药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/01/27 – 2026/02/02
- New acceptances this week
- 378
- Drugs with new generic filings (by drug name, de-duplicated)
- 45
- Accepted this week, now under review
- 92
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
378filings, 61 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 223 |
| Generic | 61 |
| New drug | 59 |
| Import | 16 |
| Import re-registration | 10 |
| Unspecified | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 206 |
| TCM | 106 |
| 治疗用生物制品 | 58 |
| 预防用生物制品 | 4 |
| Biologic | 3 |
| 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
45 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 注射用头孢美唑钠 | 3 | 1 | 7 |
| 2 | 莫立司他钠片 | 3 | 1 | 0 |
| 3 | 褪黑素颗粒 | 2 | 2 | 12 |
| 4 | 双氯芬酸二乙胺乳胶剂 | 2 | 1 | 21 |
| 5 | 复方氨基酸注射液（17AA-Ⅲ） | 2 | 1 | 2 |
| 6 | 左羟丙哌嗪口服溶液 | 2 | 1 | 8 |
| 7 | 恩格列净片 | 2 | 1 | 20 |
| 8 | 氢溴酸加兰他敏片 | 2 | 1 | 2 |
| 9 | 注射用头孢他啶/氯化钠注射液 | 2 | 1 | 3 |
| 10 | 注射用盐酸多西环素 | 2 | 1 | 12 |
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
215 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 江右制药（常德）有限公司 | 14 | 14 | 0 |
| 2 | 哈药集团生物工程有限公司 | 14 | 7 | 0 |
| 3 | 百济神州（苏州）生物科技有限公司 | 7 | 2 | 0 |
| 4 | 神威药业集团有限公司 | 6 | 6 | 0 |
| 5 | 达嘉维康生物制药有限公司 | 6 | 6 | 0 |
| 6 | Bayer AG | 6 | 2 | 0 |
| 7 | Novo Nordisk A/S | 6 | 1 | 0 |
| 8 | Pfizer Inc. | 4 | 4 | 0 |
| 9 | 丹东药业集团有限公司 | 4 | 4 | 0 |
| 10 | 广东万年青制药股份有限公司 | 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
96 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/02/02New drug · Class 1 | HX102片CXHL2600137 | 华夏生生药业（北京）有限公司 |
| 2026/02/02New drug · Class 1 | HX102片CXHL2600136 | 华夏生生药业（北京）有限公司 |
| 2026/01/31Import · Class 1 | PF-08634404JXSL2600036 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/01/31Import · Class 1 | PF-08046047JXSL2600035 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2026/01/31Import · Class 1 | PF-08046054 (注射用冻干粉针)JXSL2600034 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2026/01/31Import · Class 1 | BMS-986504片JXHL2600031 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/01/31Generic · Class 3 | 氢溴酸加兰他敏片CYHS2600329 | 杭州康恩贝制药有限公司; 浙江金华康恩贝生物制药有限公司 |
| 2026/01/31Generic · Class 3 | 氢溴酸加兰他敏片CYHS2600328 | 杭州康恩贝制药有限公司; 浙江金华康恩贝生物制药有限公司 |
| 2026/01/31Generic · Class 3 | 依托泊苷注射液CYHS2600327 | 无锡紫杉药业股份有限公司; 合肥亿帆生物制药有限公司 |
| 2026/01/31Generic · Class 3 | 注射用盐酸多西环素CYHS2600321 | 海南卫康制药（潜山）有限公司 |
| 2026/01/31Generic · Class 3 | 羧甲司坦口服溶液CYHS2600320 | 成都欣捷高新技术开发股份有限公司; 湖南九典制药股份有限公司 |
| 2026/01/31Generic · Class 3 | 注射用盐酸多西环素CYHS2600319 | 海南卫康制药（潜山）有限公司 |
| 2026/01/31Generic · Class 3 | 莫立司他钠片CYHL2600019 | 上海博志研新药物研究有限公司 |
| 2026/01/31Generic · Class 3 | 莫立司他钠片CYHL2600018 | 上海博志研新药物研究有限公司 |
| 2026/01/31Generic · Class 3 | 莫立司他钠片CYHL2600017 | 上海博志研新药物研究有限公司 |
| 2026/01/31New drug · Class 1.1 | 金柴胶囊CXZS2600010 | 神威药业集团有限公司 |
| 2026/01/31New drug · Class 3.1 | 清金化痰颗粒CXZS2600009 | 江阴天江药业有限公司 |
| 2026/01/31New drug · Class 3.1 | 黄芪桂枝五物汤颗粒CXZS2600008 | 神威药业集团有限公司 |
| 2026/01/31New drug · Class 1.1 | 地黄宝源颗粒CXZL2600020 | 精医和生医药（广东横琴粤澳深度合作区）有限公司; 北京精医和生医药科技有限公司 |
| 2026/01/31New drug · Class 1.1 | 地黄宝源颗粒CXZL2600019 | 精医和生医药（广东横琴粤澳深度合作区）有限公司; 北京精医和生医药科技有限公司 |
| 2026/01/31New drug · Class 1.1 | 茯苓运化颗粒CXZL2600018 | 精医和生医药（广东横琴粤澳深度合作区）有限公司; 北京精医和生医药科技有限公司 |
| 2026/01/31New drug · Class 1 | GS3-007a干混悬剂CXHL2600135 | 长春金赛药业有限责任公司 |
| 2026/01/30Generic · Class 3 | 倍他米松磷酸钠注射液CYHS2600316 | 河南润弘制药股份有限公司 |
| 2026/01/30New drug · Class 3.1 | 清骨散颗粒CXZS2600007 | 神威药业集团有限公司 |
| 2026/01/30New drug · Class 1 | CMG2349注射液CXSL2600156 | 成都恩沐生物科技有限公司 |
| 2026/01/30New drug · Class 1 | 注射用MK-1045CXSL2600155 | 默沙东研发（中国）有限公司 |
| 2026/01/30New drug · Class 1 | 注射用MK-1045CXSL2600154 | 默沙东研发（中国）有限公司 |
| 2026/01/30New drug · Class 1 | SG301注射液CXSL2600152 | 杭州尚健生物技术股份有限公司 |
| 2026/01/30New drug · Class 1 | SYS6051CXSL2600151 | 石药集团巨石生物制药有限公司 |
| 2026/01/30New drug · Class 1 | 注射用LY4170156CXSL2600149 | 礼来苏州制药有限公司 |
66 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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