药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/01/03 – 2023/01/09
- New acceptances this week
- 449
- Drugs with new generic filings (by drug name, de-duplicated)
- 55
- 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
449filings, 74 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 246 |
| Generic | 74 |
| New drug | 66 |
| Import | 36 |
| Import re-registration | 20 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 300 |
| TCM | 84 |
| 治疗用生物制品 | 59 |
| 预防用生物制品 | 6 |
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
55 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 注射用青霉素钠 | 3 | 1 | 2 |
| 2 | 盐酸多巴胺注射液 | 3 | 1 | 3 |
| 3 | 利托那韦片 | 2 | 2 | 0 |
| 4 | 法莫替丁注射液 | 2 | 2 | 8 |
| 5 | 间苯三酚注射液 | 2 | 2 | 2 |
| 6 | 乳果糖口服溶液 | 2 | 1 | 36 |
| 7 | 富马酸非索罗定缓释片 | 2 | 1 | 0 |
| 8 | 布比卡因脂质体注射液 | 2 | 1 | 7 |
| 9 | 恩格列净二甲双胍缓释片 | 2 | 1 | 12 |
| 10 | 恩格列净片 | 2 | 1 | 18 |
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
225 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 广西维威制药有限公司 | 40 | 40 | 0 |
| 2 | 国大(黑龙江)制药科技有限公司 | 16 | 16 | 0 |
| 3 | 广州百特医疗用品有限公司 | 9 | 6 | 0 |
| 4 | 江西心正药业有限责任公司 | 7 | 6 | 0 |
| 5 | Pfizer Europe MA EEIG | 6 | 3 | 0 |
| 6 | Novo Nordisk A/S | 6 | 2 | 0 |
| 7 | 哈药集团世一堂制药厂 | 5 | 5 | 0 |
| 8 | Novartis Pharma Schweiz AG | 5 | 3 | 0 |
| 9 | 信达生物制药(苏州)有限公司 | 5 | 2 | 0 |
| 10 | 上海皇象铁力蓝天制药有限公司 | 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
133 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/01/09Import · Class 1 | Balcinrenone达格列净胶囊JXHL2300004 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/01/09Import · Class 1 | Balcinrenone达格列净胶囊JXHL2300003 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/01/09Generic · Class 3 | 布比卡因脂质体注射液CYHS2300071 | 湖南科伦制药有限公司 |
| 2023/01/09Generic · Class 3 | 布比卡因脂质体注射液CYHS2300070 | 湖南科伦制药有限公司 |
| 2023/01/09Generic · Class 3 | 注射用左亚叶酸钙CYHS2300068 | 四川汇宇制药股份有限公司 |
| 2023/01/09Generic · Class 3 | 注射用左亚叶酸钙CYHS2300067 | 四川汇宇制药股份有限公司 |
| 2023/01/09Generic · Class 3 | 恩格列净二甲双胍缓释片CYHS2300066 | 乐普药业股份有限公司 |
| 2023/01/09Generic · Class 3 | 恩格列净二甲双胍缓释片CYHS2300065 | 乐普药业股份有限公司 |
| 2023/01/09New drug · Class 2.4 | 注射用重组促皮质素CXSL2300021 | 上海多米瑞生物技术有限公司 |
| 2023/01/08New drug · Class 1 | BRG01注射液CXSL2300020 | 广州百吉生物制药有限公司 |
| 2023/01/08New drug · Class 1 | XZP-6877片CXHL2300038 | 轩竹生物科技股份有限公司; 山东轩竹医药科技有限公司 |
| 2023/01/08New drug · Class 1 | XZP-6877片CXHL2300037 | 轩竹生物科技股份有限公司; 山东轩竹医药科技有限公司 |
| 2023/01/08New drug · Class 1 | XZP-6877片CXHL2300036 | 轩竹生物科技股份有限公司; 山东轩竹医药科技有限公司 |
| 2023/01/08New drug · Class 1 | WXFL10030390片CXHL2300035 | 上海嘉坦医药科技有限公司 |
| 2023/01/08New drug · Class 1 | WXFL10030390片CXHL2300034 | 上海嘉坦医药科技有限公司 |
| 2023/01/08New drug · Class 1 | WXFL10030390片CXHL2300033 | 上海嘉坦医药科技有限公司 |
| 2023/01/08New drug · Class 1 | WXFL10030390片CXHL2300032 | 上海嘉坦医药科技有限公司 |
| 2023/01/08New drug · Class 1 | HS-10506片CXHL2300031 | 江苏豪森药业集团有限公司; 上海翰森生物医药科技有限公司 |
| 2023/01/08New drug · Class 1 | HS-10506片CXHL2300030 | 江苏豪森药业集团有限公司; 上海翰森生物医药科技有限公司 |
| 2023/01/08New drug · Class 1 | CGT-2201胶囊CXHL2300029 | 盛世泰科生物医药技术(苏州)有限公司 |
| 2023/01/08New drug · Class 1 | CGT-2201胶囊CXHL2300028 | 盛世泰科生物医药技术(苏州)有限公司 |
| 2023/01/07Import · Class 3.1 | 赖脯胰岛素注射液JXSS2300004 | Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd |
| 2023/01/07Import · Class 3.1 | 赖脯胰岛素注射液JXSS2300003 | Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd |
| 2023/01/07Import · Class 3.1 | 注射用Vonicog alfaJXSS2300002 | Baxalta US Inc.; Takeda (China) International Trading Co. Ltd |
| 2023/01/07Import · Class 3.1 | 注射用Vonicog alfaJXSS2300001 | Baxalta US Inc.; Takeda (China) International Trading Co. Ltd |
| 2023/01/07Import · Class 2.1 | RO7030816JXSL2300019 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2023/01/07Import · Class 2.1 | RO7030816JXSL2300018 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2023/01/07Import · Class 2.4 | 巴瑞替尼片JXHS2300006 | Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd |
| 2023/01/07Import · Class 2.4 | 巴瑞替尼片JXHS2300005 | Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd |
| 2023/01/07Import · Class 1 | BAY 2433334片JXHL2300002 | Bayer AG; Bayer Healthcare Company Ltd. |
103 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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