药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/09/27 – 2022/10/03
- New acceptances this week
- 250
- Drugs with new generic filings (by drug name, de-duplicated)
- 42
- 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
250filings, 53 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 132 |
| Generic | 53 |
| New drug | 42 |
| Import | 11 |
| Import re-registration | 7 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 194 |
| 治疗用生物制品 | 34 |
| TCM | 18 |
| Biologic | 2 |
| 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
42 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 己酮可可碱注射液 | 3 | 3 | 3 |
| 2 | 卡络磺钠注射液 | 3 | 1 | 1 |
| 3 | 盐酸左沙丁胺醇雾化吸入溶液 | 3 | 1 | 2 |
| 4 | 阿司匹林肠溶片 | 2 | 2 | 10 |
| 5 | 多索茶碱注射液 | 2 | 1 | 5 |
| 6 | 奥硝唑注射液 | 2 | 1 | 0 |
| 7 | 左卡尼汀注射液 | 2 | 1 | 5 |
| 8 | 注射用盐酸多西环素 | 2 | 1 | 11 |
| 9 | 丙戊酸钠口服溶液 | 1 | 1 | 1 |
| 10 | 中性低钙腹膜透析液（碳酸氢盐-G2.5%） | 1 | 1 | 8 |
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
151 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 达嘉维康生物制药有限公司 | 16 | 10 | 0 |
| 2 | 北京亚东生物制药有限公司 | 11 | 11 | 0 |
| 3 | 河南利欣制药股份有限公司 | 9 | 2 | 0 |
| 4 | NAPP PHARMACEUTICALS LIMITED | 6 | 1 | 0 |
| 5 | 广东方盛健盟药业有限公司 | 5 | 5 | 0 |
| 6 | 河北宸寰生物科技有限公司 | 4 | 4 | 0 |
| 7 | 芜湖道润药业有限责任公司 | 4 | 4 | 4 |
| 8 | Janssen Research & Development LLC | 4 | 2 | 0 |
| 9 | 成都倍特药业股份有限公司 | 4 | 2 | 4 |
| 10 | 湖北民康药业集团有限公司 | 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
73 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/10/01Import · Class 2.1 | Amivantamab注射液（皮下注射）JXSL2200178 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/10/01Import · Class 2.1 | Amivantamab注射液（皮下注射）JXSL2200177 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/10/01Import · Class 2.1 | Amivantamab注射液（皮下注射）JXSL2200176 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/10/01Import · Class 2.4 | Lazertinib片JXHL2200296 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/10/01New drug · Class 3.1 | 苓桂术甘颗粒CXZS2200011 | 江苏康缘药业股份有限公司 |
| 2022/10/01New drug · Class 1 | IBI343CXSL2200501 | 信达生物制药（苏州）有限公司 |
| 2022/10/01New drug · Class 1 | IBR733细胞注射液CXSL2200500 | 英百瑞（杭州）生物医药有限公司 |
| 2022/10/01New drug · Class 1 | IBR733细胞注射液CXSL2200499 | 英百瑞（杭州）生物医药有限公司 |
| 2022/10/01New drug · Class 2.2 | 艾司奥美拉唑镁碳酸氢钠胶囊CXHS2200049 | 厦门恩成制药有限公司 |
| 2022/10/01New drug · Class 1 | TY705注射液CXHL2200752 | 天津药物研究院有限公司 |
| 2022/10/01New drug · Class 1 | TY705注射液CXHL2200751 | 天津药物研究院有限公司 |
| 2022/09/30Import · Class 1 | VAY736注射液JXSL2200175 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2022/09/30Import · Class 1 | DS-1062aJXSL2200174 | ASTRAZENECA AB; AstraZeneca Investment (China) Co. Limited |
| 2022/09/30Generic · Class 3 | 酮咯酸氨丁三醇片CYHS2201655 | 成都倍特药业股份有限公司 |
| 2022/09/30Generic · Class 3 | 叶酸片CYHS2201652 | 浙江诺得药业有限公司 |
| 2022/09/30New drug · Class 3.4 | 人纤维蛋白粘合剂CXSL2200498 | 四川远大蜀阳药业有限责任公司 |
| 2022/09/30New drug · Class 3.3 | 司美格鲁肽注射液CXSL2200497 | 北京质肽生物医药科技有限公司 |
| 2022/09/30New drug · Class 1 | RB0011注射液CXSL2200496 | 瑞阳（苏州）生物科技有限公司 |
| 2022/09/30New drug · Class 2.2 | 右布洛芬缓控释双层片CXHL2200750 | 越洋医药开发（广州）有限公司 |
| 2022/09/30New drug · Class 2.2 | 枸橼酸坦度螺酮缓释片CXHL2200749 | 四川科瑞德制药股份有限公司 |
| 2022/09/30New drug · Class 2.2 | 枸橼酸坦度螺酮缓释片CXHL2200748 | 四川科瑞德制药股份有限公司 |
| 2022/09/30New drug · Class 1 | Kylo-0603胶囊CXHL2200747 | 厦门甘宝利生物医药有限公司 |
| 2022/09/30New drug · Class 1 | Kylo-0603胶囊CXHL2200746 | 厦门甘宝利生物医药有限公司 |
| 2022/09/29Import · Class 1 | 输注用无菌冻干粉Telisotuzumab vedotinJXSL2200173 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai)Co. Ltd |
| 2022/09/29Generic · Class 3 | 中性腹膜透析液（碳酸氢盐-G4.25%）CYHS2201647 | 芜湖道润药业有限责任公司 |
| 2022/09/29Generic · Class 3 | 中性腹膜透析液（碳酸氢盐-G2.5%）CYHS2201646 | 芜湖道润药业有限责任公司 |
| 2022/09/29Generic · Class 3 | 中性腹膜透析液（碳酸氢盐-G1.5%）CYHS2201644 | 芜湖道润药业有限责任公司 |
| 2022/09/29Generic · Class 3 | 盐酸氨溴索滴剂CYHS2201643 | 北京民康百草医药科技有限公司; 北京华润高科天然药物有限公司 |
| 2022/09/29Generic · Class 3 | 中性低钙腹膜透析液（碳酸氢盐-G2.5%）CYHS2201642 | 芜湖道润药业有限责任公司 |
| 2022/09/29Generic · Class 3 | 己酮可可碱注射液CYHS2201641 | 广州绿十字制药股份有限公司; 山西普德药业有限公司 |
43 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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