药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2026/03/17 – 2026/03/23

Period
2026/03/17 to 2026/03/23, 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
310
Drugs with new generic filings (by drug name, de-duplicated)
29
Accepted this week, now under review
64

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

310filings, 34 of them generic

By application type

Application typeFilings
Supplement203
New drug45
Generic34
Import16
Unspecified7
Import re-registration5

By drug type

Drug typeFilings
Chemical drug167
TCM113
治疗用生物制品25
Biologic4
预防用生物制品1

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

29 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

178 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

70 this week

AcceptedDrugApplicants
2026/03/23Import · Class 2.4 那米司特片JXHL2600090 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2026/03/23Import · Class 2.4 那米司特片JXHL2600089 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2026/03/23Import · Class 2.4 那米司特片JXHL2600088 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2026/03/23Generic · Class 3 头孢克肟干混悬剂CYHS2600697 海南广升誉制药有限公司; 金鸿药业股份有限公司
2026/03/23Generic · Class 3 硫酸特布他林口服溶液CYHS2600696 苏州弘森药业股份有限公司; 扬州市三药制药有限公司
2026/03/23New drug · Class 2.2 DMI019鼻喷雾剂CXHL2600361 江苏德迈药业有限公司
2026/03/23New drug · Class 2.2 DMI019鼻喷雾剂CXHL2600360 江苏德迈药业有限公司
2026/03/23New drug · Class 2.2 DMI019鼻喷雾剂CXHL2600359 江苏德迈药业有限公司
2026/03/21Import · Class 2.1 注射用贝林妥欧单抗(皮下注射)JXSL2600084 Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd.
2026/03/21Import · Class 2.1 注射用贝林妥欧单抗(皮下注射)JXSL2600083 Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd.
2026/03/21Import · Class 1 MK-1084片JXHL2600087 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2026/03/21Import · Class 1 MK-1084片JXHL2600086 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2026/03/21New drug · Class 2.2 夫那奇珠单抗注射液CXSL2600342 苏州盛迪亚生物医药有限公司
2026/03/21New drug · Class 2.2 夫那奇珠单抗注射液CXSL2600341 苏州盛迪亚生物医药有限公司
2026/03/21New drug · Class 2.2 夫那奇珠单抗注射液CXSL2600340 苏州盛迪亚生物医药有限公司
2026/03/21New drug · Class 1 SHR-6914注射液CXSL2600339 苏州盛迪亚生物医药有限公司
2026/03/21New drug · Class 1 HP-002片CXHL2600356 上海超阳药业有限公司
2026/03/21New drug · Class 1 HP-002片CXHL2600355 上海超阳药业有限公司
2026/03/21New drug · Class 1 HP-002片CXHL2600354 上海超阳药业有限公司
2026/03/21New drug · Class 1 HRS9531注射液CXHL2600353 福建盛迪医药有限公司
2026/03/21New drug · Class 1 HRS9531注射液CXHL2600352 福建盛迪医药有限公司
2026/03/21New drug · Class 1 HRS9531注射液CXHL2600351 福建盛迪医药有限公司
2026/03/21New drug · Class 1 HRS9531注射液CXHL2600350 福建盛迪医药有限公司
2026/03/21New drug · Class 1 HRS9531注射液CXHL2600349 福建盛迪医药有限公司
2026/03/21New drug · Class 1 HRS9531注射液CXHL2600348 福建盛迪医药有限公司
2026/03/20Import · Class 2.4 乌帕替尼缓释片JXHS2600032 AbbVie Deutschland GmbH & Co. KG; AbbVie Ireland NL B.V.
2026/03/20Import · Class 2.4 乌帕替尼缓释片JXHS2600031 AbbVie Deutschland GmbH & Co. KG; AbbVie Ireland NL B.V.
2026/03/20Generic · Class 3 二硫化硒洗剂CYHS2600687 山西振东安欣生物制药有限公司
2026/03/20New drug · Class 2.1 YK-2001注射液CXHS2600044 南京力博维制药有限公司; 南京优科制药有限公司
2026/03/20New drug · Class 2.1 YK-2001注射液CXHS2600043 南京力博维制药有限公司; 南京优科制药有限公司

40 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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