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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 229 drug applications between 25 March 2023 and 31 March 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 50, covering 36 drug names.

2023/03/25 – 2023/03/31

Period
2023/03/25 to 2023/03/31, 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
229
Drugs with new generic filings (by drug name, de-duplicated)
36
Accepted this week, now under review
2

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

229filings, 50 of them generic

By application type

Application typeFilings
Supplement110
Generic50
New drug30
Import25
Import re-registration7
Unspecified5
Drug-device combination product2

By drug type

Drug typeFilings
Chemical drug173
Therapeutic biologic26
TCM22
Prophylactic biologic8

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

36 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Pranoprofen Eye Drops337
2Sildenafil Citrate Tablets3112
3Diprophylline Injection227
4聚乙二醇钠钾散 · No verified English name223
5Polyvinyl Alcohol Eye Drops2224
6Linaclotide Capsules2113
7Oxcarbazepine Oral Suspension212
8Trimetazidine Dihydrochloride Tablets210
9Ondansetron Hydrochloride Tablets216
10Citicoline Sodium Injection213

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

145 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Eli Lilly and Company610
2Novartis Europharm Limited530
3Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized530
4Shijiazhuang No.4 Pharmaceutical Co., Ltd.533
5Shanghai Luo Shi Pharmaceutical Co., Ltd. romanized520
6Celgene Corporation510
7Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized430
8Chengdu Kang Hua Bio Zhi Pin Co., Ltd. romanized420
9Chongqing Rui En Pharmaceuticals Co., Ltd. romanized420
10Roche Pharma (Schweiz) AG410

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

59 this week

AcceptedDrugApplicants
2023/03/31Import · Class 1 AMG 509 · No verified English nameJXSL2300063 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2023/03/31Import · Class 1 ASP1570片 · No verified English nameJXHL2300074 Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd.
2023/03/31Import · Class 1 ASP1570片 · No verified English nameJXHL2300073 Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd.
2023/03/31Generic · Class 3 Diprophylline InjectionCYHS2300943 Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2023/03/31Generic · Class 3 Diprophylline InjectionCYHS2300942 Anhui Chang Jiang Pharma Co., Ltd. romanized; Anhui Heng Xing Pharmaceutical Co., Ltd. romanized
2023/03/31Generic · Class 3 Pregabalin Oral SolutionCYHS2300936 Beijing Hai Bu Pharmaceuticals Technology Co., Ltd. romanized; Beijing Jiu Long Pharmaceutical Co., Ltd. romanized
2023/03/31Generic · Class 3 Pimavanserin Tartrate CapsulesCYHL2300042 Zhejiang Bai Ao Pharmaceuticals Technology Co., Ltd. romanized
2023/03/31New drug · Class 1.1 芎芍止痛颗粒 · No verified English nameCXZL2300024 Guangdong Kai Zhong Bio Technology Co., Ltd. romanized
2023/03/31New drug · Class 1 SIM1811-03注射液 · No verified English nameCXSL2300223 Jiangsu Xian Sheng Biopharmaceutical Co., Ltd. romanized
2023/03/31New drug · Class 1 SHR8554注射液 · No verified English nameCXHL2300346 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/03/31New drug · Class 1 SHR8554注射液 · No verified English nameCXHL2300345 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/03/31New drug · Class 2.2; 2.4 美洛昔康混悬注射液 · No verified English nameCXHL2300344 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/03/31New drug · Class 1 注射用甲磺酸普依司他 · No verified English nameCXHL2300343 Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized
2023/03/31New drug · Class 1 注射用甲磺酸普依司他 · No verified English nameCXHL2300342 Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized
2023/03/31New drug · Class 1 HS-10516胶囊 · No verified English nameCXHL2300341 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2023/03/31New drug · Class 1 HS-10516胶囊 · No verified English nameCXHL2300340 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2023/03/30Import · Class 1 Iberdomide胶囊 · No verified English nameJXHL2300065 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2023/03/30Import · Class 1 Iberdomide胶囊 · No verified English nameJXHL2300064 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2023/03/30Import · Class 1 Iberdomide胶囊 · No verified English nameJXHL2300063 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2023/03/30Import · Class 1 Iberdomide胶囊 · No verified English nameJXHL2300062 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2023/03/30Import · Class 1 Iberdomide胶囊 · No verified English nameJXHL2300061 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2023/03/30Generic · Class 3 聚乙二醇钠钾散 · No verified English nameCYHS2300934 Ji Chuan Pharma Group Co., Ltd. romanized
2023/03/30Generic · Class 3 Nicergoline TabletsCYHS2300931 Suzhou Te Rui Pharma Co., Ltd. romanized
2023/03/29Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSS2300028 Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2023/03/29Generic · Class 3 Timolol Maleate Eye DropsCYHS2300927 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2023/03/29Generic · Class 3 Isosorbide Mononitrate Extended-Release TabletsCYHS2300926 Lu Nan Pharmaceutical Group Co., Ltd. romanized; Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized
2023/03/29Generic · Class 3 Zoledronic Acid InjectionCYHS2300923 Sichuan Nuo Fei Te Bio Pharma Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2023/03/29New drug · Class 1 BC3402注射液 · No verified English nameCXSL2300222 Wuxi Zhi Kang Hong Yi Bio Technology Co., Ltd. romanized
2023/03/29New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2300221 Hangzhou Yi Wen Sai Bio Technology Co., Ltd. romanized
2023/03/28Import · Class 1.1 重组呼吸道合胞病毒(RSV)疫苗(AS01E 佐剂系统) · No verified English nameJXSL2300062 GlaxoSmithKline Biologicals SA

29 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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