药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/12/20 – 2022/12/26
- New acceptances this week
- 123
- Drugs with new generic filings (by drug name, de-duplicated)
- 16
- 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
123filings, 19 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 59 |
| Import | 20 |
| Generic | 19 |
| New drug | 14 |
| Unspecified | 9 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 87 |
| 治疗用生物制品 | 29 |
| TCM | 4 |
| 预防用生物制品 | 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
16 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 乳果糖口服溶液 | 2 | 2 | 36 |
| 2 | 氯替泼诺混悬滴眼液 | 2 | 1 | 1 |
| 3 | 碘普罗胺注射液 | 2 | 1 | 27 |
| 4 | 丙泊酚中/长链脂肪乳注射液 | 1 | 1 | 3 |
| 5 | 他达拉非片 | 1 | 1 | 23 |
| 6 | 别嘌醇片 | 1 | 1 | 4 |
| 7 | 吸入用硫酸沙丁胺醇溶液 | 1 | 1 | 2 |
| 8 | 哌柏西利片 | 1 | 1 | 2 |
| 9 | 左氧氟沙星注射液 | 1 | 1 | 1 |
| 10 | 布洛芬混悬液 | 1 | 1 | 14 |
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
70 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 湖北一半天制药有限公司 | 12 | 12 | 0 |
| 2 | 杭州九源基因工程有限公司 | 10 | 1 | 0 |
| 3 | 山东威高输血技术装备有限公司 | 9 | 3 | 0 |
| 4 | 安庆回音必制药股份有限公司 | 5 | 4 | 0 |
| 5 | Microlabs | 3 | 3 | 0 |
| 6 | Amgen Inc. | 3 | 1 | 0 |
| 7 | Aspen Pharma Trading Limited | 3 | 1 | 0 |
| 8 | Otsuka Pharmaceutical Co.，Ltd. | 3 | 1 | 0 |
| 9 | 北京赛升药业股份有限公司 | 3 | 1 | 0 |
| 10 | 湖南科伦制药有限公司 | 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
28 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/12/26New drug · Class 1.1 | 苏合颗粒CXZL2200055 | 重庆巨琪诺美制药有限公司; 北京中医药大学 |
| 2022/12/26New drug · Class 2.3 | 痹克片CXZL2200054 | 合肥今越制药有限公司 |
| 2022/12/26New drug · Class 1 | YH008注射用冻干粉CXSL2200614 | 祐和医药科技（北京）有限公司 |
| 2022/12/26New drug · Class 2.2 | BCM347口溶膜CXHL2200950 | 上海博志研新药物技术有限公司 |
| 2022/12/26New drug · Class 1 | HRS-5965片CXHL2200949 | 成都盛迪医药有限公司 |
| 2022/12/26New drug · Class 1 | HRS-5965片CXHL2200948 | 成都盛迪医药有限公司 |
| 2022/12/24Import · Class 3.1 | 依库珠单抗注射液JXSS2200041 | Alexion Europe SAS; Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Investment (China) Co. Ltd |
| 2022/12/24Import · Class 1 | LY3473329片JXHL2200351 | Eli Lilly and Company |
| 2022/12/24Import · Class 1 | LY3473329片JXHL2200350 | Eli Lilly and Company |
| 2022/12/23Import · Class 1 | AMG 451JXSL2200211 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2022/12/23Import · Class 1 | AMG 451JXSL2200210 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2022/12/23Import · Class 1 | AMG 451JXSL2200209 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2022/12/23Import · Class 1 | Cetrelimab 注射液JXSL2200208 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/12/23Import · Class 1 | Cetrelimab 注射液（皮下注射）JXSL2200207 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/12/23Import · Class 1 | MEDI5752JXSL2200206 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2022/12/23New drug · Class 1 | AP017单克隆抗体注射液CXSL2200613 | 安源医药科技（上海）有限公司 |
| 2022/12/23New drug · Class 1 | LK101注射液CXSL2200612 | 北京立康生命科技有限公司 |
| 2022/12/22Import · Class 1 | 仑卡奈单抗注射液JXSS2200040 | Eisai Inc.; Biogen US Corporation; Eisai China Inc. |
| 2022/12/22Import · Class 1 | 仑卡奈单抗注射液JXSS2200039 | Eisai Inc.; Biogen US Corporation; Eisai China Inc. |
| 2022/12/22New drug · Class 1 | HMI-115CXSL2200611 | 和其瑞医药（南京）有限公司 |
| 2022/12/21Generic · Class 3 | 别嘌醇片CYHS2202092 | 浙江普利药业有限公司 |
| 2022/12/21New drug · Class 1 | 重组人IL-21溶瘤痘病毒注射液（hV01）CXSL2200610 | 杭州康万达医药科技有限公司 |
| 2022/12/21New drug · Class 1 | 注射用重组抗HER2结构域II和结构域IV双特异性抗体-MMAE偶联物CXSL2200609 | 轩竹生物科技股份有限公司; 北京轩竹康明生物科技有限公司 |
| 2022/12/20Generic · Class 3 | 左氧氟沙星注射液CYHS2202080 | 国仁健康制药（北京）有限公司; 山东罗欣药业集团股份有限公司 |
| 2022/12/20Generic · Class 3 | 氯化钾口服溶液CYHS2202079 | 北京诚济制药股份有限公司 |
| 2022/12/20New drug · Class 1.1 | 健脾益气口服液CXZL2200053 | 广西中医药大学第一附属医院（广西中医医院） |
| 2022/12/20New drug · Class 1 | 注射用SKB410CXSL2200608 | 四川科伦博泰生物医药股份有限公司 |
| 2022/12/20New drug · Class 1 | PE0116注射液CXSL2200606 | 上海怀越生物科技有限公司 |
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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