YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 213 drug applications between 19 May 2021 and 25 May 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 27, covering 20 drug names.

2021/05/19 – 2021/05/25

Period
2021/05/19 to 2021/05/25, 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
213
Drugs with new generic filings (by drug name, de-duplicated)
20
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

213filings, 27 of them generic

By application type

Application typeFilings
Supplement123
New drug35
Generic27
Import19
Unspecified5
Import re-registration4

By drug type

Drug typeFilings
Chemical drug162
Therapeutic biologic38
TCM10
Prophylactic biologic2
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

20 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Escitalopram Oxalate Tablets316
2Sodium Valproate Concentrated Solution for Injection220
3Montelukast Sodium Chewable Tablets224
4Potassium Chloride Granules214
5Sugammadex Sodium Injection216
6Atorvastatin Calcium Tablets2124
7Ezetimibe Tablets114
8Linagliptin Tablets112
9Irbesartan Tablets114
10Pimecrolimus Cream115

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

128 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.13130
2Merck Sharp & Dohme B.V.820
3AstraZeneca AB640
4Jiangsu Hao Sen Pharma Group Co., Ltd. romanized630
5Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized610
6Zhejiang You Sheng Mei Te Zhong Yao Co., Ltd. romanized430
7N.V.Organon410
8Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized330
9Bayer AG320
10Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized321

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

57 this week

AcceptedDrugApplicants
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
2021/05/24New drug · Class 1 BGB-15025胶囊 · No verified English nameCXHL2101150 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2021/05/24New drug · Class 2.1; 2.2; 2.4 右美托咪定透皮贴剂 · No verified English nameCXHL2101149 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2021/05/24New drug · Class 1 HS-20094注射液 · No verified English nameCXHL2101148 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/05/24New drug · Class 1 HS-20094注射液 · No verified English nameCXHL2101147 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/05/24New drug · Class 1 HS-20094注射液 · No verified English nameCXHL2101146 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/05/21Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2101029 Merck Sharp & Dohme Corp.; MSD R&D(China)Co. Ltd.
2021/05/21Import · Class 1 PB2452注射液 · No verified English nameJXSL2101028 SFJ Pharmaceuticals Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd
2021/05/21Generic · Class 3 阿普斯特片 · No verified English nameCYHS2101190 Gui Lin Nan Yao Co., Ltd. romanized
2021/05/21New drug · Class 1 注射用DN015089 · No verified English nameCXHL2101140 Shanghai Di Nuo Pharmaceuticals Technology Co., Ltd. romanized
2021/05/20Import · Class 1 泽弗利单抗注射液 · No verified English nameJXSL2101030 Agenus Inc.; Betta Pharmaceuticals Co. Ltd.
2021/05/20Import · Class 1 Capivasertib · No verified English nameJXHL2101051 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2021/05/20Import · Class 1 Capivasertib · No verified English nameJXHL2101050 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2021/05/20Import · Class 2.4 Selumetinib胶囊 · No verified English nameJXHL2101049 AstraZeneca AB; AstraZeneca Investment (China) Co. Limited
2021/05/20Import · Class 2.4 Selumetinib胶囊 · No verified English nameJXHL2101048 AstraZeneca AB; AstraZeneca Investment (China) Co. Limited
2021/05/20Import · Class 2.4 达罗他胺片 · No verified English nameJXHL2101047 Bayer HealthCare Pharmaceuticals Inc.; Bayer Healthcare Company Ltd.
2021/05/20Import · Class 2.4 Tucatinib片 · No verified English nameJXHL2101046 Seagen Inc.; MSD R&D (China) Co. Ltd.
2021/05/20Import · Class 2.4 Tucatinib片 · No verified English nameJXHL2101045 Seagen Inc.; MSD R&D (China) Co. Ltd.
2021/05/20New drug · Class 1.1 参远片 · No verified English nameCXZL2101010 Zhongguo Yi Xue Ke College Yao Yong Zhi Wu Research Institute romanized
2021/05/20New drug · Class 1 HR17031注射液 · No verified English nameCXSL2101090 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized

27 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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