药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2022/07/12 – 2022/07/18
- New acceptances this week
- 301
- Drugs with new generic filings (by drug name, de-duplicated)
- 37
- Accepted this week, now under review
- 3
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
301filings, 50 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 168 |
| Generic | 50 |
| Import | 39 |
| New drug | 31 |
| Import re-registration | 8 |
| Unspecified | 3 |
| 药械组合产品 | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 238 |
| 治疗用生物制品 | 34 |
| TCM | 24 |
| 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
37 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 间苯三酚注射液 | 3 | 3 | 2 |
| 2 | 哌柏西利胶囊 | 3 | 1 | 0 |
| 3 | 磷酸芦可替尼片 | 3 | 1 | 27 |
| 4 | 阿立哌唑口崩片 | 3 | 1 | 1 |
| 5 | 吡仑帕奈片 | 2 | 1 | 2 |
| 6 | 度骨化醇注射液 | 2 | 1 | 1 |
| 7 | 氨茶碱注射液 | 2 | 1 | 3 |
| 8 | 盐酸右美托咪定注射液 | 2 | 1 | 0 |
| 9 | 缩宫素注射液 | 2 | 1 | 8 |
| 10 | 丁溴东莨菪碱注射液 | 1 | 1 | 6 |
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
164 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 石家庄四药有限公司 | 13 | 4 | 3 |
| 2 | Actelion Pharmaceuticals Ltd | 8 | 1 | 0 |
| 3 | 哈药集团世一堂制药厂 | 7 | 7 | 0 |
| 4 | 四川国瑞药业有限责任公司 | 7 | 2 | 0 |
| 5 | 海南广升誉制药有限公司 | 7 | 2 | 0 |
| 6 | AstraZeneca AB | 6 | 2 | 0 |
| 7 | Novo Nordisk A/S | 6 | 2 | 0 |
| 8 | Eli Lilly and Company | 6 | 1 | 0 |
| 9 | 上海壹典医药科技开发有限公司 | 6 | 1 | 0 |
| 10 | 青岛瑞奈医疗科技有限公司 | 5 | 5 | 5 |
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
93 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/07/18Import · Class 3.1 | 依库珠单抗注射液JXSS2200023 | Alexion Europe SAS; Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Investment (China) Co. Ltd |
| 2022/07/18Import · Class 1 | Nolasiban分散片JXHL2200201 | ObsEva S.A.; Hangzhou Yuyuan Bioscience Technology Co. Ltd. |
| 2022/07/18Import · Class 1 | Nolasiban分散片JXHL2200200 | ObsEva S.A.; Hangzhou Yuyuan Bioscience Technology Co. Ltd. |
| 2022/07/18Generic · Class 3 | 硫酸镁注射液CYHS2201096 | 广州瑞尔医药科技有限公司; 成都市海通药业有限公司 |
| 2022/07/18Generic · Class 3 | 贝前列素钠片CYHS2201090 | 北京诚济制药股份有限公司 |
| 2022/07/18Generic · Class 3 | 盐酸多巴酚丁胺注射液CYHS2201088 | 成都苑东生物制药股份有限公司 |
| 2022/07/18Generic · Class 3 | 盐酸阿考替胺片CYHS2201087 | 北京亚宝生物药业有限公司 |
| 2022/07/18Generic · Class 3 | 硫酸沙丁胺醇注射液CYHS2201078 | 石家庄四药有限公司 |
| 2022/07/18Generic · Class 3 | 度骨化醇注射液CYHL2200060 | 南京海融医药科技股份有限公司 |
| 2022/07/18Generic · Class 3 | 度骨化醇注射液CYHL2200059 | 南京海融医药科技股份有限公司 |
| 2022/07/18Generic · Class 3 | 立他司特滴眼液CYHL2200058 | 鲁南贝特制药有限公司 |
| 2022/07/18New drug · Class 1 | 注射用SG1408CXSL2200323 | 中生尚健生物医药(杭州)有限公司 |
| 2022/07/18New drug · Class 1 | HTMC0435片CXHL2200514 | 上海壹典医药科技开发有限公司 |
| 2022/07/18New drug · Class 1 | HTMC0435片CXHL2200513 | 上海壹典医药科技开发有限公司 |
| 2022/07/18New drug · Class 1 | HTMC0435片CXHL2200512 | 上海壹典医药科技开发有限公司 |
| 2022/07/18New drug · Class 1 | HTMC0435片CXHL2200511 | 上海壹典医药科技开发有限公司 |
| 2022/07/18New drug · Class 1 | HTMC0435片CXHL2200510 | 上海壹典医药科技开发有限公司 |
| 2022/07/18New drug · Class 1 | HTMC0435片CXHL2200509 | 上海壹典医药科技开发有限公司 |
| 2022/07/18New drug · Class 1 | HZ-A-018胶囊CXHL2200507 | 杭州和正医药有限公司 |
| 2022/07/18New drug · Class 1 | HZ-A-018胶囊CXHL2200506 | 杭州和正医药有限公司 |
| 2022/07/18New drug · Class 2.4 | 盐酸纳布啡注射液CXHL2200505 | 宜昌人福药业有限责任公司 |
| 2022/07/18New drug · Class 1 | LF0001片CXHL2200504 | 杭州瓴方生物医药科技有限公司 |
| 2022/07/18New drug · Class 2.2 | LJ01005颗粒CXHL2200503 | 长春澜江医药科技有限公司 |
| 2022/07/15Import · Class 1 | 锆[89Zr]吉伦妥昔单抗注射液JXSL2200123 | Telix International Pty Ltd; Grand Pharmaceutical (China) Co. Ltd |
| 2022/07/15Import · Class 1 | Talquetamab注射液JXSL2200122 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/07/15Import · Class 1 | Talquetamab注射液JXSL2200121 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/07/15Import · Class 1 | 氘可来昔替尼片JXHS2200061 | Bristol-Myers Squibb Pharma EEIG; PATHEON INC.; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2022/07/15Import · Class 2.4 | Tirzepatide注射液JXHL2200199 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/07/15Import · Class 2.4 | Tirzepatide注射液JXHL2200198 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/07/15Import · Class 2.4 | Tirzepatide注射液JXHL2200197 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
63 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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