药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2021/03/16 – 2021/03/22

Period
2021/03/16 to 2021/03/22, 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
164
Drugs with new generic filings (by drug name, de-duplicated)
11
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

164filings, 20 of them generic

By application type

Application typeFilings
Supplement89
Import24
Generic20
New drug16
Import re-registration9
Unspecified6

By drug type

Drug typeFilings
Chemical drug128
治疗用生物制品24
TCM6
预防用生物制品3
Biologic2
体外诊断试剂1

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

11 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

89 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

36 this week

AcceptedDrugApplicants
2021/03/22New drug · Class 1 IBI302CXSL2101006 信达生物制药(苏州)有限公司
2021/03/20Import · Class 1 Maralixibat口服溶液JXHL2100100 Mirum Pharmaceuticals Inc.
2021/03/20Import · Class 1 Maralixibat口服溶液JXHL2100099 Mirum Pharmaceuticals Inc.
2021/03/20Import · Class 1 Maralixibat口服溶液JXHL2100098 Mirum Pharmaceuticals Inc.
2021/03/20Import · Class 1 Maralixibat口服溶液JXHL2100097 Mirum Pharmaceuticals Inc.
2021/03/20Import · Class 1 Atrasentan片JXHL2100096 Chinook Therapeutics U.S. Inc.
2021/03/20Import · Class 1 LOXO-305JXHL2100093 Loxo Oncology Inc.
2021/03/20Import · Class 1 LOXO-305JXHL2100092 Loxo Oncology Inc.
2021/03/20Import · Class 1 LOXO-305JXHL2100091 Loxo Oncology Inc.
2021/03/20Import · Class 1 LOXO-305JXHL2100090 Loxo Oncology Inc.
2021/03/20Import · Class 2.4 甲磺酸仑伐替尼胶囊JXHL2100089 Eisai Europe Ltd.
2021/03/20Import · Class 2.4 甲磺酸仑伐替尼胶囊JXHL2100088 Eisai Europe Ltd.
2021/03/20New drug · Class 1 阿基仑赛注射液CXSL2100098 复星凯特生物科技有限公司
2021/03/19New drug · Class 2.4 富马酸丙酚替诺福韦片CXHS2100010 华北制药华坤河北生物技术有限公司; 华北制药股份有限公司
2021/03/19New drug · Class 1 ASC42片CXHL2101008 歌礼生物科技(杭州)有限公司
2021/03/19New drug · Class 1 ASC42片CXHL2101007 歌礼生物科技(杭州)有限公司
2021/03/18Generic · Class 3 丙戊酸钠注射用浓溶液CYHS2101023 四川汇宇制药股份有限公司
2021/03/18Generic · Class 3 丙戊酸钠注射用浓溶液CYHS2101022 四川汇宇制药股份有限公司
2021/03/18Generic · Class 3 丙戊酸钠注射用浓溶液CYHS2101021 四川汇宇制药股份有限公司
2021/03/18New drug · Class 2.2 替雷利珠单抗注射液CXSL2101005 百济神州(上海)生物科技有限公司
2021/03/18New drug · Class 1 HTD1801胶囊CXHL2100190 深圳君圣泰生物技术有限公司
2021/03/17Generic · Class 3 氯甲西泮注射液CYHL2100017 江苏华泰晨光药业有限公司
2021/03/17New drug · Class 1 阴道用四联乳杆菌活菌胶囊CXSL2101004 四川厌氧生物科技有限责任公司
2021/03/17New drug · Class 1 阴道用四联乳杆菌活菌胶囊CXSL2101003 四川厌氧生物科技有限责任公司
2021/03/17New drug · Class 1 ASC42片CXHL2101004 甘莱制药有限公司
2021/03/17New drug · Class 1 ASC42片CXHL2101003 甘莱制药有限公司
2021/03/16Generic · Class 3 氯化钾缓释片(I)CYHS2100285 宜昌人福药业有限责任公司
2021/03/16Generic · Class 3 布瑞哌唑片CYHS2100283 重庆药友制药有限责任公司
2021/03/16Generic · Class 3 布瑞哌唑片CYHS2100282 重庆药友制药有限责任公司
2021/03/16Generic · Class 3 布瑞哌唑片CYHS2100281 重庆药友制药有限责任公司

6 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.