药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2023/01/03 – 2023/01/09

Period
2023/01/03 to 2023/01/09, 7 days inclusive
Data as of
2026/11/08 06:00
Cached records
94,440 acceptance records, 11,586 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
449
Drugs with new generic filings (by drug name, de-duplicated)
55
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

449filings, 74 of them generic

By application type

Application typeFilings
Supplement246
Generic74
New drug66
Import36
Import re-registration20
Unspecified7

By drug type

Drug typeFilings
Chemical drug300
TCM84
治疗用生物制品59
预防用生物制品6

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

55 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

225 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

133 this week

AcceptedDrugApplicants
2023/01/09Import · Class 1 Balcinrenone达格列净胶囊JXHL2300004 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/01/09Import · Class 1 Balcinrenone达格列净胶囊JXHL2300003 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/01/09Generic · Class 3 布比卡因脂质体注射液CYHS2300071 湖南科伦制药有限公司
2023/01/09Generic · Class 3 布比卡因脂质体注射液CYHS2300070 湖南科伦制药有限公司
2023/01/09Generic · Class 3 注射用左亚叶酸钙CYHS2300068 四川汇宇制药股份有限公司
2023/01/09Generic · Class 3 注射用左亚叶酸钙CYHS2300067 四川汇宇制药股份有限公司
2023/01/09Generic · Class 3 恩格列净二甲双胍缓释片CYHS2300066 乐普药业股份有限公司
2023/01/09Generic · Class 3 恩格列净二甲双胍缓释片CYHS2300065 乐普药业股份有限公司
2023/01/09New drug · Class 2.4 注射用重组促皮质素CXSL2300021 上海多米瑞生物技术有限公司
2023/01/08New drug · Class 1 BRG01注射液CXSL2300020 广州百吉生物制药有限公司
2023/01/08New drug · Class 1 XZP-6877片CXHL2300038 轩竹生物科技股份有限公司; 山东轩竹医药科技有限公司
2023/01/08New drug · Class 1 XZP-6877片CXHL2300037 轩竹生物科技股份有限公司; 山东轩竹医药科技有限公司
2023/01/08New drug · Class 1 XZP-6877片CXHL2300036 轩竹生物科技股份有限公司; 山东轩竹医药科技有限公司
2023/01/08New drug · Class 1 WXFL10030390片CXHL2300035 上海嘉坦医药科技有限公司
2023/01/08New drug · Class 1 WXFL10030390片CXHL2300034 上海嘉坦医药科技有限公司
2023/01/08New drug · Class 1 WXFL10030390片CXHL2300033 上海嘉坦医药科技有限公司
2023/01/08New drug · Class 1 WXFL10030390片CXHL2300032 上海嘉坦医药科技有限公司
2023/01/08New drug · Class 1 HS-10506片CXHL2300031 江苏豪森药业集团有限公司; 上海翰森生物医药科技有限公司
2023/01/08New drug · Class 1 HS-10506片CXHL2300030 江苏豪森药业集团有限公司; 上海翰森生物医药科技有限公司
2023/01/08New drug · Class 1 CGT-2201胶囊CXHL2300029 盛世泰科生物医药技术(苏州)有限公司
2023/01/08New drug · Class 1 CGT-2201胶囊CXHL2300028 盛世泰科生物医药技术(苏州)有限公司
2023/01/07Import · Class 3.1 赖脯胰岛素注射液JXSS2300004 Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd
2023/01/07Import · Class 3.1 赖脯胰岛素注射液JXSS2300003 Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd
2023/01/07Import · Class 3.1 注射用Vonicog alfaJXSS2300002 Baxalta US Inc.; Takeda (China) International Trading Co. Ltd
2023/01/07Import · Class 3.1 注射用Vonicog alfaJXSS2300001 Baxalta US Inc.; Takeda (China) International Trading Co. Ltd
2023/01/07Import · Class 2.1 RO7030816JXSL2300019 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/01/07Import · Class 2.1 RO7030816JXSL2300018 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/01/07Import · Class 2.4 巴瑞替尼片JXHS2300006 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd
2023/01/07Import · Class 2.4 巴瑞替尼片JXHS2300005 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd
2023/01/07Import · Class 1 BAY 2433334片JXHL2300002 Bayer AG; Bayer Healthcare Company Ltd.

103 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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