药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2023/08/22 – 2023/08/28

Period
2023/08/22 to 2023/08/28, 7 days inclusive
Data as of
2026/11/07 06:00
Cached records
94,440 acceptance records, 11,686 under review now
Source
Public data from the CDE acceptance list and under-review list
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 typeFilings
Supplement211
Generic84
New drug48
Unspecified14
Import12
Import re-registration9

By drug type

Drug typeFilings
Chemical drug248
TCM90
治疗用生物制品33
Biologic6
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

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

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

AcceptedDrugApplicants
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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