药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2025/05/13 – 2025/05/19

Period
2025/05/13 to 2025/05/19, 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
360
Drugs with new generic filings (by drug name, de-duplicated)
74
Accepted this week, now under review
56

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

360filings, 102 of them generic

By application type

Application typeFilings
Supplement180
Generic102
New drug52
Import18
Unspecified5
Import re-registration3

By drug type

Drug typeFilings
Chemical drug241
治疗用生物制品60
TCM53
预防用生物制品4
Biologic2

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

74 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

217 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

118 this week

AcceptedDrugApplicants
2025/05/19Generic · Class 3 氯化钙注射液CYHS2501810 山西普恒制药有限公司
2025/05/19New drug · Class 1 CM512注射液CXSL2500397 康诺亚生物医药科技(成都)有限公司
2025/05/19New drug · Class 1 SCTB14注射液CXSL2500396 神州细胞工程有限公司
2025/05/19New drug · Class 1 SCTB14注射液CXSL2500395 神州细胞工程有限公司
2025/05/19New drug · Class 1 SM17单克隆抗体注射液(皮下注射)CXSL2500394 杏联药业(苏州)有限公司
2025/05/19New drug · Class 1 CM512注射液CXSL2500391 康诺亚生物医药科技(成都)有限公司
2025/05/19New drug · Class 2.2 QLM2012CXHL2500489 齐鲁制药有限公司
2025/05/19New drug · Class 2.2 QLM2012CXHL2500488 齐鲁制药有限公司
2025/05/17Import · Class 1 AMG 890JXHL2500115 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd.
2025/05/17Import · Class 1 AMG 890JXHL2500114 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd.
2025/05/17Import · Class 2.4 匹妥布替尼片JXHL2500113 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/05/17Import · Class 1 Rilzabrutinib片JXHL2500112 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2025/05/17Generic · Class 3 布立西坦片CYHS2501808 浙江和泽医药科技股份有限公司; 浙江京新药业股份有限公司
2025/05/17Generic · Class 3 布立西坦片CYHS2501807 浙江和泽医药科技股份有限公司; 浙江京新药业股份有限公司
2025/05/17Generic · Class 3 氯化钾口服溶液CYHS2501803 安徽杰玺医药有限公司; 合肥诚志生物制药有限公司
2025/05/17Generic · Class 3 维生素B12注射液CYHS2501802 海南海和制药有限公司; 海南灵康制药有限公司
2025/05/17Generic · Class 3 硝酸咪康唑乳膏CYHS2501801 苏州高迈药业有限公司; 药源生物科技(启东)有限公司
2025/05/17Generic · Class 3 唑尼沙胺口服混悬液CYHS2501795 山东朗诺制药有限公司
2025/05/17Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G2.5%)CYHS2501794 石家庄四药有限公司
2025/05/17Generic · Class 3 硫酸阿米卡星注射液CYHS2501791 吉林敖东药业集团延吉股份有限公司
2025/05/17Generic · Class 3 叶酸片CYHS2501789 安徽圣鹰药业有限公司
2025/05/17Generic · Class 3 硫酸阿米卡星注射液CYHS2501788 吉林敖东药业集团延吉股份有限公司
2025/05/17New drug · Class 2.2 菖麻熄风颗粒CXZS2500020 黑龙江省济仁药业有限公司
2025/05/17New drug · Class 1 SCTB14注射液CXSL2500393 神州细胞工程有限公司
2025/05/17New drug · Class 1 SCTB14注射液CXSL2500392 神州细胞工程有限公司
2025/05/17New drug · Class 1 重组人IL12/15单纯疱疹I型双调控溶瘤病毒注射液(Vero细胞)CXSL2500390 上海复诺健生物科技有限公司; 深圳复诺健生物科技有限公司
2025/05/17New drug · Class 1 SCT640C注射液CXSL2500389 神州细胞工程有限公司
2025/05/17New drug · Class 2.2 1536ACXHL2500484 北京康联智汇科技有限公司
2025/05/16Generic · Class 3 复方聚乙二醇(3350)电解质散CYHS2501787 重庆赛诺生物药业股份有限公司
2025/05/16Generic · Class 3 复方电解质醋酸钠葡萄糖注射液CYHS2501786 浙江高跖医药科技股份有限公司; 浙江赛默制药有限公司

88 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.