药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/09/10 – 2024/09/16

Period
2024/09/10 to 2024/09/16, 7 days inclusive
Data as of
2026/11/05 06:00
Cached records
94,245 acceptance records, 11,689 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
515
Drugs with new generic filings (by drug name, de-duplicated)
106
Accepted this week, now under review
10

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

515filings, 150 of them generic

By application type

Application typeFilings
Supplement250
Generic150
New drug91
Import16
Import re-registration5
Unspecified3

By drug type

Drug typeFilings
Chemical drug374
TCM71
治疗用生物制品62
预防用生物制品6
体外诊断试剂1
Biologic1

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

106 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

282 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

165 this week

AcceptedDrugApplicants
2024/09/15Import · Class 1 DS-1062aJXSL2400171 ASTRAZENECA AB; AstraZeneca Investment (China) Co. Limited
2024/09/15Import · Class 2.4 替尔泊肽注射液JXHS2400068 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/09/15Import · Class 2.4 替尔泊肽注射液JXHS2400067 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/09/15Import · Class 2.4 替尔泊肽注射液JXHS2400066 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/09/15Import · Class 2.4 替尔泊肽注射液JXHS2400065 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/09/15Generic · Class 3 碳酸氢钠林格注射液(I)CYHS2403111 浙江康吉尔药业有限公司
2024/09/15Generic · Class 3 对乙酰氨基酚维生素C泡腾片CYHS2403104 郑州泰丰制药有限公司
2024/09/15New drug · Class 1.2 复制缺陷型猴痘疫苗CXSL2400627 北京生物制品研究所有限责任公司
2024/09/15New drug · Class 1 注射用BG-C477CXSL2400626 广州百济神州生物制药有限公司
2024/09/15New drug · Class 2.2 司美格鲁肽注射液CXHS2400095 齐鲁制药有限公司
2024/09/15New drug · Class 2.2 司美格鲁肽注射液CXHS2400094 齐鲁制药有限公司
2024/09/15New drug · Class 2.4 注射用苯磺酸瑞马唑仑CXHS2400093 宜昌人福药业有限责任公司
2024/09/15New drug · Class 2.4 注射用苯磺酸瑞马唑仑CXHS2400092 宜昌人福药业有限责任公司
2024/09/15New drug · Class 1 CMS-D005注射液CXHL2400975 深圳市康哲生物科技有限公司
2024/09/15New drug · Class 1 CMS-D005注射液CXHL2400974 深圳市康哲生物科技有限公司
2024/09/14Import · Class 1 AZD2936JXSL2400170 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/14Import · Class 2.2 度普利尤单抗注射液JXSL2400169 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2024/09/14Import · Class 1 AZD0486JXSL2400168 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/14Import · Class 1 DS-6000aJXSL2400167 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2024/09/14Import · Class 1 AZD5462片JXHL2400218 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/14Import · Class 1 AZD5462片JXHL2400217 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/14Generic · Class 3 脂溶性维生素注射液(Ⅱ)CYHS2403099 沈阳海思科制药有限公司
2024/09/14Generic · Class 3 维生素B6注射液CYHS2403098 广州艾奇西新药研究有限公司; 津药和平(天津)制药有限公司
2024/09/14Generic · Class 3 氯化钙注射液CYHS2403094 海南倍特药业有限公司
2024/09/14Generic · Class 3 氯化钙注射液CYHS2403093 海南倍特药业有限公司
2024/09/14Generic · Class 3 注射用左亚叶酸钙CYHS2403091 安徽省先锋制药有限公司
2024/09/14Generic · Class 3 硫酸麻黄碱注射液CYHS2403085 浙江普洛康裕制药有限公司
2024/09/14Generic · Class 3 硫酸镁注射液CYHS2403083 国药集团国瑞药业有限公司
2024/09/14Generic · Class 3 阿仑膦酸钠口服溶液CYHS2403082 武汉华尔生物科技有限公司; 湖北多瑞药业有限公司
2024/09/14Generic · Class 3 米诺地尔搽剂CYHS2403080 曼秀雷敦(中国)药业有限公司; 中山万汉制药有限公司

135 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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