药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/08/09 – 2022/08/15
- New acceptances this week
- 255
- Drugs with new generic filings (by drug name, de-duplicated)
- 37
- 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
255filings, 47 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 156 |
| Generic | 47 |
| New drug | 29 |
| Import | 12 |
| Import re-registration | 6 |
| Unspecified | 4 |
| 药械组合产品 | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 173 |
| TCM | 46 |
| 治疗用生物制品 | 33 |
| 预防用生物制品 | 2 |
| 体外诊断试剂 | 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
37 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 吸入用硫酸沙丁胺醇溶液 | 3 | 1 | 2 |
| 2 | 咪达唑仑注射液 | 3 | 1 | 0 |
| 3 | 注射用哌拉西林钠他唑巴坦钠 | 3 | 1 | 5 |
| 4 | 恩格列净片 | 2 | 1 | 18 |
| 5 | 替莫唑胺胶囊 | 2 | 1 | 0 |
| 6 | 氢溴酸伏硫西汀片 | 2 | 1 | 8 |
| 7 | 盐酸氨溴索口服溶液 | 2 | 1 | 45 |
| 8 | 丁酸氯维地平乳状注射液 | 1 | 1 | 0 |
| 9 | 喷他佐辛注射液 | 1 | 1 | 0 |
| 10 | 复方氨基酸注射液（20AA） | 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
152 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 北京御生堂集团石家庄制药有限公司 | 9 | 9 | 0 |
| 2 | 山西同达药业有限公司 | 8 | 8 | 0 |
| 3 | Roche Pharma (Schweiz) AG | 7 | 3 | 0 |
| 4 | 福安药业集团庆余堂制药有限公司 | 7 | 3 | 7 |
| 5 | 广西修正制药有限公司 | 6 | 6 | 0 |
| 6 | 山西汾河制药有限公司 | 5 | 5 | 0 |
| 7 | 河北武罗药业有限公司 | 4 | 4 | 0 |
| 8 | Merck Sharp & Dohme B.V. | 4 | 3 | 0 |
| 9 | 上海昊海生物科技股份有限公司 | 4 | 1 | 0 |
| 10 | 海南通用康力制药有限公司 | 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
54 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/08/15Import · Class 2.2 | Amivantamab注射液JXSL2200133 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/08/15Generic · Class 3 | 甲硝唑凝胶CYHS2201296 | 无锡朗润医药有限公司; 江苏知原药业股份有限公司 |
| 2022/08/15Generic · Class 3 | 喷他佐辛注射液CYHS2201295 | 福安药业集团庆余堂制药有限公司 |
| 2022/08/15Generic · Class 3 | 帕拉米韦注射液CYHS2201294 | 海南紫程众投生物科技有限公司; 海南合瑞制药股份有限公司 |
| 2022/08/15New drug · Class 1.1 | 双根口服液CXZL2200038 | 中国人民解放军总医院第五医学中心 |
| 2022/08/15New drug · Class 1 | U16注射液CXSL2200375 | 上海优卡迪智造生命科技有限公司; 上海优卡迪生物医药科技有限公司 |
| 2022/08/15New drug · Class 2.1 | 人干扰素α2b喷雾剂CXSL2200374 | 科兴生物制药股份有限公司 |
| 2022/08/15New drug · Class 2.4 | 奥布替尼片CXHS2200044 | 北京诺诚健华医药科技有限公司; 广州诺诚健华医药科技有限公司; 无锡合全药业有限公司 |
| 2022/08/15New drug · Class 1 | HRS-1780片CXHL2200589 | 山东盛迪医药有限公司 |
| 2022/08/15New drug · Class 1 | HRS-1780片CXHL2200588 | 山东盛迪医药有限公司 |
| 2022/08/15New drug · Class 2.3 | 格隆溴铵奥达特罗吸入喷雾剂CXHL2200587 | 上海谷森医药有限公司 |
| 2022/08/12Import · Class 3.1 | Faricimab注射液JXSS2200032 | Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG; Roche (China) Holding Ltd |
| 2022/08/12Import · Class 2.4 | 甲磺酸仑伐替尼胶囊JXHL2200237 | Eisai Europe Ltd. |
| 2022/08/12Import · Class 2.4 | 甲磺酸仑伐替尼胶囊JXHL2200236 | Eisai Europe Ltd. |
| 2022/08/12New drug · Class 3.3 | 冻干人用狂犬病疫苗（Vero细胞）CXSS2200072 | 复星雅立峰（大连）生物制药有限公司 |
| 2022/08/12New drug · Class 1 | 血浆生物净化柱CXSL2200373 | 上海微知卓生物科技有限公司 |
| 2022/08/12New drug · Class 1 | LD013自体T细胞注射液CXSL2200372 | 南京蓝盾生物科技有限公司 |
| 2022/08/12New drug · Class 2.2 | 布瑞哌唑口溶膜CXHL2200586 | 四川科伦药物研究院有限公司 |
| 2022/08/12New drug · Class 2.2 | 布瑞哌唑口溶膜CXHL2200585 | 四川科伦药物研究院有限公司 |
| 2022/08/12New drug · Class 2.2 | HECB1502201注射液CXHL2200584 | 广东东阳光药业有限公司 |
| 2022/08/12New drug · Class 2.2 | HECB1502201注射液CXHL2200583 | 广东东阳光药业有限公司 |
| 2022/08/11Import · Class 1 | XXB750注射液JXSL2200132 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2022/08/11Import · Class 1 | LOXO-783片JXHL2200239 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/08/11Import · Class 1 | LOXO-783片JXHL2200238 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/08/11Generic · Class 3 | 拉莫三嗪缓释片CYHS2201288 | 上海奥科达医药科技股份有限公司; 浙江康恩贝制药股份有限公司 |
| 2022/08/11Generic · Class 3 | 米诺地尔搽剂CYHS2201287 | 浙江远力健药业有限责任公司; 浙江赛默制药有限公司 |
| 2022/08/11Generic · Class 3 | 盐酸氨溴索口服溶液CYHS2201283 | 江西施美药业股份有限公司 |
| 2022/08/11Generic · Class 3 | 盐酸氨溴索口服溶液CYHS2201282 | 江西施美药业股份有限公司 |
| 2022/08/11Generic · Class 3 | 盐酸利多卡因注射液CYHS2201281 | 通合生物医药（山东）有限公司; 山西诺成制药有限公司 |
| 2022/08/11New drug · Class 1 | CUD002注射液CXSL2200371 | 四川康德赛医疗科技有限公司 |
24 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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