药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2026/07/21 – 2026/07/27

Period
2026/07/21 to 2026/07/27, 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)
48
Accepted this week, now under review
199

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, 62 of them generic

By application type

Application typeFilings
Supplement309
New drug79
Generic62
Import29
Unspecified17
Import re-registration3

By drug type

Drug typeFilings
Chemical drug243
TCM165
治疗用生物制品77
Biologic8
预防用生物制品6

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

48 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

295 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

115 this week

AcceptedDrugApplicants
2026/07/27Import · Class 1 PF-08653944注射液JXHL2600291 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/27Import · Class 1 PF-08653944注射液JXHL2600290 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/27Import · Class 1 PF-08653944注射液JXHL2600289 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/27Import · Class 1 PF-08653944注射液JXHL2600288 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/27Import · Class 1 RO7568282胶囊JXHL2600287 F. Hoffmann-La Roche Ltd; Roche R&D Center (China) Ltd.
2026/07/27Import · Class 1 RO7568282胶囊JXHL2600286 F. Hoffmann-La Roche Ltd; Roche R&D Center (China) Ltd.
2026/07/27Generic · Class 3 乳酸钠林格冲洗液CYHS2601790 湖南康源制药有限公司
2026/07/27Generic · Class 3 吸入用盐酸氨溴索溶液CYHS2601788 南京华盖制药有限公司
2026/07/27Generic · Class 3 联苯苄唑溶液CYHS2601784 苏州高迈药业有限公司; 唐山红星药业有限责任公司
2026/07/27New drug · Class 1.1 TDX105颗粒CXZL2600066 天士力医药集团股份有限公司
2026/07/27New drug · Class 2.4 注射用重组A型肉毒毒素(Sf9细胞,150 kD天然氨基酸序列)CXSL2600779 苏州若弋生物科技有限公司
2026/07/27New drug · Class 1 Cizutamig注射液(皮下注射)CXSL2600778 上海坦蒂生物医药科技有限公司
2026/07/27New drug · Class 1 TGI-10注射液CXSL2600777 合肥天港免疫药物有限公司
2026/07/27New drug · Class 1 NouvSight001CXSL2600776 睿健毅联医药科技(成都)有限公司; 武汉睿健医药科技有限公司
2026/07/27New drug · Class 1 GenSci155注射液CXSL2600775 长春金赛药业有限责任公司
2026/07/27New drug · Class 1 GenSci155注射液CXSL2600774 长春金赛药业有限责任公司
2026/07/27New drug · Class 1 LDR1259注射液CXHL2600918 成都先衍生物技术有限公司
2026/07/27New drug · Class 1 IMP1734片CXHL2600917 上海瑛派药业有限公司
2026/07/27New drug · Class 1 IMP1734片CXHL2600916 上海瑛派药业有限公司
2026/07/27New drug · Class 1 QX-6胶囊CXHL2600915 江西普正制药股份有限公司; 中国医学科学院药用植物研究所
2026/07/27New drug · Class 1 QX-6胶囊CXHL2600914 江西普正制药股份有限公司; 中国医学科学院药用植物研究所
2026/07/27New drug · Class 1 737NL01注射液CXHL2600913 中山万汉制药有限公司
2026/07/27New drug · Class 1 737NL01注射液CXHL2600912 中山万汉制药有限公司
2026/07/27New drug · Class 1 HSK56630片CXHL2600911 海思科医药集团股份有限公司
2026/07/27New drug · Class 1 HSK56630片CXHL2600910 海思科医药集团股份有限公司
2026/07/27New drug · Class 2.4 复方RY2乳膏CXHL2600909 南京睿鹰润泽生物医药科技有限公司; 中国药科大学; 山东润泽紫花药业有限公司
2026/07/27New drug · Class 2.4 复方RY2乳膏CXHL2600908 南京睿鹰润泽生物医药科技有限公司; 中国药科大学; 山东润泽紫花药业有限公司
2026/07/27New drug · Class 2.4 复方RY2乳膏CXHL2600907 南京睿鹰润泽生物医药科技有限公司; 中国药科大学; 山东润泽紫花药业有限公司
2026/07/24Import · Class 2.2 MK-3475A注射液JXSL2600177 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2026/07/24Import · Class 2.2 MK-3475A注射液JXSL2600176 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd

85 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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