药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/03/15 – 2022/03/21
- New acceptances this week
- 256
- Drugs with new generic filings (by drug name, de-duplicated)
- 18
- 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
256filings, 23 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 180 |
| Generic | 23 |
| New drug | 18 |
| Unspecified | 18 |
| Import | 12 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 173 |
| 治疗用生物制品 | 45 |
| TCM | 22 |
| 预防用生物制品 | 10 |
| Biologic | 6 |
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
18 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 米诺地尔搽剂 | 2 | 2 | 49 |
| 2 | 丙戊酸钠注射用浓溶液 | 2 | 1 | 0 |
| 3 | 吸入用异丙托溴铵溶液 | 2 | 1 | 2 |
| 4 | 普瑞巴林胶囊 | 2 | 1 | 12 |
| 5 | 艾塞那肽注射液 | 2 | 1 | 0 |
| 6 | 二硫化硒洗剂 | 1 | 1 | 14 |
| 7 | 布南色林片 | 1 | 1 | 0 |
| 8 | 氨氯地平阿托伐他汀钙片 | 1 | 1 | 2 |
| 9 | 注射用尼可地尔 | 1 | 1 | 1 |
| 10 | 瑞戈非尼片 | 1 | 1 | 3 |
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
136 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 国九堂山东阿胶有限公司 | 17 | 15 | 0 |
| 2 | 吉林省都邦药业股份有限公司 | 14 | 2 | 0 |
| 3 | 浙江都邦药业股份有限公司 | 12 | 2 | 0 |
| 4 | Novo Nordisk A/S | 8 | 3 | 0 |
| 5 | Sanofi -aventis France | 7 | 1 | 0 |
| 6 | Kyowa Kirin Co. Ltd. | 6 | 1 | 0 |
| 7 | PURISYS LLC. | 5 | 5 | 0 |
| 8 | 正大天晴药业集团股份有限公司 | 5 | 1 | 0 |
| 9 | Celgene Corporation | 4 | 1 | 0 |
| 10 | 上海上药新亚药业有限公司 | 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
35 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/03/21Import · Class 2.2 | 注射用Trastuzumab DeruxtecanJXSS2200011 | Daiichi Sankyo Europe GmbH; Baxter Oncology GmbH; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2022/03/21Import · Class 2.2 | 帕博利珠单抗注射液JXSL2200032 | Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd. |
| 2022/03/21Generic · Class 3 | 米诺地尔搽剂CYHS2200470 | 杭州沐源生物医药科技有限公司; 浙江赛默制药有限公司 |
| 2022/03/21Generic · Class 3 | 盐酸奥普力农注射液CYHS2200464 | 国药集团容生制药有限公司 |
| 2022/03/21Generic · Class 3 | 二硫化硒洗剂CYHS2200463 | 杭州和泽坤元药业有限公司; 浙江鼎泰药业股份有限公司 |
| 2022/03/21Generic · Class 3 | 雷美替胺片CYHL2200025 | 南京正大天晴制药有限公司 |
| 2022/03/21New drug · Class 1 | 皮炎诊断贴剂01贴CXSL2200135 | 浙江我武生物科技股份有限公司 |
| 2022/03/21New drug · Class 1 | GB261注射液CXSL2200133 | 嘉和生物药业有限公司 |
| 2022/03/21New drug · Class 1 | CM313注射液CXSL2200131 | 康诺亚生物医药科技（成都）有限公司 |
| 2022/03/21New drug · Class 1 | AZD4547片CXHL2200171 | 无锡和誉生物医药科技有限公司 |
| 2022/03/21New drug · Class 1 | AZD4547片CXHL2200170 | 无锡和誉生物医药科技有限公司 |
| 2022/03/21New drug · Class 2.2 | 注射用多西他赛聚合物胶束CXHL2200167 | 先声药业有限公司 |
| 2022/03/18Generic · Class 3 | 丙戊酸钠注射用浓溶液CYHS2200459 | 广东九瑞科技开发有限公司; 天津金耀药业有限公司 |
| 2022/03/18Generic · Class 3 | 丙戊酸钠注射用浓溶液CYHS2200458 | 广东九瑞科技开发有限公司; 天津金耀药业有限公司 |
| 2022/03/18New drug · Class 2.2 | 赛帕利单抗注射液CXSL2200132 | 广州誉衡生物科技有限公司 |
| 2022/03/18New drug · Class 1 | AND017胶囊CXHL2200165 | 杭州安道药业有限公司 |
| 2022/03/18New drug · Class 1 | AND017胶囊CXHL2200164 | 杭州安道药业有限公司 |
| 2022/03/18New drug · Class 1 | AND017胶囊CXHL2200163 | 杭州安道药业有限公司 |
| 2022/03/17Import · Class 3.1 | 注射用TafasitamabJXSL2200031 | Incyte Biosciences Distribution B.V.; Beijing InnoCare Pharma Tech Co. Ltd. |
| 2022/03/17Import · Class 2.4 | Inclisiran注射液JXHL2200061 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2022/03/17Import · Class 2.4 | 盐酸阿来替尼胶囊JXHL2200060 | F.Hoffmann-La Roche Ltd; Roche(China) Holding Ltd. |
| 2022/03/17Import · Class 2.4 | Entrectinib胶囊JXHL2200059 | F.Hoffmann-La Roche Ltd.; Roche（China）Holding Ltd. |
| 2022/03/17Import · Class 2.4 | Entrectinib胶囊JXHL2200058 | F. Hoffmann-La Roche Ltd.; Roche（China）Holding Ltd. |
| 2022/03/17Generic · Class 3 | 米诺地尔搽剂CYHS2200456 | 浙江恒研医药科技有限公司; 浙江赛默制药有限公司 |
| 2022/03/17New drug · Class 1.1 | 小儿香薷颗粒CXZL2200015 | 一力制药股份有限公司 |
| 2022/03/17New drug · Class 1 | MW11注射液CXSL2200128 | 圣森生物制药有限公司 |
| 2022/03/17New drug · Class 1 | 盐酸凯普拉生注射液CXHL2200166 | 江苏柯菲平医药股份有限公司 |
| 2022/03/16Generic · Class 3 | 注射用尼可地尔CYHS2200455 | 云南先施药业有限公司; 安士制药（中山）有限公司 |
| 2022/03/16New drug · Class 3.3 | ACYW135群脑膜炎球菌多糖结合疫苗CXSL2200129 | 辽宁成大生物股份有限公司; 北京成大天和生物科技有限公司; 成大生物（本溪）有限公司 |
| 2022/03/16New drug · Class 1 | 注射用ASK0912CXHL2200157 | 江苏奥赛康药业有限公司; 中国医学科学院医药生物技术研究所 |
5 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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