药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/10/18 – 2022/10/24
- New acceptances this week
- 273
- Drugs with new generic filings (by drug name, de-duplicated)
- 52
- Accepted this week, now under review
- 1
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
273filings, 64 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 119 |
| Generic | 64 |
| New drug | 58 |
| Unspecified | 15 |
| Import | 10 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 188 |
| 治疗用生物制品 | 44 |
| TCM | 30 |
| Biologic | 10 |
| 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
52 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 磷酸奥司他韦胶囊 | 3 | 1 | 42 |
| 2 | 注射用尼可地尔 | 2 | 2 | 1 |
| 3 | 奥拉帕利片 | 2 | 1 | 0 |
| 4 | 布洛芬注射液 | 2 | 1 | 4 |
| 5 | 氨磺必利注射液 | 2 | 1 | 1 |
| 6 | 盐酸左沙丁胺醇雾化吸入溶液 | 2 | 1 | 2 |
| 7 | 盐酸美金刚多奈哌齐缓释胶囊 | 2 | 1 | 2 |
| 8 | 盐酸美金刚缓释胶囊 | 2 | 1 | 2 |
| 9 | 盐酸西替利嗪滴剂 | 2 | 1 | 8 |
| 10 | 米诺地尔外用溶液 | 2 | 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
162 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 10 | 3 | 0 |
| 2 | 苏州沪云新药研发股份有限公司 | 7 | 1 | 0 |
| 3 | 西施兰（南阳）药业股份有限公司 | 6 | 6 | 0 |
| 4 | 华北制药金坦生物技术股份有限公司 | 6 | 1 | 0 |
| 5 | 广西维威制药有限公司 | 5 | 5 | 0 |
| 6 | 蚌埠宏业药业有限公司 | 5 | 5 | 0 |
| 7 | Merck Sharp & Dohme LLC | 5 | 4 | 0 |
| 8 | 哈尔滨三联药业股份有限公司 | 5 | 2 | 0 |
| 9 | 迪哲（江苏）医药股份有限公司 | 5 | 2 | 0 |
| 10 | Novartis Pharma Schweiz AG | 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
98 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/10/24Generic · Class 3 | 盐酸美金刚多奈哌齐缓释胶囊CYHS2201811 | 力品药业（厦门）股份有限公司 |
| 2022/10/24Generic · Class 3 | 盐酸美金刚多奈哌齐缓释胶囊CYHS2201810 | 力品药业（厦门）股份有限公司 |
| 2022/10/24New drug · Class 3.3 | 利妥昔单抗注射液CXSS2200086 | 盛禾（中国）生物制药有限公司 |
| 2022/10/22Import · Class 2.4 | 乌帕替尼缓释片JXHS2200097 | AbbVie Deutschland GmbH & Co.KG; AbbVie Ireland NL B.V. |
| 2022/10/22Import · Class 2.4 | 乌帕替尼缓释片JXHS2200095 | AbbVie Deutschland GmbH & Co.KG; AbbVie Ireland NL B.V. |
| 2022/10/22Import · Class 2.4 | BMS-986165片JXHL2200310 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2022/10/22Generic · Class 3 | 氨溴特罗口服溶液CYHS2201805 | 健民药业集团股份有限公司 |
| 2022/10/22New drug · Class 1 | 注射用Q-1801CXSL2200541 | 启愈生物技术（上海）有限公司 |
| 2022/10/22New drug · Class 1 | TST003注射液CXSL2200540 | 苏州创胜医药集团有限公司 |
| 2022/10/22New drug · Class 1 | RC1012注射液CXSL2200539 | 瑞创生物技术有限公司 |
| 2022/10/22New drug · Class 1 | 注射用BA1301CXSL2200538 | 山东博安生物技术股份有限公司 |
| 2022/10/21Import · Class 1 | Remternetug注射液JXSL2200185 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/10/21Import · Class 2.4 | 乌帕替尼缓释片JXHS2200096 | AbbVie Deutschland GmbH & Co.KG; AbbVie Ireland NL B.V. |
| 2022/10/21Import · Class 1 | Fitusiran注射液JXHL2200309 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2022/10/21Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液CYHS2201800 | 宏越科技（湖州）有限公司; 津药永光（河北）制药有限公司 |
| 2022/10/21Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液CYHS2201799 | 宏越科技（湖州）有限公司; 津药永光（河北）制药有限公司 |
| 2022/10/21Generic · Class 3 | 盐酸苯达莫司汀注射液CYHS2201798 | 齐鲁制药有限公司 |
| 2022/10/21Generic · Class 3 | 尼麦角林片CYHS2201795 | 福安药业集团庆余堂制药有限公司 |
| 2022/10/21Generic · Class 3 | 艾司奥美拉唑镁肠溶胶囊CYHS2201793 | 华益泰康药业股份有限公司 |
| 2022/10/21Generic · Class 3 | 艾司奥美拉唑镁肠溶胶囊CYHS2201792 | 华益泰康药业股份有限公司 |
| 2022/10/21Generic · Class 3 | 盐酸格拉司琼注射液CYHS2201790 | 德全药品（江苏）股份有限公司 |
| 2022/10/21Generic · Class 3 | 注射用尼可地尔CYHS2201789 | 陕西丽彩药业有限公司; 成都通德药业有限公司 |
| 2022/10/21New drug · Class 3.3 | 利拉鲁肽注射液CXSS2200085 | 正大天晴药业集团股份有限公司; 连云港润众制药有限公司 |
| 2022/10/21New drug · Class 1 | INES103注射液CXSL2200537 | 上海诗健生物科技有限公司 |
| 2022/10/21New drug · Class 1 | UA021胶囊CXHL2200827 | 祐森健恒生物医药（上海）有限公司 |
| 2022/10/21New drug · Class 1 | UA021胶囊CXHL2200826 | 祐森健恒生物医药（上海）有限公司 |
| 2022/10/21New drug · Class 1 | BPI-460372片CXHL2200825 | 贝达药业股份有限公司 |
| 2022/10/21New drug · Class 1 | BPI-460372片CXHL2200824 | 贝达药业股份有限公司 |
| 2022/10/20Import · Class 1 | GSK3228836 注射液JXHL2200306 | GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Co. LTD |
| 2022/10/20Generic · Class 3 | 米诺地尔外用溶液CYHS2201785 | 丽彩甘肃西峰制药有限公司 |
68 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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