药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/04/19 – 2022/04/25
- New acceptances this week
- 275
- Drugs with new generic filings (by drug name, de-duplicated)
- 40
- 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
275filings, 58 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 152 |
| Generic | 58 |
| New drug | 37 |
| Import | 14 |
| Unspecified | 7 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 194 |
| 治疗用生物制品 | 40 |
| TCM | 33 |
| Biologic | 4 |
| 预防用生物制品 | 4 |
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
40 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸卡利拉嗪胶囊 | 4 | 1 | 3 |
| 2 | 注射用头孢米诺钠 | 3 | 1 | 0 |
| 3 | 盐酸左沙丁胺醇雾化吸入溶液 | 3 | 1 | 2 |
| 4 | 吡非尼酮片 | 2 | 2 | 5 |
| 5 | 多巴丝肼片 | 2 | 2 | 2 |
| 6 | 枸橼酸坦度螺酮片 | 2 | 2 | 2 |
| 7 | 氧（液态） | 2 | 2 | 14 |
| 8 | 氨溴特罗口服溶液 | 2 | 2 | 23 |
| 9 | 他克莫司软膏 | 2 | 1 | 8 |
| 10 | 他达拉非片 | 2 | 1 | 23 |
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
162 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 四川天府康达药业集团府庆制药有限公司 | 15 | 14 | 0 |
| 2 | 南昌百济制药有限公司 | 8 | 7 | 0 |
| 3 | Bristol-Myers Squibb Pharma EEIG | 8 | 2 | 0 |
| 4 | 四川美大康佳乐药业有限公司 | 7 | 1 | 0 |
| 5 | 湖北荟海医药技术研究院有限公司 | 5 | 5 | 0 |
| 6 | 浙江京新药业股份有限公司 | 5 | 2 | 4 |
| 7 | AstraZeneca UK Limited | 4 | 1 | 0 |
| 8 | GUERBET | 4 | 1 | 0 |
| 9 | 宜昌人福药业有限责任公司 | 4 | 1 | 0 |
| 10 | 山东新时代药业有限公司 | 3 | 3 | 2 |
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
73 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/04/25Generic · Class 3 | 胞磷胆碱注射液CYHS2200652 | 成都市海通药业有限公司 |
| 2022/04/25Generic · Class 3 | 氨甲环酸注射液CYHS2200651 | 成都市海通药业有限公司 |
| 2022/04/25Generic · Class 3 | 氨溴特罗口服溶液CYHS2200649 | 黑龙江中桂制药有限公司 |
| 2022/04/25New drug · Class 2.2 | 尼妥珠单抗注射液CXSS2200041 | 百泰生物药业有限公司 |
| 2022/04/25New drug · Class 3.4 | 治疗用卡介苗CXSL2200188 | 成都可恩生物科技有限公司 |
| 2022/04/25New drug · Class 2.2 | 盐酸伊立替康脂质体注射液CXHS2200019 | 江苏恒瑞医药股份有限公司 |
| 2022/04/25New drug · Class 1 | SC0062胶囊CXHL2200260 | 无锡智康弘义生物科技有限公司 |
| 2022/04/25New drug · Class 1 | RJ4287片CXHL2200259 | 南京奥利墨斯医药科技有限公司 |
| 2022/04/25New drug · Class 1 | RJ4287片CXHL2200258 | 南京奥利墨斯医药科技有限公司 |
| 2022/04/25New drug · Class 1 | TSN333片CXHL2200257 | 泰励生物科技（上海）有限公司 |
| 2022/04/25New drug · Class 1 | TSN333片CXHL2200256 | 泰励生物科技（上海）有限公司 |
| 2022/04/24Import · Class 2.2 | Efgartigimod浓缩注射液JXSL2200050 | argenx BV; Zai Lab (Shanghai) Co. Ltd. |
| 2022/04/24Import · Class 2.4 | 达罗他胺片JXHS2200041 | Bayer HealthCare Pharmaceuticals Inc.; Orion Corporation，Orion Pharma，Espoo; Bayer Healthcare Company Ltd. |
| 2022/04/24Import · Class 2.4 | Ibrexafungerp片JXHL2200090 | SCYNEXIS Inc.; JIANGSU HANSOH PHARMACEUTICAL GROUP CO. LTD |
| 2022/04/24Generic · Class 3 | 吡非尼酮片CYHS2200634 | 浙江金华康恩贝生物制药有限公司 |
| 2022/04/24Generic · Class 3 | 盐酸卡利拉嗪胶囊CYHL2200039 | 浙江京新药业股份有限公司 |
| 2022/04/24Generic · Class 3 | 盐酸卡利拉嗪胶囊CYHL2200038 | 浙江京新药业股份有限公司 |
| 2022/04/24Generic · Class 3 | 盐酸卡利拉嗪胶囊CYHL2200037 | 浙江京新药业股份有限公司 |
| 2022/04/24Generic · Class 3 | 盐酸卡利拉嗪胶囊CYHL2200036 | 浙江京新药业股份有限公司 |
| 2022/04/24Generic · Class 3 | 瑞加诺生注射液CYHL2200035 | 南京瑞克卫生物医药有限公司 |
| 2022/04/24New drug · Class 3.3 | 肠道病毒71型灭活疫苗（Vero细胞）CXSS2200043 | 武汉生物制品研究所有限责任公司 |
| 2022/04/24New drug · Class 3.3 | 肠道病毒71型灭活疫苗（Vero细胞）CXSS2200042 | 武汉生物制品研究所有限责任公司 |
| 2022/04/24New drug · Class 3.3 | 司美格鲁肽注射液CXSL2200185 | 重庆派金生物科技有限公司; 杭州中美华东制药有限公司 |
| 2022/04/24New drug · Class 1 | CMAB017注射液CXSL2200183 | 泰州迈博太科药业有限公司 |
| 2022/04/24New drug · Class 1 | 安达西尼胶囊CXHS2200018 | 浙江京新药业股份有限公司 |
| 2022/04/24New drug · Class 2.2 | HY-071221口服溶液CXHL2200254 | 合肥医工医药股份有限公司 |
| 2022/04/24New drug · Class 1 | BGM0504注射液CXHL2200253 | 博瑞生物医药（苏州）股份有限公司 |
| 2022/04/24New drug · Class 1 | BR790片CXHL2200252 | 上海歌斐木生物医药科技有限公司 |
| 2022/04/22Import · Class 3.1 | 纳武利尤单抗注射液JXSS2200015 | Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb （China）Investment Co. Ltd |
| 2022/04/22Import · Class 3.1 | 纳武利尤单抗注射液JXSS2200014 | Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb （China）Investment Co. Ltd |
43 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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