药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2023/05/16 – 2023/05/22

Period
2023/05/16 to 2023/05/22, 7 days inclusive
Data as of
2026/11/07 06:00
Cached records
94,440 acceptance records, 11,686 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
405
Drugs with new generic filings (by drug name, de-duplicated)
44
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

405filings, 59 of them generic

By application type

Application typeFilings
Supplement237
New drug68
Generic59
Import18
Import re-registration14
Unspecified9

By drug type

Drug typeFilings
Chemical drug254
TCM101
治疗用生物制品45
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

44 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

184 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

112 this week

AcceptedDrugApplicants
2023/05/22Import · Class 1 SAR442501JXSL2300097 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2023/05/22Generic · Class 3 盐酸林可霉素注射液CYHS2301368 华夏生生药业(北京)有限公司
2023/05/22Generic · Class 3 注射用比阿培南CYHS2301365 安徽省先锋制药有限公司
2023/05/22Generic · Class 3 甲氨蝶呤片CYHS2301363 国药一心制药有限公司
2023/05/22Generic · Class 3 喷他佐辛注射液CYHS2301361 山东新华制药股份有限公司
2023/05/22New drug · Class 1 注射用XNW28012CXSL2300365 上海信诺维生物医药有限公司
2023/05/22New drug · Class 1 SM17单克隆抗体注射液CXSL2300364 杏联药业(苏州)有限公司
2023/05/22New drug · Class 1 ONC-392注射液CXSL2300363 广州昂科免疫生物技术有限公司
2023/05/22New drug · Class 1 靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液CXSL2300362 上海先博生物科技有限公司
2023/05/22New drug · Class 1 靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液CXSL2300361 上海先博生物科技有限公司
2023/05/22New drug · Class 1 靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液CXSL2300360 上海先博生物科技有限公司
2023/05/22New drug · Class 1 TQ-B3525片CXHS2300050 正大天晴药业集团南京顺欣制药有限公司
2023/05/22New drug · Class 1 XYD-A01CXHL2300555 昆山新蕴达生物科技有限公司
2023/05/22New drug · Class 1 BGB-24714胶囊CXHL2300554 百济神州(苏州)生物科技有限公司
2023/05/22New drug · Class 1 BGB-24714胶囊CXHL2300553 百济神州(苏州)生物科技有限公司
2023/05/22New drug · Class 1 BGB-24714胶囊CXHL2300552 百济神州(苏州)生物科技有限公司
2023/05/22New drug · Class 2.1 SF001CXHL2300551 普济生物科技(台州)有限公司
2023/05/22New drug · Class 2.1 SF001CXHL2300550 普济生物科技(台州)有限公司
2023/05/22New drug · Class 2.1 SF001CXHL2300549 普济生物科技(台州)有限公司
2023/05/22New drug · Class 1 YL-17231片CXHL2300548 上海璎黎药业有限公司
2023/05/22New drug · Class 1 YL-17231片CXHL2300547 上海璎黎药业有限公司
2023/05/22New drug · Class 1 YL-17231片CXHL2300546 上海璎黎药业有限公司
2023/05/22New drug · Class 1 ASP3082注射液CXHL2300545 安斯泰来(中国)投资有限公司
2023/05/22New drug · Class 1 APG-2449胶囊CXHL2300544 苏州亚盛药业有限公司
2023/05/22New drug · Class 1 DF-006CXHL2300543 浙江药苑生物科技有限公司
2023/05/19Import · Class 1 Cenerimod片JXHL2300122 Idorsia Pharmaceuticals Ltd; Idorsia (Beijing) Pharmaceuticals Co. Ltd
2023/05/19Import · Class 1 Aficamten片JXHL2300121 Cytokinetics Incorporated; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd
2023/05/19Import · Class 1 Aficamten片JXHL2300120 Cytokinetics Incorporated; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd
2023/05/19Generic · Class 3 盐酸纳洛酮注射液CYHS2301360 成都瑞尔医药科技有限公司; 成都市海通药业有限公司
2023/05/19Generic · Class 3 盐酸纳洛酮注射液CYHS2301359 成都瑞尔医药科技有限公司; 成都市海通药业有限公司

82 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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