YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 520 drug applications between 4 January 2025 and 10 January 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 210, covering 154 drug names.

2025/01/04 – 2025/01/10

Period
2025/01/04 to 2025/01/10, 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
520
Drugs with new generic filings (by drug name, de-duplicated)
154
Accepted this week, now under review
18

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

520filings, 210 of them generic

By application type

Application typeFilings
Generic210
Supplement200
New drug86
Import12
Unspecified5
Import re-registration5
Drug-device combination2

By drug type

Drug typeFilings
Chemical drug379
Therapeutic biologic68
TCM67
Biologic3
Prophylactic biologic3

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

154 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Rosuvastatin Calcium and Ezetimibe Tablets (I)559
2Metformin Hydrochloride And Empagliflozin Extended Release Tablets5212
3Brexpiprazole Tablets4231
4Azilsartan Medoxomil Potassium Tablets4235
5Crisaborole Ointment3326
6Vonoprazan Fumarate Tablets3260
7Bromfenac Sodium Eye Drops327
8Mivacurium Chloride Injection323
9Etoricoxib Tablets318
10阿贝西利片 · No verified English name312

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

305 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized20180
2Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized1090
3Shijiazhuang No.4 Pharmaceutical Co., Ltd.766
4ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.757
5Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized710
6Qilu Pharmaceutical Co., Ltd.540
7Beijing Foyou Pharma CO.,LTD535
8Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized535
9Nan Tong Lian Ya Pharma Co., Ltd. romanized525
10Novo Nordisk A/S510

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

168 this week

AcceptedDrugApplicants
2025/01/10Generic · Class 3 Minoxidil LinimentCYHS2500239 Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/01/10Generic · Class 3 Minoxidil LinimentCYHS2500238 Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/01/10Generic · Class 3 Bumetanide InjectionCYHS2500229 Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Jiangsu Su Zhong Pharma Group Biopharmaceutical Co., Ltd. romanized
2025/01/10Generic · Class 3 Magnesium Sulfate InjectionCYHS2500228 Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2025/01/10Generic · Class 3 Indocyaninegreen for InjectionCYHS2500221 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/01/10Generic · Class 3 Bumetanide InjectionCYHS2500216 Shandong Nuo Ming Kang Drug Research Institute Co., Ltd. romanized; Ji Ning Shen Zhou Pharmaceuticals Co., Ltd. romanized
2025/01/10Generic · Class 3 复方电解质注射液(V) · No verified English nameCYHS2500207 Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2025/01/10Generic · Class 3 磷酸奥司他韦颗粒 · No verified English nameCYHS2500204 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2025/01/10Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2500203 Anhui Wan Bang Pharmaceuticals Technology Co., Ltd. romanized; Jilin Tian Heng Ying Rui Pharmaceutical Co., Ltd. romanized
2025/01/10Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2500199 Ao Mei Pharmaceutical (Hainan) Co., Ltd. romanized
2025/01/10Generic · Class 3 Dexketoprofen Trometamol InjectionCYHL2500011 Shandong Qidu Pharmaceutical Co., Ltd.
2025/01/10New drug · Class 1 XS411细胞注射液 · No verified English nameCXSL2500035 Shi Ze Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2025/01/10New drug · Class 1 CM518D1 · No verified English nameCXSL2500034 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2025/01/10New drug · Class 1 JSKN016注射液 · No verified English nameCXSL2500033 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2025/01/10New drug · Class 1 P134细胞注射液 · No verified English nameCXSL2500032 Tian Shi Li Pharmaceuticals Group Co., Ltd. romanized
2025/01/10New drug · Class 3.2 皮下注射人免疫球蛋白 · No verified English nameCXSL2500031 Hua Run Bo Ya Biopharmaceutical Group Co., Ltd. romanized
2025/01/10New drug · Class 2.2 纳基奥仑赛注射液 · No verified English nameCXSL2500030 Guangdong He Yuan Biopharmaceuticals Co., Ltd. romanized; He Yuan Bio Technology (Tianjin) Co., Ltd. romanized
2025/01/10New drug · Class 1 注射用IMBZ18g · No verified English nameCXHL2500053 Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized; Zhongguo Yi Xue Ke College Pharmaceuticals Bio Technology Research Institute romanized
2025/01/10New drug · Class 1 HRS-9813胶囊 · No verified English nameCXHL2500052 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/01/10New drug · Class 2.2 HKGM-333 · No verified English nameCXHL2500051 Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized
2025/01/10New drug · Class 2.2 BCM896缓释片 · No verified English nameCXHL2500050 Shanghai Qi Hang Pharmaceuticals Technology Development Co., Ltd. romanized
2025/01/10New drug · Class 2.2 BCM896缓释片 · No verified English nameCXHL2500049 Shanghai Qi Hang Pharmaceuticals Technology Development Co., Ltd. romanized
2025/01/09Import · Class 1 AZD2936 · No verified English nameJXSL2500006 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/01/09Import · Class 2.2 Tremelimumab · No verified English nameJXSL2500005 MedImmune LLC; AstraZeneca Global R&D (China) Co. Ltd.
2025/01/09Import · Class 2.2 Tremelimumab · No verified English nameJXSL2500004 MedImmune LLC; AstraZeneca Global R&D (China) Co. Ltd.
2025/01/09Generic · Class 3 Aztreonam For InjectionCYHS2500196 Shaanxi Hai Hui Pharmaceuticals Technology Co., Ltd. romanized; Haikou Shi Pharmaceutical Factory Co., Ltd. romanized
2025/01/09Generic · Class 3 Aztreonam For InjectionCYHS2500195 Shaanxi Hai Hui Pharmaceuticals Technology Co., Ltd. romanized; Haikou Shi Pharmaceutical Factory Co., Ltd. romanized
2025/01/09Generic · Class 3 硫酸特布他林口服溶液 · No verified English nameCYHS2500186 Bao Li Hua (Nanjing) Pharmaceutical Co., Ltd. romanized; Shanghai Mei You Pharmaceutical Co., Ltd. romanized
2025/01/09Generic · Class 3 Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate and Aspirin Tablets(Ⅱ)CYHS2500185 Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized; Le Pu Pharmaceutical Technology Co., Ltd. romanized
2025/01/09Generic · Class 3 Sodium Bicarbonate InjectionCYHS2500184 Ta He Shi Hui Chuang Pharmaceuticals Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.

138 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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