药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/12/17 – 2024/12/23
- New acceptances this week
- 398
- Drugs with new generic filings (by drug name, de-duplicated)
- 79
- Accepted this week, now under review
- 7
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
398filings, 109 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 173 |
| Generic | 109 |
| New drug | 75 |
| Import | 22 |
| Unspecified | 11 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 259 |
| TCM | 78 |
| 治疗用生物制品 | 55 |
| Biologic | 4 |
| 预防用生物制品 | 2 |
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
79 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 甲磺酸沙非胺片 | 6 | 3 | 20 |
| 2 | 盐酸溴己新口服溶液 | 4 | 2 | 22 |
| 3 | 吸入用盐酸丙卡特罗溶液 | 3 | 2 | 2 |
| 4 | 他达拉非片 | 3 | 1 | 23 |
| 5 | 枸橼酸西地那非片 | 3 | 1 | 12 |
| 6 | 阿法骨化醇软胶囊 | 3 | 1 | 9 |
| 7 | 阿贝西利片 | 3 | 1 | 2 |
| 8 | 夫西地酸乳膏 | 2 | 2 | 16 |
| 9 | 比索洛尔氨氯地平片 | 2 | 2 | 8 |
| 10 | 盐酸尼卡地平注射液 | 2 | 2 | 12 |
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
245 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 重庆迪康中药制药有限公司 | 12 | 10 | 0 |
| 2 | AstraZeneca AB | 5 | 3 | 0 |
| 3 | Pfizer Inc. | 5 | 3 | 0 |
| 4 | Novartis Pharma AG | 5 | 2 | 0 |
| 5 | 浙江京新药业股份有限公司 | 5 | 2 | 1 |
| 6 | 山西广誉远国药有限公司 | 4 | 4 | 0 |
| 7 | 江西诚志永丰药业有限责任公司 | 4 | 4 | 0 |
| 8 | 青岛国信制药有限公司 | 4 | 4 | 0 |
| 9 | 石家庄四药有限公司 | 4 | 3 | 3 |
| 10 | Novartis Europharm Limited | 4 | 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
135 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/12/23Generic · Class 3 | 重酒石酸间羟胺注射液CYHS2404463 | 河南群益医药科技开发有限公司; 信合援生制药股份有限公司 |
| 2024/12/23Generic · Class 3 | 普瑞巴林口服溶液CYHS2404462 | 岳阳新华达制药有限公司 |
| 2024/12/23New drug · Class 1 | IBR854细胞注射液CXSL2400891 | 英百瑞（杭州）生物医药有限公司 |
| 2024/12/23New drug · Class 1 | IBR854细胞注射液CXSL2400890 | 英百瑞（杭州）生物医药有限公司 |
| 2024/12/23New drug · Class 1 | HL-1186片CXHL2401429 | 上海壹典医药科技开发有限公司 |
| 2024/12/22New drug · Class 1 | JX2201胶囊CXHL2401428 | 浙江京新药业股份有限公司 |
| 2024/12/22New drug · Class 1 | JX2201胶囊CXHL2401427 | 浙江京新药业股份有限公司 |
| 2024/12/22New drug · Class 1 | JX2201胶囊CXHL2401426 | 浙江京新药业股份有限公司 |
| 2024/12/22New drug · Class 1 | JX2201胶囊CXHL2401425 | 浙江京新药业股份有限公司 |
| 2024/12/21Import · Class 2.2 | 布西珠单抗注射液JXSS2400112 | Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd. |
| 2024/12/21Import · Class 2.2 | 布西珠单抗注射液JXSS2400111 | Novartis Pharma Schweiz AG; Alcon-Couvreur N.V.; Beijing Novartis Pharma Co. Ltd. |
| 2024/12/21Import · Class 1 | PF-07220060JXHL2400299 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2024/12/21Import · Class 1 | PF-07220060JXHL2400298 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2024/12/21Import · Class 1 | PF-07220060JXHL2400297 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2024/12/21Generic · Class 3 | 维生素B6注射液CYHS2404453 | 江西远超医药科技有限公司; 朗天药业（湖北）有限公司 |
| 2024/12/21Generic · Class 3 | 重酒石酸去甲肾上腺素注射液CYHS2404450 | 山西普恒制药有限公司 |
| 2024/12/21Generic · Class 3 | 复合磷酸氢钾注射液CYHS2404445 | 内蒙古白医制药股份有限公司 |
| 2024/12/21Generic · Class 3 | 碘[131I]化钠口服溶液CYHS2404438 | 广东君奇医药科技有限公司 |
| 2024/12/21New drug · Class 1 | PT886CXSL2400889 | 凡恩世制药（北京）有限公司 |
| 2024/12/21New drug · Class 1 | 注射用T320CXSL2400888 | 山西纳安生物科技股份有限公司 |
| 2024/12/21New drug · Class 2.1;2.2;2.4 | 注射用LX22001CXHL2401424 | 山东罗欣药业集团股份有限公司; 罗欣药业（上海）有限公司 |
| 2024/12/21New drug · Class 2.1;2.2;2.4 | 注射用LX22001CXHL2401423 | 山东罗欣药业集团股份有限公司; 罗欣药业（上海）有限公司 |
| 2024/12/21New drug · Class 2.2 | 注射用BSY001CXHL2401422 | 北京北生研医药科技有限公司 |
| 2024/12/21New drug · Class 1 | D-2570片CXHL2401421 | 益方生物科技（上海）股份有限公司 |
| 2024/12/21New drug · Class 1 | LIT0922胶囊CXHL2401420 | 励缔（杭州）医药科技有限公司 |
| 2024/12/21New drug · Class 1 | LIT0922胶囊CXHL2401419 | 励缔（杭州）医药科技有限公司 |
| 2024/12/21New drug · Class 1 | FNX020片CXHL2401418 | 成都凡诺西生物医药科技有限公司 |
| 2024/12/21New drug · Class 1 | FNX020片CXHL2401417 | 成都凡诺西生物医药科技有限公司 |
| 2024/12/21New drug · Class 1 | POC101胶囊CXHL2401416 | 长春长乘医药科技有限公司 |
| 2024/12/21New drug · Class 1 | POC101胶囊CXHL2401414 | 长春长乘医药科技有限公司 |
105 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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