药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/12/06 – 2022/12/12
- New acceptances this week
- 173
- 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
173filings, 38 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 80 |
| Generic | 38 |
| New drug | 27 |
| Import re-registration | 16 |
| Import | 9 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 138 |
| 治疗用生物制品 | 27 |
| TCM | 8 |
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 | 注射用拉氧头孢钠 | 3 | 1 | 1 |
| 2 | 磷酸特地唑胺片 | 2 | 2 | 1 |
| 3 | 普瑞巴林缓释片 | 2 | 1 | 13 |
| 4 | 来那度胺胶囊 | 2 | 1 | 3 |
| 5 | 注射用氟氧头孢钠 | 2 | 1 | 9 |
| 6 | 磷酸奥司他韦胶囊 | 2 | 1 | 42 |
| 7 | 艾拉戈克钠片 | 2 | 1 | 2 |
| 8 | 利奈唑胺干混悬剂 | 1 | 1 | 1 |
| 9 | 吗啉硝唑氯化钠注射液 | 1 | 1 | 10 |
| 10 | 吲达帕胺片 | 1 | 1 | 0 |
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
95 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 四川宏明博思药业有限公司 | 12 | 8 | 0 |
| 2 | 山东威高输血技术装备有限公司 | 11 | 2 | 0 |
| 3 | Janssen Research & Development LLC | 8 | 4 | 0 |
| 4 | Fresenius Kabi AB | 6 | 1 | 0 |
| 5 | 北京硕佰医药科技有限责任公司 | 5 | 1 | 0 |
| 6 | 湖北荟海医药技术研究院有限公司 | 4 | 3 | 0 |
| 7 | 上海联合赛尔生物工程有限公司 | 4 | 1 | 0 |
| 8 | Atlantic Laboratories Corporation Ltd. | 3 | 1 | 0 |
| 9 | Pfizer Inc. | 3 | 1 | 0 |
| 10 | Santen 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
50 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/12/10Import · Class 3.1 | 帕博利珠单抗注射液JXSS2200038 | Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2022/12/10Generic · Class 3 | 腺苷注射液CYHS2202062 | 北京布霖生物科技有限公司; 华夏生生药业（北京）有限公司 |
| 2022/12/10Generic · Class 3 | 盐酸多巴酚丁胺注射液CYHS2202060 | 安徽茂康药业有限公司; 成都市海通药业有限公司 |
| 2022/12/10Generic · Class 3 | 注射用拉氧头孢钠CYHS2202057 | 山东晶辉生物技术有限公司; 山东润泽制药有限公司 |
| 2022/12/10Generic · Class 3 | 注射用拉氧头孢钠CYHS2202056 | 山东晶辉生物技术有限公司; 山东润泽制药有限公司 |
| 2022/12/10Generic · Class 3 | 注射用拉氧头孢钠CYHS2202055 | 山东晶辉生物技术有限公司; 山东润泽制药有限公司 |
| 2022/12/10Generic · Class 3 | 氨基己酸注射液CYHS2202054 | 安徽海斯美医药有限公司; 江西东抚制药有限公司 |
| 2022/12/10Generic · Class 3 | 利奈唑胺干混悬剂CYHS2202052 | 广州一品红制药有限公司 |
| 2022/12/10Generic · Class 3 | 普瑞巴林缓释片CYHL2200112 | 宜昌人福药业有限责任公司 |
| 2022/12/10Generic · Class 3 | 普瑞巴林缓释片CYHL2200111 | 宜昌人福药业有限责任公司 |
| 2022/12/10New drug · Class 1 | 注射用LBL-033CXSL2200600 | 南京维立志博生物科技有限公司 |
| 2022/12/10New drug · Class 2.2 | 替雷利珠单抗注射液CXSL2200599 | 百济神州（上海）生物科技有限公司 |
| 2022/12/10New drug · Class 1 | BGB-A445注射液CXSL2200598 | 广州百济神州生物制药有限公司 |
| 2022/12/10New drug · Class 1 | LBL-007注射液CXSL2200597 | 广州百济神州生物制药有限公司 |
| 2022/12/10New drug · Class 1 | EOC202注射液CXSL2200596 | 泰州亿腾景昂药业股份有限公司 |
| 2022/12/10New drug · Class 1 | AP301胶囊CXHL2200936 | 上海礼邦医药科技有限公司; 礼邦生物医药（江苏）有限公司 |
| 2022/12/09Import · Class 1 | PF-07284892片JXHL2200347 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2022/12/09Import · Class 1 | PF-07284892片JXHL2200346 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2022/12/09Import · Class 1 | PF-07284892片JXHL2200345 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2022/12/09Generic · Class 3 | 氟尿嘧啶注射液CYHS2202050 | 国药一心制药有限公司; 哈药集团生物工程有限公司 |
| 2022/12/09Generic · Class 3 | 盐酸利多卡因注射液CYHS2202049 | 华润双鹤利民药业（济南）有限公司 |
| 2022/12/09Generic · Class 3 | 镓[68Ga]多特安肽注射液CYHL2200110 | 原子高科股份有限公司 |
| 2022/12/09Generic · Class 3 | 注射用多特安肽药盒CYHL2200109 | 原子高科股份有限公司 |
| 2022/12/09New drug · Class 1 | 重组人CD80突变体-Fc融合蛋白注射液CXSL2200595 | 轩竹生物科技股份有限公司; 北京轩竹康明生物科技有限公司 |
| 2022/12/09New drug · Class 1 | SG1906注射液CXSL2200594 | 中生尚健生物医药（杭州）有限公司 |
| 2022/12/09New drug · Class 1 | DBM-1152A吸入溶液CXHL2200934 | 北京硕佰医药科技有限责任公司; 安徽硕佰制药有限公司 |
| 2022/12/09New drug · Class 1 | DBM-1152A吸入溶液CXHL2200933 | 北京硕佰医药科技有限责任公司; 安徽硕佰制药有限公司 |
| 2022/12/09New drug · Class 1 | DBM-1152A吸入溶液CXHL2200932 | 北京硕佰医药科技有限责任公司; 安徽硕佰制药有限公司 |
| 2022/12/09New drug · Class 1 | DBM-1152A吸入溶液CXHL2200931 | 北京硕佰医药科技有限责任公司; 安徽硕佰制药有限公司 |
| 2022/12/09New drug · Class 1 | DBM-1152A吸入溶液CXHL2200930 | 北京硕佰医药科技有限责任公司; 安徽硕佰制药有限公司 |
20 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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