药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/01/11 – 2022/01/17
- New acceptances this week
- 354
- 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
354filings, 73 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 203 |
| Generic | 73 |
| New drug | 42 |
| Import | 21 |
| Import re-registration | 10 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 289 |
| 治疗用生物制品 | 39 |
| TCM | 21 |
| Biologic | 3 |
| 体外诊断试剂 | 1 |
| 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
55 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸乌拉地尔注射液 | 3 | 2 | 5 |
| 2 | 注射用拉氧头孢钠 | 3 | 1 | 1 |
| 3 | 阿普米司特片 | 3 | 1 | 3 |
| 4 | 利伐沙班片 | 2 | 2 | 3 |
| 5 | 盐酸托莫西汀口服溶液 | 2 | 2 | 0 |
| 6 | 吸入用七氟烷 | 2 | 1 | 0 |
| 7 | 来那度胺胶囊 | 2 | 1 | 3 |
| 8 | 甲硫酸新斯的明注射液 | 2 | 1 | 4 |
| 9 | 甲苯磺酸艾多沙班片 | 2 | 1 | 9 |
| 10 | 盐酸右美托咪定氯化钠注射液 | 2 | 1 | 1 |
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
197 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 广西昆泽药业有限公司 | 21 | 3 | 0 |
| 2 | 湖北睿泽药业有限公司 | 18 | 18 | 0 |
| 3 | 华润双鹤药业股份有限公司 | 11 | 9 | 0 |
| 4 | 华北制药集团先泰药业有限公司 | 9 | 4 | 0 |
| 5 | Bayer Vital GmbH | 9 | 2 | 0 |
| 6 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc. | 5 | 3 | 0 |
| 7 | 深圳市天道医药有限公司 | 5 | 1 | 0 |
| 8 | LES LABORATOIRES SERVIER | 4 | 3 | 0 |
| 9 | 成都苑东生物制药股份有限公司 | 4 | 2 | 4 |
| 10 | 四川美大康佳乐药业有限公司 | 4 | 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
81 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/01/17Import · Class 1 | VAY736注射液JXSL2200007 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2022/01/17Import · Class 1 | RO7191863注射液JXHL2200020 | F. Hoffmann-La Roche Ltd.; Roche R & D Center (China) Ltd. |
| 2022/01/17Import · Class 1 | RO7445482注射液JXHL2200019 | F. Hoffmann-La Roche Ltd.; Roche R & D Center (China) Ltd. |
| 2022/01/17Generic · Class 3 | 阿立哌唑口崩片CYHS2200101 | 哈尔滨三联药业股份有限公司 |
| 2022/01/17Generic · Class 3 | 阿立哌唑口崩片CYHS2200100 | 哈尔滨三联药业股份有限公司 |
| 2022/01/17Generic · Class 3 | 甲硫酸新斯的明注射液CYHS2200099 | 成都苑东生物制药股份有限公司 |
| 2022/01/17Generic · Class 3 | 甲硫酸新斯的明注射液CYHS2200098 | 成都苑东生物制药股份有限公司 |
| 2022/01/17Generic · Class 3 | 硫酸特布他林注射液CYHS2200096 | 广东金城金素制药有限公司; 山东华鲁制药有限公司 |
| 2022/01/17Generic · Class 3 | 硫酸特布他林注射液CYHS2200095 | 广东金城金素制药有限公司; 山东华鲁制药有限公司 |
| 2022/01/17New drug · Class 3.1 | 苓桂术甘颗粒CXZS2200002 | 江苏康缘药业股份有限公司 |
| 2022/01/17New drug · Class 1 | CM352注射液CXSL2200023 | 康诺亚生物医药科技（成都）有限公司 |
| 2022/01/17New drug · Class 1 | GC101腺相关病毒注射液CXSL2200022 | 北京锦篮基因科技有限公司 |
| 2022/01/17New drug · Class 1 | GC101腺相关病毒注射液CXSL2200021 | 北京锦篮基因科技有限公司 |
| 2022/01/17New drug · Class 1 | JYB1904注射液CXSL2200020 | 江苏济烨生物制药有限公司 |
| 2022/01/17New drug · Class 1 | HRX0701片（Ⅱ）CXHL2200025 | 山东盛迪医药有限公司 |
| 2022/01/17New drug · Class 1 | HRX0701片（Ⅰ）CXHL2200024 | 山东盛迪医药有限公司 |
| 2022/01/17New drug · Class 2.2 | ABRJ口服微乳溶液CXHL2200013 | 深圳海王医药科技研究院有限公司 |
| 2022/01/14Import · Class 1 | Depemokimab注射液JXSL2200006 | GlaxoSmithKline (Ireland) Limited; GlaxoSmithKline(China) Investment Co. Ltd |
| 2022/01/14Import · Class 1 | Depemokimab注射液JXSL2200005 | GlaxoSmithKline (Ireland) Limited; GlaxoSmithKline(China) Investment Co. Ltd |
| 2022/01/14Generic · Class 3 | 磷酸奥司他韦干混悬剂CYHS2200069 | 乐普制药科技有限公司 |
| 2022/01/14New drug · Class 3.3 | 注射用曲妥珠单抗CXSS2200005 | 海正生物制药有限公司 |
| 2022/01/14New drug · Class 1 | 注射用DP303cCXSL2200019 | 石药集团中奇制药技术（石家庄）有限公司 |
| 2022/01/14New drug · Class 3.3 | 美泊利珠单抗注射液CXSL2200018 | 百奥泰生物制药股份有限公司 |
| 2022/01/14New drug · Class 1 | FHND5071片CXHL2200023 | 江苏正大丰海制药有限公司 |
| 2022/01/14New drug · Class 1 | FHND5071片CXHL2200022 | 江苏正大丰海制药有限公司 |
| 2022/01/14New drug · Class 1 | AC682胶囊CXHL2200021 | 冰洲石生物科技(上海)有限公司 |
| 2022/01/13Generic · Class 3 | 奥美拉唑碳酸氢钠胶囊CYHS2200074 | 河北欣瑞未来科技有限公司; 河北仁合益康药业有限公司 |
| 2022/01/13Generic · Class 3 | 盐酸多巴胺注射液CYHS2200063 | 合肥亿帆生物制药有限公司 |
| 2022/01/13Generic · Class 3 | 地氯雷他定口服溶液CYHS2200031 | 广西维威制药有限公司 |
| 2022/01/13Generic · Class 3 | 磷酸奥司他韦干糖浆CYHS2200030 | 中润药业有限公司; 华益药业科技（安徽）有限公司 |
51 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.