药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2022/11/15 – 2022/11/21

Period
2022/11/15 to 2022/11/21, 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
332
Drugs with new generic filings (by drug name, de-duplicated)
41
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

332filings, 51 of them generic

By application type

Application typeFilings
Supplement215
Generic51
New drug38
Import16
Import re-registration7
Unspecified5

By drug type

Drug typeFilings
Chemical drug250
TCM50
治疗用生物制品32

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

41 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

162 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

61 this week

AcceptedDrugApplicants
2022/11/21Import · Class 3.1 托珠单抗注射液(皮下注射)JXSS2200037 Roche Registration GmbH; Vetter Pharma-Fertigung GmbH & Co. KG; Roche(China)Holding Ltd.
2022/11/21Import · Class 1 RO7200220 注射液JXSL2200203 F. Hoffmann-La Roche Ltd
2022/11/21Import · Class 1 RO7200220 注射液JXSL2200202 F. Hoffmann-La Roche Ltd
2022/11/21Generic · Class 3 琥珀酸呋罗曲坦片CYHS2202020 正大制药(青岛)有限公司
2022/11/21Generic · Class 3 吸入用格隆溴铵溶液CYHL2200106 仁合益康集团有限公司
2022/11/21New drug · Class 1 洛奈利单抗注射液CXSL2200584 山东新时代药业有限公司
2022/11/19Import · Class 1 BAY 2433334片JXHL2200339 Bayer AG; Bayer Healthcare Company Ltd.
2022/11/19Generic · Class 3 注射用泮托拉唑钠(Ⅰ)CYHS2202017 广东金城金素制药有限公司; 广东隆赋药业股份有限公司
2022/11/19New drug · Class 1 SAL0119片CXHL2200915 深圳信立泰药业股份有限公司
2022/11/19New drug · Class 1 SAL0119片CXHL2200914 深圳信立泰药业股份有限公司
2022/11/19New drug · Class 1 SAL0119片CXHL2200913 深圳信立泰药业股份有限公司
2022/11/19New drug · Class 1 SAL0119片CXHL2200912 深圳信立泰药业股份有限公司
2022/11/19New drug · Class 1 SAL0119片CXHL2200911 深圳信立泰药业股份有限公司
2022/11/19New drug · Class 1 SAL0119片CXHL2200910 深圳信立泰药业股份有限公司
2022/11/19New drug · Class 1 BR1733片CXHL2200909 上海青煜医药科技有限公司
2022/11/19New drug · Class 1 BR1733片CXHL2200908 上海青煜医药科技有限公司
2022/11/19New drug · Class 1 KF-0210片CXHL2200907 凯复(苏州)生物医药有限公司
2022/11/19New drug · Class 1 KF-0210片CXHL2200906 凯复(苏州)生物医药有限公司
2022/11/18Generic · Class 3 盐酸纳洛酮注射液CYHS2202015 重庆莱美药业股份有限公司
2022/11/18Generic · Class 3 头孢克肟颗粒CYHS2201935 合肥恩瑞特药业有限公司; 安徽安科恒益药业有限公司
2022/11/18New drug · Class 3.4 人凝血酶原复合物CXSS2200091 深圳市卫光生物制品股份有限公司
2022/11/18New drug · Class 1 注射用IMM0306CXSL2200583 宜明昂科生物医药技术(上海)股份有限公司
2022/11/18New drug · Class 1 注射用PRO1184CXSL2200582 普方生物制药(苏州)有限公司
2022/11/18New drug · Class 1 ELPIS人脐带间充质干细胞注射液CXSL2200581 华夏源(上海)生物科技有限公司
2022/11/17Generic · Class 3 地高辛注射液CYHS2202003 杭州沐源生物医药科技有限公司; 成都市海通药业有限公司
2022/11/17Generic · Class 3 富马酸福莫特罗吸入溶液CYHS2202000 上海奥科达医药科技股份有限公司; 山东华鲁制药有限公司
2022/11/17New drug · Class 1.1 金连消风颗粒CXZL2200052 盈科瑞(天津)创新医药研究有限公司
2022/11/17New drug · Class 1 注射用BB-1709CXSL2200580 百力司康生物医药(杭州)有限公司
2022/11/17New drug · Class 2.2 普特利单抗注射液CXSL2200578 乐普生物科技股份有限公司
2022/11/17New drug · Class 1 GC012F注射液CXSL2200577 苏州亘喜生物科技有限公司; 亘喜生物科技(上海)有限公司

31 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.