药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/12/13 – 2022/12/19
- New acceptances this week
- 112
- Drugs with new generic filings (by drug name, de-duplicated)
- 12
- 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
112filings, 13 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 68 |
| New drug | 14 |
| Generic | 13 |
| Import re-registration | 9 |
| Import | 6 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 86 |
| TCM | 16 |
| 治疗用生物制品 | 9 |
| 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
12 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 地夸磷索钠滴眼液 | 2 | 1 | 5 |
| 2 | 卡泊三醇软膏 | 1 | 1 | 5 |
| 3 | 来特莫韦注射液 | 1 | 1 | 6 |
| 4 | 氟哌噻吨美利曲辛片 | 1 | 1 | 4 |
| 5 | 氧（液态） | 1 | 1 | 14 |
| 6 | 沙库巴曲缬沙坦钠片 | 1 | 1 | 68 |
| 7 | 注射用盐酸罗沙替丁醋酸酯 | 1 | 1 | 5 |
| 8 | 注射用达托霉素 | 1 | 1 | 1 |
| 9 | 甲苯磺酸卢美哌隆胶囊 | 1 | 1 | 2 |
| 10 | 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
54 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 湖北荟海医药技术研究院有限公司 | 10 | 9 | 0 |
| 2 | 湖北一半天制药有限公司 | 9 | 9 | 0 |
| 3 | 江西人可医药科技有限公司 | 8 | 7 | 0 |
| 4 | 上海皇象铁力蓝天制药有限公司 | 5 | 5 | 0 |
| 5 | Fresenius Kabi AB | 5 | 1 | 0 |
| 6 | Medice Arzneimittel Pütter GmbH & Co.KG | 5 | 1 | 0 |
| 7 | KOBAYASHI Pharmaceutical Co. Ltd. | 4 | 1 | 0 |
| 8 | 江西浩然生物制药有限公司 | 4 | 1 | 0 |
| 9 | 国源国药（广东）制药集团有限公司 | 3 | 3 | 0 |
| 10 | 凌科药业（杭州）有限公司 | 3 | 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 |
|---|---|---|
| 2022/12/17Import · Class 1 | TQB2223注射液JXSL2200205 | CLARUSUN PHARMACEUTICAL CORP.; Chia Tai Tianqing Pharmaceutical Group Co. Ltd. |
| 2022/12/17Generic · Class 3 | 甲苯磺酸卢美哌隆胶囊CYHL2200113 | 江苏恩华药业股份有限公司 |
| 2022/12/17New drug · Class 1 | 自分泌PD1抗体靶向间皮素嵌合抗原受体T细胞注射液CXSL2200605 | 上海细胞治疗集团药物技术有限公司 |
| 2022/12/17New drug · Class 1 | VC005凝胶CXHL2200943 | 江苏威凯尔医药科技有限公司 |
| 2022/12/17New drug · Class 1 | VC005凝胶CXHL2200942 | 江苏威凯尔医药科技有限公司 |
| 2022/12/17New drug · Class 1 | VC005凝胶CXHL2200941 | 江苏威凯尔医药科技有限公司 |
| 2022/12/16New drug · Class 3.4 | 静注人免疫球蛋白(pH4)CXSL2200604 | 广东丹霞生物制药有限公司 |
| 2022/12/16New drug · Class 3.4 | 静注人免疫球蛋白(pH4)CXSL2200603 | 广东丹霞生物制药有限公司 |
| 2022/12/14New drug · Class 1 | JMKX003002片CXHL2200940 | 浙江杭煜制药有限公司; 江西国药有限责任公司 |
| 2022/12/14New drug · Class 1 | JMKX003002片CXHL2200939 | 浙江杭煜制药有限公司; 江西国药有限责任公司 |
| 2022/12/14New drug · Class 1 | JMKX003002片CXHL2200938 | 浙江杭煜制药有限公司; 江西国药有限责任公司 |
| 2022/12/14New drug · Class 2.2 | 氟尿嘧啶植入剂CXHL2200937 | 合肥即安医药研究有限公司 |
| 2022/12/13Generic · Class 3 | 注射用盐酸罗沙替丁醋酸酯CYHS2202066 | 双鹤药业（海南）有限责任公司 |
| 2022/12/13New drug · Class 1 | 赫基仑赛注射液（暂定）CXSS2200093 | 合源生物科技（天津）有限公司 |
| 2022/12/13New drug · Class 3.3 | 利妥昔单抗注射液CXSS2200092 | 上海生物制品研究所有限责任公司 |
| 2022/12/13New drug · Class 2.2 | 注射用A型肉毒毒素CXSL2200602 | 兰州生物技术开发有限公司 |
| 2022/12/13New drug · Class 2.2 | 注射用A型肉毒毒素CXSL2200601 | 兰州生物技术开发有限公司 |
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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