药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/02/21 – 2023/02/27
- New acceptances this week
- 413
- Drugs with new generic filings (by drug name, de-duplicated)
- 59
- Accepted this week, now under review
- 1
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
413filings, 78 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 237 |
| Generic | 78 |
| New drug | 44 |
| Import | 26 |
| Import re-registration | 20 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 298 |
| TCM | 67 |
| 治疗用生物制品 | 40 |
| 预防用生物制品 | 8 |
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
59 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 磷酸奥司他韦胶囊 | 4 | 2 | 42 |
| 2 | 盐酸度洛西汀肠溶胶囊 | 3 | 1 | 5 |
| 3 | 丙戊酸钠口服溶液 | 2 | 1 | 1 |
| 4 | 他克莫司缓释胶囊 | 2 | 1 | 6 |
| 5 | 对乙酰氨基酚注射液 | 2 | 1 | 1 |
| 6 | 左氧氟沙星片 | 2 | 1 | 8 |
| 7 | 布立西坦片 | 2 | 1 | 16 |
| 8 | 氯化钾颗粒 | 2 | 1 | 4 |
| 9 | 注射用尼可地尔 | 2 | 1 | 1 |
| 10 | 注射用盐酸吉西他滨 | 2 | 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
241 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 沈阳君元药业有限公司 | 16 | 10 | 0 |
| 2 | 广西裕源药业有限公司 | 12 | 9 | 0 |
| 3 | 广东松下药业有限公司 | 11 | 11 | 0 |
| 4 | 重庆千方药物研究有限公司 | 7 | 5 | 0 |
| 5 | 瑞阳制药股份有限公司 | 6 | 3 | 3 |
| 6 | 四川科伦药业股份有限公司 | 5 | 3 | 2 |
| 7 | 陕西年青保制药有限公司 | 5 | 3 | 0 |
| 8 | Pfizer Inc. | 5 | 2 | 0 |
| 9 | Pfizer Australia Pty Ltd | 5 | 1 | 0 |
| 10 | 贵州汉方药业有限公司 | 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
99 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/02/27Import · Class 2.4 | 阿扎胞苷薄膜衣片JXHL2300038 | Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2023/02/27Import · Class 2.4 | 阿扎胞苷薄膜衣片JXHL2300037 | Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2023/02/27Import · Class 1 | AZD9833片JXHL2300035 | AstraZeneca AB; AstraZeneca Investment (China) Co. Limited |
| 2023/02/27Generic · Class 3 | 生理氯化钠溶液CYHS2300654 | 辽宁民康制药有限公司; 贵州科伦药业有限公司 |
| 2023/02/27Generic · Class 3 | 盐酸氨溴索口服溶液CYHS2300648 | 安徽海斯美医药有限公司; 江苏欧歌制药有限公司 |
| 2023/02/27Generic · Class 3 | 复方聚乙二醇（3350）电解质散CYHS2300647 | 重庆迈川医药科技有限公司; 四川维奥制药有限公司 |
| 2023/02/27Generic · Class 3 | 二羟丙茶碱注射液CYHS2300643 | 四川汇宇海玥医药科技有限公司; 太极集团四川太极制药有限公司 |
| 2023/02/27Generic · Class 3 | 法莫替丁注射液CYHS2300642 | 四川汇宇海玥医药科技有限公司; 太极集团四川太极制药有限公司 |
| 2023/02/27New drug · Class 1.1 | 十一方药酒CXZL2300013 | 广西中医药大学第一附属医院（广西中医医院） |
| 2023/02/27New drug · Class 2.2 | 苏黄止咳颗粒CXZL2300012 | 北京东方运嘉科技发展有限公司 |
| 2023/02/27New drug · Class 1 | SHR-1654注射液CXSL2300158 | 广东恒瑞医药有限公司 |
| 2023/02/27New drug · Class 1 | PB-722注射液CXHL2300257 | 派格生物医药（苏州）股份有限公司 |
| 2023/02/25Generic · Class 3 | 盐酸溴己新口服溶液CYHS2300641 | 合肥国药诺和药业有限公司; 安徽永生堂药业有限责任公司 |
| 2023/02/25Generic · Class 3 | 盐酸溴己新口服溶液CYHS2300640 | 合肥国药诺和药业有限公司; 安徽永生堂药业有限责任公司 |
| 2023/02/25Generic · Class 3 | 布立西坦片CYHS2300639 | 江西青峰药业有限公司 |
| 2023/02/25Generic · Class 3 | 布立西坦片CYHS2300638 | 江西青峰药业有限公司 |
| 2023/02/25Generic · Class 3 | 乙酰半胱氨酸注射液CYHS2300637 | 舒美奇成都生物科技有限公司; 四川美大康佳乐药业有限公司 |
| 2023/02/25New drug · Class 2.2 | 注射用重组葡激酶CXSL2300157 | 通化康缘玉金药业有限公司 |
| 2023/02/25New drug · Class 1 | HLX26单抗注射液CXSL2300156 | 上海复宏汉霖生物制药有限公司 |
| 2023/02/25New drug · Class 1 | 盐酸妥诺达非片CXHS2300035 | 扬子江药业集团有限公司 |
| 2023/02/25New drug · Class 2.2 | 右布洛芬咀嚼片CXHL2300256 | 北京佳诚生物医药科技开发有限公司 |
| 2023/02/25New drug · Class 2.2 | 右布洛芬咀嚼片CXHL2300255 | 北京佳诚生物医药科技开发有限公司 |
| 2023/02/25New drug · Class 2.2 | 右布洛芬咀嚼片CXHL2300254 | 北京佳诚生物医药科技开发有限公司 |
| 2023/02/25New drug · Class 2.2 | 右布洛芬咀嚼片CXHL2300253 | 北京佳诚生物医药科技开发有限公司 |
| 2023/02/25New drug · Class 1 | HRS-1893片CXHL2300252 | 山东盛迪医药有限公司 |
| 2023/02/25New drug · Class 1 | HRS-1893片CXHL2300251 | 山东盛迪医药有限公司 |
| 2023/02/25New drug · Class 2.2 | TAP-1502喷雾剂CXHL2300250 | 上海泽德曼医药科技有限公司 |
| 2023/02/25New drug · Class 1 | HRS-1893片CXHL2300249 | 山东盛迪医药有限公司 |
| 2023/02/24Import · Class 3.1 | 帕博利珠单抗注射液JXSS2300018 | Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2023/02/24Import · Class 2.2 | 佩索利单抗注射液JXSL2300042 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
69 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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