药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/08/10 – 2021/08/16
- New acceptances this week
- 252
- Drugs with new generic filings (by drug name, de-duplicated)
- 33
- Accepted this week, now under review
- 1
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
252filings, 47 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 115 |
| Generic | 47 |
| New drug | 44 |
| Unspecified | 24 |
| Import | 14 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 169 |
| 治疗用生物制品 | 55 |
| TCM | 27 |
| 体外诊断试剂 | 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
33 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 利伐沙班片 | 3 | 2 | 3 |
| 2 | 草酸艾司西酞普兰口服溶液 | 3 | 2 | 11 |
| 3 | 普瑞巴林胶囊 | 3 | 1 | 12 |
| 4 | 注射用美罗培南 | 3 | 1 | 5 |
| 5 | 奥硝唑注射液 | 2 | 1 | 0 |
| 6 | 奥美拉唑碳酸氢钠胶囊 | 2 | 1 | 0 |
| 7 | 注射用盐酸吉西他滨 | 2 | 1 | 1 |
| 8 | 盐酸伊立替康注射液 | 2 | 1 | 2 |
| 9 | 盐酸伐地那非片 | 2 | 1 | 4 |
| 10 | 硫酸沙丁胺醇吸入溶液 | 2 | 1 | 0 |
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
139 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Oncotec Pharma Produktion GmbH | 8 | 1 | 0 |
| 2 | Eurofins Analytical Science Laboratories Inc. | 6 | 6 | 0 |
| 3 | Upjohn EESV | 6 | 3 | 0 |
| 4 | 成都蓉生药业有限责任公司 | 6 | 3 | 0 |
| 5 | AstraZeneca AB | 6 | 2 | 0 |
| 6 | Novartis Pharma Schweiz AG | 6 | 2 | 0 |
| 7 | 黄石卫生材料药业有限公司 | 5 | 5 | 0 |
| 8 | Janssen Research & Development LLC | 5 | 3 | 0 |
| 9 | 江苏恒瑞医药股份有限公司 | 5 | 3 | 0 |
| 10 | Pfizer Europe MA EEIG | 5 | 2 | 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
70 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/08/16Import · Class 1 | Teclistamab 注射液JXSL2101096 | Janssen Research & Development， LLC; Johnson & Johnson (China) Investment Ltd. |
| 2021/08/16Import · Class 1 | Teclistamab 注射液JXSL2101095 | Janssen Research & Development， LLC; Johnson & Johnson (China) Investment Ltd. |
| 2021/08/16Import · Class 1 | Tiragolumab注射液JXSL2101094 | F.Hoffmann-La Roche Ltd.; Roche（China）Holding Ltd. |
| 2021/08/16Import · Class 1 | MHV370胶囊JXHL2101164 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2021/08/16Generic · Class 3 | 草酸艾司西酞普兰口服溶液CYHS2101584 | 成都康弘药业集团股份有限公司; 成都迪康药业股份有限公司 |
| 2021/08/16Generic · Class 3 | 奥硝唑注射液CYHS2101578 | 山东致泰医药技术有限公司; 山西普德药业有限公司 |
| 2021/08/16Generic · Class 3 | 奥硝唑注射液CYHS2101577 | 山东致泰医药技术有限公司; 山西普德药业有限公司 |
| 2021/08/16New drug · Class 1 | 冻干GT90008抗体蛋白CXSL2101268 | 开拓药业（广东）有限公司 |
| 2021/08/16New drug · Class 1 | 靶向间皮素嵌合抗原受体NK细胞注射液CXSL2101267 | 国健呈诺生物科技（北京）有限公司 |
| 2021/08/16New drug · Class 1 | 注射用SHR-A1921CXSL2101266 | 苏州盛迪亚生物医药有限公司 |
| 2021/08/13Import · Class 2.2 | DS-8201aJXSL2101093 | Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited |
| 2021/08/13Generic · Class 3 | 普瑞巴林口服溶液CYHS2101579 | 广州大光制药有限公司; 南京星银药业集团有限公司 |
| 2021/08/13Generic · Class 3 | 骨化三醇口服溶液CYHS2101575 | 正大制药（青岛）有限公司 |
| 2021/08/13New drug · Class 1 | ADG126注射液CXSL2101263 | 天演药业（苏州）有限公司 |
| 2021/08/13New drug · Class 1 | 重组人源化抗CD47单克隆抗体注射液CXSL2101262 | 山东新时代药业有限公司 |
| 2021/08/13New drug · Class 1 | ASC22注射液CXSL2101261 | 歌礼生物科技（杭州）有限公司 |
| 2021/08/13New drug · Class 1 | TQB2450注射液CXSL2101260 | 正大天晴药业集团股份有限公司 |
| 2021/08/13New drug · Class 1 | SHR8554注射液CXHL2101403 | 江苏恒瑞医药股份有限公司 |
| 2021/08/13New drug · Class 1 | SHR8554注射液CXHL2101402 | 江苏恒瑞医药股份有限公司 |
| 2021/08/13New drug · Class 1 | SHR0410注射液CXHL2101401 | 江苏恒瑞医药股份有限公司 |
| 2021/08/13New drug · Class 1 | CGT-6321片CXHL2101400 | 盛世泰科生物医药技术（苏州）有限公司 |
| 2021/08/13New drug · Class 1 | CGT-6321片CXHL2101399 | 盛世泰科生物医药技术（苏州）有限公司 |
| 2021/08/13New drug · Class 2.3 | YK-1169CXHL2101398 | 南京力博维制药有限公司 |
| 2021/08/13New drug · Class 1 | SHR2285片CXHL2101397 | 上海恒瑞医药有限公司 |
| 2021/08/12Import · Class 1 | Ziltivekimab 注射液JXSL2101092 | Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd |
| 2021/08/12Import · Class 1 | ricolinostatJXHL2101163 | Beijing B3R Pharmaceutical Technology HK Limited; PAREXEL CHINA CO. LTD |
| 2021/08/12Generic · Class 3 | 奥美拉唑碳酸氢钠胶囊CYHS2101565 | 浙江花园药业有限公司 |
| 2021/08/12Generic · Class 3 | 奥美拉唑碳酸氢钠胶囊CYHS2101564 | 浙江花园药业有限公司 |
| 2021/08/12Generic · Class 3 | 甲硝唑氯化钠注射液CYHS2101559 | 哈尔滨三联药业股份有限公司 |
| 2021/08/12New drug · Class 1 | QX002N注射液CXSL2101259 | 江苏荃信生物医药有限公司 |
40 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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