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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 379 drug applications between 29 August 2025 and 4 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 105, covering 78 drug names.

2025/08/29 – 2025/09/04

Period
2025/08/29 to 2025/09/04, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
379
Drugs with new generic filings (by drug name, de-duplicated)
78
Accepted this week, now under review
111

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.

Names with a public page are linked.

New acceptances this week

By application type and drug type

379filings, 105 of them generic

By application type

Application typeFilings
Supplement155
Generic105
New drug81
Import24
Unspecified8
Import re-registration6

By drug type

Drug typeFilings
Chemical drug258
Therapeutic biologic58
TCM54
Biologic7
Prophylactic biologic2

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

78 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets6270
2Dapoxetine Hydrochloride Tablets3220
3Ozagrel Sodium Injection313
4Glucosamine Sulfate Capsules2251
5Rivaroxaban Tablets213
6地氯雷他定口服溶液 · No verified English name2126
7小儿复方氨基酸注射液(19AA-Ⅰ) · No verified English name211
8帕拉米韦氯化钠注射液 · No verified English name2117
9Flomoxef Sodium for Injection219
10注射用氨苄西林钠舒巴坦钠/氯化钠注射液 · No verified English name212

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

221 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Jian Bin Pharmaceuticals Technology Co., Ltd. romanized12110
2Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized910
3Gui Lin Hua Run Tian He Pharma Co., Ltd. romanized770
4Novo Nordisk A/S730
5Zhuhai Tong Yuan Pharma Co., Ltd. romanized632
6Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized530
7Eli Lilly and Company520
8Takeda Canada Inc510
9Terumo Corporation Kofu Factory510
10Hubei Ke Lun Pharma Co., Ltd. romanized510

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

139 this week

AcceptedDrugApplicants
2025/09/04Import · Class 2.4 阿贝西利片 · No verified English nameJXHS2500094 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd
2025/09/04Import · Class 2.4 Trametinib TabletsJXHS2500093 Novartis Europharm Limited; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd.
2025/09/04Import · Class 2.4 Trametinib TabletsJXHS2500092 Novartis Europharm Limited; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd.
2025/09/04Import · Class 2.4 BI 1810631 片 · No verified English nameJXHL2500256 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2025/09/04Import · Class 1 Dexpramipexole片 · No verified English nameJXHL2500255 Areteia Therapeutics Inc.; Parexel China Co Ltd.
2025/09/04Generic · Class 3 Pirarubicin Hydrochloride for InjectionCYHS2503252 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2025/09/04New drug · Class 1 注射用DB-1418 · No verified English nameCXSL2500764 Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/09/04New drug · Class 1 QM103细胞注射液 · No verified English nameCXSL2500762 Beijing Qi Mai Yong Hua Bio Technology Co., Ltd. romanized
2025/09/04New drug · Class 1 HS_SW01 细胞注射液 · No verified English nameCXSL2500761 Shenzhen Hui Shan Bio Technology Co., Ltd. romanized
2025/09/04New drug · Class 1 注射用AN8025 · No verified English nameCXSL2500760 Hangzhou A Nuo Biopharmaceuticals Technology Co., Ltd. romanized
2025/09/04New drug · Class 1 注射用LM-350 · No verified English nameCXSL2500759 Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2025/09/03Import · Class 1 LY4064809片 · No verified English nameJXHL2500254 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/03Import · Class 1 LY4064809片 · No verified English nameJXHL2500253 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/03Generic · Class 3 Diprophylline InjectionCYHS2503238 Jilin Sheng Shuang Sheng Feng Pharma Co., Ltd. romanized
2025/09/03New drug · Class 1.1 1301-01颗粒 · No verified English nameCXZL2500072 Zhongguo Yao Ke University romanized
2025/09/03New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2500089 Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized
2025/09/03New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2500088 Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized
2025/09/03New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2500087 Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized
2025/09/03New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2500086 Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized
2025/09/03New drug · Class 1 QX027N注射液 · No verified English nameCXSL2500758 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2025/09/03New drug · Class 1 QX027N注射液 · No verified English nameCXSL2500757 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2025/09/03New drug · Class 1 玛氘诺沙韦颗粒 · No verified English nameCXHS2500115 Jia Xing An Di Kang Bio Technology Co., Ltd. romanized; Hainan Xian Sheng Pharma Co., Ltd. romanized
2025/09/03New drug · Class 1 BGM1812注射液 · No verified English nameCXHL2500946 Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized
2025/09/03New drug · Class 1 HRS-8364片 · No verified English nameCXHL2500945 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/09/03New drug · Class 1 HRS-8364片 · No verified English nameCXHL2500944 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/09/03New drug · Class 1 SAL0139片 · No verified English nameCXHL2500943 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2025/09/03New drug · Class 1 SAL0139片 · No verified English nameCXHL2500942 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2025/09/02Import · Class 1 斯贝利单抗注射液 · No verified English nameJXSS2500118 Otsuka Pharmaceutical Co. Ltd.; Vetter Pharma-Fertigung GmbH & Co. KG; Otsuka Beijing Research Institute
2025/09/02Import · Class 2.2 本瑞利珠单抗注射液 · No verified English nameJXSS2500117 AstraZeneca AB; Name not romanized
2025/09/02Import · Class 2.2 本瑞利珠单抗注射液 · No verified English nameJXSS2500116 AstraZeneca AB; Name not romanized

109 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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