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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 361 drug applications between 17 July 2025 and 23 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 109, covering 79 drug names.

2025/07/17 – 2025/07/23

Period
2025/07/17 to 2025/07/23, 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
361
Drugs with new generic filings (by drug name, de-duplicated)
79
Accepted this week, now under review
83

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

361filings, 109 of them generic

By application type

Application typeFilings
Supplement150
Generic109
New drug57
Import27
Unspecified14
Import re-registration4

By drug type

Drug typeFilings
Chemical drug263
TCM53
Therapeutic biologic28
Prophylactic biologic10
Biologic7

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

79 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dapoxetine Hydrochloride Tablets4220
2Mirogabalin Besilate Tablets4261
3Ruxolitinib Phosphate Tablets3127
4Upadacitinib Sustained-release Tablets2243
5Morinidazole and Sodium Chloride Injection229
6Bumetanide Injection2213
7甘油磷酸钠注射液 · No verified English name227
8维生素B6注射液 · No verified English name2210
9Ilaprazole Enteric-coated Tablets2226
10蔗糖羟基氧化铁咀嚼片 · No verified English name220

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

233 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Beijing Min Hai Bio Technology Co., Ltd. romanized650
2Eli Lilly and Company610
3Ningbo Tian Yi Pharma Technology Co., Ltd. romanized555
4Changchun Hai Wai Pharmaceutical Group Co., Ltd. romanized550
5Henan Zhen Shi Bio Technology Co., Ltd. romanized520
6Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized510
7Revance Therapeutics Inc.440
8Zhu Zhou Qian Jin Pharma Co., Ltd. romanized440
9Guangdong Xiang Shan Tang Pharmaceutical Co., Ltd. romanized430
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

116 this week

AcceptedDrugApplicants
2025/07/23Import · Class 1 Depemokimab注射液 · No verified English nameJXSL2500126 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd.
2025/07/23Import · Class 1 PF-08046054 (注射用冻干粉针) · No verified English nameJXSL2500125 Pfizer Inc.; Pfizer Investment CO. Ltd.
2025/07/23Import · Class 1 BAY 2927088片 · No verified English nameJXHS2500077 Bayer HealthCare Pharmaceuticals Inc.; Bayer AG; Bayer Healthcare Company Ltd.
2025/07/23Import · Class 1 Orforglipron片 · No verified English nameJXHL2500199 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/07/23Import · Class 1 Orforglipron片 · No verified English nameJXHL2500198 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/07/23Import · Class 1 Orforglipron片 · No verified English nameJXHL2500197 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/07/23Import · Class 1 Orforglipron片 · No verified English nameJXHL2500196 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/07/23Import · Class 1 Orforglipron片 · No verified English nameJXHL2500195 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/07/23Import · Class 1 Orforglipron片 · No verified English nameJXHL2500194 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/07/23Import · Class 2.4 LNP023胶囊 · No verified English nameJXHL2500192 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/07/23Import · Class 1 PKN605片 · No verified English nameJXHL2500191 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/07/23Generic · Class 3 复方聚乙二醇3350电解质散 · No verified English nameCYHS2502666 Hong You Pharma (Hainan) Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/07/23Generic · Class 3 Doxycycline Hyclate for InjectionCYHS2502665 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanized
2025/07/23Generic · Class 3 Doxycycline Hyclate for InjectionCYHS2502663 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanized
2025/07/23Generic · Class 3 维生素K1片 · No verified English nameCYHS2502661 Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized
2025/07/23Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2502660 Wuhan Tong Ji Zhong Wei Pharmaceuticals Co., Ltd. romanized; Wuhan Bin Hu Shuang He Pharma Co., Ltd. romanized
2025/07/23Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2502659 Wuhan Tong Ji Zhong Wei Pharmaceuticals Co., Ltd. romanized; Wuhan Bin Hu Shuang He Pharma Co., Ltd. romanized
2025/07/23Generic · Class 3 Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2502656 Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized; Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.
2025/07/23Generic · Class 3 复方聚乙二醇(3350)电解质维C散 · No verified English nameCYHS2502655 Sichuan Kelun Pharmaceutical Co., Ltd.
2025/07/23Generic · Class 3 Sodium Nitroprusside InjectionCYHS2502646 Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2025/07/23New drug · Class 1 脐血单个核细胞注射液 · No verified English nameCXSL2500614 Guangzhou Xi Di Bio Technology Co., Ltd. romanized
2025/07/23New drug · Class 1 SCTB14注射液 · No verified English nameCXSL2500613 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2025/07/23New drug · Class 1 SCTB14注射液 · No verified English nameCXSL2500612 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2025/07/23New drug · Class 1 KC1036片 · No verified English nameCXHL2500741 Beijing Kang Chen Pharma Co., Ltd. romanized
2025/07/23New drug · Class 1 KC1036片 · No verified English nameCXHL2500740 Beijing Kang Chen Pharma Co., Ltd. romanized
2025/07/23New drug · Class 1 HTMC0435片 · No verified English nameCXHL2500739 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2025/07/23New drug · Class 1 HTMC0435片 · No verified English nameCXHL2500738 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2025/07/23New drug · Class 1 HTMC0435片 · No verified English nameCXHL2500737 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2025/07/23New drug · Class 1 HTMC0435片 · No verified English nameCXHL2500736 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2025/07/23New drug · Class 2.2 HL017 · No verified English nameCXHL2500735 Hui Li Pharma (Suzhou) Co., Ltd. romanized

86 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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