药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/05/30 – 2023/06/05
- New acceptances this week
- 304
- Drugs with new generic filings (by drug name, de-duplicated)
- 59
- Accepted this week, now under review
- 4
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
304filings, 93 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 144 |
| Generic | 93 |
| New drug | 40 |
| Import | 16 |
| Unspecified | 6 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 237 |
| 治疗用生物制品 | 35 |
| TCM | 32 |
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
59 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 注射用苯唑西林钠 | 7 | 3 | 13 |
| 2 | 乳果糖口服溶液 | 4 | 4 | 36 |
| 3 | 硫酸氨基葡萄糖胶囊 | 3 | 3 | 51 |
| 4 | 多索茶碱注射液 | 3 | 2 | 5 |
| 5 | 盐酸乌拉地尔注射液 | 3 | 2 | 5 |
| 6 | 司来帕格片 | 3 | 1 | 24 |
| 7 | 琥珀酸去甲文拉法辛缓释片 | 3 | 1 | 0 |
| 8 | 阿普米司特片 | 3 | 1 | 3 |
| 9 | 预充式甲氨蝶呤注射液 | 3 | 1 | 0 |
| 10 | 帕拉米韦注射液 | 2 | 2 | 7 |
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
180 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 平光制药股份有限公司 | 10 | 10 | 0 |
| 2 | AbbVie Inc. | 9 | 4 | 0 |
| 3 | 长沙爱贝高药业有限公司 | 5 | 5 | 0 |
| 4 | Novo Nordisk A/S | 5 | 1 | 0 |
| 5 | 杭州高光制药有限公司 | 5 | 1 | 0 |
| 6 | 重庆赛维药业有限公司 | 5 | 1 | 0 |
| 7 | 宜昌人福药业有限责任公司 | 4 | 2 | 3 |
| 8 | 百济神州(苏州)生物科技有限公司 | 4 | 2 | 0 |
| 9 | 康融东方(广东)医药有限公司 | 4 | 1 | 0 |
| 10 | 修正药业集团天汉药业有限公司 | 3 | 3 | 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
88 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/06/05Generic · Class 3 | 西咪替丁注射液CYHS2301528 | 山西诺成制药有限公司 |
| 2023/06/03Import · Class 3.1 | 司美格鲁肽注射液JXSS2300045 | Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd. |
| 2023/06/03Import · Class 3.1 | 司美格鲁肽注射液JXSS2300044 | Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd. |
| 2023/06/03Import · Class 3.1 | 司美格鲁肽注射液JXSS2300043 | Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd. |
| 2023/06/03Import · Class 3.1 | 司美格鲁肽注射液JXSS2300042 | Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd. |
| 2023/06/03Import · Class 3.1 | 司美格鲁肽注射液JXSS2300041 | Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd. |
| 2023/06/03New drug · Class 1 | HW060015胶囊CXHL2300604 | 武汉人福创新药物研发中心有限公司 |
| 2023/06/03New drug · Class 1 | HW060015胶囊CXHL2300603 | 武汉人福创新药物研发中心有限公司 |
| 2023/06/03New drug · Class 1 | HW060015胶囊CXHL2300602 | 武汉人福创新药物研发中心有限公司 |
| 2023/06/03New drug · Class 1 | TLL-018缓释片CXHL2300601 | 杭州高光制药有限公司 |
| 2023/06/03New drug · Class 1 | TLL-018缓释片CXHL2300600 | 杭州高光制药有限公司 |
| 2023/06/03New drug · Class 1 | TLL-018缓释片CXHL2300599 | 杭州高光制药有限公司 |
| 2023/06/03New drug · Class 1 | TLL-018缓释片CXHL2300598 | 杭州高光制药有限公司 |
| 2023/06/03New drug · Class 1 | TLL-018缓释片CXHL2300597 | 杭州高光制药有限公司 |
| 2023/06/02Import · Class 2.4 | BMS-986165片JXHL2300136 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2023/06/02Import · Class 2.4 | BMS-986165片JXHL2300135 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2023/06/02Generic · Class 3 | 枸橼酸钾缓释片CYHS2301506 | 成都硕德药业有限公司 |
| 2023/06/02Generic · Class 3 | 枸橼酸钾缓释片CYHS2301505 | 成都硕德药业有限公司 |
| 2023/06/02Generic · Class 3 | 帕拉米韦注射液CYHS2301504 | 山西阳和医药技术有限公司; 山西国润制药有限公司 |
| 2023/06/02Generic · Class 3 | 盐酸艾司洛尔注射液CYHS2301503 | 湖南赛隆药业(长沙)有限公司; 湖南赛隆药业有限公司 |
| 2023/06/02Generic · Class 3 | 盐酸西替利嗪注射液CYHL2300074 | 山东新时代药业有限公司 |
| 2023/06/02New drug · Class 1 | 伊努西单抗注射液CXSS2300043 | 康融东方(广东)医药有限公司 |
| 2023/06/02New drug · Class 1 | 伊努西单抗注射液CXSS2300042 | 康融东方(广东)医药有限公司 |
| 2023/06/02New drug · Class 1 | 伊努西单抗注射液CXSS2300041 | 康融东方(广东)医药有限公司 |
| 2023/06/02New drug · Class 1 | 伊努西单抗注射液CXSS2300040 | 康融东方(广东)医药有限公司 |
| 2023/06/02New drug · Class 1 | 重组抗PD-1全人源单克隆抗体注射液CXSL2300389 | 石药集团中奇制药技术(石家庄)有限公司 |
| 2023/06/02New drug · Class 1 | BGB-A445注射液CXSL2300388 | 广州百济神州生物制药有限公司 |
| 2023/06/02New drug · Class 1 | HRS-6209片CXHL2300596 | 江苏恒瑞医药股份有限公司 |
| 2023/06/02New drug · Class 1 | HRS-6209片CXHL2300595 | 江苏恒瑞医药股份有限公司 |
| 2023/06/02New drug · Class 1 | BGB-15025片CXHL2300594 | 百济神州(苏州)生物科技有限公司 |
58 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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