YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 399 drug applications between 10 January 2025 and 16 January 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 138, covering 101 drug names.

2025/01/10 – 2025/01/16

Period
2025/01/10 to 2025/01/16, 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
399
Drugs with new generic filings (by drug name, de-duplicated)
101
Accepted this week, now under review
6

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

399filings, 138 of them generic

By application type

Application typeFilings
Supplement184
Generic138
New drug56
Import12
Unspecified4
Import re-registration4
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug292
TCM59
Therapeutic biologic43
Biologic4
Prophylactic biologic1

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

101 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets4260
2Brexpiprazole Tablets4231
3Diclofenac Diethylamine Emulgel2220
4Pentoxifylline Modified Release Tablets226
5Bumetanide Injection2213
6Sildenafil Citrate Oral Disintegrating Tablets228
7Bisoprolol Fumarate and Amlodipine Besylate Tablets229
8Indocyaninegreen for Injection227
9Sodium Hyaluronate Eye Drops2230
10Benzbromarone Tablets224

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

239 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xiu Zheng Pharma Group Lin Yi Xiu Zheng Pharmaceutical Co., Ltd. romanized12120
2Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized1070
3Anhui Shuang He Pharma Co., Ltd. romanized820
4Shandong Qidu Pharmaceutical Co., Ltd.775
5Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized760
6Shijiazhuang No.4 Pharmaceutical Co., Ltd.757
7Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized730
8Lang Li Biopharmaceuticals (Wuhan) Co., Ltd. romanized660
9Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized640
10Hainan Brilliant Pharmaceutical Co., Ltd.535

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

114 this week

AcceptedDrugApplicants
2025/01/16Import · Class 1 Tozorakimab注射液 · No verified English nameJXSL2500009 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/01/16Generic · Class 3 Pentoxifylline Modified Release TabletsCYHS2500327 Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.
2025/01/16Generic · Class 3 Benzbromarone TabletsCYHS2500326 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2025/01/16Generic · Class 3 Benzbromarone TabletsCYHS2500325 Mu Yuan (Anhui) Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/01/16Generic · Class 3 Zoledronic Acid InjectionCYHS2500323 Sichuan Tai Ping Yang Pharma Co., Ltd. romanized
2025/01/16Generic · Class 3 Fluorouracil InjectionCYHS2500317 Hainan Brilliant Pharmaceutical Co., Ltd.
2025/01/16Generic · Class 3 Fluorouracil InjectionCYHS2500316 Hainan Brilliant Pharmaceutical Co., Ltd.
2025/01/16Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2500313 Hefei Kang Hui Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Hai Hong Industrial (Group) Chao Hu Jin Chen Pharma Co., Ltd. romanized
2025/01/16New drug · Class 1 EA5注射液 · No verified English nameCXSL2500051 Shanghai Lan Yi Pharmaceuticals Technology Co., Ltd. romanized
2025/01/16New drug · Class 1 注射用DB-2304 · No verified English nameCXSL2500050 Ying En Bio Technology (Shanghai) Co., Ltd. romanized
2025/01/16New drug · Class 1 注射用LY4052031 · No verified English nameCXSL2500049 Li Lai Suzhou Pharmaceutical Co., Ltd. romanized
2025/01/16New drug · Class 1 HSK41959片 · No verified English nameCXHL2500077 Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized
2025/01/16New drug · Class 1 HSK41959片 · No verified English nameCXHL2500076 Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized
2025/01/16New drug · Class 2.4 谷美替尼片 · No verified English nameCXHL2500075 Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized; Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2025/01/16New drug · Class 2.4 吡非尼酮胶囊 · No verified English nameCXHL2500074 Beijing Kang Di Ni Pharma Co., Ltd. romanized
2025/01/15Import · Class 1 宗格替尼片 · No verified English nameJXHS2500002 Boehringer Ingelheim International GmbH; Hovione Farmaciencia S.A.; Boehringer Ingelheim (China) Investment Co. Ltd
2025/01/15Import · Class 1 Eneboparatide 注射液 · No verified English nameJXHL2500010 Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2025/01/15Import · Class 1 Eneboparatide 注射液 · No verified English nameJXHL2500009 Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2025/01/15Generic · Class 3 Pentoxifylline Modified Release TabletsCYHS2500310 Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized; Guangdong An Nuo Pharma Co., Ltd. romanized
2025/01/15Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2500307 Jiangsu Shen Hua Pharma Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2025/01/15Generic · Class 3 Isoprenaline Hydrochloride InjectionCYHS2500305 Hainan Brilliant Pharmaceutical Co., Ltd.
2025/01/15Generic · Class 3 Isoprenaline Hydrochloride InjectionCYHS2500304 Hainan Brilliant Pharmaceutical Co., Ltd.
2025/01/15Generic · Class 3 盐酸非索非那定干混悬剂 · No verified English nameCYHS2500300 Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized
2025/01/15Generic · Class 3 盐酸非索非那定干混悬剂 · No verified English nameCYHS2500298 Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized
2025/01/15Generic · Class 3 Oxycodone And Acetaminophen TabletsCYHS2500297 Hebei Li Sheng Pharma Group Co., Ltd. romanized
2025/01/15Generic · Class 3 Sodium Bicarbonate InjectionCYHS2500296 Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/01/15Generic · Class 3 Sodium Bicarbonate InjectionCYHS2500295 Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/01/15Generic · Class 3 硫酸沙丁胺醇口服溶液 · No verified English nameCYHS2500292 Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized
2025/01/15Generic · Class 3 Relugolix TabletsCYHL2500017 Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized
2025/01/15New drug · Class 1.1 三芪颗粒 · No verified English nameCXZL2500003 Guangxi Zhong Heng Innovation Pharmaceuticals Research Co., Ltd. romanized

84 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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