药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/04/06 – 2021/04/12
- New acceptances this week
- 184
- 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
184filings, 18 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 92 |
| New drug | 37 |
| Import | 27 |
| Generic | 18 |
| Unspecified | 7 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 124 |
| 治疗用生物制品 | 41 |
| TCM | 10 |
| 预防用生物制品 | 9 |
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 | 头孢羟氨苄干混悬剂 | 2 | 1 | 2 |
| 2 | 小儿复方氨基酸注射液（20AA） | 2 | 1 | 2 |
| 3 | 伊布替尼胶囊 | 1 | 1 | 9 |
| 4 | 利伐沙班片 | 1 | 1 | 3 |
| 5 | 吗替麦考酚酯胶囊 | 1 | 1 | 3 |
| 6 | 多索茶碱注射液 | 1 | 1 | 5 |
| 7 | 左氧氟沙星注射液 | 1 | 1 | 1 |
| 8 | 己酮可可碱注射液 | 1 | 1 | 3 |
| 9 | 欧米加-3-酸乙酯90软胶囊 | 1 | 1 | 0 |
| 10 | 注射用特利加压素 | 1 | 1 | 1 |
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
109 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 上海君实生物医药科技股份有限公司 | 9 | 1 | 0 |
| 2 | 四川科伦博泰生物医药股份有限公司 | 5 | 3 | 0 |
| 3 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc. | 5 | 2 | 0 |
| 4 | 佛山德芮可制药有限公司 | 5 | 1 | 0 |
| 5 | Pfizer Inc | 4 | 3 | 0 |
| 6 | 山西康宝生物制品股份有限公司 | 4 | 2 | 0 |
| 7 | Janssen-Cilag International NV | 4 | 1 | 0 |
| 8 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc | 4 | 1 | 0 |
| 9 | 科兴生物制药股份有限公司 | 4 | 1 | 0 |
| 10 | Eurofins Analytical Science Laboratories Inc. | 3 | 3 | 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
65 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/04/12Import · Class 2.2 | 帕博利珠单抗注射液JXSL2101007 | Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd. |
| 2021/04/12New drug · Class 2.2 | 特瑞普利单抗注射液CXSL2101023 | 上海君实生物医药科技股份有限公司 |
| 2021/04/12New drug · Class 2.2 | 特瑞普利单抗注射液CXSL2101022 | 上海君实生物医药科技股份有限公司 |
| 2021/04/12New drug · Class 2.2 | 特瑞普利单抗注射液CXSL2101021 | 上海君实生物医药科技股份有限公司 |
| 2021/04/12New drug · Class 1 | SKB336注射液CXSL2101020 | 四川科伦博泰生物医药股份有限公司 |
| 2021/04/12New drug · Class 1 | D-0120-NA片CXHL2101029 | 益方生物科技（上海）股份有限公司 |
| 2021/04/12New drug · Class 1 | KL280006注射液CXHL2101028 | 四川科伦博泰生物医药股份有限公司 |
| 2021/04/12New drug · Class 1 | KL280006注射液CXHL2101027 | 四川科伦博泰生物医药股份有限公司 |
| 2021/04/12New drug · Class 2.4 | 甲磺酸仑伐替尼胶囊CXHL2101026 | 先声药业有限公司 |
| 2021/04/10Import · Class 3.1 | 奥马珠单抗注射液JXSS2101003 | Novartis Europharm Limited; Vetter Pharma-Fertigung GmbH & Co. KG; Beijing Novartis Pharma Co. Ltd. |
| 2021/04/10Import · Class 3.1 | 奥马珠单抗注射液JXSS2101002 | Novartis Europharm Limited; Vetter Pharma-Fertigung GmbH & Co. KG; Beijing Novartis Pharma Co. Ltd. |
| 2021/04/10Import · Class 1 | BI655130注射液JXSL2101006 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/04/10Import · Class 1 | LNP023胶囊JXHL2101008 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2021/04/10Import · Class 1 | LNP023胶囊JXHL2101007 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2021/04/10Generic · Class 3 | 小儿复方氨基酸注射液（20AA）CYHS2101053 | 内蒙古白医制药股份有限公司 |
| 2021/04/10Generic · Class 3 | 小儿复方氨基酸注射液（20AA）CYHS2101052 | 内蒙古白医制药股份有限公司 |
| 2021/04/10Generic · Class 3 | 己酮可可碱注射液CYHS2101051 | 石家庄四药有限公司 |
| 2021/04/10Generic · Class 3 | 左氧氟沙星注射液CYHS2101048 | 华夏生生药业（北京）有限公司 |
| 2021/04/10Generic · Class 3 | 西格列汀二甲双胍缓释片CYHS2101046 | 正大天晴药业集团股份有限公司 |
| 2021/04/10Generic · Class 3 | 欧米加-3-酸乙酯90软胶囊CYHS2101042 | 扬子江药业集团有限公司 |
| 2021/04/10New drug · Class 1.2 | 阿可拉定软胶囊CXZS2101001 | 北京珅诺基医药科技有限公司; 北京康而福药业有限责任公司 |
| 2021/04/10New drug · Class 1.2 | 阿可拉定CXZS2101000 | 山东珅诺基药业有限公司 |
| 2021/04/10New drug · Class 2.2 | 特瑞普利单抗注射液CXSL2101018 | 上海君实生物医药科技股份有限公司 |
| 2021/04/10New drug · Class 2.2 | 特瑞普利单抗注射液CXSL2101017 | 上海君实生物医药科技股份有限公司 |
| 2021/04/10New drug · Class 2.2 | 特瑞普利单抗注射液CXSL2101016 | 上海君实生物医药科技股份有限公司 |
| 2021/04/10New drug · Class 2.2 | 人干扰素α2b喷雾剂CXSL2101015 | 安徽安科生物工程（集团）股份有限公司 |
| 2021/04/10New drug · Class 2.2 | 特瑞普利单抗注射液CXSL2101014 | 上海君实生物医药科技股份有限公司 |
| 2021/04/10New drug · Class 2.2 | 特瑞普利单抗注射液CXSL2101013 | 上海君实生物医药科技股份有限公司 |
| 2021/04/10New drug · Class 2.2 | 特瑞普利单抗注射液CXSL2101012 | 上海君实生物医药科技股份有限公司 |
| 2021/04/10New drug · Class 2.2 | 盐酸帕洛诺司琼口颊膜CXHL2101022 | 力品药业（厦门）股份有限公司 |
35 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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