药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/05/23 – 2023/05/29
- New acceptances this week
- 305
- Drugs with new generic filings (by drug name, de-duplicated)
- 47
- Accepted this week, now under review
- 3
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
305filings, 73 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 163 |
| Generic | 73 |
| New drug | 42 |
| Import | 13 |
| Import re-registration | 12 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 210 |
| TCM | 56 |
| 治疗用生物制品 | 34 |
| 预防用生物制品 | 4 |
| 体外诊断试剂 | 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
47 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 罗沙司他胶囊 | 10 | 5 | 17 |
| 2 | 盐酸罗哌卡因注射液 | 4 | 1 | 5 |
| 3 | 米诺地尔外用溶液 | 3 | 2 | 0 |
| 4 | 枸橼酸西地那非片 | 3 | 1 | 12 |
| 5 | 氨甲环酸注射液 | 3 | 1 | 11 |
| 6 | 注射用卡非佐米 | 3 | 1 | 0 |
| 7 | 注射用苯唑西林钠 | 3 | 1 | 13 |
| 8 | 间苯三酚注射液 | 2 | 2 | 2 |
| 9 | 注射用尼可地尔 | 2 | 1 | 1 |
| 10 | 盐酸左沙丁胺醇雾化吸入溶液 | 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
188 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 湖北朗德药业有限公司 | 14 | 6 | 0 |
| 2 | Eli Lilly and Company | 6 | 1 | 0 |
| 3 | 上海壹典医药科技开发有限公司 | 6 | 1 | 0 |
| 4 | 安国亚东生物制药有限公司 | 5 | 5 | 0 |
| 5 | AstraZeneca AB | 4 | 2 | 0 |
| 6 | 中嘉生物科技（湖北省）有限公司 | 4 | 2 | 0 |
| 7 | 四川汇宇制药股份有限公司 | 4 | 2 | 4 |
| 8 | 辽宁民康制药有限公司 | 4 | 2 | 0 |
| 9 | NAPP PHARMACEUTICALS LIMITED | 4 | 1 | 0 |
| 10 | 北京普祺医药科技股份有限公司 | 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
81 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/05/27Import · Class 1 | OMTX705注射用浓溶液JXSL2300098 | InxMed (Hong Kong) Limited; InxMed (Nanjing) Co. Ltd |
| 2023/05/27Import · Class 1 | LY3502970胶囊JXHL2300131 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/05/27Import · Class 1 | LY3502970胶囊JXHL2300130 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/05/27Import · Class 1 | LY3502970胶囊JXHL2300129 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/05/27Import · Class 1 | LY3502970胶囊JXHL2300128 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/05/27Import · Class 1 | LY3502970胶囊JXHL2300127 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/05/27Import · Class 1 | LY3502970胶囊JXHL2300126 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/05/27Import · Class 2.4 | 盐酸醋克利定滴眼液JXHL2300125 | LENZ Therapeutics Inc.; Ji Xing Pharmaceuticals (Shanghai) Co.，Ltd |
| 2023/05/27Import · Class 2.3;2.4 | 醋克利定溴莫尼定滴眼液JXHL2300124 | LENZ Therapeutics Inc.; Ji Xing Pharmaceuticals (Shanghai) Co.，Ltd |
| 2023/05/27Generic · Class 3 | 盐酸肾上腺素注射液CYHS2301442 | 石家庄四药有限公司 |
| 2023/05/27Generic · Class 3 | 吲哚布芬片CYHS2301441 | 山东鲁盛制药有限公司 |
| 2023/05/27Generic · Class 3 | 羧甲司坦口服溶液CYHS2301440 | 北京沃邦医药科技有限公司; 扬州市三药制药有限公司 |
| 2023/05/27Generic · Class 3 | 盐酸多巴胺注射液CYHS2301439 | 吉林省辉南长龙生化药业股份有限公司 |
| 2023/05/27Generic · Class 3 | 法莫替丁注射液CYHS2301437 | 南京康发生物科技有限公司; 马鞍山丰原制药有限公司 |
| 2023/05/27Generic · Class 3 | 西格列汀二甲双胍缓释片CYHS2301432 | 宁波美舒医药科技有限公司; 宁波美诺华天康药业有限公司 |
| 2023/05/27New drug · Class 1.1 | 参芪软斑颗粒CXZL2300038 | 山东禹泽药康产业技术研究院有限公司 |
| 2023/05/27New drug · Class 3.4 | 注射用奥马珠单抗αCXSL2300378 | 泰州迈博太科药业有限公司 |
| 2023/05/27New drug · Class 3.4 | 注射用奥马珠单抗αCXSL2300377 | 泰州迈博太科药业有限公司 |
| 2023/05/26Generic · Class 3 | 米诺地尔外用溶液CYHS2301430 | 江苏润邦药业有限公司; 中山万汉制药有限公司 |
| 2023/05/26Generic · Class 3 | 米诺地尔外用溶液CYHS2301429 | 江苏润邦药业有限公司; 中山万汉制药有限公司 |
| 2023/05/26Generic · Class 3 | 氟尿嘧啶注射液CYHS2301428 | 湖南赛隆药业（长沙）有限公司; 山西普德药业有限公司 |
| 2023/05/26Generic · Class 3 | 普瑞巴林口服溶液CYHS2301427 | 哈尔滨市康隆药业有限责任公司 |
| 2023/05/26Generic · Class 3 | 氟哌啶醇注射液CYHS2301426 | 成都瑞尔医药科技有限公司; 成都市海通药业有限公司 |
| 2023/05/26New drug · Class 1.1 | 麻荆宣肺颗粒CXZL2300037 | 中国中医科学院西苑医院 |
| 2023/05/26New drug · Class 1.4 | 口服六价重配轮状病毒活疫苗（Vero细胞）CXSS2300039 | 武汉生物制品研究所有限责任公司 |
| 2023/05/26New drug · Class 2.2 | 四价流感病毒亚单位疫苗（MDCK细胞）CXSL2300376 | 长春生物制品研究所有限责任公司 |
| 2023/05/26New drug · Class 3.2 | 人纤溶酶原CXSL2300375 | 深圳市卫光生物制品股份有限公司 |
| 2023/05/26New drug · Class 1 | KQ-2003自体嵌合抗原受体T细胞注射液CXSL2300374 | 上海科棋药业科技有限公司 |
| 2023/05/26New drug · Class 1 | JY03注射液CXSL2300373 | 北京东方百泰生物科技股份有限公司; 北京精益泰翔技术发展有限公司 |
| 2023/05/26New drug · Class 1 | YH2000片CXHL2300580 | 武汉市金诺赛生物医药有限公司 |
51 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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