药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2023/09/12 – 2023/09/18

Period
2023/09/12 to 2023/09/18, 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
371
Drugs with new generic filings (by drug name, de-duplicated)
45
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

371filings, 62 of them generic

By application type

Application typeFilings
Supplement196
New drug65
Generic62
Import25
Unspecified14
Import re-registration9

By drug type

Drug typeFilings
Chemical drug258
TCM62
治疗用生物制品44
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

45 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

192 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

117 this week

AcceptedDrugApplicants
2023/09/18Import · Class 1 BI 456906 注射液JXHL2300231 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/18Import · Class 1 BI 456906 注射液JXHL2300230 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/18Import · Class 1 BI 456906 注射液JXHL2300229 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/09/18Import · Class 1 LOXO-435片JXHL2300228 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/09/18Import · Class 1 LOXO-435片JXHL2300227 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/09/17New drug · Class 1 艾帕洛利单抗注射液CXSS2300077 齐鲁制药有限公司
2023/09/16Import · Class 2.4 米罗那非片JXHL2300226 AriBio Co. Ltd.; Panacro (Hefei) Pharmaceutical Technology Co. Ltd.
2023/09/16Import · Class 2.4 米罗那非片JXHL2300225 AriBio Co. Ltd.; Panacro (Hefei) Pharmaceutical Technology Co. Ltd.
2023/09/16Generic · Class 3 法莫替丁注射液CYHS2302501 四川益生智同医药生物科技发展有限公司; 太极集团四川太极制药有限公司
2023/09/16Generic · Class 3 法莫替丁注射液CYHS2302500 四川益生智同医药生物科技发展有限公司; 太极集团四川太极制药有限公司
2023/09/16Generic · Class 3 奥美拉唑碳酸氢钠胶囊CYHS2302498 海南广升誉制药有限公司; 浙江赛默制药有限公司
2023/09/16Generic · Class 3 奥美拉唑碳酸氢钠胶囊CYHS2302497 海南广升誉制药有限公司; 浙江赛默制药有限公司
2023/09/16New drug · Class 1 人源多巴胺能前体细胞注射液CXSL2300628 睿健医药科技(苏州)有限公司; 武汉睿健医药科技有限公司
2023/09/16New drug · Class 1 SKG0201注射液CXSL2300627 揽月生物医药科技(杭州)有限公司
2023/09/16New drug · Class 1 SHR2554片CXHL2301008 江苏恒瑞医药股份有限公司
2023/09/16New drug · Class 1 SYH2053注射液CXHL2301007 石药集团中诺药业(石家庄)有限公司; 石药集团中奇制药技术(石家庄)有限公司
2023/09/15Import · Class 1 SAR442168JXHL2300224 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2023/09/15Generic · Class 3 氨溴特罗口服溶液CYHS2302491 海门普适医药有限公司
2023/09/15Generic · Class 3 右酮洛芬氨丁三醇注射液CYHL2300118 中润药业有限公司
2023/09/15Generic · Class 3 酒石酸阿福特罗雾化吸入用溶液CYHL2300117 江苏和晨药业有限公司
2023/09/15New drug · Class 2.3 菖麻熄风片CXZL2300061 黑龙江省济仁药业有限公司
2023/09/15New drug · Class 2.2 特瑞普利单抗注射液CXSL2300626 上海君实生物医药科技股份有限公司
2023/09/15New drug · Class 2.2 特瑞普利单抗注射液CXSL2300625 上海君实生物医药科技股份有限公司
2023/09/15New drug · Class 1 C-13-60细胞制剂CXSL2300624 重庆精准生物技术有限公司
2023/09/15New drug · Class 1 注射用重组WNV-HCD86CXSL2300623 四川安可康生物医药有限公司
2023/09/15New drug · Class 1 注射用重组WNV-HCD86CXSL2300622 四川安可康生物医药有限公司
2023/09/15New drug · Class 1 注射用重组WNV-HCD86CXSL2300621 四川安可康生物医药有限公司
2023/09/15New drug · Class 1 MC-1-50细胞制剂CXSL2300620 重庆精准生物技术有限公司
2023/09/15New drug · Class 1 BGT-004胶囊CXHL2301006 博骥源(上海)生物医药有限公司
2023/09/15New drug · Class 1 BGT-004胶囊CXHL2301005 博骥源(上海)生物医药有限公司

87 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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