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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 439 drug applications between 29 October 2026 and 4 November 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 60, covering 43 drug names.

2026/10/29 – 2026/11/04

Period
2026/10/29 to 2026/11/04, 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
439
Drugs with new generic filings (by drug name, de-duplicated)
43
Accepted this week, now under review
439

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

439filings, 60 of them generic

By application type

Application typeFilings
Supplement216
New drug109
Generic60
Import37
Import re-registration15
Unspecified2

By drug type

Drug typeFilings
Chemical drug220
TCM134
Therapeutic biologic78
Prophylactic biologic5
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

43 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1氟比洛芬凝胶贴膏 · No verified English name3316
2氧 · No verified English name3315
3Vortioxetine Hydrobromide Tablets3110
4Metformin Hydrochloride Extended-release Tablets3110
5Polidocanol Injection3123
6Emedastine Difumarate Eye Drops229
7Ezetimibe and Atorvastatin Calcium Trihydrate Tablets214
8复方氨基酸注射液(17AA-SF) · No verified English name214
9对乙酰氨基酚颗粒 · No verified English name212
10帕拉米韦氯化钠注射液 · No verified English name2117

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

252 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Eli Lilly and Company910
2Sichuan Xin Da Kang Pharma Co., Ltd. romanized770
3AstraZeneca AB740
4Fresenius Kabi AB720
5Hebei Wan Sui Pharma Co., Ltd. romanized660
6Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized660
7MUNDIPHARMA GmbH610
8Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized610
9Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized530
10Amgen Inc.520

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

Entered review this week
394
Left the under-review list this week
397

Of these, NMPA published approval-document delivery for 175 (including 170 supplemental applications, not counted as new marketing approvals) and notification delivery for 18; the outcome of the other 204 is to be checked.

Most filings leaving review, by company

Most filings leaving review, by company
#Company (first applicant)FilingsDrugs
1Novo Nordisk A/S152
2Beijing Bao Shu Tang Technology Pharma Co., Ltd. romanized1111
3Xin Da Bio Technology Co., Ltd. romanized81
4Shijiazhuang No.4 Pharmaceutical Co., Ltd.66
5Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.54
6Topfond Pharmaceutical Co., Ltd.44
7Hainan Ai Ke Pharmaceutical Co., Ltd. romanized44
8Jiao Zuo Fu Rui Tang Pharmaceutical Co., Ltd. romanized44
9Pfizer Europe MA EEIG43
10Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized42

Most filings entering review, by company

Most filings entering review, by company
#Company (first applicant)FilingsDrugs
1AstraZeneca AB105
2Eli Lilly and Company91
3Sichuan Xin Da Kang Pharma Co., Ltd. romanized77
4Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized76
5Fresenius Kabi AB72
6Hebei Wan Sui Pharma Co., Ltd. romanized66
7Sichuan Qi Li Pharmaceutical Co., Ltd. romanized65
8MUNDIPHARMA GmbH61
9Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized61
10Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized53

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

161 this week

AcceptedDrugApplicants
2026/11/04Import · Class 1 卡瑞林肽司美格鲁肽注射液 · No verified English nameJXSL2600302 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2026/11/04Import · Class 1 卡瑞林肽司美格鲁肽注射液 · No verified English nameJXSL2600301 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2026/11/04Import · Class 1 卡瑞林肽司美格鲁肽注射液 · No verified English nameJXSL2600300 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2026/11/04Import · Class 1 卡瑞林肽司美格鲁肽注射液 · No verified English nameJXSL2600299 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2026/11/04Import · Class 1 卡瑞林肽司美格鲁肽注射液 · No verified English nameJXSL2600298 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2026/11/04Import · Class 1 AMG 562 · No verified English nameJXSL2600297 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd.
2026/11/04Import · Class 1 AMG 562 · No verified English nameJXSL2600296 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd.
2026/11/04Import · Class 2.2 Nadofaragene firadenovec · No verified English nameJXSL2600295 Ferring Pharmaceuticals A/S; Ferring Pharmaceuticals (Asia) Company Limited
2026/11/04Import · Class 1 Giredestrant胶囊 · No verified English nameJXHL2600484 Genentech Inc.; Roche (China) Holding Ltd.
2026/11/04Import · Class 2.4 Icotrokinra片 · No verified English nameJXHL2600483 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/11/04Generic · Class 3 Cetylpyridinium Chloride Buccal TabletsCYHS2602699 Beijing Wo Bang Pharmaceuticals Technology Co., Ltd. romanized; Shanxi De Yuan Tang Pharma Co., Ltd. romanized
2026/11/04Generic · Class 3 硫酸长春碱注射液 · No verified English nameCYHS2602696 Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized
2026/11/04Generic · Class 3 Sivelestat Sodium for InjectionCYHS2602695 Chongqing Huapont Pharmaceutical Co., Ltd.
2026/11/04Generic · Class 3 Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesCYHS2602691 Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2026/11/04Generic · Class 3 Memantine Hydrochloride Extended-release and Donepezil Hydrochloride CapsulesCYHS2602690 Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2026/11/04Generic · Class 3 Tobramycin Inhalation SolutionCYHS2602688 Jinan Jing Sheng Technology Co., Ltd. romanized; Luo Xin An Ruo Wei Ta Pharma (Chengdu) Co., Ltd. romanized
2026/11/04New drug · Class 2.3 温经汤颗粒 · No verified English nameCXZL2600114 China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.; Name not romanized
2026/11/04New drug · Class 1.1 六味络痹颗粒 · No verified English nameCXZL2600113 Zhongguo Zhong Yi Ke College Zhong Yi Lin Chuang Ji Chu Yi Xue Research Institute romanized
2026/11/04New drug · Class 1 EXP012注射液 · No verified English nameCXSL2601227 Ai Ke Lian Bio Technology (Shanghai) Co., Ltd. romanized
2026/11/04New drug · Class 1 CC312冻干粉针剂 · No verified English nameCXSL2601226 Hui He Bio Technology (Shanghai) Co., Ltd. romanized
2026/11/04New drug · Class 1 Claseprubart注射液 · No verified English nameCXSL2601225 Yuan Yi Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2026/11/04New drug · Class 1 Claseprubart注射液 · No verified English nameCXSL2601224 Yuan Yi Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2026/11/04New drug · Class 1 注射用MWX301 · No verified English nameCXSL2601223 Shanghai Min Wei Bio Technology Co., Ltd. romanized
2026/11/04New drug · Class 1.2 大流行流感病毒mRNA疫苗 · No verified English nameCXSL2601222 Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized
2026/11/04New drug · Class 1 注射用YL413 · No verified English nameCXSL2601221 Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized
2026/11/04New drug · Class 1 注射用IMD2358 · No verified English nameCXSL2601220 Shanghai Ying Mai De Medical Technology Co., Ltd. romanized
2026/11/04New drug · Class 1 YTS109细胞注射液 · No verified English nameCXSL2601219 Hua Xia Ying Tai (Beijing) Bio Technology Co., Ltd. romanized; Hua Xia Ying Tai (Beijing) Pharmaceuticals Technology Co., Ltd. romanized
2026/11/04New drug · Class 1 YZ-1638注射液 · No verified English nameCXSL2601218 Shanghai Yue Zeng Bio Technology Co., Ltd. romanized
2026/11/04New drug · Class 1 泽普昔替尼胶囊 · No verified English nameCXHS2600147 Ling Ke Pharma (Zhejiang) Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized
2026/11/04New drug · Class 1 RO7840734 · No verified English nameCXHL2601369 Luo Shi (Zhongguo) Investment Co., Ltd. romanized

131 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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