药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2026/03/24 – 2026/03/30

Period
2026/03/24 to 2026/03/30, 7 days inclusive
Data as of
2026/11/05 06:00
Cached records
94,245 acceptance records, 11,689 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
365
Drugs with new generic filings (by drug name, de-duplicated)
39
Accepted this week, now under review
79

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

365filings, 48 of them generic

By application type

Application typeFilings
Supplement225
New drug61
Generic48
Import re-registration13
Unspecified10
Import8

By drug type

Drug typeFilings
Chemical drug190
TCM142
治疗用生物制品29
Biologic2
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

39 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

219 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

81 this week

AcceptedDrugApplicants
2026/03/30Generic · Class 3 利格列汀二甲双胍缓释片CYHS2600746 南通联亚药业股份有限公司
2026/03/30Generic · Class 3 利格列汀二甲双胍缓释片CYHS2600745 南通联亚药业股份有限公司
2026/03/30New drug · Class 2.1 热毒宁颗粒CXZS2600018 江苏康缘药业股份有限公司
2026/03/30New drug · Class 1 注射用QLF4113CXSL2600363 齐鲁制药有限公司
2026/03/30New drug · Class 1.2 猴痘mRNA疫苗CXSL2600362 江苏中慧元通生物科技股份有限公司; 易慧生物技术(上海)有限公司
2026/03/30New drug · Class 1 注射用BL-M14D1CXSL2600361 成都百利多特生物药业有限责任公司; 四川百利药业有限责任公司
2026/03/30New drug · Class 1 IBI354CXSL2600360 信达生物医药科技(杭州)有限公司
2026/03/30New drug · Class 1 ICP-B208CXSL2600359 北京诺诚健华医药科技有限公司
2026/03/30New drug · Class 1 ADRX-0405CXSL2600358 上海德烽药业有限公司
2026/03/30New drug · Class 2.2;2.4 DMET25001缓释片CXHL2600397 武汉龙升医药科技有限责任公司
2026/03/30New drug · Class 2.2;2.4 DMET25001缓释片CXHL2600396 武汉龙升医药科技有限责任公司
2026/03/30New drug · Class 1 注射用WP1302CXHL2600395 百明信康生物技术(浙江)股份有限公司
2026/03/28Import · Class 1 AZD2936JXSL2600087 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/03/28Generic · Class 3 磷酸奥司他韦颗粒CYHS2600737 湖南普道医药技术有限公司; 湖南九典制药股份有限公司
2026/03/28New drug · Class 3.1 麦门冬汤颗粒CXZS2600017 广东一方制药有限公司
2026/03/28New drug · Class 1.1 香术调脾和中颗粒CXZL2600032 山西省中医药研究院(山西省中医院)
2026/03/28New drug · Class 2.2 特瑞普利单抗注射液CXSL2600357 上海君实生物医药科技股份有限公司
2026/03/28New drug · Class 2.2 特瑞普利单抗注射液CXSL2600356 上海君实生物医药科技股份有限公司
2026/03/28New drug · Class 1 GT201注射液CXSL2600355 北京沙砾生物医药股份有限公司
2026/03/28New drug · Class 1 SCTB10注射液CXSL2600354 神州细胞工程有限公司
2026/03/28New drug · Class 1 JYP0035胶囊CXHL2600394 嘉越(成都)医药科技有限公司
2026/03/28New drug · Class 1 JYP0015片CXHL2600393 广州嘉越医药科技股份有限公司
2026/03/28New drug · Class 1 JYP0015片CXHL2600392 广州嘉越医药科技股份有限公司
2026/03/28New drug · Class 1 WXFL10030390片CXHL2600391 上海嘉坦医药科技有限公司
2026/03/28New drug · Class 1 JYP0015片CXHL2600390 广州嘉越医药科技股份有限公司
2026/03/28New drug · Class 1 WXFL10030390片CXHL2600389 上海嘉坦医药科技有限公司
2026/03/28New drug · Class 1 JYP0015片CXHL2600388 广州嘉越医药科技股份有限公司
2026/03/27Import · Class 2.2 阿伏利尤单抗注射液JXSL2600086 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2026/03/27Import · Class 1 贝普若韦生注射液JXHS2600033 GlaxoSmithKline Trading Services Limited; GLAXO OPERATIONS UK LTD TRADING AS GLAXO WELLCOME OPERATIONS; GlaxoSmithKline (China) Investment Company Limited
2026/03/27Import · Class 1 Brenipatide注射液JXHL2600094 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.

51 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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