药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/08/23 – 2022/08/29
- New acceptances this week
- 283
- Drugs with new generic filings (by drug name, de-duplicated)
- 38
- Accepted this week, now under review
- 2
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
283filings, 60 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 154 |
| Generic | 60 |
| New drug | 40 |
| Import | 20 |
| Unspecified | 6 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 199 |
| 治疗用生物制品 | 44 |
| TCM | 33 |
| 预防用生物制品 | 4 |
| Biologic | 3 |
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
38 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 吸入用乙酰半胱氨酸溶液 | 3 | 3 | 4 |
| 2 | 氯化钾注射液 | 3 | 2 | 10 |
| 3 | 硫酸镁注射液 | 3 | 1 | 7 |
| 4 | 帕拉米韦注射液 | 2 | 2 | 7 |
| 5 | 盐酸艾司洛尔注射液 | 2 | 2 | 3 |
| 6 | 碳酸司维拉姆片 | 2 | 2 | 4 |
| 7 | 碳酸氢钠林格注射液 | 2 | 2 | 1 |
| 8 | 他克莫司软膏 | 2 | 1 | 8 |
| 9 | 吡拉西坦注射液 | 2 | 1 | 9 |
| 10 | 妥布霉素滴眼液 | 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
155 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 河南润弘本草制药有限公司 | 16 | 15 | 0 |
| 2 | 湖北美林药业有限公司 | 10 | 6 | 0 |
| 3 | 兰州佛慈（瑞诺欣）药业股份有限公司 | 9 | 9 | 0 |
| 4 | 河南辅仁堂制药有限公司 | 8 | 8 | 0 |
| 5 | 国药集团工业有限公司 | 7 | 7 | 0 |
| 6 | Novartis Pharma AG | 7 | 3 | 0 |
| 7 | 沈阳三生制药有限责任公司 | 7 | 2 | 2 |
| 8 | 湖北康为远药业有限公司 | 4 | 4 | 0 |
| 9 | 辰欣药业股份有限公司 | 4 | 3 | 3 |
| 10 | 宜昌东阳光长江药业股份有限公司 | 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
89 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/08/29Import · Class 1 | Cytopeutics？脐带间充质干细胞（Neuroncell-EX）JXSL2200142 | Cytopeutics Sdn Bhd (MY) |
| 2022/08/29Generic · Class 3 | 胞磷胆碱注射液CYHS2201408 | 湖北神州华瑞医药有限公司; 天方药业有限公司 |
| 2022/08/29Generic · Class 3 | 胞磷胆碱注射液CYHS2201407 | 湖北神州华瑞医药有限公司; 天方药业有限公司 |
| 2022/08/29Generic · Class 3 | 盐酸美金刚口服溶液CYHS2201406 | 合肥科大生物技术有限公司; 安徽东盛友邦制药有限公司 |
| 2022/08/29Generic · Class 3 | 盐酸美金刚口服溶液CYHS2201405 | 合肥科大生物技术有限公司; 安徽东盛友邦制药有限公司 |
| 2022/08/29Generic · Class 3 | 复方聚乙二醇（3350）电解质口服溶液CYHS2201398 | 浙江远力健药业有限责任公司; 安徽永生堂药业有限责任公司 |
| 2022/08/29Generic · Class 3 | 阿立哌唑口服溶液CYHS2201397 | 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 |
| 2022/08/29New drug · Class 3.3 | 德谷胰岛素利拉鲁肽注射液CXSL2200411 | 通化东宝药业股份有限公司 |
| 2022/08/29New drug · Class 1 | ESG206注射液CXSL2200408 | 上海诗健生物科技有限公司 |
| 2022/08/29New drug · Class 1 | DP303cCXSL2200407 | 石药集团中奇制药技术（石家庄）有限公司 |
| 2022/08/29New drug · Class 1 | TR115片CXHL2200632 | 安徽中科拓苒药物科学研究有限公司 |
| 2022/08/26Import · Class 1 | Ponsegromab 注射液JXSL2200147 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2022/08/26Import · Class 1 | Ponsegromab 注射液JXSL2200146 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2022/08/26Import · Class 3.1 | 注射用A型肉毒毒素JXSL2200145 | AbbVie Limited; Allergan Information Consulting (Shanghai) Co. Ltd. |
| 2022/08/26Import · Class 3.1 | 注射用A型肉毒毒素JXSL2200144 | AbbVie Limited; Allergan Information Consulting (Shanghai) Co. Ltd. |
| 2022/08/26Import · Class 3.1 | 注射用A型肉毒毒素JXSL2200143 | AbbVie Limited; Allergan Information Consulting (Shanghai) Co. Ltd. |
| 2022/08/26Generic · Class 3 | 氯化钾注射液CYHS2201394 | 广州艾奇西医药科技有限公司; 河北天成药业股份有限公司 |
| 2022/08/26Generic · Class 3 | 氯化钾注射液CYHS2201393 | 广州艾奇西医药科技有限公司; 河北天成药业股份有限公司 |
| 2022/08/26Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液CYHS2201392 | 山东禾琦制药有限公司; 浙江赛默制药有限公司 |
| 2022/08/26Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液CYHS2201391 | 山东禾琦制药有限公司; 浙江赛默制药有限公司 |
| 2022/08/26Generic · Class 3 | 帕拉米韦注射液CYHS2201390 | 青海晨菲制药有限公司 |
| 2022/08/26Generic · Class 3 | 复方维生素C聚乙二醇（3350）钠钾散CYHS2201371 | 舒泰神（北京）生物制药股份有限公司 |
| 2022/08/26Generic · Class 3 | 普瑞巴林缓释片CYHL2200073 | 江苏恩华药业股份有限公司; 苏州恩华生物医药科技有限公司 |
| 2022/08/26New drug · Class 2.2 | 斯鲁利单抗注射液CXSS2200076 | 上海复宏汉霖生物制药有限公司 |
| 2022/08/26New drug · Class 1 | RGT-264磷酸盐片CXHL2200631 | 上海齐鲁锐格医药研发有限公司 |
| 2022/08/26New drug · Class 1 | RGT-264磷酸盐片CXHL2200630 | 上海齐鲁锐格医药研发有限公司 |
| 2022/08/26New drug · Class 1 | 注射用KMHH-03CXHL2200629 | 北京康明海慧生物科技有限公司 |
| 2022/08/25Generic · Class 3 | 吡拉西坦注射液CYHS2201383 | 江西亿友药业有限公司; 马鞍山丰原制药有限公司 |
| 2022/08/25Generic · Class 3 | 吡拉西坦注射液CYHS2201382 | 江西亿友药业有限公司; 马鞍山丰原制药有限公司 |
| 2022/08/25Generic · Class 3 | 碳酸氢钠林格注射液CYHS2201376 | 辰欣药业股份有限公司 |
59 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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