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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 478 drug applications between 9 January 2025 and 15 January 2025 (data as of 14 November 2026 06:00). Of these, generic applications numbered 183, covering 132 drug names.

2025/01/09 – 2025/01/15

Period
2025/01/09 to 2025/01/15, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
478
Drugs with new generic filings (by drug name, de-duplicated)
132
Accepted this week, now under review
5

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

478filings, 183 of them generic

By application type

Application typeFilings
Supplement199
Generic183
New drug70
Import17
Unspecified6
Import re-registration2
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug349
TCM69
Therapeutic biologic52
Biologic6
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

132 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Azilsartan Medoxomil Potassium Tablets6335
2Vonoprazan Fumarate Tablets5358
3Brexpiprazole Tablets4231
4Sodium Bicarbonate Injection429
5Etoricoxib Tablets318
6Crisaborole Ointment2226
7Diclofenac Diethylamine Emulgel2220
8Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid Oral Solution222
9Bumetanide Injection2213
10Sildenafil Citrate Oral Disintegrating Tablets228

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

286 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xiu Zheng Pharma Group Lin Yi Xiu Zheng Pharmaceutical Co., Ltd. romanized12120
2Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized11100
3Shijiazhuang No.4 Pharmaceutical Co., Ltd.868
4Shandong Qidu Pharmaceutical Co., Ltd.775
5Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized745
6Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized730
7Lang Li Biopharmaceuticals (Wuhan) Co., Ltd. romanized660
8Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized640
9Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized540
10ZHE JIANG HUA HAI PHARMACEUTICALCO.,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

141 this week

AcceptedDrugApplicants
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
2025/01/15New drug · Class 3.4 注射用重组人凝血因子Ⅶa · No verified English nameCXSS2500005 Chengdu Rong Sheng Pharma Co., Ltd. romanized
2025/01/15New drug · Class 1 注射用HS-20108 · No verified English nameCXSL2500048 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2025/01/15New drug · Class 1 注射用HS-20122 · No verified English nameCXSL2500047 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2025/01/15New drug · Class 1 HDM3019 · No verified English nameCXSL2500046 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2025/01/15New drug · Class 1 SHR-3792注射液 · No verified English nameCXSL2500045 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/01/15New drug · Class 1 注射用TQB2934 · No verified English nameCXSL2500044 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2025/01/15New drug · Class 1 MRANK-106胶囊 · No verified English nameCXHL2500073 Hangzhou De Rui Zhi Yao Technology Co., Ltd. romanized
2025/01/15New drug · Class 1 MRANK-106胶囊 · No verified English nameCXHL2500072 Hangzhou De Rui Zhi Yao Technology Co., Ltd. romanized
2025/01/15New drug · Class 1 HB-48片 · No verified English nameCXHL2500071 Gu Chong Pharmaceuticals (Beijing) Co., Ltd. romanized
2025/01/15New drug · Class 2.2 磷酸奥司他韦微片 · No verified English nameCXHL2500070 Beijing Wei Zhi Rui Pharmaceuticals Technology Co., Ltd. romanized
2025/01/14Import · Class 2.2 Ropeginterferon alfa-2b (P1101) 注射液 · No verified English nameJXSL2500008 PharmaEssentia Corporation; PharmaEssentia Biotechnology(Beijing)Company limited
2025/01/14Generic · Class 3 硫糖铝片 · No verified English nameCYHS2500284 Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2025/01/14Generic · Class 3 Allopurinol TabletsCYHS2500282 Anhui Sheng Ying Pharma Co., Ltd. romanized
2025/01/14Generic · Class 3 酒石酸阿福特罗吸入溶液 · No verified English nameCYHS2500279 Jiangsu Zhang Tai Pharma Co., Ltd. romanized
2025/01/14Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2500276 Hua Zhong Pharma Co., Ltd. romanized

111 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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