YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 59 drug applications between 28 September 2023 and 4 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 11, covering 11 drug names.

2023/09/28 – 2023/10/04

Period
2023/09/28 to 2023/10/04, 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
59
Drugs with new generic filings (by drug name, de-duplicated)
11
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

59filings, 11 of them generic

By application type

Application typeFilings
Supplement35
Generic11
New drug7
Import6

By drug type

Drug typeFilings
Chemical drug34
TCM17
Therapeutic biologic8

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

11 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Acetylcysteine Effervescent Tablets113
2Linagliptin Tablets112
3Carboplatin Injection1110
4Formoterol Fumarate Inhalation Solution115
5布南色林片 · No verified English name110
6Sacubitril Valsartan Sodium Tablets1170
7Roxatidine Acetate Hydrochloride For Injection115
8Venlafaxine Hydrochloride Sustained-Release Capsules110
9Magnesium Sulfate Injection117
10Sodium Bicarbonate Ringer’s Injection111

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

42 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Amgen Inc.420
2Li Shi Zhen Pharmaceuticals Group Co., Ltd. romanized320
3Jiangxi Jiu Hua Pharma Co., Ltd. romanized320
4Fresenius Kabi AB310
5Dong Bao Zi Xing (Hangzhou) Biopharmaceuticals Co., Ltd. romanized310
6Novartis Pharma AG220
7Chengdu Di Kang Pharma Co., Ltd. romanized220
8Xizang Peng Lai Hui Bao Pharmaceuticals Co., Ltd. romanized220
9Shanghai Pharmaceuticals Group Qingdao Guo Feng Pharma Co., Ltd. romanized210
10Zhejiang Cheng Yi Pharma Co., Ltd. romanized210

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

13 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

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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