药格局 YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
2023/08/22 – 2023/08/28
- New acceptances this week
- 378
- Drugs with new generic filings (by drug name, de-duplicated)
- 61
- Accepted this week, now under review
- 1
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
378filings, 84 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 211 |
| Generic | 84 |
| New drug | 48 |
| Unspecified | 14 |
| Import | 12 |
| Import re-registration | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 248 |
| TCM | 90 |
| 治疗用生物制品 | 33 |
| Biologic | 6 |
| 预防用生物制品 | 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
61 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 他达拉非片 | 5 | 3 | 23 |
| 2 | 氯化钾注射液 | 4 | 3 | 10 |
| 3 | 利伐沙班片 | 3 | 1 | 3 |
| 4 | 比索洛尔氨氯地平片 | 2 | 2 | 8 |
| 5 | 法莫替丁注射液 | 2 | 2 | 8 |
| 6 | 注射用氯诺昔康 | 2 | 2 | 2 |
| 7 | 注射用硼替佐米 | 2 | 2 | 1 |
| 8 | 磷酸奥司他韦干混悬剂 | 2 | 2 | 2 |
| 9 | 复方奥美拉唑干混悬剂 | 2 | 1 | 0 |
| 10 | 孟鲁司特钠咀嚼片 | 2 | 1 | 4 |
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
209 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | 修正药业集团天汉药业有限公司 | 47 | 46 | 0 |
| 2 | 贵州瑞和制药有限公司 | 13 | 13 | 0 |
| 3 | 长沙爱贝高药业有限公司 | 6 | 6 | 0 |
| 4 | GE Healthcare AS | 6 | 1 | 0 |
| 5 | Sanofi Winthrop Industrie | 6 | 1 | 0 |
| 6 | Sanofi-Aventis Deutschland GmbH | 5 | 5 | 0 |
| 7 | AstraZeneca AB | 5 | 2 | 0 |
| 8 | 海南斯达制药有限公司 | 5 | 1 | 0 |
| 9 | 上海信谊万象药业股份有限公司 | 4 | 3 | 0 |
| 10 | 浙江金华康恩贝生物制药有限公司 | 4 | 2 | 1 |
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
104 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/08/28New drug · Class 1.1 | 骨性关节炎软膏CXZL2300053 | 义乌市振伟中草药科技开发有限公司 |
| 2023/08/28New drug · Class 1 | 注射用BC001CXSL2300578 | 四川泸州步长生物制药有限公司 |
| 2023/08/26Generic · Class 3 | 氨氯地平贝那普利胶囊CYHS2302279 | 杭州沐源生物医药科技有限公司; 新乡市常乐制药有限责任公司 |
| 2023/08/26Generic · Class 3 | 氯化钾注射液CYHS2302276 | 广东科泓药业有限公司; 河南科伦药业有限公司 |
| 2023/08/26Generic · Class 3 | 氯化钾注射液CYHS2302275 | 广东科泓药业有限公司; 河南科伦药业有限公司 |
| 2023/08/26Generic · Class 3 | 磷酸奥司他韦干混悬剂CYHS2302274 | 广东红珊瑚药业有限公司; 天津汉瑞药业有限公司 |
| 2023/08/26New drug · Class 1 | SCG101自体T细胞注射液CXSL2300577 | 星汉德生物医药(大连)有限公司 |
| 2023/08/26New drug · Class 3.3 | 重组抗CTLA-4全人单克隆抗体注射液CXSL2300576 | 上海复宏汉霖生物制药有限公司 |
| 2023/08/26New drug · Class 1 | IMP4297胶囊CXHS2300074 | 上海英派药业有限公司; 无锡合全药业有限公司 |
| 2023/08/26New drug · Class 1 | IMP4297胶囊CXHS2300073 | 上海英派药业有限公司; 无锡合全药业有限公司 |
| 2023/08/26New drug · Class 1 | SZJK-0421片CXHL2300917 | 深圳济康医药科技有限公司 |
| 2023/08/26New drug · Class 2.2 | 司美格鲁肽注射液CXHL2300916 | 华润双鹤药业股份有限公司 |
| 2023/08/26New drug · Class 2.2 | 司美格鲁肽注射液CXHL2300915 | 华润双鹤药业股份有限公司 |
| 2023/08/25Import · Class 1 | AZD5335JXSL2300158 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/08/25Import · Class 1 | AZD5305JXHL2300200 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/08/25Import · Class 1 | AZD5305JXHL2300199 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/08/25Import · Class 1 | AZD5305JXHL2300198 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/08/25Import · Class 1 | AZD5305JXHL2300197 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/08/25Generic · Class 3 | 阿瑞匹坦注射液CYHS2302273 | 江苏康禾生物制药有限公司 |
| 2023/08/25Generic · Class 3 | 乙酰半胱氨酸注射液CYHS2302272 | 福安药业集团庆余堂制药有限公司 |
| 2023/08/25Generic · Class 3 | 脑脊髓手术用灌流液CYHS2302269 | 山东齐都药业有限公司 |
| 2023/08/25Generic · Class 3 | 米诺地尔外用溶液CYHS2302268 | 江苏睿实生物科技有限公司; 江苏知原药业股份有限公司 |
| 2023/08/25Generic · Class 3 | 米诺地尔外用溶液CYHS2302267 | 江苏睿实生物科技有限公司; 江苏知原药业股份有限公司 |
| 2023/08/25Generic · Class 3 | 氟[18F]洛贝平注射液CYHS2302261 | 北京欣翮医药科技有限公司; 南京江原安迪科正电子研究发展有限公司 |
| 2023/08/25Generic · Class 3 | 左卡尼汀片CYHL2300107 | 辽宁诺维诺制药股份有限公司 |
| 2023/08/25Generic · Class 3 | 注射用乳糖酸克拉霉素CYHL2300106 | 广东金城金素制药有限公司 |
| 2023/08/25New drug · Class 1 | ZX2021注射液CXSL2300575 | 江苏中新医药有限公司 |
| 2023/08/25New drug · Class 1 | ZX2021注射液CXSL2300574 | 江苏中新医药有限公司 |
| 2023/08/25New drug · Class 1 | EB070注射液CXSL2300573 | 北京东方百泰生物科技股份有限公司; 北京精益泰翔技术发展有限公司 |
| 2023/08/25New drug · Class 1 | CRTE7A2-01 TCR-T细胞注射液CXSL2300572 | 北京可瑞生物科技有限公司 |
74 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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