药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/04/05 – 2022/04/11
- New acceptances this week
- 150
- Drugs with new generic filings (by drug name, de-duplicated)
- 27
- 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
150filings, 37 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 76 |
| Generic | 37 |
| New drug | 20 |
| Import | 12 |
| Unspecified | 4 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 123 |
| 治疗用生物制品 | 16 |
| TCM | 9 |
| 预防用生物制品 | 2 |
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
27 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸卡利拉嗪胶囊 | 4 | 1 | 3 |
| 2 | 磷酸西格列汀片 | 3 | 1 | 2 |
| 3 | 依托考昔片 | 2 | 1 | 8 |
| 4 | 吡拉西坦注射液 | 2 | 1 | 9 |
| 5 | 拉考沙胺片 | 2 | 1 | 0 |
| 6 | 盐酸昂丹司琼片 | 2 | 1 | 6 |
| 7 | 缩宫素注射液 | 2 | 1 | 8 |
| 8 | 利奈唑胺氯化钠注射液 | 1 | 1 | 0 |
| 9 | 吸入用复方异丙托溴铵溶液 | 1 | 1 | 4 |
| 10 | 吸入用盐酸氨溴索溶液 | 1 | 1 | 10 |
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
100 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 安徽省轶风堂科技有限公司 | 6 | 5 | 0 |
| 2 | Boehringer Ingelheim International GmbH | 5 | 1 | 0 |
| 3 | 石家庄四药有限公司 | 4 | 3 | 3 |
| 4 | Novo Nordisk A/S | 4 | 1 | 0 |
| 5 | 成都康弘药业集团股份有限公司 | 4 | 1 | 4 |
| 6 | Biocon Pharma Limited | 3 | 1 | 0 |
| 7 | Blueprint Medicines Corporation | 3 | 1 | 0 |
| 8 | Celgene International II Sarl | 3 | 1 | 0 |
| 9 | 上海海和药物研究开发股份有限公司 | 3 | 1 | 0 |
| 10 | 常州制药厂有限公司 | 3 | 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
40 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/04/11Import · Class 1 | CK-3773274片JXHL2200084 | Cytokinetics Incorporated; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd |
| 2022/04/11Generic · Class 3 | 缩宫素注射液CYHS2200553 | 杭州云柏医药科技有限公司; 新乡市常乐制药有限责任公司 |
| 2022/04/11Generic · Class 3 | 缩宫素注射液CYHS2200552 | 杭州云柏医药科技有限公司; 新乡市常乐制药有限责任公司 |
| 2022/04/11New drug · Class 2.2 | 斯鲁利单抗注射液CXSS2200037 | 上海复宏汉霖生物制药有限公司 |
| 2022/04/11New drug · Class 1 | TAA06注射液CXSL2200164 | 博生吉医药科技（苏州）有限公司 |
| 2022/04/11New drug · Class 1 | 安纳拉唑钠肠溶片CXHL2200229 | 轩竹（北京）医药科技有限公司 |
| 2022/04/11New drug · Class 2.4;2.1 | 左旋盐酸班布特罗片CXHL2200228 | 东莞市凯法生物医药有限公司 |
| 2022/04/11New drug · Class 1 | TT-01488片CXHL2200227 | 药捷安康（南京）科技股份有限公司 |
| 2022/04/11New drug · Class 1 | TT-01488片CXHL2200226 | 药捷安康（南京）科技股份有限公司 |
| 2022/04/11New drug · Class 1 | TT-01488片CXHL2200225 | 药捷安康（南京）科技股份有限公司 |
| 2022/04/11New drug · Class 1 | KL340399注射液CXHL2200224 | 四川科伦博泰生物医药股份有限公司 |
| 2022/04/11New drug · Class 1 | KL340399注射液CXHL2200223 | 四川科伦博泰生物医药股份有限公司 |
| 2022/04/08Import · Class 1 | Donanemab注射液JXSL2200044 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/04/08Generic · Class 3 | 盐酸昂丹司琼片CYHS2200547 | 石家庄四药有限公司 |
| 2022/04/08Generic · Class 3 | 盐酸昂丹司琼片CYHS2200546 | 石家庄四药有限公司 |
| 2022/04/08Generic · Class 3 | 利奈唑胺氯化钠注射液CYHS2200543 | 石家庄四药有限公司 |
| 2022/04/08Generic · Class 3 | 瑞巴派特片CYHS2200541 | 重庆圣华曦药业股份有限公司 |
| 2022/04/08Generic · Class 3 | 盐酸卡利拉嗪胶囊CYHL2200031 | 成都康弘药业集团股份有限公司 |
| 2022/04/08Generic · Class 3 | 盐酸卡利拉嗪胶囊CYHL2200030 | 成都康弘药业集团股份有限公司 |
| 2022/04/08Generic · Class 3 | 盐酸卡利拉嗪胶囊CYHL2200029 | 成都康弘药业集团股份有限公司 |
| 2022/04/08Generic · Class 3 | 盐酸卡利拉嗪胶囊CYHL2200028 | 成都康弘药业集团股份有限公司 |
| 2022/04/08New drug · Class 1 | AK112注射液CXSL2200163 | 中山康方生物医药有限公司 |
| 2022/04/08New drug · Class 1 | 人源脂肪间充质干细胞注射液CXSL2200162 | 博品骨德生物医药科技（上海）有限公司 |
| 2022/04/07Import · Class 3.1 | Erenumab注射液JXSS2200012 | Novartis Europharm Limited; Amgen Manufacturing Limited |
| 2022/04/07Import · Class 1 | BCX9930片JXHL2200083 | BioCryst Pharmaceuticals Inc.; Hangzhou Tigermed Consulting Co. Ltd. |
| 2022/04/07Import · Class 1 | 注射用PEN-866钠JXHL2200082 | Tarveda Therapeutics，Inc.; SciClone Pharmaceuticals (China) Co. Ltd. |
| 2022/04/07Generic · Class 3 | 吡拉西坦注射液CYHS2200540 | 海南全星制药有限公司 |
| 2022/04/07Generic · Class 3 | 吡拉西坦注射液CYHS2200539 | 海南全星制药有限公司 |
| 2022/04/07Generic · Class 3 | 对乙酰氨基酚注射液CYHS2200533 | 宜昌人福药业有限责任公司; 宜昌三峡制药有限公司 |
| 2022/04/07Generic · Class 3 | 吸入用盐酸氨溴索溶液CYHS2200530 | 湖北兴华制药有限公司 |
10 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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