药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2025/05/27 – 2025/06/02

Period
2025/05/27 to 2025/06/02, 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
335
Drugs with new generic filings (by drug name, de-duplicated)
66
Accepted this week, now under review
47

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

335filings, 89 of them generic

By application type

Application typeFilings
Supplement165
Generic89
New drug51
Import13
Unspecified8
Import re-registration8
药械组合1

By drug type

Drug typeFilings
Chemical drug203
TCM72
治疗用生物制品47
预防用生物制品9
Biologic4

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

66 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

212 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

90 this week

AcceptedDrugApplicants
2025/05/31Generic · Class 3 利伐沙班颗粒CYHS2501949 广州大光制药有限公司
2025/05/31Generic · Class 3 利伐沙班颗粒CYHS2501948 广州大光制药有限公司
2025/05/31Generic · Class 3 硫酸沙丁胺醇注射液CYHS2501947 亚邦医药股份有限公司
2025/05/31Generic · Class 3 氟比洛芬贴剂CYHS2501944 湖南九典制药股份有限公司
2025/05/31Generic · Class 3 硫酸妥布霉素注射液CYHS2501943 湖北华鸿医药有限公司; 湖北津药药业股份有限公司
2025/05/31Generic · Class 3 辅酶Q10片CYHS2501942 海南元盈医药科技有限公司; 天津汉瑞药业有限公司
2025/05/31Generic · Class 3 硫酸特布他林注射液CYHL2500102 广东万泰科创药业有限公司
2025/05/31Generic · Class 3 氨苯砜凝胶CYHL2500101 深圳珐玛易药品科技有限公司
2025/05/31New drug · Class 3.1 桃红四物汤颗粒CXZS2500023 瑞阳制药股份有限公司
2025/05/31New drug · Class 1 注射用STSP-0601CXSS2500057 江苏贝捷泰生物科技有限公司; 舒泰神(北京)生物制药股份有限公司
2025/05/31New drug · Class 3.2 ACYW???群脑膜炎球菌多糖结合疫苗CXSS2500056 北京智飞绿竹生物制药有限公司
2025/05/31New drug · Class 1 SM2275注射液CXSL2500443 珠海烁星生物医药科技有限公司
2025/05/31New drug · Class 3.3 冻干b型流感嗜血杆菌结合疫苗CXSL2500442 艾美坚持生物制药有限公司
2025/05/31New drug · Class 1 注射用YL201CXSL2500441 苏州宜联生物医药有限公司
2025/05/31New drug · Class 1 注射用BAT8008CXSL2500440 百奥泰生物制药股份有限公司
2025/05/31New drug · Class 2.4 BAT4706注射液CXSL2500439 百奥泰生物制药股份有限公司
2025/05/31New drug · Class 1 BAT1308注射液CXSL2500438 百奥泰生物制药股份有限公司
2025/05/31New drug · Class 1 伊托法替布软膏CXHS2500058 明慧医药(杭州)有限公司; 广州玻思韬控释药业有限公司
2025/05/31New drug · Class 2.2 HEC20002胶囊CXHL2500527 广东东阳光药业股份有限公司
2025/05/30Import · Class 2.2 伊奈利珠单抗注射液JXSS2500070 Horizon Therapeutics Ireland DAC; AstraZeneca Nijmegen B.V.; Changzhou Hansoh Pharmaceutical Co. Ltd.
2025/05/30Import · Class 1 PF-08046047JXSL2500085 Pfizer Inc.; Pfizer Investment CO. Ltd.
2025/05/30Import · Class 2.1 Mosunetuzumab Injection (Subcutaneous Injection)JXSL2500084 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2025/05/30Import · Class 2.1 Mosunetuzumab Injection (Subcutaneous Injection)JXSL2500083 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2025/05/30Generic · Class 3 维生素B6注射液CYHS2501936 上海禾丰制药有限公司
2025/05/30Generic · Class 3 复方氨基酸注射液(20AA-Ⅱ)CYHS2501930 内蒙古白医制药股份有限公司
2025/05/30Generic · Class 3 复方氨基酸注射液(20AA-Ⅱ)CYHS2501929 内蒙古白医制药股份有限公司
2025/05/30Generic · Class 3 维生素B6注射液CYHS2501927 南京海鲸药业股份有限公司; 山西诺成制药有限公司
2025/05/30Generic · Class 3 盐酸氨溴索滴剂CYHS2501926 浙江赛默制药有限公司
2025/05/30Generic · Class 3 盐酸氨溴索滴剂CYHS2501925 浙江赛默制药有限公司
2025/05/30New drug · Class 3.3 雷珠单抗注射液CXSS2500055 杭州中美华东制药有限公司

60 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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