药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/09/26 – 2023/10/02
- New acceptances this week
- 177
- Drugs with new generic filings (by drug name, de-duplicated)
- 30
- Accepted this week, now under review
- 0
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
177filings, 40 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 97 |
| Generic | 40 |
| New drug | 33 |
| Import | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 117 |
| TCM | 32 |
| 治疗用生物制品 | 27 |
| 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
30 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 米诺地尔搽剂 | 6 | 1 | 49 |
| 2 | 富马酸伏诺拉生片 | 2 | 1 | 58 |
| 3 | 富马酸比索洛尔片 | 2 | 1 | 6 |
| 4 | 普瑞巴林胶囊 | 2 | 1 | 12 |
| 5 | 玻璃酸钠滴眼液 | 2 | 1 | 29 |
| 6 | 骨化三醇注射液 | 2 | 1 | 0 |
| 7 | 乙酰半胱氨酸泡腾片 | 1 | 1 | 3 |
| 8 | 二甲双胍恩格列净片（Ⅰ） | 1 | 1 | 7 |
| 9 | 二甲双胍恩格列净片（Ⅵ） | 1 | 1 | 4 |
| 10 | 二羟丙茶碱注射液 | 1 | 1 | 7 |
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
105 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 中嘉生物科技（湖北省）有限公司 | 10 | 4 | 0 |
| 2 | 上海银诺医药技术有限公司 | 8 | 1 | 0 |
| 3 | 神威药业集团有限公司 | 7 | 4 | 0 |
| 4 | 山东泰合医药科技有限公司 | 6 | 1 | 6 |
| 5 | Amgen Inc. | 4 | 2 | 0 |
| 6 | 成都康弘药业集团股份有限公司 | 4 | 2 | 1 |
| 7 | 四川制药制剂有限公司 | 4 | 1 | 0 |
| 8 | 吉林省尚城药业有限公司 | 3 | 3 | 0 |
| 9 | 四川智强医药科技开发有限公司 | 3 | 3 | 0 |
| 10 | 上海医药集团青岛国风药业股份有限公司 | 3 | 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
52 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/09/29Import · Class 2.4 | 马立巴韦片JXHL2300245 | Takeda Pharmaceuticals U.S.A. Inc.; Takeda(China) International |
| 2023/09/29New drug · Class 1 | NB002注射液CXSL2300663 | 苏州逻晟生物医药有限公司 |
| 2023/09/29New drug · Class 2.2 | 巯嘌呤微片CXHS2300091 | 华润双鹤药业股份有限公司 |
| 2023/09/28Import · Class 1 | XXB750注射液JXSL2300170 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2023/09/28Generic · Class 3 | 注射用盐酸罗沙替丁醋酸酯CYHS2302623 | 广东众生药业股份有限公司 |
| 2023/09/28Generic · Class 3 | 腺苷钴胺胶囊CYHS2302622 | 成都慧德医药科技有限公司; 四川贝灵合益制药有限公司 |
| 2023/09/28Generic · Class 3 | 碳酸氢钠林格注射液CYHS2302620 | 河北天成药业股份有限公司 |
| 2023/09/28Generic · Class 3 | 硫酸镁注射液CYHS2302618 | 海南全盈药业有限公司; 上海锦帝九州药业（安阳）有限公司 |
| 2023/09/28New drug · Class 2.3 | 尪痹胶囊CXZL2300065 | 辽宁华润本溪三药有限公司 |
| 2023/09/28New drug · Class 1 | CAB-AXL-ADC注射剂CXSL2300662 | 凯博斯（上海）生物医药有限公司 |
| 2023/09/28New drug · Class 1 | 注射用THDBH120CXHL2301040 | 东宝紫星（杭州）生物医药有限公司 |
| 2023/09/28New drug · Class 1 | 注射用THDBH120CXHL2301039 | 东宝紫星（杭州）生物医药有限公司 |
| 2023/09/28New drug · Class 1 | 注射用THDBH120CXHL2301038 | 东宝紫星（杭州）生物医药有限公司 |
| 2023/09/27Generic · Class 3 | 磷酸奥司他韦干混悬剂CYHS2302613 | 江苏加友药业集团有限公司; 武汉海特生物制药股份有限公司 |
| 2023/09/27New drug · Class 1 | 苏帕鲁肽注射液CXSS2300085 | 上海银诺医药技术有限公司; 智享生物（苏州）有限公司 |
| 2023/09/27New drug · Class 1 | 苏帕鲁肽注射液CXSS2300084 | 上海银诺医药技术有限公司; 智享生物（苏州）有限公司 |
| 2023/09/27New drug · Class 1 | 苏帕鲁肽注射液CXSS2300083 | 上海银诺医药技术有限公司; 智享生物（苏州）有限公司 |
| 2023/09/27New drug · Class 1 | 苏帕鲁肽注射液CXSS2300082 | 上海银诺医药技术有限公司; 智享生物（苏州）有限公司 |
| 2023/09/27New drug · Class 1 | 苏帕鲁肽注射液CXSS2300081 | 上海银诺医药技术有限公司; 智享生物（苏州）有限公司 |
| 2023/09/27New drug · Class 1 | 苏帕鲁肽注射液CXSS2300080 | 上海银诺医药技术有限公司; 智享生物（苏州）有限公司 |
| 2023/09/27New drug · Class 1 | 苏帕鲁肽注射液CXSS2300079 | 上海银诺医药技术有限公司; 智享生物（苏州）有限公司 |
| 2023/09/27New drug · Class 1 | 苏帕鲁肽注射液CXSS2300078 | 上海银诺医药技术有限公司; 智享生物（苏州）有限公司 |
| 2023/09/27New drug · Class 1 | RJMty19注射液CXSL2300661 | 浙江瑞加美生物科技有限公司 |
| 2023/09/27New drug · Class 1 | GC012F注射液CXSL2300660 | 苏州亘喜生物科技有限公司; 亘喜生物科技（上海）有限公司 |
| 2023/09/27New drug · Class 1 | HGI-001注射液CXSL2300659 | 深圳市禾沐基因生物技术有限责任公司 |
| 2023/09/27New drug · Class 2.4 | 注射用重组A型肉毒毒素CXSL2300658 | 君合盟生物制药（通化）有限公司 |
| 2023/09/27New drug · Class 2.4 | 脯氨酸恒格列净片CXHS2300090 | 江苏恒瑞医药股份有限公司 |
| 2023/09/27New drug · Class 2.4 | 脯氨酸恒格列净片CXHS2300089 | 江苏恒瑞医药股份有限公司 |
| 2023/09/27New drug · Class 1 | 注射用JMKX003801CXHL2301037 | 浙江杭煜制药有限公司 |
| 2023/09/26Generic · Class 3 | 米诺地尔搽剂CYHS2302604 | 山东泰合医药科技有限公司; 山东京卫制药有限公司 |
22 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.