药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2025/01/07 – 2025/01/13

Period
2025/01/07 to 2025/01/13, 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
519
Drugs with new generic filings (by drug name, de-duplicated)
150
Accepted this week, now under review
20

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

519filings, 212 of them generic

By application type

Application typeFilings
Generic212
Supplement200
New drug84
Import13
Unspecified4
Import re-registration4
药械组合2

By drug type

Drug typeFilings
Chemical drug387
TCM70
治疗用生物制品57
Biologic3
预防用生物制品2

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

150 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

301 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

171 this week

AcceptedDrugApplicants
2025/01/13Generic · Class 3 维生素B12注射液CYHS2500265 南京赛瑞谱顿制药有限公司; 山东新时代药业有限公司
2025/01/13New drug · Class 1 TQC2938注射液CXSL2500038 正大天晴药业集团南京顺欣制药有限公司
2025/01/11Import · Class 1 AZD2936JXSL2500007 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/01/11Import · Class 1 TAK-360片JXHL2500008 Takeda Development Center Americas Inc.
2025/01/11Import · Class 1 TAK-360片JXHL2500007 Takeda Development Center Americas Inc.
2025/01/11Import · Class 1 TAK-360片JXHL2500006 Takeda Development Center Americas Inc.
2025/01/11Generic · Class 3 盐酸普萘洛尔片CYHS2500261 合肥国药诺和药业有限公司; 华益药业科技(安徽)有限公司
2025/01/11Generic · Class 3 复方匹可硫酸钠口服溶液CYHS2500260 江苏润恒制药有限公司
2025/01/11Generic · Class 3 维生素B6注射液CYHS2500259 江苏迪赛诺制药有限公司
2025/01/11Generic · Class 3 氯化钾口服溶液CYHS2500249 山东齐都药业有限公司; 山东益康药业股份有限公司
2025/01/11Generic · Class 3 氯雷他定口服溶液CYHS2500246 海南万玮制药有限公司
2025/01/11Generic · Class 3 氯雷他定口服溶液CYHS2500245 海南万玮制药有限公司
2025/01/11Generic · Class 3 注射用吲哚菁绿CYHS2500244 河北锐健医药科技有限公司; 成都通德药业有限公司
2025/01/11Generic · Class 3 布立西坦注射液CYHS2500242 江西科睿药业有限公司; 江西青峰药业有限公司
2025/01/11Generic · Class 3 阿瑞匹坦注射液CYHL2500016 山东齐都药业有限公司
2025/01/11Generic · Class 3 尿素[13C]呼气试验药盒CYHL2500015 辐瑞森生物科技(昆山)有限公司
2025/01/11Generic · Class 3 尿素[13C]呼气试验药盒CYHL2500014 辐瑞森生物科技(昆山)有限公司
2025/01/11Generic · Class 3 利多卡因软膏CYHL2500013 北京中泰邦医药科技有限公司
2025/01/11Generic · Class 3 利多卡因软膏CYHL2500012 北京中泰邦医药科技有限公司
2025/01/11New drug · Class 3.1 清金化痰颗粒CXZS2500001 山东齐都药业有限公司
2025/01/11New drug · Class 1 ZHB117舌下片CXSL2500037 江苏众红生物工程创药研究院有限公司
2025/01/11New drug · Class 1 ZHB117舌下片CXSL2500036 江苏众红生物工程创药研究院有限公司
2025/01/11New drug · Class 2.2 布瑞哌唑口服混悬液CXHS2500007 山东朗诺制药有限公司
2025/01/11New drug · Class 1 KHN702片CXHL2500057 成都康弘药业集团股份有限公司
2025/01/11New drug · Class 1 KHN702片CXHL2500056 成都康弘药业集团股份有限公司
2025/01/11New drug · Class 1 KHN702片CXHL2500055 成都康弘药业集团股份有限公司
2025/01/11New drug · Class 2.2 XZ157CXHL2500054 山东新时代药业有限公司
2025/01/10Generic · Class 3 米诺地尔搽剂CYHS2500239 湖南千金湘江药业股份有限公司; 浙江赛默制药有限公司
2025/01/10Generic · Class 3 米诺地尔搽剂CYHS2500238 湖南千金湘江药业股份有限公司; 浙江赛默制药有限公司
2025/01/10Generic · Class 3 布美他尼注射液CYHS2500229 江苏开元药业有限公司; 江苏苏中药业集团生物制药有限公司

141 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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