药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2025/07/15 – 2025/07/21

Period
2025/07/15 to 2025/07/21, 7 days inclusive
Data as of
2026/11/05 06:00
Cached records
94,245 acceptance records, 11,689 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
336
Drugs with new generic filings (by drug name, de-duplicated)
80
Accepted this week, now under review
70

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

336filings, 99 of them generic

By application type

Application typeFilings
Supplement148
Generic99
New drug58
Import12
Unspecified10
Import re-registration9

By drug type

Drug typeFilings
Chemical drug233
TCM57
治疗用生物制品30
预防用生物制品11
Biologic5

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

80 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

214 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

105 this week

AcceptedDrugApplicants
2025/07/21New drug · Class 1.1 重组金黄色葡萄球菌四组分疫苗(大肠杆菌)CXSL2500611 江苏坤力生物制药有限责任公司
2025/07/21New drug · Class 3.2 三价流感病毒裂解疫苗(BK-01佐剂)CXSL2500608 长春百克生物科技股份公司
2025/07/21New drug · Class 1 CMS-D002胶囊CXHL2500728 深圳市康哲生物科技有限公司
2025/07/21New drug · Class 1 CMS-D002胶囊CXHL2500727 深圳市康哲生物科技有限公司
2025/07/19Generic · Class 3 生理氯化钠溶液CYHS2502610 山东华茂药业有限公司
2025/07/19Generic · Class 3 吲哚美辛凝胶贴膏CYHL2500130 海南回元堂药业有限公司
2025/07/19New drug · Class 2.2 AKZ001直服颗粒CXHL2500726 海南爱科制药有限公司
2025/07/19New drug · Class 1 CKBA乳膏CXHL2500725 江苏博创园生物医药科技有限公司
2025/07/19New drug · Class 1 CKBA乳膏CXHL2500724 江苏博创园生物医药科技有限公司
2025/07/19New drug · Class 1 CKBA乳膏CXHL2500723 江苏博创园生物医药科技有限公司
2025/07/19New drug · Class 1 CKBA乳膏CXHL2500722 江苏博创园生物医药科技有限公司
2025/07/19New drug · Class 1 CKBA乳膏CXHL2500721 江苏博创园生物医药科技有限公司
2025/07/19New drug · Class 1 YUQ-A1007片CXHL2500720 元启(苏州)生物制药有限公司
2025/07/19New drug · Class 1 YUQ-A1007片CXHL2500719 元启(苏州)生物制药有限公司
2025/07/18Import · Class 1 BMS-986504片JXHL2500189 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2025/07/18Import · Class 1 BMS-986504片JXHL2500188 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2025/07/18Import · Class 1 BMS-986504片JXHL2500187 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2025/07/18Generic · Class 3 碳酸氢钠血滤置换液(无钾、无钙、0.6 mmol/L镁)CYHS2502596 宁波天益药业科技有限公司
2025/07/18Generic · Class 3 碳酸氢钠血滤置换液(无钾)CYHS2502595 宁波天益药业科技有限公司
2025/07/18Generic · Class 3 碳酸氢钠血滤置换液(钾4mmol/L无钙)CYHS2502592 宁波天益药业科技有限公司
2025/07/18Generic · Class 3 布美他尼注射液CYHS2502591 海南普利制药股份有限公司
2025/07/18Generic · Class 3 维生素B6注射液CYHS2502590 海南普利制药股份有限公司
2025/07/18Generic · Class 3 碳酸氢钠血滤置换液(钾4mmol/L)CYHS2502589 宁波天益药业科技有限公司
2025/07/18Generic · Class 3 碳酸氢钠血滤置换液(钾2mmol/L无钙)CYHS2502587 宁波天益药业科技有限公司
2025/07/18Generic · Class 3 盐酸溴己新口服溶液CYHS2502586 石家庄四药有限公司; 湖南科伦制药有限公司
2025/07/18Generic · Class 3 头孢羟氨苄干混悬剂CYHS2502583 苏州第三制药厂有限责任公司
2025/07/18Generic · Class 3 头孢羟氨苄干混悬剂CYHS2502582 苏州第三制药厂有限责任公司
2025/07/18Generic · Class 3 盐酸克林霉素棕榈酸酯颗粒CYHS2502578 安徽省先锋制药有限公司
2025/07/18Generic · Class 3 异烟肼口服溶液CYHS2502577 江苏润恒制药有限公司
2025/07/18New drug · Class 3.2 人血管性血友病因子/凝血因子Ⅷ复合物CXSS2500076 山东泰邦生物制品有限公司

75 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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