YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 273 drug applications between 27 June 2021 and 3 July 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 41, covering 31 drug names.

2021/06/27 – 2021/07/03

Period
2021/06/27 to 2021/07/03, 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
273
Drugs with new generic filings (by drug name, de-duplicated)
31
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

273filings, 41 of them generic

By application type

Application typeFilings
Supplement151
Generic41
New drug41
Import23
Unspecified12
Import re-registration5

By drug type

Drug typeFilings
Chemical drug170
TCM55
Therapeutic biologic43
Prophylactic 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

31 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets3223
2Compound Ipratropium Bromide Solution For Inhalation224
3Clindamycin Injection214
4Ornidazole Injection210
5Epinastine Hydrochloride Tablets212
6Lidocaine Hydrochloride Injection216
7Ropivacaine hydrochloride injection215
8Dabigatran Etexilate Capsules212
9Desmopressin Acetate Injection210
10ω-3 鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液 · 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

145 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhejiang You Sheng Mei Te Zhong Yao Co., Ltd. romanized37340
2Guizhou Liang Ji Pharma Co., Ltd. romanized14140
3Roche Pharma (Schweiz) Ltd.610
4AstraZeneca AB530
5Boehringer Ingelheim International GmbH520
6Mao Xiang Group Jilin Pharmaceutical Co., Ltd. romanized440
7Merck Sharp & Dohme Corp.420
8Pliva Croatia Ltd.420
9Jiangsu Zhang Tai Pharma Co., Ltd. romanized410
10Jiangsu Guang Cheng Pharma Co., Ltd. romanized330

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

77 this week

AcceptedDrugApplicants
2021/07/02Import · Class 3.1 莫格利珠单抗注射液 · No verified English nameJXSS2101015 Kyowa Kirin Co. Ltd.; Toyobo Company Limited Otsu Pharmaceutical Plant
2021/07/02Import · Class 2.2 DS-8201a · No verified English nameJXSL2101064 Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited
2021/07/02Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2101063 Merck Sharp & Dohme Corp.; MSD R&D(China)Co. Ltd.
2021/07/02Import · Class 1 RO7247669注射液 · No verified English nameJXSL2101059 F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd
2021/07/02Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2101380 Beijing Jiu Neng Tian Yuan Technology Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd.
2021/07/02Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2101379 Beijing Jiu Neng Tian Yuan Technology Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd.
2021/07/02New drug · Class 1.2 广金钱草总黄酮胶囊 · No verified English nameCXZS2101003 Wuhan Guang Gu Ren Fu Biopharmaceuticals Co., Ltd. romanized; Wuhan Kang Le Pharma Co., Ltd. romanized
2021/07/02New drug · Class 1 EP-9001A注射液 · No verified English nameCXSL2101166 Chengdu You Luo Bio Technology Co., Ltd. romanized
2021/07/02New drug · Class 2.2 苯甲酸氨氯地平干混悬剂 · No verified English nameCXHL2101258 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2021/07/02New drug · Class 1 AK3280乳膏 · No verified English nameCXHL2101257 Shanghai Ai Ke Bai Fa Biopharmaceuticals Technology Co., Ltd. romanized
2021/07/02New drug · Class 1 AK3280乳膏 · No verified English nameCXHL2101256 Shanghai Ai Ke Bai Fa Biopharmaceuticals Technology Co., Ltd. romanized
2021/07/02New drug · Class 1 AK3280乳膏 · No verified English nameCXHL2101255 Shanghai Ai Ke Bai Fa Biopharmaceuticals Technology Co., Ltd. romanized
2021/07/02New drug · Class 2.2 泊沙康唑干混悬剂 · No verified English nameCXHL2101254 Zhejiang Pu Li Pharma Co., Ltd. romanized
2021/07/02New drug · Class 1 AN0025片 · No verified English nameCXHL2101247 Hangzhou A Nuo Biopharmaceuticals Technology Co., Ltd. romanized
2021/07/01Import · Class 1 MK-1308A注射液 · No verified English nameJXSL2101062 Merck Sharp & Dohme Corp.; MSD R&D(China)Co. Ltd.
2021/07/01Import · Class 3.1 九价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSL2101061 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2021/07/01Import · Class 3.1 九价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSL2101060 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2021/07/01Generic · Class 3 头孢丙烯干混悬剂 · No verified English nameCYHS2101376 Shenzhen Li Jian Pharma Co., Ltd. romanized
2021/07/01Generic · Class 3 Aripiprazole Oral SolutionCYHS2101372 Sichuan Da Zhong Pharmaceutical Co., Ltd. romanized
2021/07/01Generic · Class 3 Fluoxetine Hydrochloride Oral SolutionCYHS2101369 Anhui Xin Shi Ji Pharma Co., Ltd. romanized
2021/07/01New drug · Class 3.4 人凝血因子Ⅷ · No verified English nameCXSS2101006 Hua Run Bo Ya Biopharmaceutical Group Co., Ltd. romanized
2021/07/01New drug · Class 3.3 注射用人高血糖素 · No verified English nameCXSL2101165 Shanghai Duo Mi Rui Bio Technology Co., Ltd. romanized
2021/07/01New drug · Class 2.4 Remimazolam Besylate For InjectionCXHS2101026 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2021/07/01New drug · Class 1 HTMC0503片 · No verified English nameCXHL2101250 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2021/07/01New drug · Class 1 HTMC0503片 · No verified English nameCXHL2101249 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2021/07/01New drug · Class 1 HTMC0503片 · No verified English nameCXHL2101248 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2021/06/30Import · Class 2.2 阿替利珠单抗注射液 · No verified English nameJXSS2101014 Roche Registration GmbH; Roche Diagnostics GmbH; Roche (China) Holding Ltd.
2021/06/30Import · Class 1 RO7030816 · No verified English nameJXSL2101058 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2021/06/30Import · Class 1 RO7030816 · No verified English nameJXSL2101057 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2021/06/30Import · Class 1 avalglucosidase alfa for injection · No verified English nameJXSL2101056 Sanofi-aventis Recherche & Développement; Sanofi (China) investment Co. Ltd

47 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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