL2500601 | 海思科医药集团股份有限公司 |
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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.