药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/03/17 – 2026/03/23
- New acceptances this week
- 310
- Drugs with new generic filings (by drug name, de-duplicated)
- 29
- Accepted this week, now under review
- 64
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
310filings, 34 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 203 |
| New drug | 45 |
| Generic | 34 |
| Import | 16 |
| Unspecified | 7 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 167 |
| TCM | 113 |
| 治疗用生物制品 | 25 |
| Biologic | 4 |
| 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
29 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 左氧氟沙星滴眼液 | 3 | 1 | 16 |
| 2 | 单硝酸异山梨酯缓释片 | 2 | 1 | 5 |
| 3 | 司来帕格片 | 2 | 1 | 24 |
| 4 | 拉西地平片 | 2 | 1 | 7 |
| 5 | 二硫化硒洗剂 | 1 | 1 | 14 |
| 6 | 伏硫西汀滴剂 | 1 | 1 | 1 |
| 7 | 依非米替片(I) | 1 | 1 | 2 |
| 8 | 利多卡因凝胶贴膏 | 1 | 1 | 7 |
| 9 | 头孢克肟干混悬剂 | 1 | 1 | 3 |
| 10 | 富马酸酮替芬口服溶液 | 1 | 1 | 8 |
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
178 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 福建盛迪医药有限公司 | 9 | 1 | 0 |
| 2 | 锦州福寿堂医药科技有限公司 | 8 | 8 | 0 |
| 3 | 陕西盘龙药业集团股份有限公司 | 8 | 8 | 0 |
| 4 | 哈尔滨三联药业股份有限公司 | 7 | 1 | 0 |
| 5 | 津药达仁堂集团股份有限公司达仁堂制药厂 | 6 | 5 | 0 |
| 6 | 内蒙古库伦蒙药有限公司 | 5 | 5 | 0 |
| 7 | 齐鲁制药有限公司 | 5 | 4 | 0 |
| 8 | 苏州盛迪亚生物医药有限公司 | 5 | 3 | 0 |
| 9 | Amgen Inc. | 5 | 2 | 0 |
| 10 | 南京同仁堂药业有限责任公司 | 4 | 4 | 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
70 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/03/23Import · Class 2.4 | 那米司特片JXHL2600090 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2026/03/23Import · Class 2.4 | 那米司特片JXHL2600089 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2026/03/23Import · Class 2.4 | 那米司特片JXHL2600088 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2026/03/23Generic · Class 3 | 头孢克肟干混悬剂CYHS2600697 | 海南广升誉制药有限公司; 金鸿药业股份有限公司 |
| 2026/03/23Generic · Class 3 | 硫酸特布他林口服溶液CYHS2600696 | 苏州弘森药业股份有限公司; 扬州市三药制药有限公司 |
| 2026/03/23New drug · Class 2.2 | DMI019鼻喷雾剂CXHL2600361 | 江苏德迈药业有限公司 |
| 2026/03/23New drug · Class 2.2 | DMI019鼻喷雾剂CXHL2600360 | 江苏德迈药业有限公司 |
| 2026/03/23New drug · Class 2.2 | DMI019鼻喷雾剂CXHL2600359 | 江苏德迈药业有限公司 |
| 2026/03/21Import · Class 2.1 | 注射用贝林妥欧单抗(皮下注射)JXSL2600084 | Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd. |
| 2026/03/21Import · Class 2.1 | 注射用贝林妥欧单抗(皮下注射)JXSL2600083 | Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd. |
| 2026/03/21Import · Class 1 | MK-1084片JXHL2600087 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2026/03/21Import · Class 1 | MK-1084片JXHL2600086 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2026/03/21New drug · Class 2.2 | 夫那奇珠单抗注射液CXSL2600342 | 苏州盛迪亚生物医药有限公司 |
| 2026/03/21New drug · Class 2.2 | 夫那奇珠单抗注射液CXSL2600341 | 苏州盛迪亚生物医药有限公司 |
| 2026/03/21New drug · Class 2.2 | 夫那奇珠单抗注射液CXSL2600340 | 苏州盛迪亚生物医药有限公司 |
| 2026/03/21New drug · Class 1 | SHR-6914注射液CXSL2600339 | 苏州盛迪亚生物医药有限公司 |
| 2026/03/21New drug · Class 1 | HP-002片CXHL2600356 | 上海超阳药业有限公司 |
| 2026/03/21New drug · Class 1 | HP-002片CXHL2600355 | 上海超阳药业有限公司 |
| 2026/03/21New drug · Class 1 | HP-002片CXHL2600354 | 上海超阳药业有限公司 |
| 2026/03/21New drug · Class 1 | HRS9531注射液CXHL2600353 | 福建盛迪医药有限公司 |
| 2026/03/21New drug · Class 1 | HRS9531注射液CXHL2600352 | 福建盛迪医药有限公司 |
| 2026/03/21New drug · Class 1 | HRS9531注射液CXHL2600351 | 福建盛迪医药有限公司 |
| 2026/03/21New drug · Class 1 | HRS9531注射液CXHL2600350 | 福建盛迪医药有限公司 |
| 2026/03/21New drug · Class 1 | HRS9531注射液CXHL2600349 | 福建盛迪医药有限公司 |
| 2026/03/21New drug · Class 1 | HRS9531注射液CXHL2600348 | 福建盛迪医药有限公司 |
| 2026/03/20Import · Class 2.4 | 乌帕替尼缓释片JXHS2600032 | AbbVie Deutschland GmbH & Co. KG; AbbVie Ireland NL B.V. |
| 2026/03/20Import · Class 2.4 | 乌帕替尼缓释片JXHS2600031 | AbbVie Deutschland GmbH & Co. KG; AbbVie Ireland NL B.V. |
| 2026/03/20Generic · Class 3 | 二硫化硒洗剂CYHS2600687 | 山西振东安欣生物制药有限公司 |
| 2026/03/20New drug · Class 2.1 | YK-2001注射液CXHS2600044 | 南京力博维制药有限公司; 南京优科制药有限公司 |
| 2026/03/20New drug · Class 2.1 | YK-2001注射液CXHS2600043 | 南京力博维制药有限公司; 南京优科制药有限公司 |
40 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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