药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/07/14 – 2026/07/20
- New acceptances this week
- 446
- Drugs with new generic filings (by drug name, de-duplicated)
- 49
- Accepted this week, now under review
- 170
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
446filings, 70 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 280 |
| Generic | 70 |
| New drug | 58 |
| Import | 20 |
| Unspecified | 12 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 221 |
| TCM | 145 |
| 治疗用生物制品 | 69 |
| 预防用生物制品 | 8 |
| Biologic | 3 |
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
49 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 巴瑞替尼片 | 4 | 2 | 32 |
| 2 | 多替诺雷片 | 3 | 1 | 49 |
| 3 | 布立西坦片 | 3 | 1 | 16 |
| 4 | 瑞维那新吸入溶液 | 2 | 2 | 53 |
| 5 | 丁丙诺啡透皮贴剂 | 2 | 1 | 6 |
| 6 | 二十碳五烯酸乙酯软胶囊 | 2 | 1 | 25 |
| 7 | 加替沙星滴眼液 | 2 | 1 | 3 |
| 8 | 奥沙利铂注射液 | 2 | 1 | 2 |
| 9 | 富马酸比索洛尔片 | 2 | 1 | 6 |
| 10 | 注射用头孢呋辛钠 | 2 | 1 | 8 |
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
270 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 吉林吉尔吉药业有限公司 | 9 | 9 | 0 |
| 2 | 青海帝玛尔藏药药业有限公司 | 9 | 9 | 0 |
| 3 | 安康正大制药有限公司 | 6 | 5 | 0 |
| 4 | Pfizer Inc. | 6 | 2 | 0 |
| 5 | Fresenius Kabi Austria GmbH | 6 | 1 | 0 |
| 6 | 山西黄河中药有限公司 | 5 | 5 | 0 |
| 7 | Novo Nordisk A/S | 5 | 2 | 0 |
| 8 | 北京先声祥瑞生物制品股份有限公司 | 5 | 2 | 0 |
| 9 | 成都闻泰医药科技股份有限公司 | 5 | 1 | 0 |
| 10 | 深圳市亦诺微医药科技有限公司 | 5 | 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 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
105 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/07/20Import · Class 3.1 | 伊匹木单抗注射液JXSS2600063 | Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Samsung Biologics Co. Ltd; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2026/07/20Import · Class 1 | AZD5335JXSL2600172 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/07/20Import · Class 2.4 | 贝组替凡片JXHL2600279 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2026/07/20Import · Class 2.4 | 塞伐艾替尼片JXHL2600278 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2026/07/20Import · Class 2.4 | 塞伐艾替尼片JXHL2600277 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2026/07/20Generic · Class 3 | 盐酸艾司氯胺酮注射液CYHS2601737 | 国药集团工业有限公司廊坊分公司 |
| 2026/07/20Generic · Class 3 | 布美他尼片CYHS2601736 | 江苏润恒制药有限公司 |
| 2026/07/20Generic · Class 3 | 氯化钾注射液CYHS2601732 | 济南康桥医药科技有限公司; 西安利君康乐制药有限责任公司 |
| 2026/07/20Generic · Class 3 | 盐酸奥洛他定口崩片CYHS2601723 | 海南元盈医药科技有限公司; 天津汉瑞药业有限公司 |
| 2026/07/20Generic · Class 3 | 双嘧达莫片CYHS2601722 | 成都归合科技有限公司; 成都天台山制药股份有限公司 |
| 2026/07/20New drug · Class 1 | 注射用CS5007CXSL2600752 | 基石药业（苏州）有限公司 |
| 2026/07/20New drug · Class 1 | EB070注射液CXSL2600751 | 百泰生物药业有限公司 |
| 2026/07/20New drug · Class 1 | EB070注射液CXSL2600750 | 百泰生物药业有限公司 |
| 2026/07/20New drug · Class 1 | EB070注射液CXSL2600749 | 百泰生物药业有限公司 |
| 2026/07/20New drug · Class 1.2 | 冻干重组呼吸道合胞病毒疫苗（CHO细胞）CXSL2600748 | 厦门万泰沧海生物技术有限公司; 厦门大学 |
| 2026/07/20New drug · Class 1 | SHR-3201注射液CXSL2600746 | 北京盛迪医药有限公司 |
| 2026/07/20New drug · Class 1 | VCT220片CXHS2600104 | 成都闻泰医药科技股份有限公司; 无锡合全药业有限公司 |
| 2026/07/20New drug · Class 1 | VCT220片CXHS2600103 | 成都闻泰医药科技股份有限公司; 无锡合全药业有限公司 |
| 2026/07/20New drug · Class 2.2 | N02CXHL2600879 | 北京博恩特药业有限公司 |
| 2026/07/20New drug · Class 2.2 | N02CXHL2600878 | 北京博恩特药业有限公司 |
| 2026/07/20New drug · Class 1 | VCT220片CXHL2600877 | 成都闻泰医药科技股份有限公司 |
| 2026/07/20New drug · Class 1 | VCT220片CXHL2600876 | 成都闻泰医药科技股份有限公司 |
| 2026/07/20New drug · Class 1 | VCT220片CXHL2600875 | 成都闻泰医药科技股份有限公司 |
| 2026/07/20New drug · Class 2.4 | HS-10561胶囊CXHL2600874 | 江苏豪森药业集团有限公司; 上海翰森生物医药科技有限公司 |
| 2026/07/20New drug · Class 1 | BAY 3713372 片CXHL2600873 | 拜耳医药保健有限公司 |
| 2026/07/20New drug · Class 1 | BAY 3713372 片CXHL2600872 | 拜耳医药保健有限公司 |
| 2026/07/18Generic · Class 3 | 枸橼酸铁片CYHS2601721 | 江苏知原药业股份有限公司 |
| 2026/07/18New drug · Class 1 | 注射用依康坦博妥塔单抗CXSS2600109 | 上海宜联生物医药有限公司; 上海凯莱英生物技术有限公司（注射用YL201的连接子-有效载荷YL0010062：凯莱英医药集团（天津）股份有限公司） |
| 2026/07/18New drug · Class 2.4 | 瑞维鲁胺片CXHL2600871 | 江苏恒瑞医药股份有限公司 |
| 2026/07/18New drug · Class 1 | 注射用JZ1108i聚合物胶束CXHL2600870 | 杭州珺泽生物医药有限公司 |
75 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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