药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/03/10 – 2026/03/16
- New acceptances this week
- 348
- Drugs with new generic filings (by drug name, de-duplicated)
- 34
- Accepted this week, now under review
- 84
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
348filings, 41 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 190 |
| New drug | 80 |
| Generic | 41 |
| Import | 16 |
| Unspecified | 14 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 182 |
| TCM | 94 |
| 治疗用生物制品 | 62 |
| Biologic | 9 |
| 预防用生物制品 | 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
34 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 达普司他片 | 3 | 1 | 0 |
| 2 | 他克莫司胶囊 | 2 | 1 | 2 |
| 3 | 克唑替尼胶囊 | 2 | 1 | 7 |
| 4 | 沙库巴曲缬沙坦钠片 | 2 | 1 | 72 |
| 5 | 注射用阿立哌唑 | 2 | 1 | 4 |
| 6 | 苯磺酸美洛加巴林片 | 2 | 1 | 58 |
| 7 | 乳果糖口服溶液 | 1 | 1 | 40 |
| 8 | 乳酸钠林格冲洗液 | 1 | 1 | 5 |
| 9 | 八氟丙烷脂质微球注射液 | 1 | 1 | 3 |
| 10 | 右酮洛芬氨丁三醇注射液 | 1 | 1 | 5 |
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
197 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 湖北济安堂药业股份有限公司 | 12 | 12 | 0 |
| 2 | 江西普丽尔药业有限公司 | 11 | 10 | 0 |
| 3 | 上海君实生物医药科技股份有限公司 | 8 | 1 | 0 |
| 4 | 黑龙江省松花江医药科技有限公司 | 7 | 7 | 0 |
| 5 | 新石阳光药业（河北）有限公司 | 6 | 4 | 0 |
| 6 | 海思科医药集团股份有限公司 | 6 | 1 | 0 |
| 7 | 长风苏粤药业（广州）有限公司 | 6 | 1 | 0 |
| 8 | 齐鲁制药有限公司 | 5 | 4 | 2 |
| 9 | 江苏恒瑞医药股份有限公司 | 5 | 3 | 0 |
| 10 | 杭州高光制药股份有限公司 | 5 | 2 | 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
108 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/03/16New drug · Class 1 | ASKC202片CXHL2600328 | 江苏奥赛康药业有限公司 |
| 2026/03/16New drug · Class 1 | ASKC202片CXHL2600327 | 江苏奥赛康药业有限公司 |
| 2026/03/14Import · Class 3.1 | 帕博利珠单抗注射液（皮下注射）JXSS2600022 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2026/03/14Import · Class 3.1 | 帕博利珠单抗注射液（皮下注射）JXSS2600021 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2026/03/14Import · Class 2.2 | Amivantamab注射液（皮下注射）JXSL2600079 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/03/14Generic · Class 3 | 盐酸溴己新口服溶液CYHS2600665 | 浙江领创优品药业有限公司; 浙江赛默制药有限公司 |
| 2026/03/14Generic · Class 3 | 盐酸氨溴索滴剂CYHS2600664 | 江西盛翔制药有限公司 |
| 2026/03/14Generic · Class 3 | 西甲硅油咀嚼片CYHS2600662 | 河北华晨药业集团有限公司 |
| 2026/03/14Generic · Class 3 | 达普司他片CYHL2600036 | 广东方盛健盟药业有限公司 |
| 2026/03/14Generic · Class 3 | 达普司他片CYHL2600035 | 广东方盛健盟药业有限公司 |
| 2026/03/14Generic · Class 3 | 达普司他片CYHL2600034 | 广东方盛健盟药业有限公司 |
| 2026/03/14New drug · Class 1 | 舒地胰岛素诺利糖肽注射液CXSS2600049 | 江苏恒瑞医药股份有限公司 |
| 2026/03/14New drug · Class 1 | 舒地胰岛素诺利糖肽注射液CXSS2600048 | 江苏恒瑞医药股份有限公司 |
| 2026/03/14New drug · Class 1 | BTL-101注射液CXSL2600331 | 本道生物科技（杭州）有限公司 |
| 2026/03/14New drug · Class 2.2 | 注射用重组葡激酶CXSL2600330 | 通化康缘玉金药业有限公司 |
| 2026/03/14New drug · Class 1 | 富马酸立康可泮胶囊CXHS2600042 | 成都盛迪医药有限公司 |
| 2026/03/13Import · Class 1 | Telisotuzumab Adizutecan 注射用粉末JXSL2600078 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2026/03/13Import · Class 1 | Telisotuzumab Adizutecan 注射用粉末JXSL2600077 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2026/03/13Import · Class 2.4 | Lazertinib片JXHL2600082 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/03/13Generic · Class 3 | 马来酸阿塞那平舌下片CYHS2600659 | 哈尔滨三联药业股份有限公司 |
| 2026/03/13New drug · Class 1.1 | 温肺化纤颗粒CXZL2600030 | 江西中医药大学 |
| 2026/03/13New drug · Class 1.1 | ZGZHR-061颗粒CXZL2600029 | 扬子江药业集团江苏龙凤堂中药有限公司; 南京海陵中药制药工艺技术研究有限公司 |
| 2026/03/13New drug · Class 1 | 注射用HLX48CXSL2600329 | 上海复宏瑞霖生物技术有限公司; 上海复宏汉霖生物医药有限公司 |
| 2026/03/13New drug · Class 1 | HS-IT101注射液CXSL2600328 | 青岛中赛伯曼生物科技有限公司 |
| 2026/03/13New drug · Class 1 | 注射用SKB315CXSL2600326 | 四川科伦博泰生物医药股份有限公司 |
| 2026/03/13New drug · Class 1 | ABSK043片CXHL2600326 | 上海和誉生物医药科技有限公司 |
| 2026/03/13New drug · Class 1 | CMS-D001片CXHL2600325 | 深圳市康哲生物科技有限公司 |
| 2026/03/13New drug · Class 1 | ABSK043片CXHL2600324 | 上海和誉生物医药科技有限公司 |
| 2026/03/13New drug · Class 1 | CMS-D001片CXHL2600323 | 深圳市康哲生物科技有限公司 |
| 2026/03/13New drug · Class 1 | CMS-D001片CXHL2600322 | 深圳市康哲生物科技有限公司 |
78 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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