YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 220 drug applications between 20 May 2021 and 26 May 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 35, covering 27 drug names.

2021/05/20 – 2021/05/26

Period
2021/05/20 to 2021/05/26, 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
220
Drugs with new generic filings (by drug name, de-duplicated)
27
Accepted this week, now under review
0

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

220filings, 35 of them generic

By application type

Application typeFilings
Supplement121
Generic35
New drug27
Import24
Import re-registration9
Unspecified4

By drug type

Drug typeFilings
Chemical drug180
Therapeutic biologic30
TCM8
Biologic1
Prophylactic biologic1

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

27 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Escitalopram Oxalate Tablets316
2Olanzapine Orally Disintegrating Tablets210
3Ornidazole Injection210
4Potassium Chloride Granules214
5Metoprolol Succinate Sustained-release Tablets214
6Sugammadex Sodium Injection216
7Atorvastatin Calcium Tablets2124
8Sodium Valproate Concentrated Solution for Injection110
9Ezetimibe Tablets114
10依折麦布瑞舒伐他汀钙片(III) · No verified English name110

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

118 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.13130
2Merck Sharp & Dohme B.V.1020
3AstraZeneca AB640
4Jiangsu Hao Sen Pharma Group Co., Ltd. romanized630
5Janssen-Cilag International NV610
6Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized610
7Takeda Development Center Americas Inc.520
8Zhejiang You Sheng Mei Te Zhong Yao Co., Ltd. romanized430
9YaoPharma Co., Ltd.420
10N.V.Organon410

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

58 this week

AcceptedDrugApplicants
2021/05/26Import · Class 1 BRII-179 (VBI-2601) 注射液 · No verified English nameJXSL2101034 Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited
2021/05/26Import · Class 2.4 INC280 · No verified English nameJXHL2101058 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2021/05/26Import · Class 2.4 INC280 · No verified English nameJXHL2101057 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2021/05/26Import · Class 2.4 Ponatinib TabletsJXHL2101056 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd
2021/05/26Import · Class 2.4 Ponatinib TabletsJXHL2101055 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd
2021/05/26Import · Class 2.4 Ponatinib TabletsJXHL2101054 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd
2021/05/26Import · Class 2.4 泊那替尼胶囊 · No verified English nameJXHL2101053 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd
2021/05/26Import · Class 2.4 泊那替尼胶囊 · No verified English nameJXHL2101052 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd
2021/05/26Generic · Class 3 Ornidazole InjectionCYHS2101202 Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2021/05/26Generic · Class 3 Ornidazole InjectionCYHS2101201 Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2021/05/26Generic · Class 3 Levofloxacin InjectionCYHS2101196 Tai Zhou Zhen He Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2021/05/26Generic · Class 3 Chloral Hydrate SuppositoriesCYHL2101012 Shandong Da Yin Hai Yang Biopharmaceutical Co., Ltd. romanized
2021/05/26Generic · Class 3 依折麦布瑞舒伐他汀钙片(III) · No verified English nameCYHL2101011 Beijing Han Mei Medicines Co., Ltd. romanized
2021/05/26Generic · Class 3 依折麦布瑞舒伐他汀钙片(II) · No verified English nameCYHL2101010 Beijing Han Mei Medicines Co., Ltd. romanized
2021/05/26Generic · Class 3 依折麦布瑞舒伐他汀钙片(I) · No verified English nameCYHL2101009 Beijing Han Mei Medicines Co., Ltd. romanized
2021/05/26New drug · Class 1 AK109注射液 · No verified English nameCXSL2101093 Kang Rong Dong Fang (Guangdong) Pharmaceuticals Co., Ltd. romanized
2021/05/26New drug · Class 1 注射用HRS9432 · No verified English nameCXHL2101157 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2021/05/26New drug · Class 1 GFH925片 · No verified English nameCXHL2101156 Zhejiang Jin Fang Pharma Co., Ltd. romanized
2021/05/26New drug · Class 1 GFH925片 · No verified English nameCXHL2101155 Zhejiang Jin Fang Pharma Co., Ltd. romanized
2021/05/25Generic · Class 3 Potassium Chloride GranulesCYHS2101210 Hua Nuo Pharmaceuticals (Guangzhou) Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized
2021/05/25Generic · Class 3 Potassium Chloride GranulesCYHS2101209 Hua Nuo Pharmaceuticals (Guangzhou) Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized
2021/05/25Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2101206 Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2021/05/25New drug · Class 3.4 乙型肝炎人免疫球蛋白 · No verified English nameCXSS2101003 Hua Lan Bio Gong Cheng Chongqing Co., Ltd. romanized
2021/05/25New drug · Class 1 TNM001注射液 · No verified English nameCXSL2101096 Zhuhai Tai Nuo Mai Bo Bio Technology Co., Ltd. romanized
2021/05/25New drug · Class 2.4 盐酸米托蒽醌脂质体注射液 · No verified English nameCXHL2101145 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.
2021/05/24Import · Class 3.1 Fremanezumab注射液 · No verified English nameJXSL2101031 TEVA GmbH; Teva Pharmaceutical Information Consulting (Shanghai) Co. Ltd.
2021/05/24Generic · Class 3 Ambroxol Hydrochloride Oral SolutionCYHS2101195 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2021/05/24New drug · Class 1 AK104注射液 · No verified English nameCXSL2101092 Kang Fang Pharma Co., Ltd. romanized
2021/05/24New drug · Class 1 BGB-15025胶囊 · No verified English nameCXHL2101152 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2021/05/24New drug · Class 1 BGB-15025胶囊 · No verified English nameCXHL2101151 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized

28 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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