YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 177 drug applications between 26 September 2023 and 2 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 40, covering 30 drug names.

2023/09/26 – 2023/10/02

Period
2023/09/26 to 2023/10/02, 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
177
Drugs with new generic filings (by drug name, de-duplicated)
30
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

177filings, 40 of them generic

By application type

Application typeFilings
Supplement97
Generic40
New drug33
Import7

By drug type

Drug typeFilings
Chemical drug117
TCM32
Therapeutic biologic27
In vitro diagnostic reagent1

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

30 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Minoxidil Liniment6152
2Vonoprazan Fumarate Tablets2160
3Bisoprolol Fumarate Tablets216
4Pregabalin Capsules2112
5Sodium Hyaluronate Eye Drops2130
6Calcitriol Injection210
7Acetylcysteine Effervescent Tablets113
8二甲双胍恩格列净片(Ⅰ) · No verified English name117
9二甲双胍恩格列净片(Ⅵ) · No verified English name114
10Diprophylline Injection117

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

105 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized1040
2Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized810
3Shen Wei Pharma Group Co., Ltd. romanized740
4Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized616
5Amgen Inc.420
6Chengdu Kang Hong Pharma Group Co., Ltd. romanized421
7Sichuan Pharmaceutical Formulations Co., Ltd. romanized410
8Jilin Sheng Shang Cheng Pharma Co., Ltd. romanized330
9Sichuan Zhi Qiang Pharmaceuticals Technology Kai Fa Co., Ltd. romanized330
10Shanghai Pharmaceuticals Group Qingdao Guo Feng Pharma Co., Ltd. romanized320

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

52 this week

AcceptedDrugApplicants
2023/09/29Import · Class 2.4 马立巴韦片 · No verified English nameJXHL2300245 Takeda Pharmaceuticals U.S.A. Inc.; Takeda(China) International
2023/09/29New drug · Class 1 NB002注射液 · No verified English nameCXSL2300663 Suzhou Luo Cheng Biopharmaceuticals Co., Ltd. romanized
2023/09/29New drug · Class 2.2 巯嘌呤微片 · No verified English nameCXHS2300091 Hua Run Shuang He Pharma Co., Ltd. romanized
2023/09/28Import · Class 1 XXB750注射液 · No verified English nameJXSL2300170 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2023/09/28Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2302623 Guangdong Zhong Sheng Pharma Co., Ltd. romanized
2023/09/28Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2302622 Chengdu Hui De Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Bei Ling He Yi Pharmaceutical Co., Ltd. romanized
2023/09/28Generic · Class 3 Sodium Bicarbonate Ringer’s InjectionCYHS2302620 Hebei Tian Cheng Pharma Co., Ltd. romanized
2023/09/28Generic · Class 3 Magnesium Sulfate InjectionCYHS2302618 Hainan Quan Ying Pharma Co., Ltd. romanized; Shanghai Jin Di Jiu Zhou Pharma (An Yang) Co., Ltd. romanized
2023/09/28New drug · Class 2.3 尪痹胶囊 · No verified English nameCXZL2300065 Liaoning Hua Run Ben Xi San Yao Co., Ltd. romanized
2023/09/28New drug · Class 1 CAB-AXL-ADC注射剂 · No verified English nameCXSL2300662 Kai Bo Si (Shanghai) Biopharmaceuticals Co., Ltd. romanized
2023/09/28New drug · Class 1 注射用THDBH120 · No verified English nameCXHL2301040 Dong Bao Zi Xing (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2023/09/28New drug · Class 1 注射用THDBH120 · No verified English nameCXHL2301039 Dong Bao Zi Xing (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2023/09/28New drug · Class 1 注射用THDBH120 · No verified English nameCXHL2301038 Dong Bao Zi Xing (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2023/09/27Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2302613 Jiangsu Jia You Pharma Group Co., Ltd. romanized; Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized
2023/09/27New drug · Class 1 苏帕鲁肽注射液 · No verified English nameCXSS2300085 Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized
2023/09/27New drug · Class 1 苏帕鲁肽注射液 · No verified English nameCXSS2300084 Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized
2023/09/27New drug · Class 1 苏帕鲁肽注射液 · No verified English nameCXSS2300083 Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized
2023/09/27New drug · Class 1 苏帕鲁肽注射液 · No verified English nameCXSS2300082 Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized
2023/09/27New drug · Class 1 苏帕鲁肽注射液 · No verified English nameCXSS2300081 Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized
2023/09/27New drug · Class 1 苏帕鲁肽注射液 · No verified English nameCXSS2300080 Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized
2023/09/27New drug · Class 1 苏帕鲁肽注射液 · No verified English nameCXSS2300079 Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized
2023/09/27New drug · Class 1 苏帕鲁肽注射液 · No verified English nameCXSS2300078 Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized
2023/09/27New drug · Class 1 RJMty19注射液 · No verified English nameCXSL2300661 Zhejiang Rui Jia Mei Bio Technology Co., Ltd. romanized
2023/09/27New drug · Class 1 GC012F注射液 · No verified English nameCXSL2300660 Suzhou Gen Xi Bio Technology Co., Ltd. romanized; Gen Xi Bio Technology (Shanghai) Co., Ltd. romanized
2023/09/27New drug · Class 1 HGI-001注射液 · No verified English nameCXSL2300659 Shenzhen Shi He Mu Ji Yin Bio Technology Co., Ltd. romanized
2023/09/27New drug · Class 2.4 注射用重组A型肉毒毒素 · No verified English nameCXSL2300658 Jun He Meng Biopharmaceutical (Tong Hua) Co., Ltd. romanized
2023/09/27New drug · Class 2.4 脯氨酸恒格列净片 · No verified English nameCXHS2300090 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/09/27New drug · Class 2.4 脯氨酸恒格列净片 · No verified English nameCXHS2300089 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/09/27New drug · Class 1 注射用JMKX003801 · No verified English nameCXHL2301037 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2023/09/26Generic · Class 3 Minoxidil LinimentCYHS2302604 Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized; Jewim Pharmaceutical (Shandong) Co., Ltd.

22 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.