药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2024/03/12 – 2024/03/18
- New acceptances this week
- 246
- Drugs with new generic filings (by drug name, de-duplicated)
- 47
- Accepted this week, now under review
- 0
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
246filings, 62 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 106 |
| Generic | 62 |
| New drug | 43 |
| Import re-registration | 15 |
| Import | 12 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 168 |
| TCM | 35 |
| 治疗用生物制品 | 32 |
| Biologic | 7 |
| 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
47 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 苯磺酸氨氯地平片 | 4 | 2 | 8 |
| 2 | 甲氨蝶呤注射液 | 3 | 2 | 12 |
| 3 | 他达拉非片 | 3 | 1 | 23 |
| 4 | 二十碳五烯酸乙酯软胶囊 | 2 | 1 | 25 |
| 5 | 卡左双多巴缓释片 | 2 | 1 | 3 |
| 6 | 吡仑帕奈片 | 2 | 1 | 2 |
| 7 | 头孢托仑匹酯颗粒 | 2 | 1 | 18 |
| 8 | 孟鲁司特钠咀嚼片 | 2 | 1 | 4 |
| 9 | 小儿复方氨基酸注射液(19AA-I) | 2 | 1 | 2 |
| 10 | 拉米地坦片 | 2 | 1 | 0 |
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
144 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 河南双鹤华利药业有限公司 | 14 | 3 | 0 |
| 2 | 国大(吉林)制药集团有限公司 | 9 | 9 | 0 |
| 3 | 慧瑞药业(湖北)有限公司 | 7 | 6 | 0 |
| 4 | 石家庄四药有限公司 | 6 | 4 | 2 |
| 5 | 上海爱博医药科技有限公司 | 4 | 2 | 0 |
| 6 | Dr. Falk Pharma GmbH | 4 | 1 | 0 |
| 7 | 厦门特宝生物工程股份有限公司 | 4 | 1 | 0 |
| 8 | 海南灵康制药有限公司 | 4 | 1 | 0 |
| 9 | 科笛生物医药(无锡)有限公司 | 4 | 1 | 0 |
| 10 | Boehringer Ingelheim International GmbH | 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
70 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/03/18Generic · Class 3 | 氯化钙注射液CYHS2400865 | 广州艾格生物科技有限公司; 广东星昊药业有限公司 |
| 2024/03/18Generic · Class 3 | 硫酸沙丁胺醇注射液CYHS2400862 | 江苏开元药业有限公司; 康普药业股份有限公司 |
| 2024/03/18Generic · Class 3 | 盐酸普萘洛尔片CYHS2400861 | 合肥国药诺和药业有限公司; 华益药业科技(安徽)有限公司 |
| 2024/03/16Import · Class 1 | 注射用Datopotamab DeruxtecanJXSS2400026 | Daiichi Sankyo Europe GmbH; Baxter Oncology GmbH; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2024/03/16Import · Class 1 | ABBV-400注射用粉末JXSL2400060 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/03/16New drug · Class 2.2 | 聚乙二醇干扰素α-2b注射液CXSS2400026 | 厦门特宝生物工程股份有限公司 |
| 2024/03/16New drug · Class 2.2 | 聚乙二醇干扰素α-2b注射液CXSS2400025 | 厦门特宝生物工程股份有限公司 |
| 2024/03/16New drug · Class 2.2 | 聚乙二醇干扰素α-2b注射液CXSS2400024 | 厦门特宝生物工程股份有限公司 |
| 2024/03/16New drug · Class 2.2 | 聚乙二醇干扰素α-2b注射液CXSS2400023 | 厦门特宝生物工程股份有限公司 |
| 2024/03/16New drug · Class 1 | 注射用苏维西塔单抗CXSS2400022 | 江苏先声生物制药有限公司 |
| 2024/03/16New drug · Class 1 | BAT6005注射液CXSL2400189 | 百奥泰生物制药股份有限公司 |
| 2024/03/16New drug · Class 1 | BAT1308注射液CXSL2400188 | 百奥泰生物制药股份有限公司 |
| 2024/03/16New drug · Class 1.2 | 呼吸道合胞病毒IN006二价mRNA疫苗CXSL2400187 | 深圳深信生物科技有限公司 |
| 2024/03/16New drug · Class 1 | ABP1618片CXHL2400285 | 上海爱博医药科技有限公司 |
| 2024/03/16New drug · Class 1 | ABP1618片CXHL2400284 | 上海爱博医药科技有限公司 |
| 2024/03/15Import · Class 2.2;2.4 | TAR-210JXHL2400065 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/03/15Import · Class 1 | Balcinrenone达格列净胶囊JXHL2400064 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/03/15Import · Class 1 | Balcinrenone达格列净胶囊JXHL2400063 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/03/15Generic · Class 3 | 硫酸阿托品注射液CYHS2400853 | 江苏开元药业有限公司; 康普药业股份有限公司 |
| 2024/03/15Generic · Class 3 | 普仑司特干糖浆CYHS2400849 | 济川药业集团有限公司 |
| 2024/03/15Generic · Class 3 | 西咪替丁注射液CYHS2400845 | 苏州朗科生物技术股份有限公司; 扬州中宝药业股份有限公司 |
| 2024/03/15Generic · Class 3 | 复方聚乙二醇电解质散(儿童型)CYHS2400838 | 四川科伦药业股份有限公司 |
| 2024/03/15New drug · Class 1 | SHR-4849注射液CXSL2400186 | 苏州盛迪亚生物医药有限公司; 上海恒瑞医药有限公司 |
| 2024/03/15New drug · Class 1 | FC084CSA片CXHL2400283 | 中山医诺维申新药研发有限公司 |
| 2024/03/15New drug · Class 1 | FC084CSA片CXHL2400282 | 中山医诺维申新药研发有限公司 |
| 2024/03/14Import · Class 1 | BI 1839100 片JXHL2400062 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2024/03/14Generic · Class 3 | 溴吡斯的明缓释片CYHS2400832 | 上海上药中西制药有限公司 |
| 2024/03/14Generic · Class 3 | 小儿复方氨基酸注射液(19AA-I)CYHS2400830 | 湖北民康药业集团有限公司; 津药和平(天津)制药有限公司 |
| 2024/03/14Generic · Class 3 | 小儿复方氨基酸注射液(19AA-I)CYHS2400829 | 湖北民康药业集团有限公司; 津药和平(天津)制药有限公司 |
| 2024/03/14Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液CYHS2400827 | 石家庄四药有限公司 |
40 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.