药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/06/21 – 2022/06/27
- New acceptances this week
- 263
- 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
263filings, 42 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 156 |
| Generic | 42 |
| New drug | 26 |
| Import | 21 |
| Unspecified | 9 |
| Import re-registration | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 176 |
| TCM | 45 |
| 治疗用生物制品 | 33 |
| Biologic | 9 |
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 | 阿普米司特片 | 4 | 2 | 3 |
| 2 | 盐酸达泊西汀片 | 3 | 2 | 20 |
| 3 | 盐酸文拉法辛缓释胶囊 | 3 | 1 | 0 |
| 4 | 盐酸多巴胺注射液 | 2 | 2 | 3 |
| 5 | 乙酰半胱氨酸颗粒 | 2 | 1 | 4 |
| 6 | 噁拉戈利片 | 2 | 1 | 2 |
| 7 | 左乙拉西坦片 | 2 | 1 | 6 |
| 8 | 氨基己酸注射液 | 2 | 1 | 0 |
| 9 | 艾司奥美拉唑镁肠溶胶囊 | 2 | 1 | 4 |
| 10 | 阿瑞匹坦胶囊 | 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
150 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 北京远方通达医药技术有限公司 | 19 | 15 | 0 |
| 2 | 河南同源制药有限公司 | 9 | 9 | 0 |
| 3 | 哈药集团世一堂制药厂 | 7 | 7 | 0 |
| 4 | 湖北华鸿医药有限公司 | 7 | 7 | 0 |
| 5 | Janssen Research & Development LLC | 7 | 4 | 0 |
| 6 | Aspen Pharma Trading Limited | 7 | 2 | 0 |
| 7 | GlaxoSmithKline Biologicals SA | 4 | 4 | 0 |
| 8 | 成都倍特药业股份有限公司 | 4 | 2 | 2 |
| 9 | McNeil Sweden AB | 4 | 1 | 0 |
| 10 | 广州康臣药业有限公司 | 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
59 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/06/24Generic · Class 3 | 盐酸多巴胺注射液CYHS2200949 | 海南倍特药业有限公司 |
| 2022/06/24Generic · Class 3 | 吡拉西坦注射液CYHS2200948 | 吉林省辉南长龙生化药业股份有限公司 |
| 2022/06/24Generic · Class 3 | 复方匹可硫酸钠颗粒CYHS2200947 | 海南万玮制药有限公司 |
| 2022/06/24Generic · Class 3 | 艾司奥美拉唑镁肠溶胶囊CYHS2200943 | 浙江永太药业有限公司 |
| 2022/06/24Generic · Class 3 | 艾司奥美拉唑镁肠溶胶囊CYHS2200941 | 浙江永太药业有限公司 |
| 2022/06/24New drug · Class 1 | IMM40H注射液CXSL2200293 | 宜明昂科生物医药技术(上海)股份有限公司 |
| 2022/06/24New drug · Class 1 | KM1溶瘤痘苗病毒注射液CXSL2200292 | 深圳市华药康明生物药业有限责任公司 |
| 2022/06/24New drug · Class 1 | NCR100注射液CXSL2200291 | 安徽中盛溯源生物科技有限公司 |
| 2022/06/23Import · Class 3.1 | 注射用TeduglutideJXSS2200021 | Takeda Pharmaceuticals International AG Ireland Branch; Patheon Italia S.p.A. |
| 2022/06/23Import · Class 2.2 | 贝利尤单抗注射液(皮下注射)JXSL2200094 | GlaxoSmithKline (Ireland) Limited; GlaxoSmithKline (China) Investment Co. LTD |
| 2022/06/23Import · Class 1 | BI 764198胶囊JXHL2200161 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2022/06/23Import · Class 1 | BI 764198胶囊JXHL2200160 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2022/06/23Import · Class 1 | BI 764198胶囊JXHL2200159 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2022/06/23Import · Class 2.4 | Belzutifan片JXHL2200158 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D(China)Co. Ltd. |
| 2022/06/23Generic · Class 3 | 卡谷氨酸片CYHS2200940 | 远大医药(中国)有限公司 |
| 2022/06/23Generic · Class 3 | 呋塞米口服溶液CYHS2200938 | 成都倍特得诺药业有限公司 |
| 2022/06/23Generic · Class 3 | 胞磷胆碱钠注射液CYHS2200933 | 华夏生生药业(北京)有限公司 |
| 2022/06/23Generic · Class 3 | 维A酸软胶囊CYHS2200932 | 山东良福制药有限公司 |
| 2022/06/23New drug · Class 1 | LM-102注射液CXSL2200290 | 上海礼新医药研发有限公司 |
| 2022/06/23New drug · Class 1 | 重组抗IL-4Rα人源化单克隆抗体注射液CXSL2200289 | 三生国健药业(上海)股份有限公司 |
| 2022/06/23New drug · Class 1 | 重组抗IL-17A人源化单克隆抗体注射液CXSL2200288 | 三生国健药业(上海)股份有限公司 |
| 2022/06/23New drug · Class 2.2 | 恩沃利单抗注射液CXSL2200287 | 四川思路康瑞药业有限公司 |
| 2022/06/23New drug · Class 1 | 注射用SHR-A2102CXSL2200286 | 上海恒瑞医药有限公司 |
| 2022/06/23New drug · Class 1 | JX7002注射液CXSL2200264 | 浙江京新药业股份有限公司 |
| 2022/06/23New drug · Class 1 | TQ-B3101胶囊CXHS2200035 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2022/06/23New drug · Class 1 | TQ-B3101胶囊CXHS2200034 | 正大天晴药业集团南京顺欣制药有限公司 |
| 2022/06/23New drug · Class 1 | MN-08片CXHL2200413 | 广州喜鹊医药有限公司 |
| 2022/06/23New drug · Class 1 | WXSH0208片CXHL2200412 | 辰欣药业股份有限公司 |
| 2022/06/23New drug · Class 1 | WXSH0208片CXHL2200411 | 辰欣药业股份有限公司 |
| 2022/06/23New drug · Class 2.2 | 注射用SAK2001CXHL2200410 | 慧禹康成(杭州)医药科技有限公司 |
29 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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