药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/08/02 – 2022/08/08
- New acceptances this week
- 279
- Drugs with new generic filings (by drug name, de-duplicated)
- 44
- 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
279filings, 54 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 145 |
| Generic | 54 |
| New drug | 46 |
| Import | 21 |
| Unspecified | 8 |
| Import re-registration | 4 |
| 药械组合产品 | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 201 |
| TCM | 44 |
| 治疗用生物制品 | 29 |
| 预防用生物制品 | 3 |
| Biologic | 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
44 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 奥扎格雷钠注射液 | 4 | 2 | 3 |
| 2 | 碳酸司维拉姆片 | 2 | 2 | 4 |
| 3 | 乙酰半胱氨酸颗粒 | 2 | 1 | 4 |
| 4 | 头孢呋辛酯干混悬剂 | 2 | 1 | 5 |
| 5 | 奥硝唑注射液 | 2 | 1 | 0 |
| 6 | 盐酸左沙丁胺醇雾化吸入溶液 | 2 | 1 | 2 |
| 7 | 硫酸特布他林雾化吸入用溶液 | 2 | 1 | 1 |
| 8 | 钆布醇注射液 | 2 | 1 | 8 |
| 9 | 他达拉非片 | 1 | 1 | 23 |
| 10 | 低钙腹膜透析液（乳酸盐-G1.5%） | 1 | 1 | 3 |
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
144 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 浙江普洛康裕制药有限公司 | 40 | 35 | 0 |
| 2 | 东陵药业科技（辽宁）有限公司 | 15 | 15 | 0 |
| 3 | Novartis Pharma AG | 10 | 6 | 0 |
| 4 | 江苏威凯尔医药科技有限公司 | 8 | 1 | 0 |
| 5 | Celgene Corporation | 6 | 1 | 0 |
| 6 | Boehringer Ingelheim International GmbH | 5 | 5 | 0 |
| 7 | 广西修正制药有限公司 | 5 | 3 | 0 |
| 8 | 海南涛生医药科技研究院有限公司 | 5 | 3 | 0 |
| 9 | 石家庄四药有限公司 | 5 | 3 | 5 |
| 10 | 广州百济神州生物制药有限公司 | 4 | 3 | 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
87 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/08/08Generic · Class 3 | 卡络磺钠注射液CYHS2201256 | 仁合益康集团有限公司; 河北仁合益康药业有限公司 |
| 2022/08/08Generic · Class 3 | 注射用氨苄西林钠CYHS2201253 | 山西铭羽生物科技有限公司; 山东鲁抗医药股份有限公司 |
| 2022/08/08Generic · Class 3 | 阿立哌唑口服溶液CYHS2201251 | 山东百诺医药股份有限公司; 中孚药业股份有限公司 |
| 2022/08/08Generic · Class 3 | 奥硝唑注射液CYHS2201250 | 西安信百欣医药科技有限公司; 太极集团四川太极制药有限公司 |
| 2022/08/08Generic · Class 3 | 奥硝唑注射液CYHS2201249 | 西安信百欣医药科技有限公司; 太极集团四川太极制药有限公司 |
| 2022/08/08Generic · Class 3 | 胞磷胆碱钠注射液CYHS2201248 | 石家庄四药有限公司 |
| 2022/08/08Generic · Class 3 | 低钙腹膜透析液（乳酸盐-G2.5%）CYHS2201233 | 安徽丰原药业股份有限公司 |
| 2022/08/08Generic · Class 3 | 低钙腹膜透析液（乳酸盐-G1.5%）CYHS2201232 | 安徽丰原药业股份有限公司 |
| 2022/08/08New drug · Class 1.1 | 通降颗粒CXZL2200037 | 健民药业集团股份有限公司 |
| 2022/08/08New drug · Class 2.3 | 舒肝解郁胶囊CXZL2200036 | 四川济生堂药业有限公司 |
| 2022/08/08New drug · Class 1 | 欧司珀利单抗注射液CXSL2200365 | 广州百济神州生物制药有限公司 |
| 2022/08/08New drug · Class 1 | 重组人源化抗BTLA单克隆抗体注射液CXSL2200364 | 上海君实生物医药科技股份有限公司 |
| 2022/08/08New drug · Class 1 | LBL-007注射液CXSL2200363 | 广州百济神州生物制药有限公司 |
| 2022/08/08New drug · Class 3.4 | 聚乙二醇化人粒细胞刺激因子注射液CXSL2200346 | 科兴生物制药股份有限公司 |
| 2022/08/08New drug · Class 2.1 | 盐酸左沙丁胺醇异丙托溴铵吸入溶液CXHL2200575 | 江苏和晨药业有限公司 |
| 2022/08/08New drug · Class 2.4 | 利多卡因凝胶贴膏CXHL2200574 | 北京泰德制药股份有限公司 |
| 2022/08/08New drug · Class 1 | BEBT-503胶囊CXHL2200573 | 广州必贝特医药股份有限公司 |
| 2022/08/08New drug · Class 1 | BEBT-503胶囊CXHL2200572 | 广州必贝特医药股份有限公司 |
| 2022/08/08New drug · Class 2.2 | 盐酸溴己新分散片CXHL2200560 | 江西亿友药业有限公司 |
| 2022/08/08New drug · Class 2.2 | 盐酸溴己新分散片CXHL2200559 | 江西亿友药业有限公司 |
| 2022/08/05Import · Class 1 | BMS-986256胶囊JXHL2200235 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2022/08/05Import · Class 1 | BMS-986256胶囊JXHL2200234 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2022/08/05Import · Class 1 | 注射用替曲朵辛JXHL2200226 | WEX Pharmaceuticals Inc.; PPC China Corporation Limited |
| 2022/08/05Generic · Class 3 | 酮咯酸氨丁三醇注射液CYHS2201244 | 鲁南贝特制药有限公司; 山东华鲁制药有限公司 |
| 2022/08/05Generic · Class 3 | 依巴斯汀口服溶液CYHS2201240 | 江苏联环药业股份有限公司; 南京海纳制药有限公司 |
| 2022/08/05New drug · Class 1 | 注射用SHR-A1811CXSL2200362 | 苏州盛迪亚生物医药有限公司 |
| 2022/08/05New drug · Class 1 | KP104注射液CXSL2200361 | 科越医药（苏州）有限公司 |
| 2022/08/05New drug · Class 2.2 | 替雷利珠单抗注射液CXSL2200360 | 百济神州（上海）生物科技有限公司 |
| 2022/08/05New drug · Class 1 | IMG-007注射液CXSL2200359 | 英脉生物医药（杭州）有限公司 |
| 2022/08/05New drug · Class 1 | SHR-1701注射液CXSL2200358 | 苏州盛迪亚生物医药有限公司 |
57 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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