药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2025/06/17 – 2025/06/23

Period
2025/06/17 to 2025/06/23, 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
369
Drugs with new generic filings (by drug name, de-duplicated)
81
Accepted this week, now under review
69

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

369filings, 120 of them generic

By application type

Application typeFilings
Supplement155
Generic120
New drug53
Import34
Unspecified4
Import re-registration3

By drug type

Drug typeFilings
Chemical drug216
TCM81
治疗用生物制品70
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

81 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

235 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

122 this week

AcceptedDrugApplicants
2025/06/23Generic · Class 3 注射用赖氨匹林CYHS2502249 南京黄龙生物科技有限公司; 山西普德药业有限公司
2025/06/23Generic · Class 3 注射用赖氨匹林CYHS2502248 南京黄龙生物科技有限公司; 山西普德药业有限公司
2025/06/23Generic · Class 3 盐酸普拉格雷片CYHL2500120 重庆医药(集团)股份有限公司
2025/06/23Generic · Class 3 盐酸普拉格雷片CYHL2500119 重庆医药(集团)股份有限公司
2025/06/23New drug · Class 1 异体人成纤维细胞注射液CXSL2500513 椎元医学技术(上海)有限公司
2025/06/23New drug · Class 1 VUM02注射液CXSL2500507 武汉光谷中源药业有限公司
2025/06/23New drug · Class 2.2 阿得贝利单抗注射液CXSL2500506 上海盛迪医药有限公司
2025/06/23New drug · Class 2.2 贝伐珠单抗注射液CXSL2500505 苏州盛迪亚生物医药有限公司
2025/06/23New drug · Class 1 注射用SHR-1826CXSL2500504 苏州盛迪亚生物医药有限公司
2025/06/23New drug · Class 1 HS-10241片CXHL2500608 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
2025/06/23New drug · Class 1 HS-10241片CXHL2500607 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
2025/06/23New drug · Class 1 JMKX003002片CXHL2500606 浙江杭煜制药有限公司
2025/06/23New drug · Class 1 JMKX003002片CXHL2500605 浙江杭煜制药有限公司
2025/06/23New drug · Class 1 JMKX003002片CXHL2500604 浙江杭煜制药有限公司
2025/06/21Import · Class 1 AMG 133JXSL2500109 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2025/06/21Import · Class 1 AMG 133JXSL2500108 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2025/06/21Import · Class 1 AMG 133JXSL2500107 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2025/06/21Import · Class 1 AMG 133JXSL2500106 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2025/06/21Import · Class 1 AMG 133JXSL2500105 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2025/06/21Import · Class 1 AMG 133JXSL2500104 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2025/06/21Import · Class 1 AZD8205JXSL2500103 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/06/21Generic · Class 3 小儿多种维生素注射液(13)CYHS2502241 亚宝药业集团股份有限公司
2025/06/21Generic · Class 3 比拉斯汀口崩片CYHS2502229 四川科伦药业股份有限公司
2025/06/21Generic · Class 3 噁拉戈利片CYHL2500118 金陵药业股份有限公司南京金陵制药厂
2025/06/21Generic · Class 3 噁拉戈利片CYHL2500117 金陵药业股份有限公司南京金陵制药厂
2025/06/21Generic · Class 3 左甲状腺素钠口服溶液CYHL2500116 江苏贝美制药有限公司
2025/06/21New drug · Class 1 T3011疱疹病毒注射液CXSL2500502 苏州亦诺微医药科技有限公司
2025/06/21New drug · Class 1 CX1440胶囊CXHL2500603 杭州邦顺制药有限公司
2025/06/21New drug · Class 1 CX1440胶囊CXHL2500602 杭州邦顺制药有限公司
2025/06/21New drug · Class 1 HSK47388片CXHL2500601 海思科医药集团股份有限公司

92 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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