药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/09/23 – 2025/09/29
- New acceptances this week
- 460
- Drugs with new generic filings (by drug name, de-duplicated)
- 72
- Accepted this week, now under review
- 112
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
460filings, 93 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 228 |
| Generic | 93 |
| New drug | 88 |
| Import | 28 |
| Import re-registration | 14 |
| Unspecified | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 264 |
| TCM | 106 |
| 治疗用生物制品 | 83 |
| 预防用生物制品 | 4 |
| Biologic | 2 |
| Unspecified | 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
72 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 糠酸莫米松乳膏 | 4 | 2 | 16 |
| 2 | 沙库巴曲缬沙坦钠片 | 3 | 1 | 72 |
| 3 | 依折麦布阿托伐他汀钙片(Ⅱ) | 2 | 2 | 9 |
| 4 | 硫酸氨基葡萄糖胶囊 | 2 | 2 | 50 |
| 5 | 蒙脱石混悬液 | 2 | 2 | 30 |
| 6 | 乙酰半胱氨酸颗粒 | 2 | 1 | 4 |
| 7 | 他克莫司软膏 | 2 | 1 | 8 |
| 8 | 卡铂注射液 | 2 | 1 | 11 |
| 9 | 头孢托仑匹酯颗粒 | 2 | 1 | 18 |
| 10 | 布比卡因脂质体注射液 | 2 | 1 | 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
279 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 湖北科伦药业有限公司 | 15 | 2 | 0 |
| 2 | 江西南昌济生制药有限责任公司 | 13 | 13 | 0 |
| 3 | 津药达仁堂集团股份有限公司达仁堂制药厂 | 11 | 8 | 0 |
| 4 | AstraZeneca AB | 7 | 5 | 0 |
| 5 | 苏州盛迪亚生物医药有限公司 | 6 | 5 | 0 |
| 6 | Otsuka Pharmaceutical Co.,Ltd. | 6 | 1 | 0 |
| 7 | 山东齐都药业有限公司 | 5 | 2 | 2 |
| 8 | 安徽安科生物工程(集团)股份有限公司 | 5 | 1 | 0 |
| 9 | 广东众生睿创生物科技有限公司 | 5 | 1 | 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 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
133 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/09/29Import · Class 1 | 注射用MK-2400JXSL2500192 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2025/09/29Import · Class 1 | 注射用MK-6070JXSL2500191 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2025/09/29Import · Class 1 | NNC6019-0001注射液JXSL2500190 | Novo Nordisk A/S; ICON Clinical Research (Beijing No. 2) Co. Ltd. |
| 2025/09/29Generic · Class 3 | 布比卡因脂质体注射液CYHS2503587 | 齐鲁制药(海南)有限公司 |
| 2025/09/29Generic · Class 3 | 布比卡因脂质体注射液CYHS2503586 | 齐鲁制药(海南)有限公司 |
| 2025/09/29Generic · Class 3 | 呋塞米片CYHS2503564 | 海鸿恒隆(海南)生物科技有限公司; 江苏云阳集团药业有限公司 |
| 2025/09/29Generic · Class 3 | 氟轻松氢醌维A酸乳膏CYHL2500175 | 浙江昂利康制药股份有限公司 |
| 2025/09/29New drug · Class 3.1 | 泻白散颗粒CXZS2500043 | 西施兰(南阳)药业股份有限公司; 绵阳一康制药有限公司 |
| 2025/09/29New drug · Class 1.1 | 金防风袋泡茶CXZL2500090 | 江西守正药业有限公司 |
| 2025/09/29New drug · Class 1 | 重组人源化单克隆抗体MIL62注射液CXSS2500102 | 北京天广实生物技术股份有限公司; 北京华放天实生物制药有限责任公司 |
| 2025/09/29New drug · Class 3.3 | GLR1044注射液CXSL2500849 | 甘李药业山东有限公司 |
| 2025/09/29New drug · Class 1 | 注射用SHR-9839(sc)CXSL2500848 | 苏州盛迪亚生物医药有限公司; 上海恒瑞医药有限公司 |
| 2025/09/29New drug · Class 2.2 | 贝伐珠单抗注射液CXSL2500847 | 苏州盛迪亚生物医药有限公司 |
| 2025/09/29New drug · Class 1 | 注射用MRG003CXSL2500846 | 乐普生物科技股份有限公司 |
| 2025/09/29New drug · Class 1 | SHR-4375注射液CXSL2500845 | 苏州盛迪亚生物医药有限公司 |
| 2025/09/29New drug · Class 2.2 | SHR-8068注射液CXSL2500844 | 苏州盛迪亚生物医药有限公司 |
| 2025/09/29New drug · Class 1 | RJMty19注射液CXSL2500843 | 浙江瑞加美生物科技有限公司 |
| 2025/09/29New drug · Class 2.2 | 阿得贝利单抗注射液CXSL2500842 | 上海盛迪医药有限公司 |
| 2025/09/29New drug · Class 2.2 | JMHT06CXHL2501056 | 湖南九典制药股份有限公司 |
| 2025/09/29New drug · Class 2.2 | JMHT06CXHL2501055 | 湖南九典制药股份有限公司 |
| 2025/09/29New drug · Class 1 | KR23343片CXHL2501054 | 江西科睿药业有限公司 |
| 2025/09/29New drug · Class 1 | KR23343片CXHL2501053 | 江西科睿药业有限公司 |
| 2025/09/29New drug · Class 1 | HRS-4642注射液CXHL2501052 | 上海恒瑞医药有限公司; 江苏恒瑞医药股份有限公司 |
| 2025/09/29New drug · Class 1 | HRS-4642注射液CXHL2501051 | 上海恒瑞医药有限公司; 江苏恒瑞医药股份有限公司 |
| 2025/09/29New drug · Class 1 | SGB-7342注射液CXHL2501050 | 苏州圣因生物医药有限公司 |
| 2025/09/29New drug · Class 1 | MAX-10181片CXHL2501049 | 北京再极医药科技有限公司 |
| 2025/09/29New drug · Class 1 | MAX-10181片CXHL2501048 | 北京再极医药科技有限公司 |
| 2025/09/28Import · Class 3.1 | 注射用维布妥昔单抗JXSS2500129 | Takeda Pharma A/S; BSP Pharmaceuticals S.p.A.; Takeda (China) International Trading Co. Ltd |
| 2025/09/28Import · Class 1 | Ponsegromab注射液JXSL2500189 | Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd. |
| 2025/09/28Import · Class 1 | AZD5335JXSL2500188 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
103 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.