药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/02/10 – 2026/02/16
- New acceptances this week
- 519
- Drugs with new generic filings (by drug name, de-duplicated)
- 66
- Accepted this week, now under review
- 143
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
519filings, 86 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 254 |
| New drug | 101 |
| Generic | 86 |
| Import | 44 |
| Unspecified | 17 |
| Import re-registration | 17 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 306 |
| 治疗用生物制品 | 110 |
| TCM | 87 |
| Biologic | 11 |
| 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
66 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 克立硼罗软膏 | 3 | 2 | 28 |
| 2 | 注射用磷酸左奥硝唑酯二钠 | 2 | 2 | 20 |
| 3 | 玻璃酸钠滴眼液 | 2 | 2 | 29 |
| 4 | 丙泊酚乳状注射液 | 2 | 1 | 2 |
| 5 | 复方氨基酸注射液（18AA-VII） | 2 | 1 | 3 |
| 6 | 帕利哌酮缓释片 | 2 | 1 | 4 |
| 7 | 帕拉米韦氯化钠注射液 | 2 | 1 | 17 |
| 8 | 替米沙坦片 | 2 | 1 | 4 |
| 9 | 沙库巴曲缬沙坦钠片 | 2 | 1 | 72 |
| 10 | 盐酸右哌甲酯缓释胶囊 | 2 | 1 | 2 |
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
307 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AstraZeneca AB | 12 | 5 | 0 |
| 2 | 哈药集团生物工程有限公司 | 9 | 5 | 0 |
| 3 | 江西普丽尔药业有限公司 | 8 | 8 | 0 |
| 4 | 广州万益特医疗用品有限公司 | 8 | 5 | 0 |
| 5 | 山西正来制药有限公司 | 7 | 6 | 0 |
| 6 | Janssen Research & Development LLC | 6 | 2 | 0 |
| 7 | Pfizer Inc. | 6 | 2 | 0 |
| 8 | Eli Lilly and Company | 6 | 1 | 0 |
| 9 | F. Hoffmann-La Roche Ltd | 6 | 1 | 0 |
| 10 | 苏州盛迪亚生物医药有限公司 | 5 | 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
168 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/02/15New drug · Class 2.4 | 注射用重组A型肉毒毒素（Sf9细胞，150 kD天然氨基酸序列）CXSL2600232 | 苏州若弋生物科技有限公司 |
| 2026/02/15New drug · Class 1 | SIR4156片CXHL2600208 | 维泰瑞隆（北京）生物科技有限公司 |
| 2026/02/15New drug · Class 2.2 | 氨酚羟考酮缓释片CXHL2600207 | 上海理想制药有限公司 |
| 2026/02/14Import · Class 3.1 | 注射用索特西普JXSS2600011 | Merck Sharp & Dohme LLC; Patheon Italia S.p.A.; MSD R&D (China) Co. Ltd. |
| 2026/02/14Import · Class 3.1 | 注射用索特西普JXSS2600010 | Merck Sharp & Dohme LLC; Patheon Italia S.p.A.; MSD R&D (China) Co. Ltd. |
| 2026/02/14Generic · Class 3 | 磷苯妥英钠注射用浓溶液CYHS2600488 | 海南慧通生物医药科技有限公司; 山东北大高科华泰制药有限公司 |
| 2026/02/14Generic · Class 3 | 磷苯妥英钠注射用浓溶液CYHS2600486 | 海南慧通生物医药科技有限公司; 山东北大高科华泰制药有限公司 |
| 2026/02/14Generic · Class 3 | 盐酸右哌甲酯缓释胶囊CYHS2600482 | 宜昌人福药业有限责任公司 |
| 2026/02/14Generic · Class 3 | 盐酸右哌甲酯缓释胶囊CYHS2600481 | 宜昌人福药业有限责任公司 |
| 2026/02/14Generic · Class 3 | 钠钾镁钙注射用浓溶液CYHS2600480 | 江西泰吉立生物医药科技有限公司; 浙江赛默制药有限公司 |
| 2026/02/14New drug · Class 1 | 达尔扑拜单抗注射液CXSS2600022 | 百奥泰生物制药股份有限公司 |
| 2026/02/14New drug · Class 1 | 芮特韦拜单抗注射液CXSS2600021 | 珠海泰诺麦博制药股份有限公司 |
| 2026/02/14New drug · Class 1 | 库莱韦单抗注射液CXSS2600020 | 瑞阳（山东）生物制药有限公司 |
| 2026/02/14New drug · Class 1 | YB1-X7注射液CXSL2600233 | 绍兴缮维特生物技术有限公司 |
| 2026/02/14New drug · Class 1 | SHR-3079注射液CXSL2600231 | 苏州盛迪亚生物医药有限公司 |
| 2026/02/14New drug · Class 1 | SHR-3079注射液CXSL2600230 | 苏州盛迪亚生物医药有限公司 |
| 2026/02/14New drug · Class 2.1 | 人胰岛素肠溶胶囊CXSL2600229 | 合肥天汇生物科技有限公司 |
| 2026/02/14New drug · Class 2.1 | 人胰岛素肠溶胶囊CXSL2600228 | 合肥天汇生物科技有限公司 |
| 2026/02/14New drug · Class 1 | NEWR0919滴眼液CXSL2600227 | 深圳新锐基因科技有限公司 |
| 2026/02/14New drug · Class 1 | NEWR0919滴眼液CXSL2600226 | 深圳新锐基因科技有限公司 |
| 2026/02/14New drug · Class 1 | NEWR0919滴眼液CXSL2600225 | 深圳新锐基因科技有限公司 |
| 2026/02/14New drug · Class 1 | SHR-1819注射液CXSL2600223 | 广东恒瑞医药有限公司 |
| 2026/02/14New drug · Class 1 | SHR-1819注射液CXSL2600222 | 广东恒瑞医药有限公司 |
| 2026/02/14New drug · Class 1 | 注射用DEC003MCXSL2600221 | 杭州多禧生物科技有限公司 |
| 2026/02/14New drug · Class 1 | 注射用SIBP-A17CXSL2600220 | 上海生物制品研究所有限责任公司 |
| 2026/02/14New drug · Class 1 | 注射用TUL108CXHL2600206 | 珠海联邦制药股份有限公司 |
| 2026/02/14New drug · Class 2.2 | NH601缓释胶囊CXHL2600205 | 江苏恩华药业股份有限公司; 苏州恩华生物医药科技有限公司 |
| 2026/02/14New drug · Class 2.2 | NH601缓释胶囊CXHL2600204 | 江苏恩华药业股份有限公司; 苏州恩华生物医药科技有限公司 |
| 2026/02/14New drug · Class 2.2 | NH601缓释胶囊CXHL2600203 | 江苏恩华药业股份有限公司; 苏州恩华生物医药科技有限公司 |
| 2026/02/14New drug · Class 1 | VV261片CXHL2600202 | 旺山旺水（上海）生物医药有限公司; 中国科学院上海药物研究所; 苏州旺山旺水生物医药股份有限公司; 中国科学院武汉病毒研究所 |
138 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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