药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/05/26 – 2026/06/01
- New acceptances this week
- 360
- Drugs with new generic filings (by drug name, de-duplicated)
- 38
- Accepted this week, now under review
- 91
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
360filings, 56 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 229 |
| Generic | 56 |
| New drug | 42 |
| Import | 19 |
| Unspecified | 9 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 173 |
| TCM | 131 |
| 治疗用生物制品 | 46 |
| Biologic | 5 |
| 预防用生物制品 | 5 |
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 | 甲硝唑凝胶 | 5 | 3 | 13 |
| 2 | 枸橼酸舒芬太尼注射液 | 5 | 1 | 0 |
| 3 | 盐酸氯普鲁卡因注射液 | 3 | 2 | 10 |
| 4 | 注射用盐酸兰地洛尔 | 2 | 2 | 19 |
| 5 | 瑞维那新吸入溶液 | 2 | 2 | 53 |
| 6 | 口服溶液用盐酸万古霉素 | 2 | 1 | 2 |
| 7 | 盐酸异丙嗪注射液 | 2 | 1 | 11 |
| 8 | 盐酸米那普仑片 | 2 | 1 | 8 |
| 9 | 苯磺酸美洛加巴林片 | 2 | 1 | 58 |
| 10 | 达格列净片 | 2 | 1 | 82 |
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
235 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 长沙东风药业有限公司 | 6 | 6 | 0 |
| 2 | 北京同仁堂科技发展股份有限公司制药厂 | 6 | 4 | 0 |
| 3 | 宜昌人福药业有限责任公司 | 6 | 2 | 6 |
| 4 | 安徽得宏生制药有限公司 | 5 | 5 | 0 |
| 5 | 津药达仁堂集团股份有限公司乐仁堂制药厂 | 5 | 5 | 0 |
| 6 | 国药集团新疆制药有限公司 | 5 | 4 | 0 |
| 7 | 北京同仁堂股份有限公司同仁堂制药厂 | 5 | 3 | 0 |
| 8 | 贵州省科晖制药有限公司 | 4 | 4 | 0 |
| 9 | Kyowa Kirin Co. Ltd. | 4 | 2 | 0 |
| 10 | Eli Lilly Nederland B.V. | 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 no longer on the under-review list whose last snapshot sighting falls in this week, meaning approved or terminated, to be verified. Companies are counted by first applicant.
Class 3 and new-drug acceptances
91 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/06/01Import · Class 2.2 | 尼卡利单抗注射液JXSS2600045 | Janssen-Cilag International NV; Vetter Pharma-Fertigung GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd. |
| 2026/06/01Import · Class 2.2 | 尼卡利单抗注射液JXSS2600044 | Janssen-Cilag International NV; Vetter Pharma-Fertigung GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd. |
| 2026/06/01Import · Class 1 | ABBV-1758注射液JXSL2600125 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2026/06/01Import · Class 2.2 | 伊奈利珠单抗注射液JXSL2600124 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2026/06/01Import · Class 1 | LY4257496注射液JXHL2600193 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2026/06/01Generic · Class 3 | 盐酸异丙嗪注射液CYHS2601244 | 亚宝药业集团股份有限公司 |
| 2026/06/01Generic · Class 3 | 盐酸异丙嗪注射液CYHS2601243 | 亚宝药业集团股份有限公司 |
| 2026/06/01Generic · Class 3 | 注射用西维来司他钠CYHS2601242 | 山东豪瑞恩制药有限公司 |
| 2026/06/01Generic · Class 3 | 聚卡波非钙片CYHS2601241 | 浙江佐力药业股份有限公司 |
| 2026/06/01Generic · Class 3 | 盐酸氯普鲁卡因注射液CYHS2601237 | 成都瑞尔医药科技有限公司; 成都百裕制药股份有限公司 |
| 2026/06/01Generic · Class 3 | 注射用盐酸兰地洛尔CYHS2601236 | 宜昌人福药业有限责任公司 |
| 2026/06/01Generic · Class 3 | 葡萄糖酸氯己定含漱液CYHS2601233 | 北京远方通达医药技术有限公司; 南京集萃剂鼎医药有限公司 |
| 2026/06/01Generic · Class 3 | 复合磷酸氢钾注射液CYHS2601232 | 仁合益康汇泽药业河北有限公司 |
| 2026/06/01Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G2.5%)CYHS2601230 | 广东科泓药业有限公司 |
| 2026/06/01Generic · Class 3 | 普罗布考片CYHS2601226 | 宁夏康亚药业股份有限公司 |
| 2026/06/01Generic · Class 3 | 盐酸氯普鲁卡因注射液CYHS2601220 | 北京紫萌医药科技有限公司; 酒泉大得利制药股份有限公司 |
| 2026/06/01Generic · Class 3 | 盐酸氯普鲁卡因注射液CYHS2601219 | 北京紫萌医药科技有限公司; 酒泉大得利制药股份有限公司 |
| 2026/06/01Generic · Class 3 | 右酮洛芬氨丁三醇注射液CYHS2601218 | 中润药业有限公司; 山西普德药业有限公司 |
| 2026/06/01New drug · Class 2.3 | 灵莲花颗粒CXZL2600050 | 浙江佐力药业股份有限公司 |
| 2026/06/01New drug · Class 1 | GR2302注射液(皮下注射)CXSL2600589 | 智翔(上海)医药科技有限公司; 重庆智翔金泰生物制药股份有限公司 |
| 2026/06/01New drug · Class 1 | GR2302注射液(皮下注射)CXSL2600588 | 智翔(上海)医药科技有限公司; 重庆智翔金泰生物制药股份有限公司 |
| 2026/06/01New drug · Class 1 | GR2302注射液CXSL2600587 | 智翔(上海)医药科技有限公司; 重庆智翔金泰生物制药股份有限公司 |
| 2026/06/01New drug · Class 1 | SHR-1179注射液CXSL2600586 | 广东恒瑞医药有限公司 |
| 2026/06/01New drug · Class 1 | 伊匹乌肽散剂CXHL2600642 | 温州益承睛湛生物科技有限公司 |
| 2026/06/01New drug · Class 1 | 注射用APG-1252CXHL2600641 | 苏州亚盛药业有限公司 |
| 2026/06/01New drug · Class 1 | TRI-611片CXHL2600640 | 诺为泰医药科技(上海)有限公司 |
| 2026/06/01New drug · Class 1 | TRI-611片CXHL2600639 | 诺为泰医药科技(上海)有限公司 |
| 2026/05/29Import · Class 2.2 | 阿替利珠单抗注射液JXSS2600043 | Roche Registration GmbH; Roche Diagnostics GmbH; F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd. |
| 2026/05/29Import · Class 1 | INCA33890注射液JXSL2600123 | Incyte Corporation; Incyte Biosciences (Shanghai) Co. Ltd. |
| 2026/05/29Import · Class 1 | Ponsegromab注射液JXSL2600122 | Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd. |
61 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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