药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2021/11/09 – 2021/11/15
- New acceptances this week
- 227
- Drugs with new generic filings (by drug name, de-duplicated)
- 28
- 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
227filings, 37 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 121 |
| New drug | 41 |
| Generic | 37 |
| Import | 16 |
| Import re-registration | 8 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 158 |
| 治疗用生物制品 | 41 |
| TCM | 23 |
| 预防用生物制品 | 4 |
| Biologic | 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
28 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸右美托咪定注射液 | 3 | 2 | 0 |
| 2 | 泊沙康唑注射液 | 2 | 2 | 1 |
| 3 | 他克莫司胶囊 | 2 | 1 | 2 |
| 4 | 富马酸伏诺拉生片 | 2 | 1 | 58 |
| 5 | 普瑞巴林胶囊 | 2 | 1 | 12 |
| 6 | 盐酸左沙丁胺醇雾化吸入溶液 | 2 | 1 | 2 |
| 7 | 硫酸特布他林注射液 | 2 | 1 | 2 |
| 8 | 舒更葡糖钠注射液 | 2 | 1 | 6 |
| 9 | 丙戊酸钠口服溶液 | 1 | 1 | 1 |
| 10 | 利丙双卡因乳膏 | 1 | 1 | 25 |
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
146 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 广西葛洪堂方略制药有限公司 | 9 | 8 | 0 |
| 2 | 湖南威尔强制药有限公司 | 6 | 4 | 0 |
| 3 | 湖南德康制药股份有限公司 | 5 | 5 | 0 |
| 4 | 广东大冢制药有限公司 | 5 | 2 | 0 |
| 5 | Bristol-Myers Squibb Company | 4 | 3 | 0 |
| 6 | Pfizer Inc. | 4 | 3 | 0 |
| 7 | Eli Lilly Nederland B.V. | 4 | 1 | 0 |
| 8 | Sanofi-aventis groupe | 4 | 1 | 0 |
| 9 | Takeda Manufacturing Austria AG | 4 | 1 | 0 |
| 10 | 深圳微芯生物科技股份有限公司 | 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
62 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/11/15Import · Class 1 | Ritlecitinib胶囊JXHL2101244 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2021/11/15Import · Class 1 | Ritlecitinib胶囊JXHL2101243 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2021/11/15Generic · Class 3 | 硫辛酸注射液CYHS2102018 | 石家庄四药有限公司 |
| 2021/11/15New drug · Class 1.1 | QA108颗粒CXZL2101033 | 珠海岐微生物科技有限公司 |
| 2021/11/15New drug · Class 1 | WJ01075片CXHL2101656 | 苏州君境生物医药科技有限公司 |
| 2021/11/15New drug · Class 1 | WJ01075片CXHL2101655 | 苏州君境生物医药科技有限公司 |
| 2021/11/12Import · Class 1 | BIIB059JXSL2101127 | Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd |
| 2021/11/12New drug · Class 3.4 | 人凝血酶原复合物CXSS2101051 | 华兰生物工程重庆有限公司 |
| 2021/11/12New drug · Class 3.4 | 人凝血酶原复合物CXSS2101050 | 华兰生物工程重庆有限公司 |
| 2021/11/12New drug · Class 1 | PM8002注射液CXSL2101423 | 普米斯生物技术(珠海)有限公司 |
| 2021/11/12New drug · Class 1 | 注射用IAE0972CXSL2101415 | 盛禾(中国)生物制药有限公司 |
| 2021/11/12New drug · Class 2.2 | 艾司奥美拉唑镁碳酸氢钠胶囊CXHS2101051 | 厦门恩成制药有限公司 |
| 2021/11/12New drug · Class 1 | HLX208片CXHL2101654 | 上海复宏汉霖生物技术股份有限公司 |
| 2021/11/12New drug · Class 1 | WXSH0057片CXHL2101653 | 浙江龙传生物医药科技有限公司 |
| 2021/11/12New drug · Class 1 | WXSH0057片CXHL2101652 | 浙江龙传生物医药科技有限公司 |
| 2021/11/12New drug · Class 2.2 | 布立西坦缓释片CXHL2101651 | 上海博志研新药物技术有限公司 |
| 2021/11/12New drug · Class 1 | BPI-371153胶囊CXHL2101650 | 贝达药业股份有限公司 |
| 2021/11/12New drug · Class 1 | BPI-371153胶囊CXHL2101649 | 贝达药业股份有限公司 |
| 2021/11/12New drug · Class 1 | HS-10382片CXHL2101648 | 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 |
| 2021/11/12New drug · Class 1 | HS-10382片CXHL2101647 | 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 |
| 2021/11/12New drug · Class 1 | HS-10382片CXHL2101646 | 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 |
| 2021/11/11Import · Class 1 | SAR444245注射液JXSL2101126 | Sanofi-aventis recherche & développement; Sanofi (China) Investment Co. Ltd. |
| 2021/11/11Import · Class 1 | Gepotidacin片JXHL2101241 | GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Co. Limited |
| 2021/11/11Generic · Class 3 | 盐酸右美托咪定注射液CYHS2102009 | 天方药业有限公司 |
| 2021/11/11Generic · Class 3 | 盐酸右美托咪定注射液CYHS2102006 | 杭州民生药业股份有限公司 |
| 2021/11/11Generic · Class 3 | 盐酸右美托咪定注射液CYHS2102005 | 杭州民生药业股份有限公司 |
| 2021/11/11New drug · Class 1.1 | 白热斯丸CXZL2101032 | 新疆维吾尔自治区维吾尔医药研究所 |
| 2021/11/11New drug · Class 1 | GR1803注射液CXSL2101420 | 重庆智翔金泰生物制药有限公司; 智翔(上海)医药科技有限公司 |
| 2021/11/11New drug · Class 1 | STI-6129注射液CXSL2101419 | 浙江艾森药业有限公司 |
| 2021/11/11New drug · Class 1 | AK112注射液CXSL2101417 | 中山康方生物医药有限公司 |
32 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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