YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 348 drug applications between 27 October 2023 and 2 November 2023 (data as of 14 November 2026 06:00). Of these, generic applications numbered 72, covering 53 drug names.

2023/10/27 – 2023/11/02

Period
2023/10/27 to 2023/11/02, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
348
Drugs with new generic filings (by drug name, de-duplicated)
53
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

348filings, 72 of them generic

By application type

Application typeFilings
Supplement181
Generic72
New drug62
Import re-registration18
Unspecified8
Import7

By drug type

Drug typeFilings
Chemical drug233
TCM67
Therapeutic biologic38
Biologic6
Prophylactic biologic4

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

53 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Piracetam Injection429
2Benidipine Hydrochloride Tablets324
3Minoxidil Liniment3252
4Perindopril tert-Butylamine Tablets315
5Betamethasone Sodium Phosphate Injection215
6Procaterol Hydrochloride Solution for Inhalation212
7Doxofylline Tablets212
8Brivaracetam Tablets2119
9Trifluridine and Tipiracil Hydrochloride Tablets210
10Potassium Chloride Granules214

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

188 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanxi Shuang Yan Pharma Co., Ltd. romanized2890
2Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized21200
3Guangdong Tuan Li Pharmaceutical Co., Ltd. romanized550
4Janssen-Cilag International NV520
5Merck Sharp & Dohme B.V.510
6Haerbin Han Bang Medical Technology Co., Ltd. romanized510
7Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized510
8Wuhan Bin Hu Shuang He Pharma Co., Ltd. romanized510
9Shandong Xin Shi Dai Pharma Co., Ltd. romanized433
10Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized420

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

102 this week

AcceptedDrugApplicants
2023/11/02Import · Class 1 Amlitelimab注射液 · No verified English nameJXSL2300190 Sanofi-Aventis Recherche & Développement; Sanofi(China) Investment Co. LTD
2023/11/02Generic · Class 3 Sodium Bicarbonate InjectionCYHS2302985 Name not romanized; Jiangxi Dong Fu Pharmaceutical Co., Ltd. romanized
2023/11/02Generic · Class 3 Ferrous Succinate TabletsCYHS2302983 Jiangsu Zhong Tian Pharma Co., Ltd. romanized
2023/11/02Generic · Class 3 Methocarbamol InjectionCYHS2302977 Jiangsu Shen Long Pharma Co., Ltd. romanized
2023/11/02Generic · Class 3 Acetylcysteine InjectionCYHS2302976 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/11/02Generic · Class 3 Minoxidil LinimentCYHS2302974 Le Tai Pharma Co., Ltd. romanized; Le Tai Pharma (Lan Xi) Co., Ltd. romanized
2023/11/02Generic · Class 3 Minoxidil LinimentCYHS2302973 Le Tai Pharma Co., Ltd. romanized; Le Tai Pharma (Lan Xi) Co., Ltd. romanized
2023/11/02Generic · Class 3 Minoxidil LinimentCYHS2302972 Le Xin Le Mei (Hainan) Bio Technology Co., Ltd. romanized; Su Zhou Yi Fan Pharma Co., Ltd. romanized
2023/11/02Generic · Class 3 Brivaracetam TabletsCYHL2300134 Chengdu Ao Bang Pharma Co., Ltd. romanized
2023/11/02Generic · Class 3 Brivaracetam TabletsCYHL2300133 Chengdu Ao Bang Pharma Co., Ltd. romanized
2023/11/02New drug · Class 3.1 温经汤颗粒 · No verified English nameCXZS2300022 Guo Yao Group De Zhong (Fo Shan) Pharma Co., Ltd. romanized
2023/11/02New drug · Class 1.1 莎毕娅片 · No verified English nameCXZL2300068 Zhongguo Ke College Xinjiang Li Hua Technology Research Institute romanized
2023/11/02New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2300754 Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized
2023/11/02New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2300753 Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized
2023/11/02New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2300752 Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized
2023/11/02New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2300751 Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized
2023/11/02New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2300750 Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized
2023/11/02New drug · Class 1 AK117注射液 · No verified English nameCXSL2300749 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2023/11/02New drug · Class 1 F008 · No verified English nameCXSL2300748 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2023/11/02New drug · Class 2.2; 2.4 醋酸阿比特龙片(Ⅰ) · No verified English nameCXHL2301208 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/11/02New drug · Class 1 XH-S004片 · No verified English nameCXHL2301206 Zhejiang Xing Hao Peng Bo Pharmaceuticals Co., Ltd. romanized
2023/11/01Generic · Class 3 Metaraminol Tartrate InjectionCYHS2302971 Hong He Pharmaceutical Co., Ltd. romanized; Jilin Zhen Ao Pharmaceutical Co., Ltd. romanized
2023/11/01Generic · Class 3 Potassium Chloride GranulesCYHS2302961 Hebei Hua Chen Pharma Group Co., Ltd. romanized
2023/11/01Generic · Class 3 Potassium Chloride GranulesCYHS2302960 Hebei Hua Chen Pharma Group Co., Ltd. romanized
2023/11/01Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2302959 Sichuan Xin Si Dun Pharmaceutical Co., Ltd. romanized
2023/11/01Generic · Class 3 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2300132 Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanized
2023/11/01New drug · Class 1.1 松针正脑颗粒 · No verified English nameCXZL2300067 Shenzhen Li Fu Bio Technology Co., Ltd. romanized
2023/11/01New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2300747 Shenzhen Shi Yin Guan Bio Technology Co., Ltd. romanized
2023/11/01New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2300746 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/11/01New drug · Class 1 GRK-008片 · No verified English nameCXHL2301205 Hui An Kai (Xiamen) Pharmaceuticals Technology Co., Ltd. romanized; Quan Zhou Hai Chuang Pharmaceuticals Technology Co., Ltd. romanized; Suzhou Ge Lan Ke Pharmaceuticals Technology Co., Ltd. romanized

72 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.