药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2023/03/28 – 2023/04/03

Period
2023/03/28 to 2023/04/03, 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
251
Drugs with new generic filings (by drug name, de-duplicated)
37
Accepted this week, now under review
2

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

251filings, 48 of them generic

By application type

Application typeFilings
Supplement129
Generic48
New drug30
Import26
Import re-registration11
Unspecified5
药械组合产品2

By drug type

Drug typeFilings
Chemical drug178
TCM39
治疗用生物制品26
预防用生物制品8

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

37 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

150 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
2023/04/03Generic · Class 3 氨溴特罗口服溶液CYHS2300951 合肥国高药业有限公司; 扬州市三药制药有限公司
2023/04/03Generic · Class 3 氨溴特罗口服溶液CYHS2300950 合肥国高药业有限公司; 扬州市三药制药有限公司
2023/04/03New drug · Class 1 TQH2929注射液CXSL2300224 正大天晴药业集团南京顺欣制药有限公司
2023/04/01Import · Class 2.4 甲苯磺酸他拉唑帕利胶囊JXHS2300032 Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd.
2023/04/01Import · Class 2.4 甲苯磺酸他拉唑帕利胶囊JXHS2300031 Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd.
2023/04/01Import · Class 2.4 甲苯磺酸他拉唑帕利胶囊JXHS2300030 Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd.
2023/04/01Import · Class 2.4 甲苯磺酸他拉唑帕利胶囊JXHS2300029 Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd.
2023/04/01Generic · Class 3 吡非尼酮片CYHS2300947 山东华铂凯盛生物科技有限公司; 安徽泰恩康制药有限公司
2023/04/01Generic · Class 3 羧甲司坦口服溶液CYHS2300946 海南斯达制药有限公司
2023/04/01Generic · Class 3 去氧肾上腺素酮咯酸溶液CYHL2300043 南京海融医药科技股份有限公司
2023/04/01New drug · Class 1.1 安体威颗粒CXZL2300025 天士力医药集团股份有限公司
2023/04/01New drug · Class 1 SYH2051片CXHL2300351 石药集团中奇制药技术(石家庄)有限公司
2023/04/01New drug · Class 1 SYH2051片CXHL2300350 石药集团中奇制药技术(石家庄)有限公司
2023/04/01New drug · Class 1 JAB-26766片CXHL2300349 北京加科思新药研发有限公司
2023/04/01New drug · Class 1 JAB-26766片CXHL2300348 北京加科思新药研发有限公司
2023/04/01New drug · Class 1 ONC201胶囊CXHL2300347 华润三九医药股份有限公司
2023/03/31Import · Class 1 AMG 509JXSL2300063 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2023/03/31Import · Class 1 ASP1570片JXHL2300074 Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd.
2023/03/31Import · Class 1 ASP1570片JXHL2300073 Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd.
2023/03/31Generic · Class 3 二羟丙茶碱注射液CYHS2300943 成都天之翼尚品医药科技有限公司; 太极集团四川太极制药有限公司
2023/03/31Generic · Class 3 二羟丙茶碱注射液CYHS2300942 安徽长江药业有限公司; 安徽恒星制药有限公司
2023/03/31Generic · Class 3 普瑞巴林口服溶液CYHS2300936 北京海步医药科技有限公司; 北京九龙制药有限公司
2023/03/31Generic · Class 3 酒石酸匹莫范色林胶囊CYHL2300042 浙江佰奥医药科技有限公司
2023/03/31New drug · Class 1.1 芎芍止痛颗粒CXZL2300024 广东凯仲生物科技有限公司
2023/03/31New drug · Class 1 SIM1811-03注射液CXSL2300223 江苏先声生物制药有限公司
2023/03/31New drug · Class 1 SHR8554注射液CXHL2300346 江苏恒瑞医药股份有限公司
2023/03/31New drug · Class 1 SHR8554注射液CXHL2300345 江苏恒瑞医药股份有限公司
2023/03/31New drug · Class 2.2;2.4 美洛昔康混悬注射液CXHL2300344 江苏恒瑞医药股份有限公司
2023/03/31New drug · Class 1 注射用甲磺酸普依司他CXHL2300343 成都赜灵生物医药科技有限公司
2023/03/31New drug · Class 1 注射用甲磺酸普依司他CXHL2300342 成都赜灵生物医药科技有限公司

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.