药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2025/06/10 – 2025/06/16
- New acceptances this week
- 433
- Drugs with new generic filings (by drug name, de-duplicated)
- 77
- Accepted this week, now under review
- 68
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
433filings, 119 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 184 |
| Generic | 119 |
| New drug | 66 |
| Import | 43 |
| Unspecified | 11 |
| Import re-registration | 9 |
| 医疗器械(联合审评) | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 281 |
| 治疗用生物制品 | 71 |
| TCM | 69 |
| Biologic | 7 |
| 预防用生物制品 | 3 |
| 体外诊断试剂 | 1 |
| Unspecified | 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
77 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 乙酰半胱氨酸注射液 | 18 | 17 | 53 |
| 2 | 布瑞哌唑片 | 4 | 2 | 31 |
| 3 | 苯磺酸左氨氯地平片 | 4 | 2 | 47 |
| 4 | 卡左双多巴缓释片 | 3 | 2 | 3 |
| 5 | 沙库巴曲缬沙坦钠片 | 3 | 2 | 72 |
| 6 | 中性低钙腹膜透析液(碳酸氢盐-G4.25%) | 2 | 2 | 1 |
| 7 | 乌帕替尼缓释片 | 2 | 2 | 43 |
| 8 | 二十碳五烯酸乙酯软胶囊 | 2 | 2 | 25 |
| 9 | 乙酰半胱氨酸口服溶液 | 2 | 1 | 11 |
| 10 | 乳果糖口服溶液 | 2 | 1 | 40 |
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
264 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Merck Sharp & Dohme B.V. | 22 | 1 | 0 |
| 2 | 河南赢丰医药有限公司 | 8 | 8 | 0 |
| 3 | 黑龙江林海雪原药业有限公司 | 7 | 7 | 0 |
| 4 | 瑞阳制药股份有限公司 | 7 | 2 | 0 |
| 5 | 苏州泽璟生物制药股份有限公司 | 5 | 3 | 0 |
| 6 | AstraZeneca AB | 5 | 2 | 0 |
| 7 | Pfizer Inc. | 5 | 2 | 0 |
| 8 | 江苏恒瑞医药股份有限公司 | 5 | 2 | 0 |
| 9 | 江苏中新医药有限公司 | 5 | 1 | 0 |
| 10 | 福建基诺厚普生物科技有限公司 | 5 | 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
140 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/06/14Import · Class 1 | 注射用MK-2400JXSL2500089 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2025/06/14Import · Class 1 | 注射用MK-5909JXSL2500088 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2025/06/14Import · Class 2.4 | 甲苯磺酸利特昔替尼胶囊JXHL2500144 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd |
| 2025/06/14Import · Class 2.4 | 甲苯磺酸利特昔替尼胶囊JXHL2500143 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd |
| 2025/06/14Import · Class 1 | AZD6793JXHL2500142 | AstraZeneca AB |
| 2025/06/14Import · Class 1 | AZD6793JXHL2500141 | AstraZeneca AB |
| 2025/06/14Import · Class 1 | AZD6793JXHL2500140 | AstraZeneca AB |
| 2025/06/14Generic · Class 3 | 酮咯酸氨丁三醇片CYHS2502133 | 南京海融制药有限公司 |
| 2025/06/14Generic · Class 3 | 盐酸溴己新口服溶液CYHS2502131 | 岳阳新华达制药有限公司 |
| 2025/06/14Generic · Class 3 | 乙酰半胱氨酸口服溶液CYHS2502130 | 合肥国药诺和药业有限公司; 合肥诚志生物制药有限公司 |
| 2025/06/14Generic · Class 3 | 乙酰半胱氨酸口服溶液CYHS2502129 | 合肥国药诺和药业有限公司; 合肥诚志生物制药有限公司 |
| 2025/06/14Generic · Class 3 | 氯化钙注射液CYHS2502125 | 成都青山利康药业股份有限公司; 广东星昊药业有限公司 |
| 2025/06/14Generic · Class 3 | 腺苷钴胺胶囊CYHS2502123 | 江苏诚康药业有限公司 |
| 2025/06/14Generic · Class 3 | 醋酸锌颗粒CYHS2502120 | 仁合益康集团有限公司; 河北仁合益康药业有限公司 |
| 2025/06/14Generic · Class 3 | 醋酸锌颗粒CYHS2502119 | 仁合益康集团有限公司; 河北仁合益康药业有限公司 |
| 2025/06/14Generic · Class 3 | 贝美前列素涂剂CYHL2500113 | 浙江孚诺医药股份有限公司 |
| 2025/06/14New drug · Class 1 | IBI343CXSL2500487 | 信达生物制药(苏州)有限公司 |
| 2025/06/14New drug · Class 1 | 注射用ZG005CXSL2500486 | 苏州泽璟生物制药股份有限公司; 上海泽璟医药技术有限公司 |
| 2025/06/14New drug · Class 1 | 洛奈利单抗注射液CXSL2500485 | 山东新时代药业有限公司 |
| 2025/06/14New drug · Class 2.2 | 兰索拉唑碳酸氢钠干混悬剂CXHS2500067 | 南京海纳制药有限公司 |
| 2025/06/14New drug · Class 1 | HP-001胶囊CXHL2500580 | 上海超阳药业有限公司 |
| 2025/06/14New drug · Class 1 | HP-001胶囊CXHL2500579 | 上海超阳药业有限公司 |
| 2025/06/14New drug · Class 1 | HP-001胶囊CXHL2500578 | 上海超阳药业有限公司 |
| 2025/06/14New drug · Class 2.4 | 盐酸吉卡昔替尼片CXHL2500577 | 苏州泽璟生物制药股份有限公司; 上海泽璟医药技术有限公司 |
| 2025/06/14New drug · Class 1 | 注射用FZ-P001钠CXHL2500576 | 上海复旦张江生物医药股份有限公司 |
| 2025/06/14New drug · Class 2.2 | JSS-222CXHL2500575 | 江西施美药业股份有限公司 |
| 2025/06/14New drug · Class 2.2 | 司美格鲁肽注射液CXHL2500574 | 福建基诺厚普生物科技有限公司 |
| 2025/06/14New drug · Class 2.2 | 司美格鲁肽注射液CXHL2500573 | 福建基诺厚普生物科技有限公司 |
| 2025/06/14New drug · Class 2.2 | 司美格鲁肽注射液CXHL2500572 | 福建基诺厚普生物科技有限公司 |
| 2025/06/14New drug · Class 2.2 | 司美格鲁肽注射液CXHL2500571 | 福建基诺厚普生物科技有限公司 |
110 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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