药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/05/11 – 2021/05/17
- New acceptances this week
- 222
- Drugs with new generic filings (by drug name, de-duplicated)
- 19
- 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
222filings, 31 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 111 |
| New drug | 50 |
| Generic | 31 |
| Import | 24 |
| Import re-registration | 4 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 156 |
| 治疗用生物制品 | 43 |
| TCM | 16 |
| 预防用生物制品 | 5 |
| 体外诊断试剂 | 1 |
| Biologic | 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
19 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 他达拉非片 | 4 | 3 | 23 |
| 2 | 克林霉素磷酸酯注射液 | 3 | 1 | 4 |
| 3 | 布瑞哌唑片 | 3 | 1 | 31 |
| 4 | 注射用帕瑞昔布钠 | 2 | 2 | 2 |
| 5 | 甲磺酸奥希替尼片 | 2 | 1 | 2 |
| 6 | 硫酸特布他林雾化吸入用溶液 | 2 | 1 | 1 |
| 7 | 磷酸奥司他韦胶囊 | 2 | 1 | 42 |
| 8 | 缬沙坦片 | 2 | 1 | 0 |
| 9 | 吸入用硫酸沙丁胺醇溶液 | 1 | 1 | 2 |
| 10 | 地氯雷他定口服溶液 | 1 | 1 | 26 |
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
120 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 浙江普洛康裕制药有限公司 | 15 | 10 | 0 |
| 2 | 内蒙古天奇中蒙制药股份有限公司 | 8 | 7 | 0 |
| 3 | 齐鲁制药有限公司 | 6 | 3 | 0 |
| 4 | Takeda Development Center Americas Inc. | 6 | 2 | 0 |
| 5 | 江苏恒瑞医药股份有限公司 | 5 | 3 | 0 |
| 6 | Novartis Pharma AG | 5 | 2 | 0 |
| 7 | 上海医药集团股份有限公司 | 4 | 2 | 0 |
| 8 | 海南海灵化学制药有限公司 | 4 | 2 | 0 |
| 9 | LTL Pharma Co. Ltd. | 4 | 1 | 0 |
| 10 | 威世药业（如皋）有限公司 | 4 | 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
82 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/05/17Generic · Class 3 | 布瑞哌唑片CYHS2101163 | 成都苑东生物制药股份有限公司 |
| 2021/05/17Generic · Class 3 | 布瑞哌唑片CYHS2101162 | 成都苑东生物制药股份有限公司 |
| 2021/05/17Generic · Class 3 | 布瑞哌唑片CYHS2101161 | 成都苑东生物制药股份有限公司 |
| 2021/05/17New drug · Class 3.2 | 四价流感病毒裂解疫苗CXSS2101001 | 华兰生物疫苗股份有限公司 |
| 2021/05/17New drug · Class 1 | BBM-H901注射液CXSL2101082 | 上海信致医药科技有限公司 |
| 2021/05/17New drug · Class 1 | SHR-1906注射液CXSL2101081 | 广东恒瑞医药有限公司 |
| 2021/05/17New drug · Class 1 | SHR-1906注射液CXSL2101080 | 广东恒瑞医药有限公司 |
| 2021/05/17New drug · Class 1 | 林普利司片CXHS2101013 | 上海璎黎药业有限公司; 江苏宣泰药业有限公司 |
| 2021/05/17New drug · Class 1 | HRS2398片CXHL2101132 | 上海恒瑞医药有限公司 |
| 2021/05/17New drug · Class 1 | HRS2398片CXHL2101131 | 上海恒瑞医药有限公司 |
| 2021/05/17New drug · Class 1 | WXWH0240片CXHL2101130 | 辰欣药业股份有限公司 |
| 2021/05/17New drug · Class 1 | WXWH0240片CXHL2101129 | 辰欣药业股份有限公司 |
| 2021/05/17New drug · Class 1 | WXWH0240片CXHL2101128 | 辰欣药业股份有限公司 |
| 2021/05/14Import · Class 1 | Relatlimab/Nivolumab固定剂量复方注射液JXSL2101027 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2021/05/14Import · Class 2.2 | 注射用维得利珠单抗JXSL2101025 | Takeda Development Center Americas Inc. |
| 2021/05/14Import · Class 1 | ZN-d5片JXHL2101039 | Zentera Therapeutics HK Limited; Zentera Therapeutics Shanghai Co. Ltd |
| 2021/05/14Import · Class 1 | ZN-d5片JXHL2101038 | Zentera Therapeutics HK Limited; Zentera Therapeutics Shanghai Co. Ltd |
| 2021/05/14Import · Class 1 | Cotadutide注射液JXHL2101037 | AstraZeneca AB; AstraZeneca Investment (China)Co. Ltd. |
| 2021/05/14Generic · Class 3 | 地氯雷他定口服溶液CYHS2101158 | 福安药业集团湖北人民制药有限公司 |
| 2021/05/14Generic · Class 3 | 枸橼酸托法替布缓释片CYHS2101133 | 上海宣泰医药科技股份有限公司; 江苏宣泰药业有限公司 |
| 2021/05/14Generic · Class 3 | 克林霉素磷酸酯注射液CYHS2101129 | 广东金城金素制药有限公司; 福安药业集团烟台只楚药业有限公司 |
| 2021/05/14Generic · Class 3 | 克林霉素磷酸酯注射液CYHS2101128 | 广东金城金素制药有限公司; 福安药业集团烟台只楚药业有限公司 |
| 2021/05/14Generic · Class 3 | 克林霉素磷酸酯注射液CYHS2101127 | 广东金城金素制药有限公司; 福安药业集团烟台只楚药业有限公司 |
| 2021/05/14New drug · Class 1.2 | 重组带状疱疹疫苗(CHO 细胞)CXSL2101078 | 北京绿竹生物技术股份有限公司 |
| 2021/05/14New drug · Class 1.2 | 重组带状疱疹疫苗(CHO 细胞)CXSL2101077 | 北京绿竹生物技术股份有限公司 |
| 2021/05/14New drug · Class 1 | 重组人源化抗PD-1单克隆抗体注射液CXSL2101076 | 泰州翰中生物医药有限公司 |
| 2021/05/14New drug · Class 1 | BR102注射液CXSL2101075 | 海正生物制药有限公司; 浙江博锐生物制药有限公司 |
| 2021/05/14New drug · Class 2.2 | 信迪利单抗注射液CXSL2101074 | 信达生物制药（苏州）有限公司 |
| 2021/05/14New drug · Class 2.2 | IBI310CXSL2101073 | 信达生物制药（苏州）有限公司 |
| 2021/05/14New drug · Class 1 | 注射用QLS31905CXSL2101072 | 齐鲁制药有限公司 |
52 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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