YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 408 drug applications between 19 April 2023 and 25 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 89, covering 66 drug names.

2023/04/19 – 2023/04/25

Period
2023/04/19 to 2023/04/25, 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
408
Drugs with new generic filings (by drug name, de-duplicated)
66
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

408filings, 89 of them generic

By application type

Application typeFilings
Supplement205
Generic89
New drug66
Import23
Import re-registration16
Unspecified9

By drug type

Drug typeFilings
Chemical drug317
Therapeutic biologic46
TCM38
Prophylactic biologic3
Biologic2
In vitro diagnostic reagent1
Drug-device combination1

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

66 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lactulose Oral Solution3234
2恩那度司他片 · No verified English name310
3Sitagliptin and Metformin Hydrochloride Extended-release Tablets3112
4Diprophylline Injection227
5Pregabalin Oral Solution225
6氧 · No verified English name2215
7Lornoxicam for Injection222
8Isosorbide Dinitrate Injection220
9硫酸特布他林雾化吸入用溶液 · No verified English name221
10Progesterone Injection225

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

236 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Changsha Ai Bei Gao Pharma Co., Ltd. romanized19140
2Heilongjiang Hua Xi Biopharmaceuticals Technology Co., Ltd. romanized990
3Zhejiang Guo Jing Pharma Co., Ltd. romanized920
4Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized830
5Celgene Corporation610
6Yan Tai Chuang He Bio Technology Co., Ltd. romanized610
7Shijiazhuang No.4 Pharmaceutical Co., Ltd.545
8Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized530
9Takeda Pharmaceutical Company Limited520
10Shandong Luo Xin Pharma Group Co., Ltd. romanized520

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

133 this week

AcceptedDrugApplicants
2023/04/25Import · Class 1 Epcoritamab注射用浓溶液 · No verified English nameJXSL2300079 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2023/04/25Import · Class 1 GSK3858279 注射液 · No verified English nameJXSL2300078 GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Company Limited
2023/04/25Import · Class 1 GSK3858279 注射液 · No verified English nameJXSL2300077 GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Company Limited
2023/04/25Import · Class 1 ARV-471(PF-07850327)片 · No verified English nameJXHL2300095 Pfizer Inc; Pfizer Investment CO. Ltd.
2023/04/25Import · Class 1 注射用Nacubactam · No verified English nameJXHL2300094 Meiji Seika Pharma Co. Ltd.; Shanghai Fosun Pharmaceutical Industrial Development Company Limited
2023/04/25Import · Class 1 Vamorolone口服混悬液 · No verified English nameJXHL2300093 Santhera Pharmaceuticals (Switzerland) Ltd; Sperogenix (Shanghai)Med Tech Co. Ltd.
2023/04/25Generic · Class 3 Aztreonam For InjectionCYHS2301158 Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized
2023/04/25Generic · Class 3 Acetylcysteine InjectionCYHS2301154 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/04/25Generic · Class 3 Famotidine InjectionCYHS2301153 Nanjing Feng Kai Si Drug Research and Development Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2023/04/25Generic · Class 3 Methocarbamol InjectionCYHS2301150 Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized
2023/04/25Generic · Class 3 利多卡因丙胺卡因气雾剂 · No verified English nameCYHL2300063 Ze Zheng (Shanghai) Bio Technology Co., Ltd. romanized
2023/04/25New drug · Class 2.1 重组人胰岛素肠溶胶囊 · No verified English nameCXSS2300021 Hefei Tian Hui Bio Technology Co., Ltd. romanized
2023/04/25New drug · Class 1 CG001 · No verified English nameCXSL2300286 Shanghai Kang Jing Biopharmaceuticals Technology Co., Ltd. romanized
2023/04/25New drug · Class 1 注射用DR30206 · No verified English nameCXSL2300285 Zhejiang Dao Er Bio Technology Co., Ltd. romanized
2023/04/25New drug · Class 2.4 硫酸阿托品滴眼液 · No verified English nameCXHS2300047 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2023/04/25New drug · Class 2.2 KEM2102凝胶贴膏 · No verified English nameCXHL2300433 Changsha Jing Yi Pharmaceuticals Technology Co., Ltd. romanized
2023/04/25New drug · Class 2.4 泽布替尼胶囊 · No verified English nameCXHL2300432 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/04/25New drug · Class 2.2 XZ21026 · No verified English nameCXHL2300431 Sichuan Ao Bang Gu De Pharma Co., Ltd. romanized
2023/04/25New drug · Class 1 SPH4336片 · No verified English nameCXHL2300430 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2023/04/25New drug · Class 1 注射用WXTJ0262 · No verified English nameCXHL2300429 CISEN PHARMACEUTICAL CO., LTD.
2023/04/25New drug · Class 1 LP-108片 · No verified English nameCXHL2300428 Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized
2023/04/25New drug · Class 1 LP-108片 · No verified English nameCXHL2300427 Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized
2023/04/25New drug · Class 1 LP-168片 · No verified English nameCXHL2300426 Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized
2023/04/25New drug · Class 1 LP-168片 · No verified English nameCXHL2300425 Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized
2023/04/24Generic · Class 3 复方醋酸钠林格注射液 · No verified English nameCYHS2301149 Chi Feng Yuan Sheng Pharma Co., Ltd. romanized
2023/04/24Generic · Class 3 复方醋酸钠林格注射液 · No verified English nameCYHS2301148 Chi Feng Yuan Sheng Pharma Co., Ltd. romanized
2023/04/24Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2301143 Nan Tong Lian Ya Pharma Co., Ltd. romanized
2023/04/24Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2301142 Nan Tong Lian Ya Pharma Co., Ltd. romanized
2023/04/24Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2301141 Nan Tong Lian Ya Pharma Co., Ltd. romanized
2023/04/24Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2301140 Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized

103 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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