药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2026/06/30 – 2026/07/06

Period
2026/06/30 to 2026/07/06, 7 days inclusive
Data as of
2026/11/03 06:00
Cached records
94,050 acceptance records, 11,694 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
499
Drugs with new generic filings (by drug name, de-duplicated)
44
Accepted this week, now under review
142

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

499filings, 74 of them generic

By application type

Application typeFilings
Supplement313
Generic74
New drug55
Import31
Unspecified15
Import re-registration11

By drug type

Drug typeFilings
Chemical drug237
TCM209
治疗用生物制品46
Biologic7

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

44 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

281 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 no longer on the under-review list whose last snapshot sighting falls in this week, meaning approved or terminated, to be verified. Companies are counted by first applicant.

Class 3 and new-drug acceptances

127 this week

AcceptedDrugApplicants
2026/07/06Import · Class 2.2 注射用维恩妥尤单抗JXSS2600058 Astellas Pharma Europe B.V.; Simtra Deutschland GmbH; Astellas (China) Investment Co. Ltd.
2026/07/06Import · Class 2.2 注射用维恩妥尤单抗JXSS2600057 Astellas Pharma Europe B.V.; Simtra Deutschland GmbH; Astellas (China) Investment Co Ltd.
2026/07/06Generic · Class 3 泊马度胺胶囊CYHS2601607 常州制药厂有限公司
2026/07/06Generic · Class 3 泊马度胺胶囊CYHS2601606 常州制药厂有限公司
2026/07/06Generic · Class 3 泊马度胺胶囊CYHS2601605 常州制药厂有限公司
2026/07/06Generic · Class 3 泊马度胺胶囊CYHS2601604 常州制药厂有限公司
2026/07/06Generic · Class 3 左甲状腺素钠口服溶液CYHS2601602 广东洛斯特制药有限公司
2026/07/06Generic · Class 3 左甲状腺素钠口服溶液CYHS2601601 广东洛斯特制药有限公司
2026/07/06Generic · Class 3 左甲状腺素钠口服溶液CYHS2601600 广东洛斯特制药有限公司
2026/07/06Generic · Class 3 盐酸赛庚啶口服溶液CYHS2601597 江苏贝佳制药有限公司
2026/07/06Generic · Class 3 草酸艾司西酞普兰口服溶液CYHS2601596 江苏贝佳制药有限公司
2026/07/06Generic · Class 3 注射用甲磺酸萘莫司他CYHS2601594 福安药业集团湖北人民制药有限公司
2026/07/06Generic · Class 3 注射用甲磺酸萘莫司他CYHS2601593 福安药业集团湖北人民制药有限公司
2026/07/06Generic · Class 3 注射用甲磺酸萘莫司他CYHS2601592 成都药宜立康医药科技有限公司; 成都百裕制药股份有限公司
2026/07/06Generic · Class 3 氨溴特罗口服溶液CYHS2601590 贵州黔药集团制药有限公司; 湖南九典制药股份有限公司
2026/07/06Generic · Class 3 注射用甲磺酸萘莫司他CYHS2601589 天津红日药业股份有限公司; 武汉人福药业有限责任公司
2026/07/06Generic · Class 3 福多司坦口服溶液CYHS2601588 成都纵联医疗健康科技有限公司; 四川先通药业有限责任公司
2026/07/06New drug · Class 2.1 QLM3017CXSL2600701 齐鲁制药有限公司
2026/07/06New drug · Class 2.1 QLM3017CXSL2600700 齐鲁制药有限公司
2026/07/06New drug · Class 1 注射用IMD2358CXSL2600699 上海英脉德医疗科技有限公司
2026/07/06New drug · Class 1 注射用psirt3/4 DNACXSL2600698 艾威亚(广州)医药科技有限公司
2026/07/06New drug · Class 1 CM529D1CXSL2600697 康诺亚生物医药科技有限公司
2026/07/06New drug · Class 1 FXS5626片CXHL2600804 上海复星医药产业发展有限公司
2026/07/06New drug · Class 2.2 SYH9102注射液CXHL2600803 北京抗创联生物制药技术研究有限公司
2026/07/06New drug · Class 1 VV147片CXHL2600802 苏州旺山旺水生物医药股份有限公司; 旺山旺水(上海)生物医药有限公司; 中国科学院上海药物研究所
2026/07/06New drug · Class 1 VV147片CXHL2600801 苏州旺山旺水生物医药股份有限公司; 旺山旺水(上海)生物医药有限公司; 中国科学院上海药物研究所
2026/07/06New drug · Class 1 VV147片CXHL2600800 苏州旺山旺水生物医药股份有限公司; 旺山旺水(上海)生物医药有限公司; 中国科学院上海药物研究所
2026/07/06New drug · Class 1 HB5凝胶CXHL2600799 北京中科先行医疗科技有限公司; 中国科学院理化技术研究所
2026/07/06New drug · Class 1 HB5凝胶CXHL2600798 北京中科先行医疗科技有限公司; 中国科学院理化技术研究所
2026/07/06New drug · Class 1 HB5凝胶CXHL2600797 北京中科先行医疗科技有限公司; 中国科学院理化技术研究所

97 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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