药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2026/01/13 – 2026/01/19

Period
2026/01/13 to 2026/01/19, 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
333
Drugs with new generic filings (by drug name, de-duplicated)
50
Accepted this week, now under review
86

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

333filings, 71 of them generic

By application type

Application typeFilings
Supplement174
Generic71
New drug61
Import19
Import re-registration5
Unspecified3

By drug type

Drug typeFilings
Chemical drug185
TCM88
治疗用生物制品51
预防用生物制品8
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

50 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

187 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

100 this week

AcceptedDrugApplicants
2026/01/17Import · Class 1 FXB0871JXSL2600005 Fosun Industrial Co. Limited; Shanghai Fosun Pharmaceutical Industrial Development Company Limited.
2026/01/17Import · Class 1 EnpatoranJXHL2600015 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd.
2026/01/17Import · Class 1 RO7771950肠溶片JXHL2600014 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/01/17Import · Class 1 RO7771950片JXHL2600013 F. Hoffmann-La Roche Ltd
2026/01/17New drug · Class 3.1 温胆汤颗粒CXZS2600003 北京同仁堂股份有限公司同仁堂制药厂
2026/01/17New drug · Class 1.3 重组带状疱疹疫苗(CHO细胞)CXSS2600011 怡道生物科技(苏州)股份有限公司
2026/01/17New drug · Class 1 HLXTE-HAase02重组人透明质酸酶注射液CXSL2600095 复星汉霖(成都)生物技术有限公司; 上海复宏汉霖生物医药有限公司
2026/01/17New drug · Class 1 人脐带间充质干细胞注射液CXSL2600094 长春拓华医药有限公司
2026/01/17New drug · Class 1 注射用QLS5132CXSL2600093 齐鲁制药有限公司
2026/01/17New drug · Class 2.2 QL2107注射液CXSL2600092 齐鲁制药有限公司
2026/01/17New drug · Class 2.2;2.4 ZYG24004CXHL2600085 江苏知原药业股份有限公司
2026/01/17New drug · Class 2.2;2.4 ZYG24004CXHL2600084 江苏知原药业股份有限公司
2026/01/16Import · Class 1 Budoprutug注射液JXSL2600004 Climb Bio Inc.; Beijing Mabworks Biotech Company Limited
2026/01/16Import · Class 1 奥博雷通片JXHS2600017 Takeda Pharmaceuticals U.S.A. Inc.; Takeda GmbH; Takeda (China) International Trading Co. Ltd
2026/01/16Import · Class 1 奥博雷通片JXHS2600016 Takeda Pharmaceuticals U.S.A. Inc.; Takeda GmbH; Takeda (China) International Trading Co. Ltd
2026/01/16Import · Class 1 奥博雷通片JXHS2600015 Takeda Pharmaceuticals U.S.A. Inc.; Takeda GmbH; Takeda (China) International Trading Co. Ltd
2026/01/16Import · Class 1 BI764198 片JXHL2600016 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China)Investment Co. Ltd.
2026/01/16Import · Class 1 verducatib 片JXHL2600012 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2026/01/16Generic · Class 3 醋酸钠林格注射液CYHS2600203 辰欣药业股份有限公司
2026/01/16Generic · Class 3 头孢呋辛酯干混悬剂CYHS2600200 华北制药河北华民药业有限责任公司
2026/01/16Generic · Class 3 头孢呋辛酯干混悬剂CYHS2600199 华北制药河北华民药业有限责任公司
2026/01/16Generic · Class 3 地拉罗司片CYHS2600193 湖南欧亚药业有限公司; 北京诚济制药股份有限公司
2026/01/16Generic · Class 3 地拉罗司片CYHS2600192 湖南欧亚药业有限公司; 北京诚济制药股份有限公司
2026/01/16Generic · Class 3 普罗布考片CYHS2600190 山西华夏泰康医药集团有限公司; 浙江普利药业有限公司
2026/01/16Generic · Class 3 薁磺酸钠片CYHS2600188 华益药业科技(安徽)有限公司
2026/01/16New drug · Class 1 古莫奇单抗注射液CXSS2600010 中山康方生物医药有限公司; 康方药业有限公司
2026/01/16New drug · Class 1 古莫奇单抗注射液CXSS2600009 中山康方生物医药有限公司; 康方药业有限公司
2026/01/16New drug · Class 3.4 人干扰素α2b注射液CXSS2600008 长春生物制品研究所有限责任公司
2026/01/16New drug · Class 1 注射用BL-B01D1CXSL2600091 成都百利多特生物药业有限责任公司; 四川百利药业有限责任公司
2026/01/16New drug · Class 1 BY002CXSL2600090 杭州百懿生物药业有限公司

70 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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