药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/02/15 – 2022/02/21
- New acceptances this week
- 262
- Drugs with new generic filings (by drug name, de-duplicated)
- 40
- 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
262filings, 57 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 141 |
| Generic | 57 |
| New drug | 39 |
| Import | 12 |
| Unspecified | 11 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 196 |
| 治疗用生物制品 | 35 |
| TCM | 30 |
| 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
40 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 泊马度胺胶囊 | 4 | 1 | 4 |
| 2 | 吡拉西坦注射液 | 3 | 1 | 9 |
| 3 | 利培酮口服溶液 | 2 | 2 | 6 |
| 4 | 氧(液态) | 2 | 2 | 14 |
| 5 | 盐酸托莫西汀口服溶液 | 2 | 2 | 0 |
| 6 | 盐酸西那卡塞片 | 2 | 2 | 2 |
| 7 | 利斯的明透皮贴剂 | 2 | 1 | 1 |
| 8 | 注射用头孢哌酮钠舒巴坦钠/氯化钠注射液 | 2 | 1 | 2 |
| 9 | 注射用头孢西丁钠/氯化钠注射液 | 2 | 1 | 0 |
| 10 | 注射用帕瑞昔布钠 | 2 | 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
150 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 河南诺美药业有限公司 | 8 | 8 | 0 |
| 2 | 百奥泰生物制药股份有限公司 | 8 | 1 | 0 |
| 3 | Sanofi-Aventis Deutschland GmbH | 6 | 6 | 0 |
| 4 | AstraZeneca UK Limited | 6 | 2 | 0 |
| 5 | 海南广升誉制药有限公司 | 6 | 2 | 0 |
| 6 | 广西圣民制药有限公司 | 5 | 5 | 0 |
| 7 | 苏州锐明新药研发有限公司 | 5 | 1 | 0 |
| 8 | 宜昌东阳光长江药业股份有限公司 | 4 | 3 | 0 |
| 9 | 北京锐业制药有限公司 | 4 | 2 | 4 |
| 10 | Alembic Pharmaceuticals Limited | 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
60 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/02/21Import · Class 1 | SAR443820JXHL2200039 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2022/02/21Import · Class 1 | 注射用WCK5222JXHL2200038 | Wockhardt Bio AG; Labcorp Pharmaceutical Research and Development (Beijing) Co. Ltd. |
| 2022/02/21Generic · Class 3 | 吡拉西坦注射液CYHS2200363 | 珠海和凡医药股份有限公司; 山东威高药业股份有限公司 |
| 2022/02/21Generic · Class 3 | 吡拉西坦注射液CYHS2200362 | 珠海和凡医药股份有限公司; 山东威高药业股份有限公司 |
| 2022/02/21Generic · Class 3 | 吡拉西坦注射液CYHS2200361 | 珠海和凡医药股份有限公司; 山东威高药业股份有限公司 |
| 2022/02/21Generic · Class 3 | 注射用头孢哌酮钠舒巴坦钠/氯化钠注射液CYHS2200360 | 北京锐业制药有限公司 |
| 2022/02/21Generic · Class 3 | 注射用头孢哌酮钠舒巴坦钠/氯化钠注射液CYHS2200359 | 北京锐业制药有限公司 |
| 2022/02/21New drug · Class 2.2 | SHR-8068注射液CXSL2200100 | 苏州盛迪亚生物医药有限公司 |
| 2022/02/21New drug · Class 1 | 阿得贝利单抗注射液CXSL2200099 | 上海盛迪医药有限公司 |
| 2022/02/21New drug · Class 1 | RA1115-B1滴眼液CXHL2200116 | 苏州锐明新药研发有限公司 |
| 2022/02/21New drug · Class 1 | RA1115-B1滴眼液CXHL2200115 | 苏州锐明新药研发有限公司 |
| 2022/02/21New drug · Class 1 | RA1115-B1滴眼液CXHL2200114 | 苏州锐明新药研发有限公司 |
| 2022/02/21New drug · Class 1 | RA1115-B1滴眼液CXHL2200113 | 苏州锐明新药研发有限公司 |
| 2022/02/21New drug · Class 1 | RA1115-B1滴眼液CXHL2200112 | 苏州锐明新药研发有限公司 |
| 2022/02/21New drug · Class 2.3 | 复方果糖电解质注射液CXHL2200108 | 上海致真生物科技有限公司 |
| 2022/02/21New drug · Class 1 | ZL-82片CXHL2200107 | 成都赜灵生物医药科技有限公司 |
| 2022/02/21New drug · Class 1 | ZL-82片CXHL2200106 | 成都赜灵生物医药科技有限公司 |
| 2022/02/21New drug · Class 1 | ZL-82片CXHL2200105 | 成都赜灵生物医药科技有限公司 |
| 2022/02/21New drug · Class 1 | HS-10386片CXHL2200104 | 江苏豪森药业集团有限公司; 上海翰森生物医药科技有限公司 |
| 2022/02/21New drug · Class 1 | HS-10386片CXHL2200103 | 江苏豪森药业集团有限公司; 上海翰森生物医药科技有限公司 |
| 2022/02/18Import · Class 1 | Olvi-Vec注射液JXSL2200020 | Genelux Corporation; Newsoara Biopharma Co. Ltd. |
| 2022/02/18Generic · Class 3 | 硫酸特布他林注射液CYHS2200341 | 成都利尔药业有限公司 |
| 2022/02/18Generic · Class 3 | 泊马度胺胶囊CYHL2200021 | 常州制药厂有限公司 |
| 2022/02/18Generic · Class 3 | 泊马度胺胶囊CYHL2200020 | 常州制药厂有限公司 |
| 2022/02/18Generic · Class 3 | 泊马度胺胶囊CYHL2200019 | 常州制药厂有限公司 |
| 2022/02/18Generic · Class 3 | 泊马度胺胶囊CYHL2200018 | 常州制药厂有限公司 |
| 2022/02/18New drug · Class 2.3 | 苁蓉总苷胶囊CXZL2200011 | 江苏康缘药业股份有限公司 |
| 2022/02/18New drug · Class 3.4 | 注射用重组人凝血因子ⅧCXSS2200014 | 成都蓉生药业有限责任公司 |
| 2022/02/18New drug · Class 1 | 人脐带间充质干细胞注射液CXSL2200098 | 上海爱萨尔生物科技有限公司 |
| 2022/02/18New drug · Class 1 | 人脐带间充质干细胞注射液CXSL2200097 | 上海爱萨尔生物科技有限公司 |
30 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.