药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/10/03 – 2023/10/09
- New acceptances this week
- 159
- Drugs with new generic filings (by drug name, de-duplicated)
- 34
- 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
159filings, 42 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 61 |
| Generic | 42 |
| New drug | 33 |
| Import re-registration | 13 |
| Unspecified | 5 |
| Import | 4 |
| 药械组合产品 | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 108 |
| 治疗用生物制品 | 30 |
| TCM | 20 |
| 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
34 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 拉考沙胺片 | 2 | 1 | 0 |
| 2 | 沙库巴曲缬沙坦钠片 | 2 | 1 | 70 |
| 3 | 注射用头孢唑肟钠 | 2 | 1 | 6 |
| 4 | 玻璃酸钠滴眼液 | 2 | 1 | 29 |
| 5 | 盐酸达泊西汀片 | 2 | 1 | 20 |
| 6 | 碘普罗胺注射液 | 2 | 1 | 27 |
| 7 | 米诺地尔搽剂 | 2 | 1 | 49 |
| 8 | 葡萄糖酸钙氯化钠注射液 | 2 | 1 | 5 |
| 9 | 乳果糖口服溶液 | 1 | 1 | 40 |
| 10 | 依巴斯汀口服溶液 | 1 | 1 | 9 |
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
103 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 正大天晴药业集团股份有限公司 | 6 | 3 | 1 |
| 2 | 江苏恩华药业股份有限公司 | 6 | 2 | 0 |
| 3 | 上海理想制药有限公司 | 5 | 3 | 5 |
| 4 | Eli Lilly Nederland B.V. | 4 | 1 | 0 |
| 5 | Sanofi-Aventis Deutschland GmbH | 4 | 1 | 0 |
| 6 | 德昇济医药（无锡）有限公司 | 4 | 1 | 0 |
| 7 | 江西青峰药业有限公司 | 3 | 3 | 0 |
| 8 | 重庆希尔安药业有限公司 | 3 | 3 | 0 |
| 9 | 江苏豪森药业集团有限公司 | 3 | 2 | 0 |
| 10 | Chugai Pharmaceutical Co. Ltd | 3 | 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
51 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/10/09Import · Class 1 | DS-1062aJXSL2300173 | Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited |
| 2023/10/09Import · Class 2.4 | 氯马昔巴特口服溶液JXHS2300094 | Mirum Pharmaceuticals Inc.; Halo Pharmaceutical Canada Inc.; CANbridge (Suzhou) Bio-pharma Co. Ltd. |
| 2023/10/09Generic · Class 3 | 依巴斯汀口服溶液CYHS2302665 | 广西维威制药有限公司 |
| 2023/10/09Generic · Class 3 | 氨氯地平贝那普利胶囊CYHS2302663 | 上海安必生制药技术有限公司; 江苏安必生制药有限公司 |
| 2023/10/09Generic · Class 3 | 葡萄糖酸钙氯化钠注射液CYHS2302661 | 安徽丰原药业股份有限公司淮海药厂 |
| 2023/10/09Generic · Class 3 | 葡萄糖酸钙氯化钠注射液CYHS2302660 | 安徽丰原药业股份有限公司淮海药厂 |
| 2023/10/09Generic · Class 3 | 盐酸去氧肾上腺素注射液CYHS2302659 | 安徽长江药业有限公司 |
| 2023/10/09Generic · Class 3 | 重酒石酸间羟胺注射液CYHS2302657 | 中山万汉制药有限公司 |
| 2023/10/09Generic · Class 3 | 地高辛片CYHS2302653 | 上海理想制药有限公司 |
| 2023/10/09Generic · Class 3 | 倍他米松磷酸钠注射液CYHS2302645 | 浙江仙琚制药股份有限公司 |
| 2023/10/09Generic · Class 3 | 米诺地尔搽剂CYHS2302644 | 山东新华制药股份有限公司; 烟台鲁银药业有限公司 |
| 2023/10/09Generic · Class 3 | 米诺地尔搽剂CYHS2302643 | 山东新华制药股份有限公司; 烟台鲁银药业有限公司 |
| 2023/10/09Generic · Class 3 | 醋氯芬酸片CYHS2302640 | 河南诺美药业有限公司 |
| 2023/10/09Generic · Class 3 | 氨苯砜凝胶CYHL2300126 | 江苏艾立康医药科技有限公司 |
| 2023/10/09New drug · Class 1 | 注射用BB-1710CXSL2300678 | 百力司康生物医药（杭州）有限公司 |
| 2023/10/09New drug · Class 1 | 重组人IL12/15单纯疱疹I型双调控溶瘤病毒注射液（Vero细胞）CXSL2300677 | 上海复诺健生物科技有限公司 |
| 2023/10/09New drug · Class 3.3 | 特立帕肽注射液CXSL2300676 | 上海多米瑞生物技术有限公司 |
| 2023/10/09New drug · Class 3.2 | 注射用重组人C1酯酶抑制剂CXSL2300673 | 成都生物制品研究所有限责任公司 |
| 2023/10/09New drug · Class 1 | 重组抗IL-4Rα人源化单克隆抗体注射液CXSL2300672 | 三生国健药业（上海）股份有限公司 |
| 2023/10/09New drug · Class 1 | 注射用AP026CXSL2300671 | 安源医药科技（上海）有限公司 |
| 2023/10/09New drug · Class 1 | 人脐带间充质干细胞注射液CXSL2300670 | 杭州易文赛生物技术有限公司 |
| 2023/10/09New drug · Class 1 | 注射用双利司他CXHS2300092 | 广州必贝特医药股份有限公司; 广东星昊药业有限公司 |
| 2023/10/09New drug · Class 1 | ND-003片CXHL2301059 | 深圳市新樾生物科技有限公司; 深圳市小分子新药创新中心有限公司 |
| 2023/10/09New drug · Class 1 | ND-003片CXHL2301058 | 深圳市新樾生物科技有限公司; 深圳市小分子新药创新中心有限公司 |
| 2023/10/09New drug · Class 1 | CAN1012 注射液CXHL2301057 | 康威（广州）生物科技有限公司 |
| 2023/10/09New drug · Class 1 | CAN1012 注射液CXHL2301056 | 康威（广州）生物科技有限公司 |
| 2023/10/09New drug · Class 1 | CAN1012 注射液CXHL2301055 | 康威（广州）生物科技有限公司 |
| 2023/10/09New drug · Class 1 | SIR2446M片CXHL2301054 | 维泰瑞隆（北京）生物科技有限公司 |
| 2023/10/09New drug · Class 1 | SIR2446M片CXHL2301053 | 维泰瑞隆（北京）生物科技有限公司 |
| 2023/10/09New drug · Class 1 | NH300231肠溶片CXHL2301052 | 江苏恩华药业股份有限公司; 上海枢境生物科技有限公司 |
21 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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