药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2022/07/05 – 2022/07/11

Period
2022/07/05 to 2022/07/11, 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
240
Drugs with new generic filings (by drug name, de-duplicated)
34
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

240filings, 45 of them generic

By application type

Application typeFilings
Supplement108
Generic45
New drug33
Import25
Import re-registration17
Unspecified12

By drug type

Drug typeFilings
Chemical drug177
治疗用生物制品34
TCM21
Biologic5
预防用生物制品3

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

34 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

144 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

69 this week

AcceptedDrugApplicants
2022/07/11Import · Class 3.1 注射用重组人凝血因子IX-白蛋白融合蛋白JXSL2200118 CSL Behring GmbH; PAREXEL CHINA CO. LTD
2022/07/11Import · Class 3.1 注射用重组人凝血因子IX-白蛋白融合蛋白JXSL2200117 CSL Behring GmbH; PAREXEL CHINA CO. LTD
2022/07/11Import · Class 3.1 注射用重组人凝血因子IX-白蛋白融合蛋白JXSL2200116 CSL Behring GmbH; PAREXEL CHINA CO. LTD
2022/07/11Import · Class 3.1 注射用重组人凝血因子IX-白蛋白融合蛋白JXSL2200115 CSL Behring GmbH; PAREXEL CHINA CO. LTD
2022/07/11Import · Class 3.1 注射用重组人凝血因子IX-白蛋白融合蛋白JXSL2200114 CSL Behring GmbH; PAREXEL CHINA CO. LTD
2022/07/11Generic · Class 3 盐酸氢吗啡酮缓释片CYHS2201047 宜昌人福药业有限责任公司
2022/07/11Generic · Class 3 盐酸氢吗啡酮缓释片CYHS2201046 宜昌人福药业有限责任公司
2022/07/11Generic · Class 3 盐酸氢吗啡酮缓释片CYHS2201045 宜昌人福药业有限责任公司
2022/07/11Generic · Class 3 醋酸特利加压素注射液CYHS2201042 杭州沐源生物医药科技有限公司; 山西威奇达光明制药有限公司
2022/07/11Generic · Class 3 葡萄糖酸钙氯化钠注射液CYHS2201041 海南紫程众投生物科技有限公司; 浙江国镜药业有限公司
2022/07/11Generic · Class 3 葡萄糖酸钙氯化钠注射液CYHS2201040 海南紫程众投生物科技有限公司; 浙江国镜药业有限公司
2022/07/11Generic · Class 3 氟[18F]比他班注射液CYHS2201037 北京先通国际医药科技股份有限公司; 天津原子高科同位素医药有限公司
2022/07/11Generic · Class 3 糠酸莫米松乳膏CYHS2201026 福元药业有限公司
2022/07/11Generic · Class 3 普瑞巴林缓释片CYHL2200057 齐鲁制药有限公司
2022/07/11Generic · Class 3 盐酸溴己新雾化吸入溶液CYHL2200056 海南葫芦娃药业集团股份有限公司
2022/07/11New drug · Class 3.3 注射用依那西普CXSS2200063 齐鲁制药有限公司
2022/07/11New drug · Class 1 BC008-1A注射液CXSL2200315 四川泸州步长生物制药有限公司
2022/07/11New drug · Class 1 PM1009注射液CXSL2200312 普米斯生物技术(珠海)有限公司
2022/07/11New drug · Class 1 注射用KH617CXHL2200491 四川弘合生物科技有限公司
2022/07/08Generic · Class 3 奥硝唑注射液CYHS2201034 四川新斯顿制药股份有限公司
2022/07/08Generic · Class 3 奥硝唑注射液CYHS2201033 四川新斯顿制药股份有限公司
2022/07/08Generic · Class 3 盐酸溴己新注射液CYHS2201032 合肥国药诺和药业有限公司; 国药集团国瑞药业有限公司
2022/07/08Generic · Class 3 盐酸阿比多尔片CYHS2201031 石家庄四药有限公司
2022/07/08New drug · Class 1 SHR8554注射液CXHS2200038 江苏恒瑞医药股份有限公司
2022/07/08New drug · Class 1 SHR8554注射液CXHS2200037 江苏恒瑞医药股份有限公司
2022/07/07Import · Class 2.2 萨特利珠单抗注射液JXSL2200113 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2022/07/07Import · Class 2.2 萨特利珠单抗注射液JXSL2200112 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2022/07/07Import · Class 1 Modakafusp Alfa注射液(TAK-573)JXSL2200111 Takeda Development Center Americas Inc.; Takeda(China) International Trading Co. Ltd
2022/07/07Import · Class 2.2 帕博利珠单抗注射液JXSL2200110 Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd.
2022/07/07Import · Class 1 MK-4830注射液JXSL2200109 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.

39 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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