药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2021/06/29 – 2021/07/05

Period
2021/06/29 to 2021/07/05, 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
243
Drugs with new generic filings (by drug name, de-duplicated)
27
Accepted this week, now under review
1

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

243filings, 37 of them generic

By application type

Application typeFilings
Supplement132
New drug39
Generic37
Import25
Unspecified7
Import re-registration3

By drug type

Drug typeFilings
Chemical drug163
治疗用生物制品41
TCM32
预防用生物制品7

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

136 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

74 this week

AcceptedDrugApplicants
2021/07/05Import · Class 1 Parsaclisib片JXHL2101116 Incyte Biosciences International Sàrl; Innovent Biologics (Suzhou) Co. Ltd
2021/07/05Import · Class 1 Parsaclisib片JXHL2101115 Incyte Biosciences International Sàrl; Innovent Biologics (Suzhou) Co. Ltd
2021/07/05Import · Class 1 Parsaclisib片JXHL2101114 Incyte Biosciences International Sàrl; Innovent Biologics (Suzhou) Co. Ltd
2021/07/05Import · Class 1 MH004乳膏JXHL2101113 MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd
2021/07/05Import · Class 1 MH004乳膏JXHL2101112 MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd
2021/07/05Import · Class 1 MH004乳膏JXHL2101111 MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd
2021/07/05Import · Class 1 MH004乳膏JXHL2101110 MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd
2021/07/05Import · Class 1 Belzutifan片JXHL2101109 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D(China)Co. Ltd.
2021/07/05Generic · Class 3 美沙拉秦缓释胶囊CYHS2101385 海南合瑞制药股份有限公司
2021/07/05Generic · Class 3 普瑞巴林缓释片CYHL2101017 扬子江药业集团南京海陵药业有限公司
2021/07/05New drug · Class 1.1 脑脉通颗粒CXZL2101016 广东药科大学
2021/07/05New drug · Class 1 普特利单抗注射液CXSS2101008 乐普生物科技股份有限公司; 鼎康(武汉)生物医药有限公司
2021/07/05New drug · Class 1 注射用QLF31907CXSL2101171 齐鲁制药有限公司
2021/07/05New drug · Class 3.3 重组人促卵泡激素注射液CXSL2101170 珠海市丽珠单抗生物技术有限公司
2021/07/05New drug · Class 1 注射用BJ-005CXSL2101168 博际生物医药科技(杭州)有限公司
2021/07/05New drug · Class 1 HS-10241片CXHL2101262 江苏豪森药业集团有限公司
2021/07/05New drug · Class 1 HS-10241片CXHL2101261 江苏豪森药业集团有限公司
2021/07/05New drug · Class 2.4 甲磺酸阿美替尼片CXHL2101260 江苏豪森药业集团有限公司
2021/07/05New drug · Class 2.4 甲磺酸仑伐替尼胶囊CXHL2101259 先声药业有限公司
2021/07/05New drug · Class 1 JYP0061片CXHL2101253 广州嘉越医药科技有限公司
2021/07/05New drug · Class 1 JYP0061片CXHL2101252 广州嘉越医药科技有限公司
2021/07/05New drug · Class 1 JYP0061片CXHL2101251 广州嘉越医药科技有限公司
2021/07/02Import · Class 3.1 莫格利珠单抗注射液JXSS2101015 Kyowa Kirin Co. Ltd.; Toyobo Company Limited Otsu Pharmaceutical Plant
2021/07/02Import · Class 2.2 DS-8201aJXSL2101064 Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited
2021/07/02Import · Class 2.2 帕博利珠单抗注射液JXSL2101063 Merck Sharp & Dohme Corp.; MSD R&D(China)Co. Ltd.
2021/07/02Import · Class 1 RO7247669注射液JXSL2101059 F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd
2021/07/02Generic · Class 3 盐酸利多卡因注射液CYHS2101380 北京九能天远科技有限公司; 山东齐都药业有限公司
2021/07/02Generic · Class 3 盐酸利多卡因注射液CYHS2101379 北京九能天远科技有限公司; 山东齐都药业有限公司
2021/07/02New drug · Class 1.2 广金钱草总黄酮胶囊CXZS2101003 武汉光谷人福生物医药有限公司; 武汉康乐药业股份有限公司
2021/07/02New drug · Class 1 EP-9001A注射液CXSL2101166 成都优洛生物科技有限公司

44 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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