药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2026/10/13 – 2026/10/19
- New acceptances this week
- 411
- Drugs with new generic filings (by drug name, de-duplicated)
- 55
- Accepted this week, now under review
- 409
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
411filings, 75 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 197 |
| New drug | 100 |
| Generic | 75 |
| Import | 23 |
| Unspecified | 12 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 219 |
| TCM | 104 |
| 治疗用生物制品 | 79 |
| Biologic | 5 |
| 预防用生物制品 | 4 |
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
55 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 多替诺雷片 | 4 | 2 | 49 |
| 2 | 磷酸芦可替尼片 | 3 | 1 | 27 |
| 3 | 盐酸普萘洛尔口服溶液 | 2 | 2 | 4 |
| 4 | 他克莫司缓释胶囊 | 2 | 1 | 6 |
| 5 | 格隆溴铵注射液 | 2 | 1 | 2 |
| 6 | 沙库巴曲缬沙坦钠片 | 2 | 1 | 74 |
| 7 | 注射用托伐普坦磷酸钠 | 2 | 1 | 15 |
| 8 | 注射用氟氧头孢钠 | 2 | 1 | 9 |
| 9 | 盐酸倍他司汀片 | 2 | 1 | 11 |
| 10 | 精氨酸布洛芬颗粒 | 2 | 1 | 11 |
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
259 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Eli Lilly and Company | 14 | 5 | 0 |
| 2 | Boehringer Ingelheim International GmbH | 7 | 1 | 0 |
| 3 | AbbVie Inc. | 6 | 2 | 0 |
| 4 | 百济神州（苏州）生物科技有限公司 | 6 | 2 | 0 |
| 5 | 山西黄河中药有限公司 | 5 | 5 | 0 |
| 6 | 绵阳一康制药有限公司 | 5 | 5 | 0 |
| 7 | 大连水产药业有限公司 | 4 | 4 | 0 |
| 8 | 内蒙古天奇中蒙制药股份有限公司 | 4 | 3 | 0 |
| 9 | 新石阳光药业（河北）有限公司 | 4 | 2 | 4 |
| 10 | 江苏恒瑞医药股份有限公司 | 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 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
149 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/10/19Import · Class 2.2 | 塔奎妥单抗注射液JXSS2600097 | Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd. |
| 2026/10/19Import · Class 2.2 | 塔奎妥单抗注射液JXSS2600096 | Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd. |
| 2026/10/19Import · Class 1 | ASP2138注射液JXSL2600275 | Astellas Pharma Global Development Inc.; Astellas (Beijing) Pharmaceutical R&D Co. Ltd. |
| 2026/10/19Import · Class 1 | Alnuctamab注射液JXSL2600274 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/10/19Import · Class 1 | Alnuctamab注射液JXSL2600273 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/10/19Generic · Class 3 | 注射用盐酸兰地洛尔CYHS2602574 | 海南海灵化学制药有限公司 |
| 2026/10/19Generic · Class 3 | 阿伐那非片CYHS2602570 | 昆明积大制药股份有限公司 |
| 2026/10/19Generic · Class 3 | 阿伐那非片CYHS2602569 | 昆明积大制药股份有限公司 |
| 2026/10/19Generic · Class 3 | 复方聚乙二醇（3350）电解质口服溶液CYHS2602564 | 湖北多瑞药业有限公司; 浙江国镜药业有限公司 |
| 2026/10/19Generic · Class 3 | 盐酸苯海拉明片CYHS2602562 | 河南朗冠药品制剂研究院有限公司; 安徽华辰制药有限公司 |
| 2026/10/19New drug · Class 2.3 | 济川煎颗粒CXZL2600101 | 合肥华润神鹿药业有限公司; 安徽省食品药品检验研究院 |
| 2026/10/19New drug · Class 1 | SHR-5670注射液CXSL2601147 | 江苏恒瑞医药股份有限公司; 北京拓界生物医药科技有限公司 |
| 2026/10/19New drug · Class 1 | 注射用TQB6411CXSL2601146 | 上海正大天晴医药科技开发有限公司 |
| 2026/10/19New drug · Class 1 | 重组抗NKG2A人源化单克隆抗体注射液CXSL2601145 | 上海怀越生物科技有限公司 |
| 2026/10/19New drug · Class 1 | B1962注射液CXSL2601144 | 天士力生物医药股份有限公司 |
| 2026/10/19New drug · Class 1 | B1962注射液CXSL2601143 | 天士力生物医药股份有限公司 |
| 2026/10/19New drug · Class 1 | SHR-5670注射液CXSL2601142 | 江苏恒瑞医药股份有限公司; 北京拓界生物医药科技有限公司 |
| 2026/10/19New drug · Class 3.3 | 司美格鲁肽注射液CXSL2601141 | 广州白云山拜迪生物医药有限公司 |
| 2026/10/19New drug · Class 3.3 | 司美格鲁肽注射液CXSL2601140 | 广州白云山拜迪生物医药有限公司 |
| 2026/10/19New drug · Class 1 | 注射用LY4170156CXSL2601139 | 礼来苏州制药有限公司 |
| 2026/10/19New drug · Class 1 | 联格列净片CXHS2600141 | 江苏联环药业股份有限公司 |
| 2026/10/19New drug · Class 1 | 联格列净片CXHS2600140 | 江苏联环药业股份有限公司 |
| 2026/10/19New drug · Class 1 | PA-XP-102CXHL2601307 | 中科帅天医药（深圳）有限公司 |
| 2026/10/19New drug · Class 1 | HPN-01肠溶胶囊CXHL2601306 | 和博恒升（上海）医药有限公司 |
| 2026/10/19New drug · Class 1 | HPN-01肠溶胶囊CXHL2601305 | 和博恒升（上海）医药有限公司 |
| 2026/10/19New drug · Class 1 | QLS1530片CXHL2601304 | 上海齐鲁制药研究中心有限公司 |
| 2026/10/19New drug · Class 1 | QLS1530片CXHL2601303 | 上海齐鲁制药研究中心有限公司 |
| 2026/10/19New drug · Class 2.2 | YY2403口崩片CXHL2601302 | 药云（西安）医药技术有限公司 |
| 2026/10/19New drug · Class 1 | HP-001胶囊CXHL2601301 | 上海超阳药业有限公司 |
| 2026/10/19New drug · Class 1 | HP-001胶囊CXHL2601300 | 上海超阳药业有限公司 |
119 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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