药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2022/04/26 – 2022/05/02

Period
2022/04/26 to 2022/05/02, 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
187
Drugs with new generic filings (by drug name, de-duplicated)
27
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

187filings, 38 of them generic

By application type

Application typeFilings
Supplement108
Generic38
New drug24
Unspecified9
Import8

By drug type

Drug typeFilings
Chemical drug142
TCM20
治疗用生物制品20
Biologic4
预防用生物制品1

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

27 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

117 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

41 this week

AcceptedDrugApplicants
2022/04/29Import · Class 1 MH080乳膏JXHL2200094 MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd
2022/04/29Import · Class 1 MH080乳膏JXHL2200093 MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd
2022/04/29Import · Class 1 MH080乳膏JXHL2200092 MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd
2022/04/29Import · Class 1 MH080乳膏JXHL2200091 MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd
2022/04/29Generic · Class 3 注射用哌拉西林钠CYHS2200694 山东道齐生物医药科技有限公司; 中孚药业股份有限公司
2022/04/29Generic · Class 3 盐酸多柔比星脂质体注射液CYHS2200689 浙江圣兆药物科技股份有限公司; 浙江海正药业股份有限公司
2022/04/29Generic · Class 3 布洛芬注射液CYHS2200644 成都苑东生物制药股份有限公司
2022/04/29New drug · Class 1.2 甘草总查耳酮胶囊CXZL2200021 北京慧宝源生物技术股份有限公司
2022/04/29New drug · Class 1.2 甘草总查耳酮CXZL2200020 北京慧宝源生物技术股份有限公司
2022/04/29New drug · Class 3.4 人凝血酶原复合物CXSS2200049 四川远大蜀阳药业有限责任公司
2022/04/29New drug · Class 1 拓培非格司亭注射液CXSS2200048 厦门特宝生物工程股份有限公司
2022/04/29New drug · Class 1 拓培非格司亭注射液CXSS2200047 厦门特宝生物工程股份有限公司
2022/04/29New drug · Class 1 拓培非格司亭注射液CXSS2200046 厦门特宝生物工程股份有限公司
2022/04/29New drug · Class 1 拓培非格司亭注射液CXSS2200045 厦门特宝生物工程股份有限公司
2022/04/29New drug · Class 1 注射用LB4330CXSL2200187 上海健信生物医药科技有限公司
2022/04/29New drug · Class 1 注射用K11CXSL2200186 江苏康禾生物制药有限公司
2022/04/29New drug · Class 1 DZD1516片CXHL2200270 迪哲(江苏)医药股份有限公司
2022/04/29New drug · Class 1 DZD1516片CXHL2200269 迪哲(江苏)医药股份有限公司
2022/04/29New drug · Class 1 ICP-490片CXHL2200267 北京诺诚健华医药科技有限公司
2022/04/29New drug · Class 1 ICP-490片CXHL2200266 北京诺诚健华医药科技有限公司
2022/04/29New drug · Class 2.2 黄体酮长效注射液CXHL2200265 四川科伦药业股份有限公司
2022/04/29New drug · Class 2.2 黄体酮长效注射液CXHL2200264 四川科伦药业股份有限公司
2022/04/29New drug · Class 1 WS015干混悬剂CXHL2200255 中美华世通生物医药科技(武汉)股份有限公司
2022/04/28Generic · Class 3 磷酸奥司他韦干混悬剂CYHS2200687 四川子仁制药有限公司
2022/04/28Generic · Class 3 奥扎格雷钠注射液CYHS2200686 华夏生生药业(北京)有限公司
2022/04/28Generic · Class 3 布洛芬混悬滴剂CYHS2200685 广西维威制药有限公司
2022/04/28Generic · Class 3 地高辛注射液CYHS2200680 成都倍特药业股份有限公司
2022/04/28Generic · Class 3 地高辛注射液CYHS2200679 成都倍特药业股份有限公司
2022/04/28Generic · Class 3 奥硝唑注射液CYHS2200678 山东海雅医药科技有限公司; 河南润弘制药股份有限公司
2022/04/28Generic · Class 3 奥硝唑注射液CYHS2200677 山东海雅医药科技有限公司; 河南润弘制药股份有限公司

11 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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