药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/04/28 – 2026/05/04
- New acceptances this week
- 372
- Drugs with new generic filings (by drug name, de-duplicated)
- 40
- Accepted this week, now under review
- 89
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
372filings, 51 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 225 |
| Generic | 51 |
| New drug | 49 |
| Import | 30 |
| Unspecified | 8 |
| Import re-registration | 8 |
| Import (made outside China) | 1 |
By drug type
| Drug type | Filings |
|---|---|
| TCM | 167 |
| Chemical drug | 163 |
| 治疗用生物制品 | 39 |
| 预防用生物制品 | 2 |
| 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
40 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 洛索洛芬钠贴剂 | 4 | 2 | 30 |
| 2 | 佩玛贝特片 | 2 | 2 | 25 |
| 3 | 塞来昔布片 | 2 | 1 | 3 |
| 4 | 左乙拉西坦片 | 2 | 1 | 6 |
| 5 | 左奥硝唑氯化钠注射液 | 2 | 1 | 5 |
| 6 | 美阿沙坦钾片 | 2 | 1 | 33 |
| 7 | 达格列净二甲双胍缓释片(Ⅰ) | 2 | 1 | 3 |
| 8 | 醋酸去氨加压素片 | 2 | 1 | 6 |
| 9 | 黄体酮软胶囊 | 2 | 1 | 2 |
| 10 | 低钙腹膜透析液（乳酸盐-G1.76%） | 1 | 1 | 2 |
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
225 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 津药达仁堂集团股份有限公司达仁堂制药厂 | 20 | 13 | 0 |
| 2 | AstraZeneca AB | 17 | 2 | 0 |
| 3 | 青海帝玛尔藏药药业有限公司 | 8 | 8 | 0 |
| 4 | 贵州益佰女子大药厂有限责任公司 | 7 | 7 | 0 |
| 5 | 江苏修正制药有限公司 | 7 | 5 | 0 |
| 6 | 青海省通天河藏药制药有限责任公司 | 6 | 6 | 0 |
| 7 | F. Hoffmann-La Roche Ltd | 5 | 2 | 0 |
| 8 | 长春金赛药业有限责任公司 | 5 | 2 | 0 |
| 9 | 云南通大生物药业有限公司 | 4 | 4 | 0 |
| 10 | 新疆麦迪森药业有限公司制药厂 | 4 | 4 | 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 no longer on the under-review list whose last snapshot sighting falls in this week, meaning approved or terminated, to be verified. Companies are counted by first applicant.
Class 3 and new-drug acceptances
87 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/05/01New drug · Class 1.1 | 天心解郁颗粒CXZL2600039 | 北京纽维珀奥医药科技有限公司 |
| 2026/05/01New drug · Class 5.1 | 多西他赛注射液（白蛋白稳定型）CXHS2600061 | 珠海贝海生物技术股份有限公司; 健进制药有限公司 |
| 2026/05/01New drug · Class 2.2 | 醋酸奥曲肽片CXHL2600525 | 三迭纪（上海）医药科技有限公司 |
| 2026/05/01New drug · Class 2.2 | GCF20216CXHL2600523 | 广州绿十字制药股份有限公司 |
| 2026/04/30Import · Class 1 | BAY 2433334片JXHS2600043 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2026/04/30Import · Class 2.4 | 盐酸阿曲生坦片JXHL2600139 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/04/30Generic · Class 3 | 依巴斯汀口服溶液CYHS2601012 | 江西盛翔制药有限公司 |
| 2026/04/30Generic · Class 3 | 塞来昔布片CYHS2601011 | 浙江易泽达医药科技有限公司; 浙江中同药业有限公司 |
| 2026/04/30Generic · Class 3 | 塞来昔布片CYHS2601010 | 浙江易泽达医药科技有限公司; 浙江中同药业有限公司 |
| 2026/04/30Generic · Class 3 | 右美沙芬安非他酮缓释片CYHS2601007 | 江苏恩华药业股份有限公司 |
| 2026/04/30Generic · Class 3 | 硫酸特布他林口服溶液CYHS2601006 | 安徽杰玺医药有限公司 |
| 2026/04/30Generic · Class 3 | 富马酸依美斯汀缓释胶囊CYHS2601004 | 福建大谱生物医药有限公司; 福建省闽东力捷迅药业股份有限公司 |
| 2026/04/30New drug · Class 1 | 万基奥仑赛注射液CXSS2600077 | 华道（上海）生物医药股份有限公司 |
| 2026/04/30New drug · Class 1 | 乐德奇拜单抗注射液（皮下注射）CXSS2600076 | 先声药业有限公司; 烟台迈百瑞国际生物医药股份有限公司 |
| 2026/04/30New drug · Class 1 | 乐德奇拜单抗注射液（皮下注射）CXSS2600075 | 先声药业有限公司; 烟台迈百瑞国际生物医药股份有限公司 |
| 2026/04/30New drug · Class 1 | 注射用培重组人凝血因子Ⅷ-Fc融合蛋白CXSS2600074 | 杭州晟斯生物制药有限公司; 晟斯（上海）生物制药有限公司 |
| 2026/04/30New drug · Class 1 | 注射用培重组人凝血因子Ⅷ-Fc融合蛋白CXSS2600073 | 杭州晟斯生物制药有限公司; 晟斯（上海）生物制药有限公司 |
| 2026/04/30New drug · Class 1 | SKB118注射液CXSL2600463 | 四川科伦博泰生物医药股份有限公司 |
| 2026/04/30New drug · Class 1.4 | 重组四价肠道病毒疫苗（汉逊酵母）CXSL2600457 | 维尔泰克（北京）生物技术有限公司 |
| 2026/04/30New drug · Class 1 | BW-41012注射液CXHL2600524 | 上海舶望制药有限公司 |
| 2026/04/30New drug · Class 1 | GLR2038片CXHL2600522 | 甘李药业股份有限公司 |
| 2026/04/30New drug · Class 1 | GLR2038片CXHL2600521 | 甘李药业股份有限公司 |
| 2026/04/30New drug · Class 2.2 | DYTH203CXHL2600520 | 山西德元堂药业有限公司 |
| 2026/04/30New drug · Class 1 | SAL0167片CXHL2600519 | 深圳信立泰药业股份有限公司 |
| 2026/04/30New drug · Class 1 | SAL0167片CXHL2600518 | 深圳信立泰药业股份有限公司 |
| 2026/04/30New drug · Class 1 | SAL0167片CXHL2600517 | 深圳信立泰药业股份有限公司 |
| 2026/04/29Import · Class 1 | RO7435846片JXHL2600138 | F. Hoffmann-La Roche Ltd |
| 2026/04/29Import · Class 1 | RO7435846片JXHL2600137 | F. Hoffmann-La Roche Ltd |
| 2026/04/29Import · Class 1 | RO7435846片JXHL2600136 | F. Hoffmann-La Roche Ltd |
| 2026/04/29Import · Class 1 | RO7435846片JXHL2600135 | F. Hoffmann-La Roche Ltd |
57 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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