药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/01/17 – 2023/01/23
- New acceptances this week
- 261
- Drugs with new generic filings (by drug name, de-duplicated)
- 51
- Accepted this week, now under review
- 0
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
261filings, 76 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 115 |
| Generic | 76 |
| New drug | 45 |
| Import | 12 |
| Import re-registration | 7 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 202 |
| 治疗用生物制品 | 35 |
| TCM | 24 |
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
51 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 他达拉非片 | 3 | 1 | 23 |
| 2 | 富马酸喹硫平片 | 3 | 1 | 0 |
| 3 | 倍他米松磷酸钠注射液 | 2 | 2 | 5 |
| 4 | 地夸磷索钠滴眼液 | 2 | 2 | 5 |
| 5 | 左西孟旦注射液 | 2 | 2 | 1 |
| 6 | 己酮可可碱注射液 | 2 | 2 | 3 |
| 7 | 替米沙坦氢氯噻嗪片 | 2 | 2 | 2 |
| 8 | 瑞戈非尼片 | 2 | 2 | 3 |
| 9 | 醋酸加尼瑞克注射液 | 2 | 2 | 1 |
| 10 | 培哚普利吲达帕胺片 | 2 | 1 | 5 |
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
155 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 平光制药股份有限公司 | 10 | 9 | 1 |
| 2 | 齐鲁制药有限公司 | 6 | 6 | 5 |
| 3 | MUNDIPHARMA GmbH | 6 | 1 | 0 |
| 4 | 康芝药业股份有限公司 | 5 | 5 | 0 |
| 5 | Pfizer Inc. | 5 | 2 | 0 |
| 6 | 江西施美药业股份有限公司 | 5 | 2 | 5 |
| 7 | 成都倍特得诺药业有限公司 | 4 | 4 | 3 |
| 8 | 江苏恒瑞医药股份有限公司 | 4 | 3 | 0 |
| 9 | 齐鲁制药(海南)有限公司 | 4 | 2 | 4 |
| 10 | Grand Medical Pty Ltd. | 3 | 3 | 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
74 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/01/21New drug · Class 1 | CT041自体CAR T细胞注射液CXSL2300059 | 上海科济制药有限公司 |
| 2023/01/20Import · Class 1 | VSA003注射液JXHL2300013 | Visirna Therapeutics HK Limited; Visirna Therapeutics (Shanghai) Co Ltd. |
| 2023/01/20Import · Class 1 | Milvexian片JXHL2300012 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/01/20Generic · Class 3 | 己酮可可碱注射液CYHS2300207 | 平光制药股份有限公司 |
| 2023/01/20Generic · Class 3 | 倍他米松磷酸钠注射液CYHS2300203 | 津药和平(天津)制药有限公司 |
| 2023/01/20Generic · Class 3 | 地氯雷他定口服溶液CYHS2300199 | 海南斯达制药有限公司 |
| 2023/01/20New drug · Class 2.2;2.3 | HYR0201颗粒CXZL2300003 | 天地恒一制药股份有限公司 |
| 2023/01/20New drug · Class 1 | 注射用SHR-4602CXSL2300058 | 苏州盛迪亚生物医药有限公司; 上海盛迪医药有限公司 |
| 2023/01/20New drug · Class 1 | 注射用AP026CXSL2300057 | 安源医药科技(上海)有限公司 |
| 2023/01/20New drug · Class 1 | 甲磺酸贝福替尼胶囊CXHS2300016 | 贝达药业股份有限公司 |
| 2023/01/20New drug · Class 1 | 甲磺酸贝福替尼胶囊CXHS2300015 | 贝达药业股份有限公司 |
| 2023/01/20New drug · Class 2.4 | 甲磺酸伏美替尼片CXHL2300110 | 上海艾力斯医药科技股份有限公司 |
| 2023/01/20New drug · Class 1 | QHRD107胶囊CXHL2300109 | 常州千红生化制药股份有限公司 |
| 2023/01/20New drug · Class 1 | QHRD107胶囊CXHL2300108 | 常州千红生化制药股份有限公司 |
| 2023/01/20New drug · Class 1 | QHRD107胶囊CXHL2300107 | 常州千红生化制药股份有限公司 |
| 2023/01/20New drug · Class 2.2 | 苯磺酸氨氯地平颗粒CXHL2300103 | 广东东阳光药业有限公司 |
| 2023/01/20New drug · Class 2.2 | 苯磺酸氨氯地平颗粒CXHL2300102 | 广东东阳光药业有限公司 |
| 2023/01/20New drug · Class 2.2 | 苯磺酸氨氯地平颗粒CXHL2300101 | 广东东阳光药业有限公司 |
| 2023/01/20New drug · Class 1 | G201-Na胶囊CXHL2300100 | 石家庄以岭药业股份有限公司 |
| 2023/01/20New drug · Class 1 | G201-Na胶囊CXHL2300099 | 石家庄以岭药业股份有限公司 |
| 2023/01/19Import · Class 1 | VSA001注射液JXHL2300011 | Visirna Therapeutics HK Limited; Visirna Therapeutics (Shanghai) Co Ltd. |
| 2023/01/19Import · Class 1 | BRM421 滴眼液JXHL2300010 | BRIM Biotechnology Inc.; Grandpharma (China) Co. Ltd. |
| 2023/01/19Generic · Class 3 | 奥硝唑注射液CYHS2300196 | 沈阳双鼎制药有限公司 |
| 2023/01/19Generic · Class 3 | 奥硝唑注射液CYHS2300195 | 沈阳双鼎制药有限公司 |
| 2023/01/19Generic · Class 3 | 盐酸肾上腺素注射液CYHS2300192 | 海南倍特药业有限公司 |
| 2023/01/19Generic · Class 3 | 醋酸维持液(含葡萄糖)CYHS2300190 | 南京赛瑞谱顿制药有限公司; 江苏大红鹰恒顺药业有限公司 |
| 2023/01/19Generic · Class 3 | 醋酸维持液(含葡萄糖)CYHS2300189 | 南京赛瑞谱顿制药有限公司; 江苏大红鹰恒顺药业有限公司 |
| 2023/01/19Generic · Class 3 | 帕拉米韦注射液CYHS2300186 | 石药集团中诺药业(石家庄)有限公司 |
| 2023/01/19Generic · Class 3 | 尼莫地平口服溶液CYHS2300185 | 成都倍特得诺药业有限公司 |
| 2023/01/19Generic · Class 3 | 倍他米松磷酸钠注射液CYHS2300183 | 成都倍特得诺药业有限公司 |
44 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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