药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2022/07/12 – 2022/07/18

Period
2022/07/12 to 2022/07/18, 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
301
Drugs with new generic filings (by drug name, de-duplicated)
37
Accepted this week, now under review
3

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

301filings, 50 of them generic

By application type

Application typeFilings
Supplement168
Generic50
Import39
New drug31
Import re-registration8
Unspecified3
药械组合产品2

By drug type

Drug typeFilings
Chemical drug238
治疗用生物制品34
TCM24
预防用生物制品4
Biologic1

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

164 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

93 this week

AcceptedDrugApplicants
2022/07/18Import · Class 3.1 依库珠单抗注射液JXSS2200023 Alexion Europe SAS; Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Investment (China) Co. Ltd
2022/07/18Import · Class 1 Nolasiban分散片JXHL2200201 ObsEva S.A.; Hangzhou Yuyuan Bioscience Technology Co. Ltd.
2022/07/18Import · Class 1 Nolasiban分散片JXHL2200200 ObsEva S.A.; Hangzhou Yuyuan Bioscience Technology Co. Ltd.
2022/07/18Generic · Class 3 硫酸镁注射液CYHS2201096 广州瑞尔医药科技有限公司; 成都市海通药业有限公司
2022/07/18Generic · Class 3 贝前列素钠片CYHS2201090 北京诚济制药股份有限公司
2022/07/18Generic · Class 3 盐酸多巴酚丁胺注射液CYHS2201088 成都苑东生物制药股份有限公司
2022/07/18Generic · Class 3 盐酸阿考替胺片CYHS2201087 北京亚宝生物药业有限公司
2022/07/18Generic · Class 3 硫酸沙丁胺醇注射液CYHS2201078 石家庄四药有限公司
2022/07/18Generic · Class 3 度骨化醇注射液CYHL2200060 南京海融医药科技股份有限公司
2022/07/18Generic · Class 3 度骨化醇注射液CYHL2200059 南京海融医药科技股份有限公司
2022/07/18Generic · Class 3 立他司特滴眼液CYHL2200058 鲁南贝特制药有限公司
2022/07/18New drug · Class 1 注射用SG1408CXSL2200323 中生尚健生物医药(杭州)有限公司
2022/07/18New drug · Class 1 HTMC0435片CXHL2200514 上海壹典医药科技开发有限公司
2022/07/18New drug · Class 1 HTMC0435片CXHL2200513 上海壹典医药科技开发有限公司
2022/07/18New drug · Class 1 HTMC0435片CXHL2200512 上海壹典医药科技开发有限公司
2022/07/18New drug · Class 1 HTMC0435片CXHL2200511 上海壹典医药科技开发有限公司
2022/07/18New drug · Class 1 HTMC0435片CXHL2200510 上海壹典医药科技开发有限公司
2022/07/18New drug · Class 1 HTMC0435片CXHL2200509 上海壹典医药科技开发有限公司
2022/07/18New drug · Class 1 HZ-A-018胶囊CXHL2200507 杭州和正医药有限公司
2022/07/18New drug · Class 1 HZ-A-018胶囊CXHL2200506 杭州和正医药有限公司
2022/07/18New drug · Class 2.4 盐酸纳布啡注射液CXHL2200505 宜昌人福药业有限责任公司
2022/07/18New drug · Class 1 LF0001片CXHL2200504 杭州瓴方生物医药科技有限公司
2022/07/18New drug · Class 2.2 LJ01005颗粒CXHL2200503 长春澜江医药科技有限公司
2022/07/15Import · Class 1 锆[89Zr]吉伦妥昔单抗注射液JXSL2200123 Telix International Pty Ltd; Grand Pharmaceutical (China) Co. Ltd
2022/07/15Import · Class 1 Talquetamab注射液JXSL2200122 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/07/15Import · Class 1 Talquetamab注射液JXSL2200121 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/07/15Import · Class 1 氘可来昔替尼片JXHS2200061 Bristol-Myers Squibb Pharma EEIG; PATHEON INC.; Bristol-Myers Squibb (China) Investment Co. Ltd.
2022/07/15Import · Class 2.4 Tirzepatide注射液JXHL2200199 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2022/07/15Import · Class 2.4 Tirzepatide注射液JXHL2200198 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2022/07/15Import · Class 2.4 Tirzepatide注射液JXHL2200197 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.

63 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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