药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2021/11/09 – 2021/11/15

Period
2021/11/09 to 2021/11/15, 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
227
Drugs with new generic filings (by drug name, de-duplicated)
28
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

227filings, 37 of them generic

By application type

Application typeFilings
Supplement121
New drug41
Generic37
Import16
Import re-registration8
Unspecified4

By drug type

Drug typeFilings
Chemical drug158
治疗用生物制品41
TCM23
预防用生物制品4
Biologic1

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

28 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

146 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

62 this week

AcceptedDrugApplicants
2021/11/15Import · Class 1 Ritlecitinib胶囊JXHL2101244 Pfizer Inc.; Pfizer Investment CO. Ltd.
2021/11/15Import · Class 1 Ritlecitinib胶囊JXHL2101243 Pfizer Inc.; Pfizer Investment CO. Ltd.
2021/11/15Generic · Class 3 硫辛酸注射液CYHS2102018 石家庄四药有限公司
2021/11/15New drug · Class 1.1 QA108颗粒CXZL2101033 珠海岐微生物科技有限公司
2021/11/15New drug · Class 1 WJ01075片CXHL2101656 苏州君境生物医药科技有限公司
2021/11/15New drug · Class 1 WJ01075片CXHL2101655 苏州君境生物医药科技有限公司
2021/11/12Import · Class 1 BIIB059JXSL2101127 Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd
2021/11/12New drug · Class 3.4 人凝血酶原复合物CXSS2101051 华兰生物工程重庆有限公司
2021/11/12New drug · Class 3.4 人凝血酶原复合物CXSS2101050 华兰生物工程重庆有限公司
2021/11/12New drug · Class 1 PM8002注射液CXSL2101423 普米斯生物技术(珠海)有限公司
2021/11/12New drug · Class 1 注射用IAE0972CXSL2101415 盛禾(中国)生物制药有限公司
2021/11/12New drug · Class 2.2 艾司奥美拉唑镁碳酸氢钠胶囊CXHS2101051 厦门恩成制药有限公司
2021/11/12New drug · Class 1 HLX208片CXHL2101654 上海复宏汉霖生物技术股份有限公司
2021/11/12New drug · Class 1 WXSH0057片CXHL2101653 浙江龙传生物医药科技有限公司
2021/11/12New drug · Class 1 WXSH0057片CXHL2101652 浙江龙传生物医药科技有限公司
2021/11/12New drug · Class 2.2 布立西坦缓释片CXHL2101651 上海博志研新药物技术有限公司
2021/11/12New drug · Class 1 BPI-371153胶囊CXHL2101650 贝达药业股份有限公司
2021/11/12New drug · Class 1 BPI-371153胶囊CXHL2101649 贝达药业股份有限公司
2021/11/12New drug · Class 1 HS-10382片CXHL2101648 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
2021/11/12New drug · Class 1 HS-10382片CXHL2101647 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
2021/11/12New drug · Class 1 HS-10382片CXHL2101646 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
2021/11/11Import · Class 1 SAR444245注射液JXSL2101126 Sanofi-aventis recherche & développement; Sanofi (China) Investment Co. Ltd.
2021/11/11Import · Class 1 Gepotidacin片JXHL2101241 GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Co. Limited
2021/11/11Generic · Class 3 盐酸右美托咪定注射液CYHS2102009 天方药业有限公司
2021/11/11Generic · Class 3 盐酸右美托咪定注射液CYHS2102006 杭州民生药业股份有限公司
2021/11/11Generic · Class 3 盐酸右美托咪定注射液CYHS2102005 杭州民生药业股份有限公司
2021/11/11New drug · Class 1.1 白热斯丸CXZL2101032 新疆维吾尔自治区维吾尔医药研究所
2021/11/11New drug · Class 1 GR1803注射液CXSL2101420 重庆智翔金泰生物制药有限公司; 智翔(上海)医药科技有限公司
2021/11/11New drug · Class 1 STI-6129注射液CXSL2101419 浙江艾森药业有限公司
2021/11/11New drug · Class 1 AK112注射液CXSL2101417 中山康方生物医药有限公司

32 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.