药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/09/24 – 2024/09/30
- New acceptances this week
- 603
- Drugs with new generic filings (by drug name, de-duplicated)
- 129
- Accepted this week, now under review
- 13
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
603filings, 189 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 230 |
| Generic | 189 |
| New drug | 100 |
| Import | 44 |
| Unspecified | 28 |
| Import re-registration | 12 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 392 |
| TCM | 94 |
| 治疗用生物制品 | 87 |
| Biologic | 20 |
| 预防用生物制品 | 10 |
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
129 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 枸橼酸芬太尼口腔贴片 | 6 | 1 | 0 |
| 2 | 注射用头孢哌酮钠舒巴坦钠 | 6 | 1 | 14 |
| 3 | 富马酸伏诺拉生片 | 4 | 2 | 58 |
| 4 | 布瑞哌唑片 | 4 | 2 | 31 |
| 5 | 钆布醇注射液 | 4 | 1 | 8 |
| 6 | 注射用硫酸多黏菌素B | 3 | 3 | 7 |
| 7 | 达格列净片 | 3 | 2 | 82 |
| 8 | 卡马西平缓释片（II） | 3 | 1 | 0 |
| 9 | 布瑞哌唑口崩片 | 3 | 1 | 10 |
| 10 | 注射用乳糖酸红霉素 | 3 | 1 | 15 |
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
356 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 百济神州（苏州）生物科技有限公司 | 10 | 3 | 0 |
| 2 | Novo Nordisk A/S | 9 | 5 | 0 |
| 3 | AstraZeneca AB | 9 | 4 | 0 |
| 4 | Amgen Inc. | 9 | 2 | 0 |
| 5 | 宜昌人福药业有限责任公司 | 9 | 2 | 9 |
| 6 | Janssen-Cilag International NV | 7 | 3 | 0 |
| 7 | 国药集团昆明血液制品有限公司 | 7 | 3 | 0 |
| 8 | Boehringer Ingelheim International GmbH | 7 | 1 | 0 |
| 9 | 浙江我武生物科技股份有限公司 | 7 | 1 | 0 |
| 10 | 江西杏林白马药业股份有限公司 | 6 | 6 | 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
226 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/09/30Import · Class 2.2 | Dostarlimab注射液JXSL2400189 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd. |
| 2024/09/30Import · Class 1 | Belrestotug注射液JXSL2400188 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited |
| 2024/09/30Import · Class 1 | MEDI5752JXSL2400187 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/30Import · Class 1 | DD01注射液JXHL2400241 | Neuraly Inc.; SHENZHEN SALUBRIS PHARMACEUTICALS CO. LTD. |
| 2024/09/30Generic · Class 3 | 己酮可可碱缓释片CYHS2403327 | 江苏慧聚药业股份有限公司; 华益泰康药业股份有限公司 |
| 2024/09/30Generic · Class 3 | 乙酰半胱氨酸片CYHS2403323 | 北京福元医药股份有限公司 |
| 2024/09/30Generic · Class 3 | 比拉斯汀口服溶液CYHS2403320 | 合肥华威药业有限公司 |
| 2024/09/30Generic · Class 3 | 重酒石酸卡巴拉汀口服溶液CYHS2403319 | 北京双鹭药业股份有限公司 |
| 2024/09/30Generic · Class 3 | 重酒石酸卡巴拉汀口服溶液CYHS2403318 | 北京双鹭药业股份有限公司 |
| 2024/09/30Generic · Class 3 | 盐酸普罗帕酮注射液CYHS2403313 | 再维药业（海南）有限公司; 海南通用三洋药业有限公司 |
| 2024/09/30Generic · Class 3 | 异烟肼注射液CYHS2403311 | 河北赛谱熠辉医药科技有限公司; 成都百裕制药股份有限公司 |
| 2024/09/30Generic · Class 3 | 注射用乳糖酸红霉素CYHS2403306 | 广东金城金素制药有限公司; 广东隆赋药业股份有限公司 |
| 2024/09/30Generic · Class 3 | 注射用乳糖酸红霉素CYHS2403305 | 广东金城金素制药有限公司; 广东隆赋药业股份有限公司 |
| 2024/09/30Generic · Class 3 | 注射用乳糖酸红霉素CYHS2403304 | 广东金城金素制药有限公司; 广东隆赋药业股份有限公司 |
| 2024/09/30Generic · Class 3 | 丙戊酸钠注射用浓溶液CYHS2403302 | 悦康药业集团股份有限公司 |
| 2024/09/30Generic · Class 3 | 钠钾镁钙注射用浓溶液CYHS2403301 | 广东南国药业有限公司 |
| 2024/09/30Generic · Class 3 | 盐酸纳美芬注射液CYHS2403300 | 成都明德至远医药科技有限公司; 成都百裕制药股份有限公司 |
| 2024/09/30Generic · Class 3 | 盐酸羟甲唑啉滴鼻液CYHS2403299 | 广州艾格生物科技有限公司; 南京海鲸药业股份有限公司 |
| 2024/09/30Generic · Class 3 | 乙酰唑胺缓释胶囊CYHS2403298 | 河南中帅医药科技有限责任公司; 河南中帅药业有限公司 |
| 2024/09/30Generic · Class 3 | 注射用盐酸兰地洛尔CYHL2400199 | 山东化药医药科技有限公司 |
| 2024/09/30New drug · Class 1.1 | 连花御屏颗粒CXZL2400063 | 北京以岭药业有限公司 |
| 2024/09/30New drug · Class 1.1 | 藤参降压颗粒CXZL2400062 | 山东古金中医药科技有限公司; 山东中医药大学附属医院 |
| 2024/09/30New drug · Class 3.3 | 四价流感病毒裂解疫苗CXSS2400106 | 安徽智飞龙科马生物制药有限公司 |
| 2024/09/30New drug · Class 2.2 | 培集成干扰素α-2注射液CXSS2400105 | 北京凯因科技股份有限公司 |
| 2024/09/30New drug · Class 1.2 | 冻干带状疱疹病毒mRNA疫苗CXSL2400675 | 北京科兴中维生物技术有限公司 |
| 2024/09/30New drug · Class 2.2 | 盐酸奥洛他定口服溶液CXHS2400101 | 安徽四环科宝制药有限公司 |
| 2024/09/30New drug · Class 2.2 | 盐酸奥洛他定口服溶液CXHS2400100 | 安徽四环科宝制药有限公司 |
| 2024/09/30New drug · Class 1 | BGB-53038胶囊CXHL2401031 | 百济神州（苏州）生物科技有限公司 |
| 2024/09/30New drug · Class 1 | BGB-53038胶囊CXHL2401030 | 百济神州（苏州）生物科技有限公司 |
| 2024/09/30New drug · Class 1 | BGB-53038胶囊CXHL2401029 | 百济神州（苏州）生物科技有限公司 |
196 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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