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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 319 drug applications between 26 July 2025 and 1 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 60 drug names.

2025/07/26 – 2025/08/01

Period
2025/07/26 to 2025/08/01, 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
319
Drugs with new generic filings (by drug name, de-duplicated)
60
Accepted this week, now under review
64

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

319filings, 74 of them generic

By application type

Application typeFilings
Supplement151
Generic74
New drug57
Import26
Import re-registration7
Unspecified2
Drug-device combination product2

By drug type

Drug typeFilings
Chemical drug191
TCM77
Therapeutic biologic46
Unspecified3
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

60 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Brexpiprazole Tablets3131
2Omega-3-acid ethyl ester 90 Soft Capsules2211
3Pemafibrate Tablets2223
4Morinidazole and Sodium Chloride Injection229
5头孢克肟干混悬剂 · No verified English name223
6Mecobalamin Tablets2216
7硝普钠氯化钠注射液 · No verified English name223
8Cefditoren Pivoxil Granules2118
9Vonoprazan Fumarate Tablets2160
10Sacubitril Valsartan Sodium Tablets2170

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

204 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanxi Hua Kang Pharma Co., Ltd. romanized12120
2Qilu Pharmaceutical Co., Ltd.841
3Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized730
4Amgen Inc.630
5Henan Xin Xiang Hua Xing Pharmaceutical Factory romanized620
6Pharmathen International S.A.510
7Changchun Hai Wai Pharmaceutical Group Co., Ltd. romanized440
8Janssen Research & Development LLC420
9Shandong Lukang Pharmaceutical Co.,Ltd.422
10Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized420

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

93 this week

AcceptedDrugApplicants
2025/08/01Import · Class 2.1 艾沙妥昔单抗注射液(皮下注射) · No verified English nameJXSS2500107 Sanofi Winthrop Industrie; Sanofi-Aventis Deutschland GmbH
2025/08/01Generic · Class 3 辅酶Q??片 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2502770 Xizang Ao Si Bi Xiu Pharmaceuticals Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2025/08/01Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2502768 Zhuhai Heng Qin Guo Yan Pharmaceuticals Technology Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized
2025/08/01Generic · Class 3 Amisulpride Oral SolutionCYHS2502767 Chengdu Kang Hong Pharma Group Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2025/08/01New drug · Class 1 注射用TQB2103 · No verified English nameCXSL2500643 Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2025/08/01New drug · Class 1.2 呼吸道合胞病毒mRNA疫苗 · No verified English nameCXSL2500642 Yunnan Wo Sen Bio Technology Co., Ltd. romanized; Beijing Wo Sen Innovation Bio Technology Co., Ltd. romanized; Fu Dan University romanized; Shanghai Lan Que Biopharmaceuticals Co., Ltd. romanized; Yu Xi Wo Sen Bio Technology Co., Ltd. romanized
2025/08/01New drug · Class 1.2 呼吸道合胞病毒mRNA疫苗 · No verified English nameCXSL2500641 Yunnan Wo Sen Bio Technology Co., Ltd. romanized; Beijing Wo Sen Innovation Bio Technology Co., Ltd. romanized; Fu Dan University romanized; Shanghai Lan Que Biopharmaceuticals Co., Ltd. romanized; Yu Xi Wo Sen Bio Technology Co., Ltd. romanized
2025/08/01New drug · Class 1 注射用7MW4911 · No verified English nameCXSL2500640 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2025/08/01New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2500791 Shanxi Jia Yuan Biopharmaceuticals Co., Ltd. romanized
2025/08/01New drug · Class 1 SA1211注射液 · No verified English nameCXHL2500790 Suzhou Shi An Bio Technology Co., Ltd. romanized; Beijing Si Yuan Rui An Bio Technology Co., Ltd. romanized
2025/08/01New drug · Class 2.2 BIFC胶囊装微片 · No verified English nameCXHL2500789 Beijing Tian Heng Drug Research Institute Co., Ltd. romanized
2025/08/01New drug · Class 2.2 BIFC胶囊装微片 · No verified English nameCXHL2500788 Beijing Tian Heng Drug Research Institute Co., Ltd. romanized
2025/08/01New drug · Class 1 ADC118片 · No verified English nameCXHL2500787 Chengdu Ai Di Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ai Di Pharma Group Co., Ltd. romanized; Nanjing Ai Di Pharmaceuticals Technology Co., Ltd. romanized
2025/08/01New drug · Class 2.2 VHDT口崩片 · No verified English nameCXHL2500786 Fuzhou Zhang Fu Xing Biopharmaceuticals Technology Co., Ltd. romanized; Xiamen En Cheng Pharmaceutical Co., Ltd. romanized
2025/07/31Import · Class 1 Icotrokinra片 · No verified English nameJXHL2500208 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/07/31Import · Class 1 Icotrokinra片 · No verified English nameJXHL2500207 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/07/31Import · Class 1 LOU064片 · No verified English nameJXHL2500206 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2025/07/31Generic · Class 3 硝普钠氯化钠注射液 · No verified English nameCYHS2502762 Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Jiangsu Chang Jiang Pharma Co., Ltd. romanized
2025/07/31Generic · Class 3 头孢克肟干混悬剂 · No verified English nameCYHS2502761 Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Sichuan Sai Zhuo Pharma Co., Ltd. romanized
2025/07/31Generic · Class 3 头孢克肟干混悬剂 · No verified English nameCYHS2502757 Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized
2025/07/31New drug · Class 1.1 益母妇炎颗粒 · No verified English nameCXZL2500058 Jian Min Pharma Group Co., Ltd. romanized
2025/07/31New drug · Class 3.2 注射用罗普司亭N01 · No verified English nameCXSL2500639 Qilu Pharmaceutical Co., Ltd.
2025/07/31New drug · Class 3.2 注射用罗普司亭N01 · No verified English nameCXSL2500638 Qilu Pharmaceutical Co., Ltd.
2025/07/31New drug · Class 1 人源多巴胺能前体细胞注射液 · No verified English nameCXSL2500637 Rui Jian Yi Lian Pharmaceuticals Technology (Chengdu) Co., Ltd. romanized; Rui Jian Pharmaceuticals Technology (Wuhan) Co., Ltd. romanized
2025/07/31New drug · Class 1 EA5注射液皮下制剂 · No verified English nameCXSL2500635 Shanghai Lan Yi Pharmaceuticals Technology Co., Ltd. romanized
2025/07/31New drug · Class 2.2 依达拉奉片 · No verified English nameCXHS2500088 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized
2025/07/31New drug · Class 2.1; 2.2; 2.4 注射用ADB116 · No verified English nameCXHL2500785 Jiangsu Ai Di Pharma Group Co., Ltd. romanized; Nanjing Nan Da Pharma Co., Ltd. romanized
2025/07/31New drug · Class 1 HSK42360-Na散 · No verified English nameCXHL2500784 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2025/07/31New drug · Class 1 HSK42360-Na散 · No verified English nameCXHL2500783 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2025/07/30Import · Class 3.1 注射用塔拉妥单抗 · No verified English nameJXSS2500105 Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd.

63 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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