药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/05/17 – 2022/05/23
- New acceptances this week
- 37
- Drugs with new generic filings (by drug name, de-duplicated)
- 3
- 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
37filings, 4 of them generic
By application type
| Application type | Filings |
|---|---|
| New drug | 14 |
| Supplement | 12 |
| Generic | 4 |
| Import re-registration | 4 |
| Import | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 24 |
| 治疗用生物制品 | 8 |
| TCM | 4 |
| 预防用生物制品 | 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
3 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 富马酸伏诺拉生片 | 2 | 1 | 58 |
| 2 | 左乙拉西坦口服溶液 | 1 | 1 | 3 |
| 3 | 盐酸乌拉地尔注射液 | 1 | 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
21 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 正大天晴药业集团南京顺欣制药有限公司 | 4 | 2 | 0 |
| 2 | Santen Pharmaceutical Co. Ltd. | 4 | 1 | 0 |
| 3 | 哈药集团世一堂制药厂 | 3 | 3 | 0 |
| 4 | Karuna Therapeutics Inc. | 3 | 1 | 0 |
| 5 | 通化东宝药业股份有限公司 | 3 | 1 | 0 |
| 6 | Kyowa Kirin Co. Ltd | 2 | 1 | 0 |
| 7 | 宜昌人福药业有限责任公司 | 2 | 1 | 2 |
| 8 | 成都盛迪医药有限公司 | 2 | 1 | 0 |
| 9 | 无锡智康弘义生物科技有限公司 | 2 | 1 | 0 |
| 10 | Janssen Biologics B.V. | 1 | 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
17 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/05/20Import · Class 1 | KarXT胶囊JXHL2200118 | Karuna Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2022/05/20Import · Class 1 | KarXT胶囊JXHL2200117 | Karuna Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2022/05/20Import · Class 1 | KarXT胶囊JXHL2200116 | Karuna Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2022/05/20New drug · Class 1.1 | 黄酯胶囊CXZL2200023 | 四川省中医药科学院(四川省中药研究所) |
| 2022/05/20New drug · Class 1 | MG-ZG122人源化单抗注射液CXSL2200218 | 上海麦济生物技术有限公司 |
| 2022/05/20New drug · Class 1 | 注射用YL201CXSL2200217 | 苏州宜联生物医药有限公司 |
| 2022/05/20New drug · Class 1 | GR1501注射液CXSL2200216 | 重庆智翔金泰生物制药股份有限公司 |
| 2022/05/20New drug · Class 1 | TQ-B3139胶囊CXHS2200026 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2022/05/20New drug · Class 1 | TQ-B3139胶囊CXHS2200025 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2022/05/20New drug · Class 1 | TQ-B3139胶囊CXHS2200024 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2022/05/20New drug · Class 1 | HRS-4642注射液CXHL2200313 | 江苏恒瑞医药股份有限公司 |
| 2022/05/20New drug · Class 1 | HRS-5965片CXHL2200312 | 成都盛迪医药有限公司 |
| 2022/05/20New drug · Class 1 | HRS-5965片CXHL2200311 | 成都盛迪医药有限公司 |
| 2022/05/20New drug · Class 1 | SC0245片CXHL2200310 | 无锡智康弘义生物科技有限公司 |
| 2022/05/20New drug · Class 1 | SC0245片CXHL2200309 | 无锡智康弘义生物科技有限公司 |
| 2022/05/20New drug · Class 1 | 氟[18F]思睿肽注射液CXHL2200308 | 上海蓝纳成生物技术有限公司 |
| 2022/05/18New drug · Class 2.2 | 冻干人用狂犬病疫苗(鸡胚细胞)CXSL2200214 | 深圳市卫光生物制品股份有限公司 |
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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