药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/06/14 – 2022/06/20
- New acceptances this week
- 292
- Drugs with new generic filings (by drug name, de-duplicated)
- 33
- 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
292filings, 41 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 157 |
| New drug | 47 |
| Generic | 41 |
| Import | 19 |
| Import re-registration | 18 |
| Unspecified | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 205 |
| 治疗用生物制品 | 53 |
| TCM | 29 |
| 预防用生物制品 | 4 |
| 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
33 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 | 3 | 2 | 49 |
| 2 | 富马酸伏诺拉生片 | 2 | 1 | 58 |
| 3 | 普瑞巴林胶囊 | 2 | 1 | 12 |
| 4 | 注射用头孢噻肟钠他唑巴坦钠 | 2 | 1 | 1 |
| 5 | 甲磺酸雷沙吉兰片 | 2 | 1 | 5 |
| 6 | 盐酸达泊西汀片 | 2 | 1 | 20 |
| 7 | 苯磺酸左氨氯地平片 | 2 | 1 | 47 |
| 8 | 二甲硅油乳剂 | 1 | 1 | 14 |
| 9 | 他达拉非片 | 1 | 1 | 23 |
| 10 | 利格列汀片 | 1 | 1 | 2 |
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
173 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 10 | 2 | 0 |
| 2 | 哈药集团世一堂制药厂 | 9 | 9 | 0 |
| 3 | Janssen-Cilag International NV | 8 | 3 | 0 |
| 4 | Lian Cardiovascular Limited | 5 | 1 | 0 |
| 5 | The Wellcome Foundation Limited | 5 | 1 | 0 |
| 6 | 深圳市天道医药有限公司 | 5 | 1 | 0 |
| 7 | LES LABORATOIRES SERVIER | 4 | 3 | 0 |
| 8 | Hetero Labs Limited | 4 | 2 | 0 |
| 9 | 正大天晴药业集团股份有限公司 | 4 | 2 | 1 |
| 10 | 海南灵康制药有限公司 | 4 | 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
72 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/06/20Import · Class 1 | 替拉扎明注射液JXHL2200140 | Raygene Inc.; Hangzhou Taibo Pharmaceutical Company Ltd. |
| 2022/06/20New drug · Class 1.1 | AC591颗粒CXZL2200029 | 江苏省中医药研究院 |
| 2022/06/20New drug · Class 2.2 | 派安普利单抗注射液CXSL2200283 | 正大天晴康方(上海)生物医药科技有限公司 |
| 2022/06/20New drug · Class 1 | CM369注射液CXSL2200282 | 北京天诺健成医药科技有限公司 |
| 2022/06/20New drug · Class 2.2 | 人干扰素α2b阴道泡腾胶囊CXSL2200281 | 科兴生物制药股份有限公司 |
| 2022/06/20New drug · Class 3.3 | 四价流感病毒裂解疫苗CXSL2200280 | 深圳康泰生物制品股份有限公司 |
| 2022/06/20New drug · Class 1 | 重组全人源抗EGFR单克隆抗体注射液CXSL2200279 | 上海赛远生物科技有限公司 |
| 2022/06/20New drug · Class 1 | EVT-401片CXHL2200403 | 浙江金华康恩贝生物制药有限公司 |
| 2022/06/20New drug · Class 1 | EVT-401片CXHL2200402 | 浙江金华康恩贝生物制药有限公司 |
| 2022/06/20New drug · Class 2.2 | HRG2101吸入剂CXHL2200400 | 江苏恒瑞医药股份有限公司 |
| 2022/06/20New drug · Class 2.2 | 注射用左西孟旦CXHL2200397 | 海南倍特药业有限公司 |
| 2022/06/17Import · Class 2.1 | Isatuximab注射液(皮下注射)JXSL2200088 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2022/06/17Import · Class 1 | Bemarituzumab注射液JXSL2200087 | Zai Lab (US) LLC; Zai Lab (Shanghai) CO. Ltd. |
| 2022/06/17Import · Class 1 | Bemarituzumab注射液JXSL2200086 | Zai Lab (US) LLC; Zai Lab (Shanghai) CO. Ltd. |
| 2022/06/17Import · Class 1 | M1774胶囊JXHL2200151 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd |
| 2022/06/17Import · Class 1 | M1774胶囊JXHL2200150 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd |
| 2022/06/17Import · Class 1 | M1774胶囊JXHL2200149 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd |
| 2022/06/17Generic · Class 3 | 铝碳酸镁混悬液CYHS2200912 | 四川益生智同医药生物科技发展有限公司; 太极集团四川太极制药有限公司 |
| 2022/06/17Generic · Class 3 | 多种微量元素注射液(Ⅰ)CYHS2200906 | 洋浦京泰药业有限公司; 内蒙古白医制药股份有限公司 |
| 2022/06/17Generic · Class 3 | 盐酸多巴酚丁胺注射液CYHS2200904 | 南京恒道医药科技股份有限公司; 海南灵康制药有限公司 |
| 2022/06/17Generic · Class 3 | 米诺地尔搽剂CYHS2200901 | 辰光(天津)制药有限公司 |
| 2022/06/17Generic · Class 3 | 米诺地尔搽剂CYHS2200900 | 辰光(天津)制药有限公司 |
| 2022/06/17New drug · Class 1.1 | 心阳片CXZL2200028 | 广州中医药大学第一附属医院 |
| 2022/06/17New drug · Class 1 | 6MW3511注射液CXSL2200278 | 迈威(上海)生物科技股份有限公司 |
| 2022/06/17New drug · Class 3.3 | 水痘减毒活疫苗CXSL2200273 | 辽宁成大生物股份有限公司; 成大生物(本溪)有限公司 |
| 2022/06/17New drug · Class 1 | QA102 胶囊CXHL2200399 | 珠海岐微生物科技有限公司 |
| 2022/06/17New drug · Class 1 | QA102 胶囊CXHL2200398 | 珠海岐微生物科技有限公司 |
| 2022/06/17New drug · Class 1 | SPH3127片CXHL2200396 | 上海医药集团股份有限公司 |
| 2022/06/17New drug · Class 1 | SPH3127片CXHL2200395 | 上海医药集团股份有限公司 |
| 2022/06/16Import · Class 3.1 | 注射用Susoctocog alfaJXSS2200020 | Baxalta US Inc.; Vetter Pharma-Fertigung GmbH & Co. KG; Takeda (China) International Trading Co. Ltd |
42 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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