药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/01/10 – 2023/01/16
- New acceptances this week
- 419
- Drugs with new generic filings (by drug name, de-duplicated)
- 60
- 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
419filings, 78 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 224 |
| Generic | 78 |
| New drug | 72 |
| Import | 19 |
| Unspecified | 13 |
| Import re-registration | 13 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 286 |
| TCM | 75 |
| 治疗用生物制品 | 51 |
| 预防用生物制品 | 4 |
| Biologic | 3 |
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
60 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 左氧氟沙星滴眼液 | 4 | 1 | 16 |
| 2 | 玻璃酸钠滴眼液 | 4 | 1 | 29 |
| 3 | 硝苯地平控释片 | 3 | 1 | 8 |
| 4 | 盐酸多巴酚丁胺注射液 | 2 | 2 | 3 |
| 5 | 马来酸氟伏沙明片 | 2 | 2 | 0 |
| 6 | 克林霉素磷酸酯注射液 | 2 | 1 | 4 |
| 7 | 沙库巴曲缬沙坦钠片 | 2 | 1 | 68 |
| 8 | 注射用哌拉西林钠 | 2 | 1 | 16 |
| 9 | 琥珀酸去甲文拉法辛缓释片 | 2 | 1 | 0 |
| 10 | 琥珀酸美托洛尔缓释胶囊 | 2 | 1 | 4 |
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
223 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 吉林省罗邦药业有限公司 | 25 | 19 | 0 |
| 2 | 平光制药股份有限公司 | 14 | 14 | 0 |
| 3 | 广西维威制药有限公司 | 12 | 12 | 0 |
| 4 | 正大天晴药业集团股份有限公司 | 9 | 4 | 0 |
| 5 | 郑州市葆龙药业有限公司 | 8 | 8 | 0 |
| 6 | 苏州弘森药业股份有限公司 | 8 | 2 | 8 |
| 7 | 珠海联邦制药股份有限公司 | 6 | 3 | 0 |
| 8 | 四川制药制剂有限公司 | 6 | 1 | 0 |
| 9 | 山东润泽制药有限公司 | 6 | 1 | 0 |
| 10 | 杭州安道药业有限公司 | 6 | 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 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
114 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/01/16New drug · Class 2.2 | BCM345口溶膜CXHL2300085 | 上海博志研新药物技术有限公司 |
| 2023/01/16New drug · Class 1 | TUL01101片CXHL2300084 | 珠海联邦制药股份有限公司 |
| 2023/01/16New drug · Class 1 | TUL01101片CXHL2300083 | 珠海联邦制药股份有限公司 |
| 2023/01/15New drug · Class 1 | FCN-159片CXHL2300082 | 上海复星医药产业发展有限公司 |
| 2023/01/15New drug · Class 1 | FCN-159片CXHL2300081 | 上海复星医药产业发展有限公司 |
| 2023/01/14Generic · Class 3 | 氨溴特罗口服溶液CYHS2300143 | 广东九明制药有限公司 |
| 2023/01/14Generic · Class 3 | 克林霉素磷酸酯注射液CYHS2300140 | 国药集团国瑞药业有限公司 |
| 2023/01/14Generic · Class 3 | 克林霉素磷酸酯注射液CYHS2300139 | 国药集团国瑞药业有限公司 |
| 2023/01/14Generic · Class 3 | 琥珀酸去甲文拉法辛缓释片CYHL2300006 | 福建瑞泰来医药科技有限公司 |
| 2023/01/14Generic · Class 3 | 琥珀酸去甲文拉法辛缓释片CYHL2300005 | 福建瑞泰来医药科技有限公司 |
| 2023/01/14New drug · Class 1 | 注射用JYB1907CXSL2300040 | 上海济煜医药科技有限公司; 江苏济烨生物制药有限公司 |
| 2023/01/14New drug · Class 1 | 苹果酸司曲替尼胶囊CXHL2300080 | 百济神州（苏州）生物科技有限公司 |
| 2023/01/14New drug · Class 1 | 苹果酸司曲替尼胶囊CXHL2300079 | 百济神州（苏州）生物科技有限公司 |
| 2023/01/14New drug · Class 1 | SVHRSP注射液CXHL2300078 | 沈阳万锦医药科技有限公司 |
| 2023/01/14New drug · Class 1 | ARTS-011胶囊CXHL2300077 | 安锐生物医药科技（广州）有限公司 |
| 2023/01/14New drug · Class 1 | ARTS-011胶囊CXHL2300076 | 安锐生物医药科技（广州）有限公司 |
| 2023/01/14New drug · Class 1 | ARTS-011胶囊CXHL2300075 | 安锐生物医药科技（广州）有限公司 |
| 2023/01/14New drug · Class 1 | TQH3910片CXHL2300074 | 正大天晴药业集团股份有限公司 |
| 2023/01/14New drug · Class 1 | TQH3910片CXHL2300073 | 正大天晴药业集团股份有限公司 |
| 2023/01/14New drug · Class 1 | TQB3823片CXHL2300072 | 正大天晴药业集团股份有限公司 |
| 2023/01/14New drug · Class 1 | TQB3823片CXHL2300071 | 正大天晴药业集团股份有限公司 |
| 2023/01/13Import · Class 3.4 | 注射用A型肉毒毒素JXSL2300024 | inibio co. ltd.; Beijing Yuzhuo Biotechnology Co. Ltd. |
| 2023/01/13Import · Class 1 | MEDI3506注射液JXSL2300023 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/01/13Generic · Class 3 | 注射用哌拉西林钠CYHS2300129 | 广东金城金素制药有限公司; 湖南科伦制药有限公司 |
| 2023/01/13Generic · Class 3 | 注射用哌拉西林钠CYHS2300128 | 广东金城金素制药有限公司; 湖南科伦制药有限公司 |
| 2023/01/13New drug · Class 1 | TQB2450注射液CXSS2300003 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2023/01/13New drug · Class 1 | KW-027注射液CXSL2300038 | 北京凯因科技股份有限公司 |
| 2023/01/13New drug · Class 3.2 | 注射用A型肉毒毒素CXSL2300037 | 兰州生物技术开发有限公司 |
| 2023/01/13New drug · Class 3.2 | 注射用A型肉毒毒素CXSL2300036 | 兰州生物技术开发有限公司 |
| 2023/01/13New drug · Class 1 | GC101腺相关病毒注射液CXSL2300035 | 北京锦篮基因科技有限公司 |
84 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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