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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 497 drug applications between 8 January 2025 and 14 January 2025 (data as of 14 November 2026 06:00). Of these, generic applications numbered 199, covering 139 drug names.

2025/01/08 – 2025/01/14

Period
2025/01/08 to 2025/01/14, 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
497
Drugs with new generic filings (by drug name, de-duplicated)
139
Accepted this week, now under review
12

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

497filings, 199 of them generic

By application type

Application typeFilings
Generic199
Supplement189
New drug83
Import14
Unspecified7
Import re-registration3
Drug-device combination2

By drug type

Drug typeFilings
Chemical drug372
TCM65
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

139 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Brexpiprazole Tablets6331
2Azilsartan Medoxomil Potassium Tablets6335
3Vonoprazan Fumarate Tablets5358
4Dapagliflozin Tablets4284
5Crisaborole Ointment3326
6Rosuvastatin Calcium and Ezetimibe Tablets (I)339
7Apalutamide Tablets3318
8Levocarnitine Oral Solution329
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

292 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized13120
2Shijiazhuang No.4 Pharmaceutical Co., Ltd.979
3Shandong Qidu Pharmaceutical Co., Ltd.776
4Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized745
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized730
6Lang Li Biopharmaceuticals (Wuhan) Co., Ltd. romanized660
7Beijing Foyou Pharma CO.,LTD646
8Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized640
9ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.646
10Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized550

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

161 this week

AcceptedDrugApplicants
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
2025/01/14Generic · Class 3 Methocarbamol TabletsCYHS2500273 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/01/14Generic · Class 3 吗替麦考酚酯干混悬剂 · No verified English nameCYHS2500271 Kunming Bei Ke Nuo Dun Pharmaceutical Co., Ltd. romanized
2025/01/14New drug · Class 1 斯乐韦米单抗注射液 · No verified English nameCXSS2500004 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2025/01/14New drug · Class 2.4 注射用重组A型肉毒毒素 · No verified English nameCXSL2500043 Beijing Bo Te Wei Ke Bio Technology Co., Ltd. romanized
2025/01/14New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2500042 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/01/14New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2500041 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/01/14New drug · Class 1.2 带状疱疹mRNA疫苗 · No verified English nameCXSL2500040 Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized; Rong Can Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2025/01/14New drug · Class 1 注射用SHR-1826 · No verified English nameCXSL2500039 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/01/14New drug · Class 1 BGB-43395片 · No verified English nameCXHL2500069 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/01/14New drug · Class 1 BGB-43395片 · No verified English nameCXHL2500068 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/01/14New drug · Class 2.2 注射用全反式维甲酸脂质体 · No verified English nameCXHL2500067 Hangzhou Gao Tian Biopharmaceuticals Co., Ltd. romanized
2025/01/14New drug · Class 1 BGB-43395片 · No verified English nameCXHL2500066 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/01/14New drug · Class 1 注射用HRS-9190 · No verified English nameCXHL2500065 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/01/14New drug · Class 1 BG-68501片 · No verified English nameCXHL2500064 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/01/14New drug · Class 1 BG-68501片 · No verified English nameCXHL2500063 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/01/14New drug · Class 1 BG-68501片 · No verified English nameCXHL2500062 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/01/14New drug · Class 1 HRS-7058片 · No verified English nameCXHL2500061 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/01/14New drug · Class 1 HRS-7058片 · No verified English nameCXHL2500060 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/01/14New drug · Class 1 HRS-7058胶囊 · No verified English nameCXHL2500059 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/01/14New drug · Class 1 HRS-7058胶囊 · No verified English nameCXHL2500058 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/01/13Generic · Class 3 维生素B12注射液 · No verified English nameCYHS2500265 Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2025/01/13New drug · Class 1 TQC2938注射液 · No verified English nameCXSL2500038 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2025/01/11Import · Class 1 AZD2936 · No verified English nameJXSL2500007 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/01/11Import · Class 1 TAK-360片 · No verified English nameJXHL2500008 Takeda Development Center Americas Inc.
2025/01/11Import · Class 1 TAK-360片 · No verified English nameJXHL2500007 Takeda Development Center Americas Inc.

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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