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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 359 drug applications between 16 July 2025 and 22 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 112, covering 85 drug names.

2025/07/16 – 2025/07/22

Period
2025/07/16 to 2025/07/22, 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
359
Drugs with new generic filings (by drug name, de-duplicated)
85
Accepted this week, now under review
82

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

359filings, 112 of them generic

By application type

Application typeFilings
Supplement155
Generic112
New drug55
Import17
Unspecified10
Import re-registration10

By drug type

Drug typeFilings
Chemical drug254
TCM58
Therapeutic biologic30
Prophylactic biologic12
Biologic5

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

85 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Metformin Hydrochloride And Empagliflozin Extended Release Tablets3112
2Ruxolitinib Phosphate Tablets3127
3Upadacitinib Sustained-release Tablets2243
4Acetylcysteine Injection2253
5Crisaborole Ointment2226
6Morinidazole and Sodium Chloride Injection229
7Bumetanide Injection2213
8瑞维那新吸入溶液 · No verified English name2253
9甘油磷酸钠注射液 · No verified English name227
10维生素B6注射液 · No verified English name2210

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

227 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangxi Qing Feng Pharma Co., Ltd. romanized880
2Beijing Min Hai Bio Technology Co., Ltd. romanized650
3Bracco Imaging S.P.A.610
4Ningbo Tian Yi Pharma Technology Co., Ltd. romanized555
5Changchun Hai Wai Pharmaceutical Group Co., Ltd. romanized550
6Hainan Sai Li Ke Pharma Co., Ltd. romanized535
7Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized510
8Revance Therapeutics Inc.440
9Zhu Zhou Qian Jin Pharma Co., Ltd. romanized440
10Bristol-Myers Squibb Company420

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

108 this week

AcceptedDrugApplicants
2025/07/22Import · Class 1 BMS-986340注射液 · No verified English nameJXSL2500124 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/07/22Import · Class 2.2 特泽利尤单抗注射液 · No verified English nameJXSL2500123 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/07/22Generic · Class 3 Ibuprofen TabletsCYHS2502645 Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized
2025/07/22Generic · Class 3 Dienogest TabletsCYHS2502632 Shanghai Hui Lun Pharmaceuticals Co., Ltd. romanized; Nanjing Bai Jing Yu Pharmaceutical Co., Ltd. romanized
2025/07/22Generic · Class 3 Doxofylline TabletsCYHS2502629 Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2025/07/22Generic · Class 3 Doxofylline TabletsCYHS2502627 Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2025/07/22Generic · Class 3 Bumetanide InjectionCYHS2502623 Jiangsu Ming Yuan Pharma Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2025/07/22Generic · Class 3 辅酶Q10片 · No verified English nameCYHS2502621 Ta He Shi Hui Chuang Pharmaceuticals Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized
2025/07/22Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2502619 Hangzhou Minsheng Pharmaceutical Co., Ltd
2025/07/22Generic · Class 3 Nebivolol TabletsCYHL2500131 Zhejiang Hua Yuan Pharma Co., Ltd. romanized
2025/07/22New drug · Class 1 RC148注射液 · No verified English nameCXSL2500610 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2025/07/22New drug · Class 1 注射用RC118 · No verified English nameCXSL2500609 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2025/07/21New drug · Class 1.1 重组金黄色葡萄球菌四组分疫苗(大肠杆菌) · No verified English nameCXSL2500611 Jiangsu Kun Li Biopharmaceutical Co., Ltd. romanized
2025/07/21New drug · Class 3.2 三价流感病毒裂解疫苗(BK-01佐剂) · No verified English nameCXSL2500608 Changchun Bai Ke Bio Technology Shareholding Company romanized
2025/07/21New drug · Class 1 CMS-D002胶囊 · No verified English nameCXHL2500728 Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized
2025/07/21New drug · Class 1 CMS-D002胶囊 · No verified English nameCXHL2500727 Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized
2025/07/19Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2502610 Shandong Hua Mao Pharma Co., Ltd. romanized
2025/07/19Generic · Class 3 吲哚美辛凝胶贴膏 · No verified English nameCYHL2500130 Hainan Hui Yuan Tang Pharma Co., Ltd. romanized
2025/07/19New drug · Class 2.2 AKZ001直服颗粒 · No verified English nameCXHL2500726 Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2025/07/19New drug · Class 1 CKBA乳膏 · No verified English nameCXHL2500725 Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized
2025/07/19New drug · Class 1 CKBA乳膏 · No verified English nameCXHL2500724 Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized
2025/07/19New drug · Class 1 CKBA乳膏 · No verified English nameCXHL2500723 Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized
2025/07/19New drug · Class 1 CKBA乳膏 · No verified English nameCXHL2500722 Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized
2025/07/19New drug · Class 1 CKBA乳膏 · No verified English nameCXHL2500721 Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized
2025/07/19New drug · Class 1 YUQ-A1007片 · No verified English nameCXHL2500720 Yuan Qi (Suzhou) Biopharmaceutical Co., Ltd. romanized
2025/07/19New drug · Class 1 YUQ-A1007片 · No verified English nameCXHL2500719 Yuan Qi (Suzhou) Biopharmaceutical Co., Ltd. romanized
2025/07/18Import · Class 1 BMS-986504片 · No verified English nameJXHL2500189 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2025/07/18Import · Class 1 BMS-986504片 · No verified English nameJXHL2500188 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2025/07/18Import · Class 1 BMS-986504片 · No verified English nameJXHL2500187 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2025/07/18Generic · Class 3 碳酸氢钠血滤置换液(无钾、无钙、0.6 mmol/L镁) · No verified English nameCYHS2502596 Ningbo Tian Yi Pharma Technology Co., Ltd. romanized

78 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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