药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2024/10/22 – 2024/10/28

Period
2024/10/22 to 2024/10/28, 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
367
Drugs with new generic filings (by drug name, de-duplicated)
80
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

367filings, 116 of them generic

By application type

Application typeFilings
Supplement176
Generic116
New drug48
Import15
Unspecified10
Import re-registration2

By drug type

Drug typeFilings
Chemical drug236
TCM74
治疗用生物制品41
Biologic9
预防用生物制品7

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

80 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

219 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

114 this week

AcceptedDrugApplicants
2024/10/28Generic · Class 3 乳酸钠林格冲洗液CYHS2403652 石家庄四药有限公司
2024/10/28Generic · Class 3 己酮可可碱注射液CYHS2403651 国药集团容生制药有限公司
2024/10/28New drug · Class 3.3 帕妥珠单抗注射液CXSS2400116 杭州博之锐生物制药有限公司
2024/10/28New drug · Class 1 SYS6045CXSL2400733 石药集团巨石生物制药有限公司
2024/10/28New drug · Class 1 1D228片CXHL2401138 广州中科莱恩药物研究有限公司; 广东莱恩医药研究院有限公司
2024/10/28New drug · Class 2.3 SMF-213CXHL2401137 江西施美药业股份有限公司
2024/10/28New drug · Class 1 伊匹乌肽雾化吸入溶液CXHL2401136 益承康泰(厦门)生物科技有限公司
2024/10/28New drug · Class 1 SYH2051片CXHL2401135 石药集团中奇制药技术(石家庄)有限公司
2024/10/28New drug · Class 1 SYH2051片CXHL2401134 石药集团中奇制药技术(石家庄)有限公司
2024/10/26Import · Class 1 Remternetug注射液JXSL2400205 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/10/26Generic · Class 3 布比卡因脂质体注射液CYHS2403649 浙江圣兆药物科技股份有限公司; 杭州澳亚生物技术股份有限公司
2024/10/26Generic · Class 3 布比卡因脂质体注射液CYHS2403648 浙江圣兆药物科技股份有限公司; 杭州澳亚生物技术股份有限公司
2024/10/26Generic · Class 3 咪达唑仑口服溶液CYHS2403647 成都苑东生物制药股份有限公司
2024/10/26Generic · Class 3 辅酶Q10片CYHS2403644 成都倍特药业股份有限公司
2024/10/26Generic · Class 3 氯化钙注射液CYHS2403638 绪必迪药业(沧州)有限公司; 河北凯威制药有限责任公司
2024/10/26Generic · Class 3 盐酸甲氧氯普胺注射液CYHS2403635 江西科为制药有限公司; 浙江赛默制药有限公司
2024/10/26New drug · Class 2.2 注射用泰它西普CXSS2400115 荣昌生物制药(烟台)股份有限公司
2024/10/26New drug · Class 1 HB0028注射液CXSL2400732 上海华奥泰生物药业股份有限公司; 华博生物医药技术(上海)有限公司
2024/10/26New drug · Class 1 HB002.1T注射液CXSL2400731 浙江华海生物科技有限公司
2024/10/26New drug · Class 1 SHR-4375注射液CXSL2400730 苏州盛迪亚生物医药有限公司
2024/10/26New drug · Class 1 MAX-10181片CXHL2401133 北京再极医药科技有限公司
2024/10/26New drug · Class 1 MAX-10181片CXHL2401132 北京再极医药科技有限公司
2024/10/26New drug · Class 1 MAX-10181片CXHL2401131 北京再极医药科技有限公司
2024/10/25Import · Class 1 S095029JXSL2400204 Institut de Recherches Internationales Servier; Servier (Beijing) Pharmaceutical Research & Development Co. LTD
2024/10/25Import · Class 2.4 甲磺酸奥希替尼片JXHL2400258 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2024/10/25Import · Class 2.4 甲磺酸奥希替尼片JXHL2400257 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2024/10/25Generic · Class 3 维生素B6注射液CYHS2403632 山东齐都药业有限公司
2024/10/25Generic · Class 3 维生素B6注射液CYHS2403631 山东济坤生物制药有限公司; 烟台鲁银药业有限公司
2024/10/25Generic · Class 3 倍他米松磷酸钠注射液CYHS2403629 四川美大康华康药业有限公司
2024/10/25Generic · Class 3 维生素B6注射液CYHS2403625 西安安健药业有限公司

84 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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