药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2021/11/16 – 2021/11/22

Period
2021/11/16 to 2021/11/22, 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
232
Drugs with new generic filings (by drug name, de-duplicated)
26
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

232filings, 38 of them generic

By application type

Application typeFilings
Supplement117
Generic38
New drug37
Import22
Import re-registration11
Unspecified7

By drug type

Drug typeFilings
Chemical drug175
治疗用生物制品27
TCM25
Biologic3
预防用生物制品2

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

26 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

140 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

64 this week

AcceptedDrugApplicants
2021/11/22Import · Class 3.1 赖脯胰岛素注射液JXSS2101032 Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2021/11/22Import · Class 3.1 赖脯胰岛素注射液JXSS2101031 Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2021/11/22Import · Class 2.2 帕博利珠单抗注射液JXSL2101135 Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd.
2021/11/22Import · Class 2.4 盐酸阿来替尼胶囊JXHL2101246 F.Hoffmann-La Roche Ltd; Roche(China) Holding Ltd.
2021/11/22Import · Class 2.4 盐酸阿来替尼胶囊JXHL2101245 F.Hoffmann-La Roche Ltd; Roche(China) Holding Ltd.
2021/11/22Generic · Class 3 缩宫素注射液CYHS2102059 远大生命科学(武汉)有限公司
2021/11/22New drug · Class 1 重组人源化抗PD-1单克隆抗体注射液CXSL2101434 神州细胞工程有限公司
2021/11/22New drug · Class 2.2 重组人源化抗VEGF单克隆抗体注射液CXSL2101433 神州细胞工程有限公司
2021/11/22New drug · Class 1 人肌母细胞注射液CXSL2101432 罗盖肌母细胞医学研究院武汉有限公司
2021/11/22New drug · Class 2.2 注射用全氟丙烷人血白蛋白微球CXSL2101431 厦门力卓药业有限公司
2021/11/22New drug · Class 1 AK115注射液CXSL2101430 中山康方生物医药有限公司
2021/11/22New drug · Class 1 AK115注射液CXSL2101429 中山康方生物医药有限公司
2021/11/22New drug · Class 1 注射用IAP0971CXSL2101428 盛禾(中国)生物制药有限公司
2021/11/22New drug · Class 1 SHR7280片CXHL2101679 江苏恒瑞医药股份有限公司
2021/11/22New drug · Class 1 SHR7280片CXHL2101678 江苏恒瑞医药股份有限公司
2021/11/22New drug · Class 1 注射用SYHA1908CXHL2101677 石药集团中奇制药技术(石家庄)有限公司
2021/11/22New drug · Class 1 HZ010注射液CXHL2101676 浙江和泽医药科技股份有限公司
2021/11/19Generic · Class 3 己酮可可碱缓释片CYHS2102028 石家庄四药有限公司
2021/11/19New drug · Class 3.2 人抗凝血酶ⅢCXSS2101053 山东泰邦生物制品有限公司
2021/11/19New drug · Class 1 泰特利单抗注射液CXSS2101052 四川科伦博泰生物医药股份有限公司
2021/11/19New drug · Class 1 重组人源化抗BTLA单克隆抗体注射液CXSL2101427 上海君实生物医药科技股份有限公司
2021/11/19New drug · Class 1 FZJ-003胶囊CXHL2101675 上海复旦张江生物医药股份有限公司
2021/11/19New drug · Class 1 BPI-442096片CXHL2101669 贝达药业股份有限公司
2021/11/19New drug · Class 1 BPI-442096片CXHL2101668 贝达药业股份有限公司
2021/11/19New drug · Class 1 HS301片CXHL2101667 瀚晖制药有限公司
2021/11/19New drug · Class 1 HS301片CXHL2101666 瀚晖制药有限公司
2021/11/18Import · Class 1 司柏索利单抗注射液JXSS2101030 Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/11/18Import · Class 1 注射用Dapirolizumab Pegol单抗JXSL2101134 UCB Biopharma SRL; UCB trading (Shanghai) Co. Ltd
2021/11/18Generic · Class 3 氨茶碱注射液CYHS2102047 山东玉满坤生物科技有限公司; 山东希尔康泰药业有限公司
2021/11/18Generic · Class 3 氨茶碱注射液CYHS2102046 山东玉满坤生物科技有限公司; 山东希尔康泰药业有限公司

34 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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